Health Studies MN

Within 


Search Results

Here are the studies that match your search criteria. If you are interested in participating, please reach out to the contact listed for the study. If no contact is listed, contact us and we'll help you find the right person.

596 Study Matches

Sorting by: Relevance Distance

MC1986 Phase I/Ib Study of Parsaclisib (INCB050465), Rituximab, Cyclophosphamide, Doxorubicin, Vincristine and Prednisone (Par-CHOP) Immunochemotherapy for Patients with Newly Diagnosed High Risk Diffuse Large B-Cell Lymphoma

A Study to Evaluate Parsaclisib (INCB050465), Rituximab, Cyclophosphamide, Doxorubicin, Vincristine And Prednisone (Par-CHOP) Immunochemotherapy for Patients with Newly Diagnosed High Risk Diffuse Large B-Cell Lymphoma

Yucai Wang
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-100961-P01-RST
19-005387
Show full eligibility criteria
Hide eligibility criteria

Registration

Inclusion Criteria:

  • Age ≥ 18 years old.
  • Newly diagnosed, untreated, histologically confirmed diffuse large B-cell lymphoma expressing the CD20 antigen, with ANY of the following:
    • Non-GCB subtype by Hans algorithm
    • Myc expression ≥40% by IHC
    • Bcl-2 expression ≥50% by IHC
    • Myc expression ≥40% AND Bcl-2 expression ≥50% by IHC (double expressor)
    • MYC rearrangement by FISH
  • Or high-grade B-cell lymphoma MYC with MYC rearrangement AND BCL2 and/or BCL6 rearrangement (double-hit or triple-hit lymphoma) but not a candidate for more aggressive chemotherapy (such as CODOX-M-IVAC)
    • NOTE: Patients with a new diagnosis of concurrent DLBCL and an indolent lymphoma (previously undiagnosed, such as follicular lymphoma or marginal zone lymphoma) are eligible. However, patients with a known prior diagnosis of indolent lymphoma with new transformation to DLBCL (i.e., transformed lymphoma) are not eligible.
  • Ann Arbor Stages II (bulky disease; i.e., ≥ 5 cm, or not a candidate for combined modality treatment with R-CHOP plus radiotherapy), III, or IV (See Appendix I for Ann Arbor Staging).
  • Measurable disease (at least 1 lesion of ≥ 1.5 cm in one diameter) as detected by CT or the CT images of PET/CT. Skins lesions can be used if the area is ≥ 2 cm in at least one diameter and photographed with a ruler.
  • ECOG Performance Status (PS) 0, 1 or 2.
  • The following laboratory values obtained ≤14 days prior to registration:
    • Absolute neutrophil count (ANC) ≥1500/mm^3;
    • Platelet count 100,000/mm^3;
    • Total bilirubin ≤ 1.5 upper limit of normal (ULN), or if total bilirubin is > 1.5 ULN, the direct bilirubin must be normal;
    • Aspartate transaminase (AST) 3 ULN (≤ 5 ULN for patients with direct liver involvement by lymphoma);
    • Alkaline phosphatase ≤ 3 ULN, unless evidence of the direct liver involvement by lymphoma, then ≤ 5 ULN;
    • Calculated creatinine clearance of ≥ 30 mL/min using the Cockcroft-Gault formula below:
      • Creatinine clear for males =     (140
        •age) x weight in Kg
                                                     72 x serum creatinine in mg/dL

      • Creatinine clear for females = (140
        •age) x weight in Kg x 0.85
                                                        72 x serum creatinine in mg/dL

 

  • Negative urine pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only.
    • NOTE: If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Persons of childbearing potential must agree to use one reliable form of birth control.
  • Provide written informed consent.
  • Willingness to provide mandatory research blood specimens for banking.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).

Registration
•Exclusion Criteria

  • Any of the following because this study involves an investigational agent whose genotoxic, mutagenic and teratogenic effects on the developing fetus and newborn are unknown:
    • Pregnant persons;
    • Nursing persons (lactating persons are eligibile provided that they aree not to breast feel while taking parscaclisib);
    • Persons of childbearing potential who are unwilling to employ adequate contraception.
  • Primary CNS lymphoma, or parenchymal, meningeal or cerebrospinal fluid involvement with malignant lymphoma cells.
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens.
  • Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy (except for patients on effective antiretroviral therapy with undetectable viral load within 6 months).
    • NOTE: If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated.
    • NOTE: If history of hepatitis C virus (HCV) infection, HCV viral load must be undetectable.
  • Uncontrolled intercurrent illness including, but not limited to:
    • ongoing or active infection;
    • symptomatic congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias;
    • unstable angina pectoris;
    • cardiac arrhythmia;
    • ongoing inflammatory bowel disease (such as ulcerative colitis) or other colitis requiring active treatment;
    • oxygen dependent baseline lung disease (such as interstitial lung disease or COPD);
    • or psychiatric illness/social situations that would limit compliance with study requirements.
  • Received or receiving any other agent which would be considered as a treatment for the lymphoma (with the exception of corticosteroid).
  • Other active malignancy requiring therapy such as radiation, chemotherapy or immunotherapy. Patients on hormonal therapy for treated breast or prostate cancer are permitted if they meet other eligibility criteria.
    • EXCEPTIONS: Localized non-melanotic skin cancer or any cancer that in the judgment of the investigator has been treated with curative intent (e.g., disease-free survival equal or more than 5 years) and will not interfere with the study treatment plan and response assessment.
    • NOTE: If there is a history of prior malignancy, they must not require therapy such as radiation, chemotherapy or immunotherapy for their cancer.
  • History of myocardial infarction ≤ 6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
  • ≥ 25% of bone marrow radiated for other diseases.
  • Ejection fraction of < 45% by either MUGA or ECHO.
Drug
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

AHEP1531, Pediatric Hepatic Malignancy International Therapeutic Trial (PHITT) (PHITT, AHEP1531)

A Study to Assess Cisplatin and Combination Chemotherapy in Treating Children and Young Adults with Hepatoblastoma or Liver Cancer After Surgery

Carola Arndt
All
up to 30 years old
Phase 2/3
This study is NOT accepting healthy volunteers
0000-100965-P01-RST
19-003163
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:
 

All clinical and laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated. Laboratory values used to assess eligibility must be no older than seven (7)  days at the start of therapy.

Laboratory tests need not be repeated if therapy starts within seven (7) days of obtaining labs to assess eligibility. Exception: repeat AFP MUST be sent within 48 hours prior to starting chemotherapy and  preferably on the same day that chemotherapy starts. However, the AFP result is NOT required prior to starting therapy.

If a post-enrollment lab value is outside the limits of eligibility, or laboratory values are > 7 days old, then the following laboratory evaluations must be re-checked within 48 hours prior to initiating therapy:

  • CBC with differential, bilirubin, ALT (SGPT) and serum creatinine. If the recheck is outside the limits of eligibility, the patient may not receive protocol therapy and will be considered off protocol therapy.  Imaging studies, if applicable, must be obtained within 2 weeks prior to start of  protocol therapy (repeat the tumor imaging if necessary). For patients with upfront resection, imaging must be obtained within 28 days prior to the start of therapy (repeat tumor imaging if necessary).
  • Patients must be ≤ 30 years of age at the time of diagnosis.
  • Patients in Group F must have a Body Surface Area (BSA) ≥ 0.6 m2.
  • Patients must have a performance status corresponding to ECOG scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age.
  • Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score.
  • Patients must be newly diagnosed with histologically-proven primary pediatric hepatic malignancies including hepatoblastoma or hepatocellular carcinoma.
  • Patients with a diagnosis of hepatocellular neoplasm, not otherwise specified, should be classified and treated per hepatoblastoma treatment arms.
    • Please note: All patients with histology as assessed by the institutional pathologist consistent with pure small cell undifferentiated (SCU) HB will be required to have testing for INI1/SMARCB1 by IHC according to  the practices at the institution.
  • Patients with histology consistent with pure SCU must have positive INI1/SMARCB1 staining.
  • In emergency situations when a patient meets all other eligibility criteria and has had baseline required observations, but is too ill to undergo a biopsy safely, the patient may be enrolled without a biopsy.  Clinical situations in which emergent treatment may be indicated include, but are not limited to, the following circumstances:
    • Anatomic or mechanical compromise of critical organ function by tumor (e.g., respiratory distress/failure, abdominal compartment syndrome, urinary obstruction, etc.).
    • Uncorrectable coagulopathy.  For a patient to maintain eligibility for AHEP1531 when emergent treatment is given, the following must occur:
      • The patient must have a clinical diagnosis of hepatoblastoma, including an elevated alphafetoprotein (AFP), and must meet all AHEP1531 eligibility criteria at the time of emergent treatment.
      • Patient must be enrolled on AHEP1531 prior to initiating protocol therapy.
  • A patient will be ineligible if any chemotherapy is administered prior to AHEP1531 enrollment.
    • Note: If the patient receives AHEP1531 chemotherapy emergently PRIOR to undergoing a diagnostic biopsy, pathologic review of material obtained in the future during either biopsy or surgical resection must either confirm the diagnosis of hepatoblastoma or not reveal another pathological diagnosis to be included in the analysis of the study aims.
  • Patients may have had surgical resection of the hepatic malignancy prior to enrollment. All other anti-cancer therapy for the current liver lesion is prohibited.
  • Adequate renal function for patients receiving chemotherapy (Groups A2, B, C, D, E2, F), defined as:
    • Creatinine clearance or radioisotope GFR ≥ 60 mL/min/1.73 m2 or a serum creatinine based on age/gender as follows:
      • 1 month to < 6 months | Male 0.4 | Female 0.4
      • 6 months to < 1 year | Male 0.5 | Female 0.5
      • 1 to < 2 years | Male 0.6 | Female 0.6
      • 2 to < 6 years | Male 0.8 | Female 0.8
      • 6 to < 10 years | Male 1.0 | Female 1.0
      • 10 to < 13 years | Male 1.2 | Female 1.2
      • 13 to < 16 years | Male 1.5 | Female 1.4
      • ≥ 16 years | Male 1.7 | Female 1.4
    • The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR utilizing child length and stature data published by the CDC.

  • Adequate liver function defined as:
    • Total bilirubin ≤ 5 x upper limit of normal (ULN) for age; and
    • SGOT (AST) or SGPT (ALT) < 10 x upper limit of normal (ULN) for age.
  • Adequate cardiac function for patients on doxorubicin-containing regimens (Groups C, D, E2, and F), which must be assessed within 8 weeks prior to study enrollment, is defined as:
    • Shortening fraction of ≥ 28% by echocardiogram; or
    • Ejection fraction of ≥ 47% by echocardiogram or radionuclide angiogram;
    • Group F patients only: QT/QTc interval ≤ 450 milliseconds for males and ≤ 470 milliseconds for females.
  • Adequate pulmonary function for patients receiving chemotherapy (Groups A2, B, C, D, E2, F), defined as:
    • Normal pulmonary function tests (including DLCO) if there is clinical indication for determination (e.g., dyspnea at rest, known requirement for supplemental oxygen).
  • For patients who do not have respiratory symptoms or requirement for supplemental oxygen, PFTs are NOT required.


Exclusion Criteria:

  • Prior chemotherapy or tumor directed therapy (i.e., radiation therapy, biologic agents, local therapy (embolization, radiofrequency ablation, and laser); therefore, patients with a pre-disposition syndrome who have a prior malignancy are not eligible.
  • Patients who are currently receiving another investigational drug.
  • Patients who are currently receiving other anticancer agents.
  • Patients with uncontrolled infection.
  • Patients who previously received a solid organ transplant, other than those who previously received an orthotopic liver transplantation (OLT) as primary treatment of their hepatocellular carcinoma.
  • Patients with hypersensitivity to any drugs on their expected treatment arm.
  • Treatment Group specific exclusion criteria:
  • Group C:
    • Patients who have known deficiency of dihydropyrimidine dehydrogenase (DPD).
  • Group D:
    • Patients with chronic inflammatory bowel disease and/or bowel obstruction.
    • Patients with concomitant use of St. John’s wort, which cannot be stopped prior to the start of trial treatment.
  • Group F:
    • Patients with peripheral sensitive neuropathy with functional impairment.
    • Patients with a personal or family history of congenital long QT syndrome.
  • Pregnancy and Breast Feeding
    •These criteria apply ONLY to patients who will receive chemotherapy (all groups other than Groups A1 and E1).
  • Female patients who are pregnant, since fetal toxicities and teratogenic effects have been noted for several of the study drugs.
  • A pregnancy test is required for female patients of childbearing potential.
  • Lactating females who plan to breastfeed their infants.
  • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation.
  • Note for Group F:
    • Patients of childbearing potential should use effective birth control during treatment with sorafenib and for at least 2 weeks after stopping treatment.
Drug, Other, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Excision of tumor of liver
Cancer, Hepatocellular carcinoma, Liver cancer
1,2-Diaminocyclohexaneplatinum II citrate, Cancer treatment, Carboplatin, Chemotherapy, Digestive system, Doxorubicin, Etoposide, Fluorouracil [USAN:USP:INN:BAN:JAN], Gemcitabine [USAN:INN:BAN], Hepatoblastoma, Irinotecan [INN:BAN], Liver cell carcinoma, Medical Oncology, Oxaliplatin, Sorafenib, Vincristine, carboplatin, cisplatin, doxorubicin, etoposide, fluorouracil, gemcitabine, irinotecan, oxaliplatin, sorafenib, vincristine, Liver resection
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

D9103C00001, A Phase III, Randomized, Placebo-controlled, Double-blind, Multi-center, International Study of Durvalumab Following Stereotactic Body Radiation Therapy (SBRT) for the Treatment of Patients With Unresected Stage I/II, Lymph-node Negative Non-small Cell Lung Cancer (PACIFIC-4/RTOG-3515) (PACIFIC-4)

A Study to Compare Durvalumab vs Placebo Following Stereotactic Body Radiation Therapy in Early Stage Non-small Cell Lung Cancer Patients

Kenneth Merrell
All
18 years to 130 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-100970-P01-RST
19-004874
Show full eligibility criteria
Hide eligibility criteria

Patients are eligible to be included in the study only if all of the following inclusion criteria and none of the exclusion criteria apply. 
Informed consent

1. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
2. Provision of signed and dated written ICF prior to any mandatory study specific procedures, sampling, and analyses
3. Genetics research study (optional) For inclusion in the optional (DNA) genetics research study, patients must fulfil the following criteria:
− Provide informed consent for the optional genetic sampling and analyses. If a patient declines to participate in the optional genetics research, there will be no penalty or loss of benefit to the patient. A patient who declines optional genetics research participation will not be excluded from any other aspect of the main study.
Note: The optional genetic research study is not conducted in China.
Age
4. Age ≥18 years at the time of screening. For patients aged <20 years and enrolled in Japan, a written informed consent should be obtained from the patient and his or her legally acceptable representative.
Type of patient and disease characteristics
5. Histologically or cytologically documented Stage I to II NSCLC (American Joint Committee on Cancer Stage [AJCC Cancer Staging Manual, Eighth Edition], with clinical Stage I/II lymph node-negative (T1 to T3N0M0) disease and planned to receive definitive treatment with SBRT. In order to be eligible for this trial, patients
should be:
Medically inoperable as determined by physician or
Medically operable with patient refusal of surgery
Patients with medically operable disease who choose to have SBRT are also eligible.
6. Planned SoC SBRT as definitive treatment (see Appendix H) using one of the following doses:
For peripheral tumors: 54 Gy total dose delivered in 3 fractions, 42 or 48 Gy total dose delivered in 4 fractions, or 50 or 55 Gy total dose delivered in 5 fractions.
For central tumors: 50 or 55 Gy total dose delivered in 5 fractions, or 50 or 60 Gy total dose delivered in 8 fractions.
7. World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) PS of 0, 1, or 2 at enrollment and randomization
8. Tumor sample requirements:
- Provision of archived tumor tissue block or slides (6 newly cut unstained slides is strongly encouraged) ≤6 months old.
If an archival sample is not available, provision of a recent (≤3 months) tumor biopsy is encouraged, provided that a biopsy procedure is technically feasible, and the procedure is not associated with unacceptable clinical risk.
If archival tumor tissue block, slides are unavailable, cell blocks or slides from fine needle aspirate (FNA) samples ≤6 months old will be accepted.
In situation when tissue from initial biopsy is exhausted, rebiopsy is encouraged but not mandatory for enrolling onto study if biopsy is associated with unacceptable clinical risk
- For China: Only tumor slides (sectioned from biopsy or FNA cell blocks) should be provided.
9. Patients with central or peripheral lesions are eligible. Central lesions are defined as tumor within or touching the zone of the proximal bronchial tree, defined as a volume of 2 cm in all directions around the proximal bronchial tree (carina, right and left main bronchi, right and left upper lobe bronchi, intermedius bronchus, right middle lobe bronchus, lingular bronchus right, and left lower lobe bronchi). Patients with Ultra-central tumors are NOT eligible. Ultra-central tumors are defined as tumors abutting the trachea, mainstem bronchus, or esophagus.
10. Patients with a history of metachronus stage I/II (T1-T3N0M0) NSCLC treated definitively with surgery only or SBRT only >1 year prior to enrollment are eligible. Patients with a previous history of SBRT to the lung are eligible provided additional radiation is deemed safe by the treating radiation oncologist and after consultation with the Study Physician/International Coordinating Investigator. Patients with synchronous NSCLC tumors are allowed when there is maximum of 2 intrathoracic lesions. Each lesion will be staged separately according to TNM system and identified in CRF. Please see section 5.3. Lesions must be treated with the same dose/fraction to each lesion and meet the Organ at Risk constraints identified in the study protocol.
11. Adequate organ and marrow function as defined below prior to randomization:
Hemoglobin ≥9.0 g/dL
Absolute neutrophil count ≥1.0 × 109/L
Platelet count ≥75 × 109/L
Serum bilirubin ≤1.5 × the upper limit of normal (ULN). This will not apply to patients with confirmed Gilbert’s syndrome, who will be allowed in consultation with their physician.
ALT and AST ≤2.5 × ULN within 2 weeks prior to randomization
Measured creatinine clearance (CL) >30 mL/min or calculated CL >30 mL/min as determined by Cockcroft-Gault (using actual body weight)
Males
Creatinine CL (mL/min) =         Weight (kg) × (140
•Age)  /  72 × serum creatinine (mg/dL)
Females:
Creatinine CL (mL/min) = Weight (kg) × (140
•Age) / 72 × serum creatinine (mg/dL) x0.85
12. Must have a life expectancy of at least 12 weeks
13. The following staging studies must be done within 10 weeks before randomization:
Positron emission tomography (PET)/CT scan from at least the base of the skull to mid-thigh is required for staging purposes. If PET scan not previously performed, may be performed during screening to ensure adequate clinical staging.
Patients with hilar or mediastinal lymph nodes ≤1 cm and no abnormal hilar or mediastinal uptake on PET will be considered N0. Mediastinal lymph node sampling by any technique is allowed but not required. Patients with >1 cm hilar or mediastinal lymph nodes on CT or abnormal PET (including suspicious but nondiagnostic uptake) may still be eligible if directed tissue biopsies of all abnormally identified areas are negative for cancer.
Weight
14
. Body weight >30 kg
Sex
15.
Male and/or female
16. Pulmonary Function Testing within 12 weeks of randomization

Exclusion criteria
Medical conditions
1.
Mixed small cell and non-small cell cancer
2. History of allogeneic organ transplantation
3. Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [eg, colitis or Crohn’s disease], diverticulitis [with the exception of diverticulosis], systemic lupus erythematosus, Sarcoidosis syndrome, or Wegener syndrome [granulomatosis with polyangiitis, Graves’ disease, rheumatoid arthritis, hypophysitis, uveitis, etc]). The following are exceptions to this criterion:
Patients with vitiligo or alopecia
Patients with hypothyroidism (eg, following Hashimoto syndrome) stable on hormone replacement
Any chronic skin condition that does not require systemic therapy
Patients without active disease in the last 5 years may be included but only after consultation with the Study Physician
Patients with celiac disease controlled by diet alone
4. Uncontrolled intercurrent illness, including but not limited to, ongoing or active infection, symptomatic congestive heart failure (NYHA Class III or IV), uncontrolled hypertension, unstable angina pectoris, uncontrolled cardiac arrhythmia, active interstitial lung disease, serious chronic gastrointestinal conditions associated with diarrhea, or psychiatric illness/social situations that would limit compliance with study requirement, substantially increase risk of incurring AEs, or compromise the ability of the patient to give written informed consent. Patients with controlled chronic obstructive pulmonary disease (COPD) are allowed.
5. History of another primary malignancy except for
Malignancy treated with curative intent and with no known active disease ≥5 years before the first dose of IP and of low potential risk for recurrence
Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease
Adequately treated carcinoma in situ without evidence of disease
6. History of active primary immunodeficiency
7. Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis testing in line with local practice), hepatitis B (known positive hepatitis B surface antigen [HBsAg] result), hepatitis C, or human immunodeficiency virus (positive human immunodeficiency virus [HIV] 1/2 antibodies). Patients with a past or resolved hepatitis B (HBV) infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Patients positive for hepatitis C (HCV) antibody are eligible only if polymerase chain reaction is negative for HCV RNA.
8. History of non-infectious pneumonitis requiring steroids, or patients with Grade ≥2 pneumonitis
9. (Exclusion Criterion #1 is no longer applicable as of Protocol Version 3.0.)
10. Known allergy or hypersensitivity to any of the study drugs or any of the study drug excipients
Prior/concomitant therapy
11.
Prior exposure to immune-mediated therapy including, but not limited to, other anti-CTLA-4, anti-PD-1, anti-PD-L1, and anti-programmed cell death ligand 2 antibodies, excluding therapeutic anticancer vaccines
12. Any concurrent chemotherapy, IP, biologic, or hormonal therapy for cancer treatment. Concurrent use of hormonal therapy for non-cancer-related conditions (eg, hormone replacement therapy) is acceptable. If patient has been on adjuvant hormonal treatment for early stage breast cancer for more than 5 years, and there is no evidence of recurrence, then patient is eligible with study physician discussion.
13. Receipt of live attenuated vaccine within 30 days prior to the first dose of IP. Note: Patients, if enrolled, should not receive live vaccine while receiving IP and up to 90 days after the last dose of IP.
14. Major surgical procedure (as defined by the Investigator) within 28 days prior to the first dose of IP.
15. Current or prior use of immunosuppressive medication within 14 days before the first dose of IP. The following are exceptions to this criterion:
Intranasal, inhaled, topical steroids, or local steroid injections (eg, intra-articular injection)
Systemic corticosteroids at physiologic doses not to exceed 10 mg/day of prednisone or its equivalent
Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication) Prior/concurrent clinical study experience
16. Participation in another clinical study with an IP administered in the last 4 weeks
17. Previous IP assignment in the present study
18. Concurrent enrollment in another clinical study, unless it is an observational (non-interventional) clinical study or during the follow-up period of an interventional study
19. Prior randomization or treatment in a previous durvalumab clinical study regardless of treatment group assignment
20. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
Other exclusions
21.
Female patients who are pregnant or breastfeeding or male or female patients of reproductive potential who are not willing to employ effective birth control from screening to 90 days after the last dose of durvalumab.
22. Judgment by the Investigator that the patient should not participate in the study if the patient is unlikely to comply with study procedures, restrictions, and requirements.
Genetics research study (optional):
23.
Exclusion criteria for participation in the optional (DNA) genetics research component of the study include:
-Previous allogeneic bone marrow transplant
-Non-leukocyte-depleted whole blood transfusion in 120 days of genetic sample collection

Biologic/Vaccine, Drug, Other, Administration of antineoplastic agent, Drug therapy, Immunotherapy for cancer, Stereotactic radiotherapy
Cancer, Lung cancer, Lung tumor, Non-small cell lung cancer
Biological therapy for cancer, Cancer treatment, Durvalumab [USAN:INN], Medical Oncology, Non-small cell lung cancer, Radiation therapy, Respiratory system, Stereotactic body radiotherapy, Tumor surgically unresectable, durvalumab
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

NRG-GY014, A Phase II Study of Tazemetostat (EPZ-6438) in Recurrent Endometrioid/Clear Cell Carcinoma of the Ovary or Peritoneum, and Recurrent Low Grade Endometrioid Endometrial Adenocarcinoma

A Study of Tazemetostat in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Endometrial Cancer

Andrea Wahner Hendrickson
Female
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-100972-P01-RST
19-003579
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Pathologically (histologically or cytologically) proven diagnosis of recurrent or persistent ovarian endometrioid or clear cell carcinoma, OR recurrent or persistent endometrioid endometrial adenocarcinoma; patients with recurrent endometrial cancer must have mismatch repair (MMR) immunohistochemistry completed; if they are found to be mismatch repair deficient, they should be offered treatment with immune checkpoint inhibition before consideration for treatment on trial; primary ovarian tumors must be at least 50% endometrioid or clear cell morphology, or have histologically documented recurrence with at least 50% endometrioid or clear cell morphology; institutional pathology reports must be provided indicating at least 50% endometrioid or clear cell morphology for ovarian tumors (primary or recurrent lesions).
  • All patients must have measurable disease as defined by Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1; measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded); each lesion must be ≥ 10 mm when measured by computed tomography (CT), magnetic resonance imaging (MRI) or caliper measurement by clinical exam; or ≥ 20 mm when measured by chest x-ray; lymph nodes must be > 15 mm in short axis when measured by CT or MRI.
  • Patients must have had at least one, but no more than 3, prior cytotoxic regimens for management of primary disease; unlimited prior hormonal therapy, targeted therapy (including immunotherapy) or antiangiogenic therapy will be permitted.
  • Patients must have completed prior therapy:
    • Chemotherapy: cytotoxic
      • At least 28 days since last dose of chemotherapy prior to registration.
    • Chemotherapy: nitrosoureas
      • At least 6 weeks since last dose of chemotherapy prior to registration.
    • Chemotherapy: non-cytotoxic (e.g. small molecule inhibitor)
      • At least 28 days since last dose of chemotherapy prior to registration.
    • Monoclonal antibody(ies)
      • At least 28 days since last dose of monoclonal antibody prior to registration.
    • Immunotherapy
      • At least 28 days since last dose of immunotherapy prior to registration.
    • Radiotherapy (RT)
      • At least 14 days from last local site RT prior to registration,
      • At least 21 days from stereotactic radiosurgery prior to registration.
      • At least 12 weeks from craniospinal, ≥ 50% radiation of pelvis or total body irradiation prior to registration.
      • Patients with central nervous system (CNS) disease should demonstrate evidence of stabilization after the 28-day time point after definitive treatment.
      • Full recovery of radiation related side effects prior to registration.
      • All subjects must have evidence of measurable disease outside of the radiation field at the time of registration.
  • Appropriate stage for study entry based on the following diagnostic workup:
    • History/physical examination within 14 days prior to registration;
    • Imaging of the chest, abdomen and pelvis within 28 days prior to registration.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 within 14 days prior to registration.
  • Platelets ≥ 100,000/mcl (within 14 days prior to registration).
  • Absolute neutrophil count (ANC) ≥ 1,500/mcl (within 14 days prior to registration).
  • Hemoglobin (Hgb) ≥ 8 g/dL (within 14 days prior to registration).
  • Differential with no clinically significant morphologic abnormalities on complete blood count (CBC) testing; manual differential is encouraged, if clinically indicated, and in cases where an automated differential is abnormal (within 14 days prior to registration).
  • Creatinine ≤ 1.5 x institutional/laboratory upper limit of normal (ULN) (within 14 days prior to registration).
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN (within 14 days prior to registration).
  • Total serum bilirubin level ≤ 1.5 x ULN; direct bilirubin ≤ ULN for subjects with total bilirubin > 1.5 x ULN (patients with isolated indirect bilirubin elevations and a history of Gilbert's syndrome are eligible) (within 14 days prior to registration).
  • Women of childbearing potential must be willing and able to use adequate contraception (hormonal and barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 30 days after the last dose of study agent; should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately; theoretically, CYP3A induction with tazemetostat use may result in the loss of efficacy in hormonal contraceptives, thus a barrier method of contraception must be used in addition to hormonal contraceptives due to the potential drug-drug interaction with tazemetostat.
  • The patient or a legally authorized representative must provide study-specific informed consent and authorization permitting release of personal health information prior to study entry.
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.


Exclusion Criteria:
 

  • Prior treatment with an investigational EZH2 inhibitor.
  • Patients who are unable to swallow pills or absorb orally administered medication.
  • A prior history of myeloid malignancies, including myelodysplastic syndrome (MDS).
  • Abnormalities known to be associated with MDS (e.g., del 5q, chr 7 abn) and myeloproliferative neoplasms (MPN) (e.g., JAK2 V617F) observed in cytogenetic testing and deoxyribonucleic acid (DNA) sequencing.
  • A prior history of T-cell lymphoblastic lymphoma (T-LBL)/T-cell acute lymphoblastic leukemia (T-ALL).
  • Severe, active co-morbidity per the treating investigator's discretion.
  • Pregnant or lactating patients.
  • Known human immunodeficiency virus (HIV) positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with tazemetostat; in addition, treatments involved in this protocol may be immunosuppressive, increasing the risk of lethal infections in this patient population.
  • Treatment with strong inhibitors or inducers of CYP3A within 14 days of registration and during the study treatment.
Drug, Other, Administration of antineoplastic agent, Chemotherapy, Drug therapy
Cancer, Endometrial cancer, Ovarian cancer, Peritoneal cancer, Recurrent cancer
Malignant tumor of peritoneum, Medical Oncology, Adenocarcinoma of endometrium, Cancer treatment, Chemotherapy, Clear cell (mesonephric) neoplasm of ovary, Malignant tumor of ovary, Primary endometrioid carcinoma of endometrium of body of uterus, Recurrent malignant neoplastic disease, Recurrent ovarian cancer, Reproductive system, Targeted drug therapy, Tazemetostat, tazemetostat
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Phase III Randomized Trial of Proton Beam Therapy (PBT) Versus Intensity Modulated Photon Radiotherapy (IMRT) for the Treatment of Esophageal Cancer

A Study to Compare Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

Christopher Hallemeier
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100973-P01-RST
19-003761
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:
 

PRIOR TO STEP 1 REGISTRATION

  • Histologically proven diagnosis of adenocarcinoma or squamous cell carcinoma of the thoracic esophagus or gastroesophageal junction (Siewert I-II).
  • Stage I-IVA, excluding T4b, according to the American Joint Committee on Cancer (AJCC) 8th edition based on the following diagnostic workup:
    • History/physical examination;
    • Whole-body fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) with or without (+/-) contrast (preferred) or chest/abdominal (include pelvic if clinically indicated) CT with contrast.
  • For patients who DID NOT receive induction chemotherapy, scan must occur within 30 days prior to Step 1 registration.
  • For patients who DID receive induction chemotherapy, scan must occur: 
    • Within 30 days after final induction chemotherapy dose; OR
    • Within 30 days prior to Step 1 registration.
      • Note: Patients who had prior endoscopic mucosal resection (EMR) with a diagnosis of AJCC stage I-IVA, excluding T4b, esophageal cancer are eligible.
  • Surgical consultation to determine whether or not the patient is a candidate for resection after completion of chemoradiation.
  • Induction chemotherapy for the current malignancy prior to concurrent chemoradiation allowed if last dose is no more than 90 days and no less than 10 days prior to Step 1 registration.
  • Zubrod performance status 0, 1, or 2.
  • Absolute neutrophil count (ANC) (within 30 days prior to Step 1 registration):
    • For patients who DID NOT receive induction chemotherapy: ANC ≥ 1,500 cells/mm^3;
    • For patients who DID receive induction chemotherapy: ANC ≥ 1,000 cells/mm^3.
  • Platelets (within 30 days prior to Step 1 registration):
    • For patients who DID NOT receive induction chemotherapy: Platelets ≥ 100,000/uL;
    • For patients who DID receive induction chemotherapy: Platelets ≥ 75,000/uL.
  • Hemoglobin ≥ 8.0 g/dl.
    • Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable (within 30 days prior to Step 1 registration).
  • Creatinine clearance > 50 mL/min estimated by Cockcroft-Gault formula (within 30 days prior to Step 1 registration).
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (within 30 days prior to Step 1 registration).
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN (within 30 days prior to Step 1 registration). 
  • Negative pregnancy test (serum or urine) within 14 days prior to Step 1 registration for women of child bearing potential.
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.


Exclusion Criteria:
 

  • Cervical esophageal cancers arisen from 15-18 cm from the incisors. 
  • Patients with T4b disease according to the AJCC 8th edition.
  • Definitive clinical or radiologic evidence of metastatic disease.
  • Any active malignancy within 2 years of study registration that may alter the course of esophageal cancer treatment. 
  • Prior thoracic radiotherapy that would result in overlap of radiation therapy fields.
  • Severe, active co-morbidity defined as follows: 
    • Active uncontrolled infection requiring IV antibiotics at the time of Step 1 registration;
    • Symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia not controlled by pacer device at the time of Step 1 registration; 
    • Myocardial infarction within 3 months prior to Step 1 registration.
  • Pregnant and/or nursing females. 
  • Human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration.
    • Note also that HIV testing is not required for eligibility for this protocol. This exclusion criterion is necessary because the treatments involved in this protocol may be significantly immunosuppressive.

PRIOR TO STEP 2 REGISTRATION

  • Unable to obtain confirmation of payment coverage (insurance or other) for either possible radiation treatment.
Drug, Other, Procedure/Surgery, Radiation, Intensity modulated radiation therapy, Proton therapy
Cancer, Esophageal cancer
Cancer treatment, Digestive system, IMRT, Malignant tumor of esophagus, Malignant tumor of thoracic part of esophagus, Medical Oncology, Primary adenocarcinoma of esophagogastric junction, Proton therapy, Radiation therapy, Squamous cell carcinoma of esophagus
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Phase III Randomized Trial of Proton Beam Therapy (PBT) Versus Intensity Modulated Photon Radiotherapy (IMRT) for the Treatment of Esophageal Cancer

A Study to Compare Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

Timothy Kozelsky
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100973-P01-ALCL
19-003761
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:
 

PRIOR TO STEP 1 REGISTRATION

  • Histologically proven diagnosis of adenocarcinoma or squamous cell carcinoma of the thoracic esophagus or gastroesophageal junction (Siewert I-II).
  • Stage I-IVA, excluding T4b, according to the American Joint Committee on Cancer (AJCC) 8th edition based on the following diagnostic workup:
    • History/physical examination;
    • Whole-body fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) with or without (+/-) contrast (preferred) or chest/abdominal (include pelvic if clinically indicated) CT with contrast.
  • For patients who DID NOT receive induction chemotherapy, scan must occur within 30 days prior to Step 1 registration.
  • For patients who DID receive induction chemotherapy, scan must occur: 
    • Within 30 days after final induction chemotherapy dose; OR
    • Within 30 days prior to Step 1 registration.
      • Note: Patients who had prior endoscopic mucosal resection (EMR) with a diagnosis of AJCC stage I-IVA, excluding T4b, esophageal cancer are eligible.
  • Surgical consultation to determine whether or not the patient is a candidate for resection after completion of chemoradiation.
  • Induction chemotherapy for the current malignancy prior to concurrent chemoradiation allowed if last dose is no more than 90 days and no less than 10 days prior to Step 1 registration.
  • Zubrod performance status 0, 1, or 2.
  • Absolute neutrophil count (ANC) (within 30 days prior to Step 1 registration):
    • For patients who DID NOT receive induction chemotherapy: ANC ≥ 1,500 cells/mm^3;
    • For patients who DID receive induction chemotherapy: ANC ≥ 1,000 cells/mm^3.
  • Platelets (within 30 days prior to Step 1 registration):
    • For patients who DID NOT receive induction chemotherapy: Platelets ≥ 100,000/uL;
    • For patients who DID receive induction chemotherapy: Platelets ≥ 75,000/uL.
  • Hemoglobin ≥ 8.0 g/dl.
    • Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable (within 30 days prior to Step 1 registration).
  • Creatinine clearance > 50 mL/min estimated by Cockcroft-Gault formula (within 30 days prior to Step 1 registration).
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (within 30 days prior to Step 1 registration).
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN (within 30 days prior to Step 1 registration). 
  • Negative pregnancy test (serum or urine) within 14 days prior to Step 1 registration for women of child bearing potential.
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.


Exclusion Criteria:
 

  • Cervical esophageal cancers arisen from 15-18 cm from the incisors. 
  • Patients with T4b disease according to the AJCC 8th edition.
  • Definitive clinical or radiologic evidence of metastatic disease.
  • Any active malignancy within 2 years of study registration that may alter the course of esophageal cancer treatment. 
  • Prior thoracic radiotherapy that would result in overlap of radiation therapy fields.
  • Severe, active co-morbidity defined as follows: 
    • Active uncontrolled infection requiring IV antibiotics at the time of Step 1 registration;
    • Symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia not controlled by pacer device at the time of Step 1 registration; 
    • Myocardial infarction within 3 months prior to Step 1 registration.
  • Pregnant and/or nursing females. 
  • Human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration.
    • Note also that HIV testing is not required for eligibility for this protocol. This exclusion criterion is necessary because the treatments involved in this protocol may be significantly immunosuppressive.

PRIOR TO STEP 2 REGISTRATION

  • Unable to obtain confirmation of payment coverage (insurance or other) for either possible radiation treatment.
Drug, Other, Procedure/Surgery, Radiation, Intensity modulated radiation therapy, Proton therapy
Cancer, Esophageal cancer
Cancer treatment, Digestive system, IMRT, Malignant tumor of esophagus, Malignant tumor of thoracic part of esophagus, Medical Oncology, Primary adenocarcinoma of esophagogastric junction, Proton therapy, Radiation therapy, Squamous cell carcinoma of esophagus
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic Health System — Albert Lea, MN

Phase III Randomized Trial of Proton Beam Therapy (PBT) Versus Intensity Modulated Photon Radiotherapy (IMRT) for the Treatment of Esophageal Cancer

A Study to Compare Proton Therapy to Photon Radiation Therapy for Esophageal Cancer

Ron Smith
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100973-P01-MAIJ
19-003761
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:
 

PRIOR TO STEP 1 REGISTRATION

  • Histologically proven diagnosis of adenocarcinoma or squamous cell carcinoma of the thoracic esophagus or gastroesophageal junction (Siewert I-II).
  • Stage I-IVA, excluding T4b, according to the American Joint Committee on Cancer (AJCC) 8th edition based on the following diagnostic workup:
    • History/physical examination;
    • Whole-body fludeoxyglucose F-18 (FDG)-positron emission tomography (PET)/computed tomography (CT) with or without (+/-) contrast (preferred) or chest/abdominal (include pelvic if clinically indicated) CT with contrast.
  • For patients who DID NOT receive induction chemotherapy, scan must occur within 30 days prior to Step 1 registration.
  • For patients who DID receive induction chemotherapy, scan must occur: 
    • Within 30 days after final induction chemotherapy dose; OR
    • Within 30 days prior to Step 1 registration.
      • Note: Patients who had prior endoscopic mucosal resection (EMR) with a diagnosis of AJCC stage I-IVA, excluding T4b, esophageal cancer are eligible.
  • Surgical consultation to determine whether or not the patient is a candidate for resection after completion of chemoradiation.
  • Induction chemotherapy for the current malignancy prior to concurrent chemoradiation allowed if last dose is no more than 90 days and no less than 10 days prior to Step 1 registration.
  • Zubrod performance status 0, 1, or 2.
  • Absolute neutrophil count (ANC) (within 30 days prior to Step 1 registration):
    • For patients who DID NOT receive induction chemotherapy: ANC ≥ 1,500 cells/mm^3;
    • For patients who DID receive induction chemotherapy: ANC ≥ 1,000 cells/mm^3.
  • Platelets (within 30 days prior to Step 1 registration):
    • For patients who DID NOT receive induction chemotherapy: Platelets ≥ 100,000/uL;
    • For patients who DID receive induction chemotherapy: Platelets ≥ 75,000/uL.
  • Hemoglobin ≥ 8.0 g/dl.
    • Note: The use of transfusion or other intervention to achieve Hgb ≥ 8.0 g/dl is acceptable (within 30 days prior to Step 1 registration).
  • Creatinine clearance > 50 mL/min estimated by Cockcroft-Gault formula (within 30 days prior to Step 1 registration).
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (within 30 days prior to Step 1 registration).
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN (within 30 days prior to Step 1 registration). 
  • Negative pregnancy test (serum or urine) within 14 days prior to Step 1 registration for women of child bearing potential.
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.


Exclusion Criteria:
 

  • Cervical esophageal cancers arisen from 15-18 cm from the incisors. 
  • Patients with T4b disease according to the AJCC 8th edition.
  • Definitive clinical or radiologic evidence of metastatic disease.
  • Any active malignancy within 2 years of study registration that may alter the course of esophageal cancer treatment. 
  • Prior thoracic radiotherapy that would result in overlap of radiation therapy fields.
  • Severe, active co-morbidity defined as follows: 
    • Active uncontrolled infection requiring IV antibiotics at the time of Step 1 registration;
    • Symptomatic congestive heart failure, unstable angina, or cardiac arrhythmia not controlled by pacer device at the time of Step 1 registration; 
    • Myocardial infarction within 3 months prior to Step 1 registration.
  • Pregnant and/or nursing females. 
  • Human immunodeficiency virus (HIV) positive with CD4 count < 200 cells/microliter. Note that patients who are HIV positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration.
    • Note also that HIV testing is not required for eligibility for this protocol. This exclusion criterion is necessary because the treatments involved in this protocol may be significantly immunosuppressive.

PRIOR TO STEP 2 REGISTRATION

  • Unable to obtain confirmation of payment coverage (insurance or other) for either possible radiation treatment.
Drug, Other, Procedure/Surgery, Radiation, Intensity modulated radiation therapy, Proton therapy
Cancer, Esophageal cancer
Cancer treatment, Digestive system, IMRT, Malignant tumor of esophagus, Malignant tumor of thoracic part of esophagus, Medical Oncology, Primary adenocarcinoma of esophagogastric junction, Proton therapy, Radiation therapy, Squamous cell carcinoma of esophagus
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic Health System — Mankato, MN

PrE0905, Randomized Trial of Gilteritinib vs Midostaurin in FLT3 Mutated Acute Myeloid Leukemia (AML) (AML)

A Study to Evaluate Gilteritinib vs. Midostaurin in FLT3 Mutated Acute Myeloid Leukemia

Mithun Shah
All
18 years to 70 years old
Phase 2
This study is NOT accepting healthy volunteers
0000-100989-P01-RST
19-005186
Show full eligibility criteria
Hide eligibility criteria

Registration Criteria: 

  • Any patient undergoing bone marrow biopsy with suspicion of or known diagnosis of acute myeloid leukemia (AML) will be asked to sign a Prescreening Consent to allow for centralized testing of bone marrow/peripheral blood samples.

Eligibility Criteria: 

  • Patient must have previously untreated FLT3 mutated Non M3 AML (FLT3-TKD or FLT3-ITD allowed).
    • NOTE: Standard of care induction 7+3 chemotherapy may start prior to randomization using same regimen and doses as defined in Section 5.2.1 while awaiting prescreening test results.

  • Patient must have had no prior systemic therapy for AML, except as noted below:
    • Hydroxyurea and emergent leukapheresis or preemptive treatment with retinoic acid prior to exclusion of Acute Promyelocytic Leukemia (APL) allowed. 
    • Prior therapy for myelodysplastic syndrome (MDS) or myeloproliferative neoplasms (MPN) (e.g., thalidomide or lenalidomide, interferon, jakafi, cytokines, 5-azacytidine or decitabine, histone deacetylase inhibitors). 
    • Initiation of standard of care 7+3 induction chemotherapy using same regimen and doses as defined in protocol (Section 5.2.1) while awaiting prescreening test results.

  • Patient may not have hypomethylating agent within 21 days. 
  • Patient may not have M3 AML. 
  • Patient may not have AML with known Core Binding Factor -t(8;21), inv(16), t(16;16). 
    • NOTE: If results return with known Core Binding Factor –t(8;21), inv(16), t(16;16) after patient is registered, patient may be allowed to remain on-study per investigator’s discretion after discussion with PrECOG.

  • Patient may not have known active Central Nervous System (CNS) leukemia. 
    • NOTE: -Prophylaxis with intrathecal chemotherapy is allowed prior to or during induction/consolidation.

      - If prophylactic lumbar puncture is performed, recommend scheduling so results are available prior to Day 8 or wait until Day 21 to perform.

  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0-3. 
  • Patient must be age ≥ 18 years to ≤ 70 years. 
  • Patient must be able to understand and willing to sign Institutional Review Board (IRB)-approved informed consent. 
  • Patient must be willing to provide mandatory bone marrow and blood samples for research. 
  • Patient must have adequate organ function as measured by the following criteria, obtained ≤ 48 hours prior to randomization except ECG and left ventricular ejection fraction (LVEF) which can be done ≤ 2 weeks prior to randomization: 
  • Serum creatinine ≤ 1.5x institutional upper limit of normal (ULN), or if serum creatinine outside normal range, then glomerular filtration rate (GFR) > 40 mL/min as measured by Cockcroft-Gault formula. 
  • Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) ≤ 3x ULN, unless secondary to leukemia. 
  • Serum total or direct bilirubin <2 mg/dL, unless due to Gilbert's, hemolysis or leukemic infiltration. 
  • Fridericia-Corrected QT Interval (QTcF) interval ≤ 500 msec (using Friderica's correction). 
  • Left Ventricular Ejection Fraction > 45%.
  • The patient may not be known to have hypokalemia and/or hypomagnesemia that does not respond to supplementation.
  • A female patient is eligible to participate if she is not pregnant and at least one of the following conditions apply: 
    • Not a woman of childbearing potential (WOCBP); or
    • WOCBP who agrees to follow the contraceptive guidance throughout the treatment period and for at least 180 days after the final study drug administration.
  • Female patient must agree not to breastfeed or donate ova starting at treatment and throughout the study period, and for at least 180 days after the final study drug administration. 
  • A male patient must agree not to donate sperm starting at treatment and throughout the study period, and for at least 120 days after the final study drug administration. 
  • A male patient with female partner(s) of child-bearing potential must agree to use contraception during the treatment period, and for at least 120 days after the final study drug administration. 
  • Male patient with a pregnant or breastfeeding partner(s) must agree to remain abstinent or use a condom for the duration of the pregnancy or time partner is breastfeeding throughout the treatment period, and for at least 120 days after the final study drug administration. 
  • Patient may not have another malignancy that could interfere with the evaluation of safety or efficacy of this combination. 
  • Patient may not have a history of Long QT Syndrome. 
  • Patient may not have evidence of uncontrolled angina, severe uncontrolled ventricular arrhythmias, electrocardiographic evidence of acute ischemia, or congestive heart failure (CHF) New York Heart Association (NYHA) Class 3 or 4. Patient may also not have a history of CHF NYHA Class 3 or 4 in the past, unless a prescreening echocardiogram (ECHO) or multigated acquisition scan (MUGA) performed within 2 weeks prior to study entry with results of left ventricular ejection fraction > 45%.
  • Patient may not have had major surgery or radiation therapy within 4 weeks of registration. 
  • Patient may not require treatment with concomitant drugs that are strong inducers of CYP3A. 
  • Patient with a known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent are not eligible. 
  • Patient with known gastrointestinal (GI) disease or prior GI procedure that could interfere with the oral absorption or tolerance of gilteritinib or midostaurin including difficulty swallowing are not eligible. 
  • Patient with any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of the treatment according to the protocol are not eligible. 
  • Patient may not participate in any other therapeutic clinical trials, including those with other investigational agents not included in this trial during treatment on this study without prior approval from PrECOG.
Drug, Administration of antineoplastic agent, Chemotherapy, Drug therapy
Acute myelogenous leukemia, Cancer, Leukemia
Acute myeloid leukemia, disease, Cancer treatment, Chemotherapy, Genetic mutation, Gilteritinib [USAN:INN], Hematopoietic system, Medical Oncology, Midostaurin, Targeted drug therapy, gilteritinib, midostaurin
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

54767414MMY2065, A Phase 2 Study of Daratumumab Subcutaneous (Dara-SC) Administration in Combination With Carfilzomib and Dexamethasone (DKd) Compared With Carfilzomib and Dexamethasone (Kd) in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab to Evaluate Daratumumab Retreatment

Daratumumab Retreatment in Participants With Multiple Myeloma Who Have Been Previously Treated With Daratumumab Intravenous (Dara-IV)

Eli Muchtar
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-100993-P01-RST
19-006761
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • At least 18 years of age.
  • Evidence of a response (partial response or better based on investigator's determination of response by International Myeloma Working Group [IMWG] criteria) to daratumumab-containing therapy with response duration of at least 4 months.
  • Participants must have progressed from or be refractory to their last line of treatment. Relapsed or refractory disease as defined as:
    • Relapsed disease is defined as an initial response to previous treatment, followed by confirmed progressive disease (PD) by IMWG criteria greater than (>) 60 days after cessation of treatment;
    • Refractory disease is defined as less than (<) 25 percent (%) reduction in M-protein or confirmed PD by IMWG criteria during previous treatment or > 60 days after cessation of treatment.
  • Received 1 to 3 prior line(s) of treatment of which one contained daratumumab, and completed daratumumab at least 3 months prior to randomization. A single line of therapy may consist of 1 or more agents, and may include induction, hematopoietic stem cell transplantation, and maintenance therapy. Radiotherapy, bisphosphonate, or a single short course of corticosteroids (no more than the equivalent of dexamethasone 40 milligram per day [mg/day] for 4 days) would not be considered prior lines of therapy.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0, 1, or 2.
  • Women of childbearing potential must have a negative urine or serum pregnancy test at screening within 14 days prior to randomization.


Exclusion Criteria:

  • Previous treatment with daratumumab within the last 3 months prior to randomization.
  • Discontinuation of daratumumab due to a daratumumab-related adverse event (AE).
  • History of malignancy (other than multiple myeloma) unless all treatment of that malignancy was completed at least 2 years before consent and the patient has no evidence of disease. Further exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or breast, or other non-invasive lesion, that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with minimal risk of recurrence within 3 years.
  • Allergies, hypersensitivity, or intolerance to daratumumab, hyaluronidase, monoclonal antibodies (mAbs), human proteins, or their excipients, or known sensitivity to mammalian-derived products. Known history of allergy to Captisol (a cyclodextrin derivative used to solubilize carfilzomib).
  • Participant is:
    • Known to be seropositive for human immunodeficiency virus (HIV) with one or more of the following: not receiving highly active antiretroviral therapy (ART), had a change in ART within 6 months of the start of screening, receiving ART that may interfere with study treatment, cluster of differentiation (CD)4 count < 350 (unit: cells per cubic millimeter of blood) at screening, acquired immunodeficiency syndrome (AIDS)-defining opportunistic infection within 6 months of start of screening, and not agreeing to start ART and be on ART > 4 weeks plus having HIV viral load <400 copies/milliliters (mL) at end of 4-week period (to ensure ART is tolerated and HIV controlled;
    • Seropositive for hepatitis B (defined by a positive test for hepatitis B surface antigen [HBsAg]). Participants with resolved infection (example: participants who are HBsAg negative but positive for antibodies to hepatitis B core antigen [anti-HBc] and/or antibodies to hepatitis B surface antigen [anti-HBs]) must be screened using real-time polymerase chain reaction (PCR) measurement of hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels. Those who are PCR positive will be excluded;
    • Known to be seropositive for hepatitis C (except in the setting of a sustained virologic response [SVR], defined as aviremia at least 12 weeks after completion of antiviral therapy).

Eligibility last updated 10/14/21. Questions regarding updates should be directed to the study team contact.

Drug, Administration of antineoplastic agent, Drug therapy, Immunotherapy for cancer, Medication administration: intravenous, Medication administration: subcutaneous
Cancer, Multiple myeloma, Plasma cell disorders
Biological therapy for cancer, Cancer treatment, Carfilzomib, Daratumumab [USAN:INN], Dexamethasone, Hematopoietic system, Immune system, Medical Oncology, Relapse multiple myeloma, Targeted drug therapy, carfilzomib, daratumumab, dexamethasone
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

EA5163, A Randomized, Phase III Study of Firstline Immunotherapy Alone or in Combination With Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) With Immunobiomarker SIGNature-Driven Analysis (NSCLC)

A Study to Evaluate Firstline Pembrolizumab Alone or in Combination with Pemetrexed and Carboplatin in Induction/Maintenance or Postprogression in Treating Patients with Stage IV Non-squamous Non-small Cell Lung Cancer

Konstantinos Leventakos
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100998-P01-RST
19-005867
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed stage IV non-squamous non‐small cell lung cancer (NSCLC) (includes M1a, M1b stage disease, American Joint Committee on Cancer [AJCC] 8th edition). Patients with T4NX disease (stage IIIB and IIIC) with nodule in ipsilateral lung lobe are eligible if they are not candidates for combined chemotherapy and radiation/
  • Patients must have PD-L1 expression Tumor Proportion Score (TPS) ≥ 1% in tumor cells. If PD-L1 expression TPS is unevaluable or the testing could not be completed, the patients are not eligible. The assay must have been performed by a Clinical Laboratory Improvement Act (CLIA) (or equivalent) certified laboratory.
  • Patients must have measurable or non-measurable disease. The presence of malignant pleural fluid alone is sufficient to satisfy this eligibility criterion. Baseline imaging assessments and measurements used to evaluate all measurable or non-measurable sites of disease must be done within 4 weeks prior to study registration.
    • NOTE: If patient receives pemetrexed, follow institutional guidelines to drain fluids.
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 
  • Patients must NOT have received the following: 
    • Prior systemic chemotherapy or immunotherapy for advanced metastatic NSCLC. Patients treated with any prior checkpoint inhibitors for metastatic lung cancer are ineligible. Chemotherapy for non-metastatic disease (e.g., adjuvant therapy) or immunotherapy for locally advanced stage III disease is allowed if at least 6 months have elapsed between the last dose of the prior therapy and study registration. Local therapy, e.g. palliative radiation, is allowed as long as a period of 14 days has passed between completion of local therapy and study registration;
    • Methotrexate (MTX) given in low doses for non-malignant conditions with last dose at least 14 days prior to date of registration will be allowed. Other low dose chemotherapeutics for non-malignant conditions will be considered, but review by the study chair is required.
  • Patients with known EGFR mutations (except exon 20 insertion), BRAF mutations (V600) or ALK or ROS1 translocations that can be treated with oral tyrosine kinase inhibitors are excluded.
  • Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.
  • Patients are eligible if off steroids for at least 14 days prior to protocol treatment.
  • Anticonvulsants are allowed.
  • Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Patients must not have known pre-existing and clinically active interstitial lung disease, or a known history of (non infectious) pneumonitis that required steroids, or current pneumonitis.
  • Patients must not have significant gastrointestinal disorders with diarrhea as a major symptom (e.g,. Crohn's disease, malabsorption, etc.). 
  • Patients must not have history of auto-immune condition requiring ongoing or intermittent systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
  • Patients must not have any other concomitant serious illness or organ system dysfunction that in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the study drug.
  • Patients must not receive any other investigational agents during the course of therapy.
  • Women must not be pregnant or breast-feeding due to potential harm to the fetus or infant from cytotoxic chemotherapy and the unknown risk of MK-3475 (pembrolizumab). Patients must also not expect to conceive or father children from the time of registration, while on study treatment, and until at least 120 days after the last dose of study treatment:
    • All females of childbearing potential must have a blood test or urine study within 72 hours prior to registration to rule out pregnancy;
    • A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: has achieved menarche at some point; has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  • Women of childbearing potential and sexually active males must use an accepted and effective method of contraception or abstain from sexual intercourse from time of registration, while on study treatment, and continue for 120 days after the last dose of study treatment.
  • Absolute neutrophil count (ANC) ≥ 1500/mm^3 (within 14 days of randomization).
  • Platelets ≥ 100,000/mm^3 (within 14 days of randomization).
  • Prothrombin time (PT)/international normalized ratio (INR) ≤ 1.5 Or if patient on therapeutic anticoagulation, PT/INR ≤ 3.0 (within 14 days of randomization).
  • Partial thromboplastin time (PTT) ≤ institutional upper limit of normal (ULN) OR, if patient is on therapeutic anticoagulation, PTT must be ≤ 1.5 x ULN (within 14 days of randomization).
  • Total bilirubin ≤ 1.5 mg/dL (obtained within 14 days of randomization).
  • Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) < 5 x upper limit of normal (ULN) (obtained within 14 days of randomization)
    •Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 5 x upper limit of normal (ULN) (obtained within 14 days of randomization).
  • Calculated creatinine clearance ≥ 45ml/min to be eligible to receive pemetrexed (obtained within 14 days prior to randomization). 
  • Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN) (obtained within 14 days prior to randomization).
  • Patients must not have a known history of active tuberculosis (TB).
  • Patients must not have a diagnosis of immunodeficiency or receive systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of protocol treatment.
  • Patients must not have received a live vaccine within 30 days prior to randomization. Seasonal flu vaccines that do not contain live virus are permitted.
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
Biologic/Vaccine, Drug, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Immunotherapy for cancer
Cancer, Lung cancer, Non-small cell lung cancer
Biological therapy for cancer, Cancer treatment, Carboplatin, Chemotherapy, Medical Oncology, Non-small cell carcinoma of lung, TNM stage 4, Nonsquamous nonsmall cell neoplasm of lung, Pembrolizumab [USAN:INN], Pemetrexed, Respiratory system, carboplatin, pembrolizumab, pemetrexed
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

EA5163, A Randomized, Phase III Study of Firstline Immunotherapy Alone or in Combination With Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) With Immunobiomarker SIGNature-Driven Analysis (NSCLC)

A Study to Evaluate Firstline Pembrolizumab Alone or in Combination with Pemetrexed and Carboplatin in Induction/Maintenance or Postprogression in Treating Patients with Stage IV Non-squamous Non-small Cell Lung Cancer

Mina Hanna
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100998-P01-ALCL
19-005867
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed stage IV non-squamous non‐small cell lung cancer (NSCLC) (includes M1a, M1b stage disease, American Joint Committee on Cancer [AJCC] 8th edition). Patients with T4NX disease (stage IIIB and IIIC) with nodule in ipsilateral lung lobe are eligible if they are not candidates for combined chemotherapy and radiation/
  • Patients must have PD-L1 expression Tumor Proportion Score (TPS) ≥ 1% in tumor cells. If PD-L1 expression TPS is unevaluable or the testing could not be completed, the patients are not eligible. The assay must have been performed by a Clinical Laboratory Improvement Act (CLIA) (or equivalent) certified laboratory.
  • Patients must have measurable or non-measurable disease. The presence of malignant pleural fluid alone is sufficient to satisfy this eligibility criterion. Baseline imaging assessments and measurements used to evaluate all measurable or non-measurable sites of disease must be done within 4 weeks prior to study registration.
    • NOTE: If patient receives pemetrexed, follow institutional guidelines to drain fluids.
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 
  • Patients must NOT have received the following: 
    • Prior systemic chemotherapy or immunotherapy for advanced metastatic NSCLC. Patients treated with any prior checkpoint inhibitors for metastatic lung cancer are ineligible. Chemotherapy for non-metastatic disease (e.g., adjuvant therapy) or immunotherapy for locally advanced stage III disease is allowed if at least 6 months have elapsed between the last dose of the prior therapy and study registration. Local therapy, e.g. palliative radiation, is allowed as long as a period of 14 days has passed between completion of local therapy and study registration;
    • Methotrexate (MTX) given in low doses for non-malignant conditions with last dose at least 14 days prior to date of registration will be allowed. Other low dose chemotherapeutics for non-malignant conditions will be considered, but review by the study chair is required.
  • Patients with known EGFR mutations (except exon 20 insertion), BRAF mutations (V600) or ALK or ROS1 translocations that can be treated with oral tyrosine kinase inhibitors are excluded.
  • Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.
  • Patients are eligible if off steroids for at least 14 days prior to protocol treatment.
  • Anticonvulsants are allowed.
  • Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Patients must not have known pre-existing and clinically active interstitial lung disease, or a known history of (non infectious) pneumonitis that required steroids, or current pneumonitis.
  • Patients must not have significant gastrointestinal disorders with diarrhea as a major symptom (e.g,. Crohn's disease, malabsorption, etc.). 
  • Patients must not have history of auto-immune condition requiring ongoing or intermittent systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
  • Patients must not have any other concomitant serious illness or organ system dysfunction that in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the study drug.
  • Patients must not receive any other investigational agents during the course of therapy.
  • Women must not be pregnant or breast-feeding due to potential harm to the fetus or infant from cytotoxic chemotherapy and the unknown risk of MK-3475 (pembrolizumab). Patients must also not expect to conceive or father children from the time of registration, while on study treatment, and until at least 120 days after the last dose of study treatment:
    • All females of childbearing potential must have a blood test or urine study within 72 hours prior to registration to rule out pregnancy;
    • A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: has achieved menarche at some point; has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  • Women of childbearing potential and sexually active males must use an accepted and effective method of contraception or abstain from sexual intercourse from time of registration, while on study treatment, and continue for 120 days after the last dose of study treatment.
  • Absolute neutrophil count (ANC) ≥ 1500/mm^3 (within 14 days of randomization).
  • Platelets ≥ 100,000/mm^3 (within 14 days of randomization).
  • Prothrombin time (PT)/international normalized ratio (INR) ≤ 1.5 Or if patient on therapeutic anticoagulation, PT/INR ≤ 3.0 (within 14 days of randomization).
  • Partial thromboplastin time (PTT) ≤ institutional upper limit of normal (ULN) OR, if patient is on therapeutic anticoagulation, PTT must be ≤ 1.5 x ULN (within 14 days of randomization).
  • Total bilirubin ≤ 1.5 mg/dL (obtained within 14 days of randomization).
  • Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) < 5 x upper limit of normal (ULN) (obtained within 14 days of randomization)
    •Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 5 x upper limit of normal (ULN) (obtained within 14 days of randomization).
  • Calculated creatinine clearance ≥ 45ml/min to be eligible to receive pemetrexed (obtained within 14 days prior to randomization). 
  • Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN) (obtained within 14 days prior to randomization).
  • Patients must not have a known history of active tuberculosis (TB).
  • Patients must not have a diagnosis of immunodeficiency or receive systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of protocol treatment.
  • Patients must not have received a live vaccine within 30 days prior to randomization. Seasonal flu vaccines that do not contain live virus are permitted.
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
Biologic/Vaccine, Drug, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Immunotherapy for cancer
Cancer, Lung cancer, Non-small cell lung cancer
Biological therapy for cancer, Cancer treatment, Carboplatin, Chemotherapy, Medical Oncology, Non-small cell carcinoma of lung, TNM stage 4, Nonsquamous nonsmall cell neoplasm of lung, Pembrolizumab [USAN:INN], Pemetrexed, Respiratory system, carboplatin, pembrolizumab, pemetrexed
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic Health System — Albert Lea, MN

EA5163, A Randomized, Phase III Study of Firstline Immunotherapy Alone or in Combination With Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non-Small Cell Lung Cancer (NSCLC) With Immunobiomarker SIGNature-Driven Analysis (NSCLC)

A Study to Evaluate Firstline Pembrolizumab Alone or in Combination with Pemetrexed and Carboplatin in Induction/Maintenance or Postprogression in Treating Patients with Stage IV Non-squamous Non-small Cell Lung Cancer

Amrit Singh
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100998-P01-MAIJ
19-005867
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Patients must have histologically or cytologically confirmed stage IV non-squamous non‐small cell lung cancer (NSCLC) (includes M1a, M1b stage disease, American Joint Committee on Cancer [AJCC] 8th edition). Patients with T4NX disease (stage IIIB and IIIC) with nodule in ipsilateral lung lobe are eligible if they are not candidates for combined chemotherapy and radiation/
  • Patients must have PD-L1 expression Tumor Proportion Score (TPS) ≥ 1% in tumor cells. If PD-L1 expression TPS is unevaluable or the testing could not be completed, the patients are not eligible. The assay must have been performed by a Clinical Laboratory Improvement Act (CLIA) (or equivalent) certified laboratory.
  • Patients must have measurable or non-measurable disease. The presence of malignant pleural fluid alone is sufficient to satisfy this eligibility criterion. Baseline imaging assessments and measurements used to evaluate all measurable or non-measurable sites of disease must be done within 4 weeks prior to study registration.
    • NOTE: If patient receives pemetrexed, follow institutional guidelines to drain fluids.
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. 
  • Patients must NOT have received the following: 
    • Prior systemic chemotherapy or immunotherapy for advanced metastatic NSCLC. Patients treated with any prior checkpoint inhibitors for metastatic lung cancer are ineligible. Chemotherapy for non-metastatic disease (e.g., adjuvant therapy) or immunotherapy for locally advanced stage III disease is allowed if at least 6 months have elapsed between the last dose of the prior therapy and study registration. Local therapy, e.g. palliative radiation, is allowed as long as a period of 14 days has passed between completion of local therapy and study registration;
    • Methotrexate (MTX) given in low doses for non-malignant conditions with last dose at least 14 days prior to date of registration will be allowed. Other low dose chemotherapeutics for non-malignant conditions will be considered, but review by the study chair is required.
  • Patients with known EGFR mutations (except exon 20 insertion), BRAF mutations (V600) or ALK or ROS1 translocations that can be treated with oral tyrosine kinase inhibitors are excluded.
  • Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression. Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate CNS specific treatment is not required and is unlikely to be required during the first cycle of therapy.
  • Patients are eligible if off steroids for at least 14 days prior to protocol treatment.
  • Anticonvulsants are allowed.
  • Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
  • Patients must not have known pre-existing and clinically active interstitial lung disease, or a known history of (non infectious) pneumonitis that required steroids, or current pneumonitis.
  • Patients must not have significant gastrointestinal disorders with diarrhea as a major symptom (e.g,. Crohn's disease, malabsorption, etc.). 
  • Patients must not have history of auto-immune condition requiring ongoing or intermittent systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better
  • Patients must not have any other concomitant serious illness or organ system dysfunction that in the opinion of the investigator would either compromise patient safety or interfere with the evaluation of the safety of the study drug.
  • Patients must not receive any other investigational agents during the course of therapy.
  • Women must not be pregnant or breast-feeding due to potential harm to the fetus or infant from cytotoxic chemotherapy and the unknown risk of MK-3475 (pembrolizumab). Patients must also not expect to conceive or father children from the time of registration, while on study treatment, and until at least 120 days after the last dose of study treatment:
    • All females of childbearing potential must have a blood test or urine study within 72 hours prior to registration to rule out pregnancy;
    • A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: has achieved menarche at some point; has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
  • Women of childbearing potential and sexually active males must use an accepted and effective method of contraception or abstain from sexual intercourse from time of registration, while on study treatment, and continue for 120 days after the last dose of study treatment.
  • Absolute neutrophil count (ANC) ≥ 1500/mm^3 (within 14 days of randomization).
  • Platelets ≥ 100,000/mm^3 (within 14 days of randomization).
  • Prothrombin time (PT)/international normalized ratio (INR) ≤ 1.5 Or if patient on therapeutic anticoagulation, PT/INR ≤ 3.0 (within 14 days of randomization).
  • Partial thromboplastin time (PTT) ≤ institutional upper limit of normal (ULN) OR, if patient is on therapeutic anticoagulation, PTT must be ≤ 1.5 x ULN (within 14 days of randomization).
  • Total bilirubin ≤ 1.5 mg/dL (obtained within 14 days of randomization).
  • Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) < 5 x upper limit of normal (ULN) (obtained within 14 days of randomization)
    •Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 5 x upper limit of normal (ULN) (obtained within 14 days of randomization).
  • Calculated creatinine clearance ≥ 45ml/min to be eligible to receive pemetrexed (obtained within 14 days prior to randomization). 
  • Serum creatinine ≤ 1.5 x institutional upper limit of normal (ULN) (obtained within 14 days prior to randomization).
  • Patients must not have a known history of active tuberculosis (TB).
  • Patients must not have a diagnosis of immunodeficiency or receive systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of protocol treatment.
  • Patients must not have received a live vaccine within 30 days prior to randomization. Seasonal flu vaccines that do not contain live virus are permitted.
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
Biologic/Vaccine, Drug, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Immunotherapy for cancer
Cancer, Lung cancer, Non-small cell lung cancer
Biological therapy for cancer, Cancer treatment, Carboplatin, Chemotherapy, Medical Oncology, Non-small cell carcinoma of lung, TNM stage 4, Nonsquamous nonsmall cell neoplasm of lung, Pembrolizumab [USAN:INN], Pemetrexed, Respiratory system, carboplatin, pembrolizumab, pemetrexed
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic Health System — Mankato, MN

MC1931 Pharmacodynamic Study of Estrogen Suppression Threshold-Directed Therapy (ESTDT) of Anastrozole as Adjuvant Therapy for Early Stage Breast Cancer

Anastrozole and Letrozole After Surgery for the Treatment of Stage I-III Breast Cancer

Tufia Haddad
Female
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-101000-P01-RST
19-006637
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria
•Registration:

  • Women of age ≥ 18 years.
  • Histological confirmation of invasive breast carcinoma.
  • Stage I-III breast cancer
  • Estrogen receptor (ER) positive disease according to ASCO/CAP guidelines as ER≥1% positive nuclear staining.
  • Completion of all planned cancer treatments prior to registration:
    • surgical resection of breast and nodal surgery;
    • NOTE: Reconstructive surgery does not have to be completed
    • adjuvant radiation therapy, if needed; and
    • neoadjuvant and/or adjuvant chemotherapy, if needed.
  • Post-menopausal defined as
  • Age ³60 and amenorrhea >12 consecutive months OR
  • Previous bilateral oophorectomy OR
  • Age <60 and amenorrhea >12 consecutive months and documented follicle stimulating hormone (FSH) level within post-menopausal range according to institutional standard
  • NOTE: Patients who did not meet these criteria at time of diagnosis and received pre-operative (neoadjuvant) or post-operative (adjuvant) chemotherapy will not be allowed to participate.
  • ECOG Performance Status (PS) 0, 1, or 2 .
  • The following laboratory values obtained ≤14 days prior to registration:
    • Hemoglobin ≥ 8.0 g/dL;
    • Absolute neutrophil count (ANC) ≥ 1500/mm^3;
    • Platelet count ≥ 70,000/mm^3;
    • Total bilirubin ≤ 1.5 x ULN;
    • Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤ 3 x ULN.
  • Ability to swallow oral medication.
  • Provide written informed consent.
  • Willingness to provide mandatory blood specimens for correlative research.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).

Exclusion Criteria
•Registration:

 

  • Pre-menopausal women receiving ovarian function suppression (goserelin, leuprolide, etc.).
  • Stage IV (metastatic) breast cancer.
  • HER2 positive breast cancer as defined by:
    • HER2 IHC ≥ 3+;
    • HER2/CEP17 ≥ 2.0;
    • HER2/CEP17 < 2.0 and average HER2 copy number of ≥ 6.0. signals/cell
  • Prior endocrine therapy for this breast cancer.
  • Exceptions:
    • Pre-operative aromatase therapy (anastrozole, letrozole, or exemestane)  and last treatment was ≥ 4 weeks prior to registration; OR
    • Pre-operative tamoxifen therapy and last treatment was ≥ 12 weeks prior to registration.
  • Currently receiving any of the following cancer-directed therapies:
    • Radiation therapy;
    • Systemic therapy such as chemotherapy (standard or investigational);
    • Bisphosphonate therapy started < 4 weeks prior to registration.
  • NOTE: If patient is currently on bisphosphonate therapy she must be on stable dose for ≥ 4 weeks prior to registration.
  • Patients not currently taking bisphosphonates will be allowed to start bisphosphonate therapy after completion of anastrozole (1mg and 10 mg daily (if given)). Information regarding bisphosphonate therapy will be collected.
  • Current use of systemic or topical exogenous estrogen or progesterone (menopausal hormone replacement therapy [HRT]).
  • Prior ovarian function suppression (leuprolide, goserelin, etc).
  • Inability to provide informed consent.
  • History of contralateral DCIS or invasive breast cancer.
  • NOTE: Exception allowed if:
    • Patient did not receive adjuvant endocrine therapy; OR
    • Patient received adjuvant endocrine therapy but has been off treatment for at least 6 months prior to registration.
  • Concurrent active malignancy or history of malignancy ≤ 3 years prior to registration.
  • NOTE: Exceptions allowed for successfully treated cervical carcinoma in situ, lobular carcinoma in situ of the breast, papillary thyroid cancer, or non-melanoma skin cancer.
  • Prior prevention therapy with an aromatase inhibitor or a SERM.
  • Exception: Therapy with a SERM (tamoxifen or raloxifene) is allowed if patient has been off treatment for ≥ 6 months prior to registration.
Drug, Administration of antineoplastic agent, Drug therapy, Estrogen hormone therapy
Breast cancer, Cancer
Cancer treatment, Malignant tumor of breast, Medical Oncology, anastrozole, Anastrozole, Breast cancer surgery, Letrozole, letrozole, Hormone therapy for breast cancer
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

PrOspective Non-interventional Study in Patients With Locally Advanced or Metastatic TRK Fusion Cancer Treated With Larotrectinib (ON-TRK)

Study to Learn More About the Safety and Effectiveness of the Drug VITRAKVI During Routine Use in Patients With TRK Fusion Cancer Which is Locally Advanced or Spread From the Place Where it Started to Other Places in the Body

Scott Okuno
All
Not specified
This study is NOT accepting healthy volunteers
0000-101002-P01-RST
19-004701
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Adult and pediatric (from birth to 18 year old) patients.
  • Patients with locally advanced or metastatic solid tumor harboring an NTRK gene fusion. NTRK (NTRK1, NTRK2, and NTRK3) gene fusions will be identified locally. Acceptable methods of detection of NTRK gene fusion include NGS, fluorescence in situ hybridization (FISH), reverse-transcription polymerase chain reaction (rt-PCR) or any other genomic testing able to detect NTRK gene fusion. If a pan-TRK IHC method is used, this result needs to be accompanied with the results using one of the other methods noted above. 
  • Life expectancy of at least 3 months based on clinical judgement.
  • Decision to treat with larotrectinib made by the treating physician prior to study enrollment.
  • Signed informed consent form.
  • For patients under legal age, signed assent by the patient (where applicable) and parental/legal guardian signed informed consent is required.


Exclusion Criteria:

  • Any contraindications as listed in the local approved product information.
  • Pregnancy.
  • Participation in an investigational program with interventions outside of routine clinical practice.
  • Prior treatment with larotrectinib or other kinase inhibitor with TRK inhibition.
  • Patients with NTRK gene amplification or NTRK point mutation.
Cancer
Alteration of genetic material, Cancer treatment, Larotrectinib [USAN:INN], Medical Oncology, Secondary malignant neoplastic disease, Solid neoplasm with neurotrophic receptor tyrosine kinase gene fusion, Targeted drug therapy, larotrectinib
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

S1806, Phase III Randomized Trial of Concurrent Chemoradiotherapy With or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer (Study SWOG/NRG 1806)

A Study to Evaluate Chemoradiotherapy with or without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer

Brian Costello
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-101018-P01-RST
19-005141
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:
 

STEP 1 REGISTRATION

  • If this will be the first patient from a registering site to receive a given RT modality (3DCRT vs. IMRT), the site must first submit pre-RT planning documents within 3 days of Step 1 registration and receive approval from Imaging and Radiation Oncology Core (IROC) before randomizing the patient to Step 2. If this will not be the first patient to receive a specific RT modality, the patient should be immediately randomized to Step 2 on the same day. 

STEP 2 RANDOMIZATION

  • If patient required review of pre-RT planning, randomization must occur within 14 days of initial registration. 
  • Patients must have histologically proven, T2-T4a N0M0 urothelial carcinoma of the bladder within 70 days prior to randomization. Patients with mixed urothelial carcinoma will be eligible for the trial, but the presence of small cell carcinoma will make a patient ineligible. Patients with lymph nodes ≥ 1.0 cm in shortest cross-sectional diameter on imaging (computed tomography [CT]/magnetic resonance imaging [MRI]) must have a biopsy of the enlarged lymph node showing no tumor involvement within 70 days prior to randomization. These patients may be suitable for neoadjuvant chemotherapy and radical cystectomy and are eligible for this trial if they seek out a bladder sparing treatment strategy, however patients who have received prior systemic chemotherapy for bladder cancer are not eligible for the trial. 
  • Patients must undergo a transurethral resection of bladder tumor (TURBT) within 70 days prior to randomization. In a situation where a patient is referred from outside to the enrolling institution, patient must have a repeat cystoscopy by the urologist who will be following the patient on the clinical trial to assess the adequacy of the prior TURBT. Patient may then undergo repeat TURBT if deemed necessary as standard of care by the treating urologist. Patients may have either completely or partially resected tumors as long as the treating urologist attempted maximal resection. Patient must not have T4b disease. 
  • Patients must undergo radiological staging within 70 days prior to randomization. Imaging of chest, abdomen, and pelvis must be performed using CT or MRI. Patients must not have evidence of T4bN1-3 disease. Eligibility is based on the local radiology report. 
  • Patients with hydronephrosis are eligible if they have unilateral hydronephrosis and kidney function meets criteria specified. 
  • Patients must not have had urothelial carcinoma or histological variant at any site outside of the urinary bladder within the previous 24 months except Ta/T1/carcinoma in situ (CIS) of the upper urinary tract including renal pelvis and ureter if the patient had undergone complete nephroureterectomy. 
  • Patients must not have diffuse CIS based on cystoscopy and biopsy. 
  • Patient must be planning to receive one of the protocol specified chemotherapy regimens.
  • All adverse events associated with any prior surgery and intravesical therapy must have resolved to Common Terminology Criteria for Adverse Events (CTCAE) grade ≤ 2 prior to randomization. 
  • Patient must not have received any systemic chemotherapy for their bladder cancer. 
  • Patient must not have had prior pelvic radiation. 
  • Patients must not have received prior treatment for muscle invasive bladder cancer including neoadjuvant chemotherapy for the current tumor. 
  • Patients must not have received any systemic therapy (including, but not limited to, interferon alfa-2b, high dose IL-2, pegylated interferon [PEG-IFN], anti-PD-1, anti-PD-L1), for non-muscle invasive bladder cancer. Prior intravesical BCG, interferon, and intravesical chemotherapy are allowed. 
  • Patients must not have received any of the following prohibited therapies within 28 days prior to randomization or be planning to receive any of the following prohibited therapies during protocol treatment: 
    • Anti-cancer systemic chemotherapy or biological therapy not specified in the protocol
    • Immunotherapy not specified in this protocol;
    • Systemic or intravesical use of any non-study anti-cancer agent (investigational or non-investigational);
    • Investigational agents other than atezolizumab;
    • Live vaccines: Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, shingles, yellow fever, rabies, bacillus Calmette-Guerin (BCG), and typhoid (oral) vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., Flu-Mist) are live attenuated vaccines, and are not allowed. Prior administration of intravesical BCG is allowed;
    • Glucocorticoids for any purpose other than to modulate symptoms from an event of suspected immunologic etiology. The use of physiologic doses of corticosteroids (defined as 10 mg prednisone) are acceptable, however site investigators should consult with the study chair for any dose higher than 10 mg prednisone. Dexamethasone 4 mg iv with chemotherapy to prevent nausea is allowed;
    • RANKL infusion: Concurrent denosumab (which binds the cytokine RANKL) for any known indication is prohibited due to interaction with study medication. 
  • Patients must not have a major surgical procedure within 28 days prior to randomization. If patient had any surgical procedure then they should have recovered to full presurgical performance status and surgical adverse events should have resolved to grade ≤ 2. TURBT is not considered a major surgical procedure. 
  • Patients must not have received treatment with systemic immunosuppressive medications (including, but not limited to, prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] agents) within 14 days prior to randomization. Exceptions: 
    • Patients may have received acute, low dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea);
    • The use of inhaled corticosteroids and mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed. Physiological doses equivalent of 10 mg prednisone daily are allowed. Short term steroids given as antiemetic therapy; e.g., 4 mg dexamethasone or equivalent once a week, is allowed. 
  • Patients must not have received a live, attenuated vaccine within 4 weeks prior to randomization or anticipate that such a live, attenuated vaccine will be required while on protocol treatment and up to 5 months after the last dose of protocol treatment. 
    • Inactivated influenza vaccination should be given during influenza season only (approximately October to March). Patients must not receive live, attenuated influenza vaccine within 4 weeks prior to randomization or while on protocol treatment and up to 5 months after the last dose of protocol treatment. 
  • Patients must not have undergone prior allogeneic bone marrow transplantation or prior solid organ transplantation. 
  • Patient may or may not be radical cystectomy candidates.
  • Absolute neutrophil count (ANC) ≥ 1,500/microliter (mcL) (within 28 days prior to randomization). 
  • Platelets ≥ 100,000/mcL (within 28 days prior to randomization).
  • Hemoglobin ≥ 9 g/dL (within 28 days prior to randomization).
  • Total bilirubin ≤ 1.5 x institutional upper limit of normal (IULN) (except patients with Gilbert's syndrome, who must have a total bilirubin < 3.0 mg/dL) (within 28 days prior to randomization). 
  • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) < 2.5 x IULN (within 28 days prior to randomization). 
  • Patients must not have clinically significant liver disease that precludes patient from treatment regimens prescribed on the study (including, but not limited to, active viral, alcoholic or other autoimmune hepatitis, cirrhosis or inherited liver disease). 
  • Patients must have adequate renal function as evidenced by calculated creatinine clearance ≥ 25 mL/min. The creatinine used to calculate the clearance result must have been obtained within 28 days prior to randomization. 
  • Patients must have Zubrod performance status ≤ 2. 
  • Patients must have a baseline electrocardiography (ECG) performed within 30 days prior to randomization. 
  • Patient must not have history of idiopathic pulmonary fibrosis, pneumonitis (including drug induced), organizing pneumonia (i.e., bronchiolitis obliterans, cryptogenic organizing pneumonia, etc.), or evidence of active pneumonitis. 
  • Patients must not have an active infection requiring oral or IV antibiotics within 14 days prior to randomization. Patients receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection or chronic obstructive pulmonary disease) are not eligible. If patient develops urinary tract infection after TURBT they must have recovered from the infection prior to registration.
  • Patients must not have active autoimmune disease that has required systemic treatment in past two years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment. Autoimmune diseases include, but are not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjögren's syndrome, Bell's palsy, Guillain-Barré syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, Graves' disease treated with methimazole or glomerulonephritis. 
  • Patient must not have a history of active tuberculosis. 
  • If patient has a known history of hepatitis B virus (HBV) or hepatitis C virus (HCV), they must meet the following criteria within 28 days prior to randomization. 
    • Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg] test and a positive anti-HBc [antibody to hepatitis B core antigen] antibody test) are eligible;
    • Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). 
  • Patients who are known to be positive for human immunodeficiency virus (HIV) are eligible only if they have all of the following: 
    • A stable regimen of highly active anti-retroviral therapy (HAART);
    • No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections;
    • A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests within 28 days prior to randomization.
  • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for two years. Patients with localized prostate cancer who are being followed by an active surveillance program are also eligible. 
  • Female patients of childbearing potential must have a serum pregnancy test prior to randomization. Patients must not be pregnant or nursing due to the potential teratogenic side effects of the protocol treatment. Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of protocol treatment, and for 5 months (150 days) after the last dose of all study drugs. A woman is considered to be of "reproductive potential" if she has had a menses at any time in the preceding 12 consecutive months. 
  • Patients must not be known to be allergic to Chinese hamster egg or ovary cell products and must not have any known major allergic reactions to any study drug. 
  • Patients must be offered the opportunity to participate in specimen banking for future studies. 
  • Patients who can complete Patient-Reported Outcome instruments in English or Spanish must agree to complete the EORTC QLQ-C30, the EORTC QLQ-BLM30, the EPIC-26 (bowel domain only), and the EQ-5D-5L per protocol schedule of assessment. 
  • As a part of the Oncology Patient Enrollment Network (OPEN) registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.
Drug, Other, Radiation, Administration of antineoplastic agent, Chemotherapy, Combined chemotherapy and radiation therapy, Drug therapy, Immunotherapy for cancer, Radiation oncology AND/OR radiotherapy
Bladder cancer, Cancer
Atezolizumab, Biological therapy for cancer, Cancer treatment, Carcinoma of urinary bladder, invasive, Chemotherapy, IMRT, Malignant tumor of urinary bladder, Medical Oncology, Radiation therapy, Transitional cell carcinoma of bladder, Urinary system, atezolizumab
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab

Chemoradiation With or Without Atezolizumab in Treating Patients With Limited Stage Small Cell Lung Cancer

Konstantinos Leventakos
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
0000-101023-P01-RST
19-005349
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Pathologically (histologically or cytologically) proven diagnosis of limited stage small cell lung cancer (Stage Tx, T1-T4, N0-3, M0, American Joint Committee on Cancer [AJCC] staging, 8th edition [Ed.]), within 60 days prior to registration.
  • Patients must have received one pre-registration cycle of platinum/etoposide chemotherapy prior to study entry, with study registration required within 21 days from day 1 of the pre-registration cycle of chemotherapy and protocol treatment designed to begin 21 days after. If patient has not recovered from pre-registration cycle chemotherapy toxicities, then an additional 14 days is permitted.
  • Patients must have had measurable disease (per Response Evaluation Criteria in Solid Tumors [RECIST], version 1.1) prior to the required cycle of platinum/etoposide chemotherapy.
  • Minimal staging requirements include:
    • History/physical examination within 30 days prior to registration;
    • Positron emission tomography (PET)/computed tomography (CT) scan for staging within 45 days prior to registration;
    • CT chest/abdomen with IV contrast (unless contraindicated based on kidney function) within 45 days prior to registration
      •this can be obtained as part of PET/CT if CT imaging is of diagnostic quality.
      • Note: If contrast allergy exists, premedication per institutional guidelines should be performed prior to obtaining CT with contrast. The only exception to this is a documented life-threatening allergy.
    • Magnetic resonance imaging (MRI) scan of the brain with contrast (preferred) or CT scan of the brain with contrast (allowable if there is a contraindication with MRI with contrast) within 30 days prior to registration. 
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 30 days prior to registration.
    • Absolute neutrophil count (ANC) ≥ 1, 500/cells/mm^3 (pre-registration cycle)
    • Platelet count ≥ 100,000 cells/mm^3 (pre-registration cycle).
    • Hemoglobin ≥ 9 g/dL (pre-registration cycle).
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (pre-registration cycle).
    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.0 x ULN (pre-registration cycle).
    • Glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m^2 (within 30 days prior to registration).
    • Patients presenting with a pleural effusion will be eligible if thoracentesis is cytologically negative and non-bloody or if pleural fluid is too small a volume to effectively sample by thoracentesis and does not show increased metabolic activity on CT/PET imaging.
    • Negative serum pregnancy test within 14 days of registration for pre-menopausal women of childbearing potential.
    • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.


Exclusion Criteria:
 

  • Definitive clinical or radiologic evidence of metastatic disease.
  • Definitive surgical resection of small cell lung cancer.
  • Prior invasive malignancy (except non-melanomatous skin cancer, localized prostate cancer, or any early stage cancer treated with curative intent resection) unless disease free for a minimum of 2 years (carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
  • More than 1 cycle of prior platinum-based chemotherapy for SCLC prior to enrollment; note that prior chemotherapy for a different cancer is allowable.
  • Any prior atezolizumab or other immunotherapy agent.
  • Prior radiotherapy to the lungs or mediastinum that would result in clinically significant overlap of radiation therapy fields; prior tangent fields for breast cancer with minimal overlap with target volumes are allowed per approval of study principal investigators (PIs).
  • Patients with cytologically positive pleural or pericardial fluid are not eligible. 
  • An active, known or suspected autoimmune disease. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
  • Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
  • History of allogeneic organ transplant
  • History of primary immunodeficiency.
  • Severe, active co-morbidity defined as follows: 
    • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease;
    • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications;
    • Active tuberculosis;
    • Active hepatitis B (chronic or acute) or hepatitis C infection.
      • Note that if hepatitis status is unknown, hepatitis B/C testing is required:
        • Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg]) test, a positive anti-HBc (antibody to hepatitis B core antigen), and a negative viral deoxyribonucleic acid (DNA) test (only obtained if HBsAg is found positive) are eligible.  Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). (The HCV RNA test must be performed for patients who have a positive HCV antibody test).
    • Known immunosuppressive disease, for example history of bone marrow transplant or chronic lymphocytic leukemia (CLL):
      • CD4 count < 200 cells/microliter.
        • Note that patients who are human immunodeficiency virus (HIV) positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol.
    • Chronic obstructive pulmonary disease (COPD) requiring chronic oral steroid therapy of > 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are not exclusionary. 
    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months. 
    • Transmural myocardial infarction within the last 3 months.
    • Clinically significant interstitial lung disease. 
  • A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception for the duration of study treatment and for 150 days after the last dose of study drug (Arm 2); this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
Drug, Other, Radiation, Administration of antineoplastic agent, Combined chemotherapy and radiation therapy, Drug therapy, Immunotherapy for cancer
Cancer, Lung cancer, Small cell lung cancer
1,2-Diaminocyclohexaneplatinum II citrate, Atezolizumab, Biological therapy for cancer, Cancer treatment, Carboplatin, Chemotherapy, Etoposide, Medical Oncology, Radiation therapy, Respiratory system, Small cell carcinoma of lung, atezolizumab, carboplatin, cisplatin, etoposide
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab

Chemoradiation With or Without Atezolizumab in Treating Patients With Limited Stage Small Cell Lung Cancer

Mina Hanna
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
0000-101023-P01-ALCL
19-005349
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Pathologically (histologically or cytologically) proven diagnosis of limited stage small cell lung cancer (Stage Tx, T1-T4, N0-3, M0, American Joint Committee on Cancer [AJCC] staging, 8th edition [Ed.]), within 60 days prior to registration.
  • Patients must have received one pre-registration cycle of platinum/etoposide chemotherapy prior to study entry, with study registration required within 21 days from day 1 of the pre-registration cycle of chemotherapy and protocol treatment designed to begin 21 days after. If patient has not recovered from pre-registration cycle chemotherapy toxicities, then an additional 14 days is permitted.
  • Patients must have had measurable disease (per Response Evaluation Criteria in Solid Tumors [RECIST], version 1.1) prior to the required cycle of platinum/etoposide chemotherapy.
  • Minimal staging requirements include:
    • History/physical examination within 30 days prior to registration;
    • Positron emission tomography (PET)/computed tomography (CT) scan for staging within 45 days prior to registration;
    • CT chest/abdomen with IV contrast (unless contraindicated based on kidney function) within 45 days prior to registration
      •this can be obtained as part of PET/CT if CT imaging is of diagnostic quality.
      • Note: If contrast allergy exists, premedication per institutional guidelines should be performed prior to obtaining CT with contrast. The only exception to this is a documented life-threatening allergy.
    • Magnetic resonance imaging (MRI) scan of the brain with contrast (preferred) or CT scan of the brain with contrast (allowable if there is a contraindication with MRI with contrast) within 30 days prior to registration. 
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 30 days prior to registration.
    • Absolute neutrophil count (ANC) ≥ 1, 500/cells/mm^3 (pre-registration cycle)
    • Platelet count ≥ 100,000 cells/mm^3 (pre-registration cycle).
    • Hemoglobin ≥ 9 g/dL (pre-registration cycle).
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (pre-registration cycle).
    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.0 x ULN (pre-registration cycle).
    • Glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m^2 (within 30 days prior to registration).
    • Patients presenting with a pleural effusion will be eligible if thoracentesis is cytologically negative and non-bloody or if pleural fluid is too small a volume to effectively sample by thoracentesis and does not show increased metabolic activity on CT/PET imaging.
    • Negative serum pregnancy test within 14 days of registration for pre-menopausal women of childbearing potential.
    • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.


Exclusion Criteria:
 

  • Definitive clinical or radiologic evidence of metastatic disease.
  • Definitive surgical resection of small cell lung cancer.
  • Prior invasive malignancy (except non-melanomatous skin cancer, localized prostate cancer, or any early stage cancer treated with curative intent resection) unless disease free for a minimum of 2 years (carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
  • More than 1 cycle of prior platinum-based chemotherapy for SCLC prior to enrollment; note that prior chemotherapy for a different cancer is allowable.
  • Any prior atezolizumab or other immunotherapy agent.
  • Prior radiotherapy to the lungs or mediastinum that would result in clinically significant overlap of radiation therapy fields; prior tangent fields for breast cancer with minimal overlap with target volumes are allowed per approval of study principal investigators (PIs).
  • Patients with cytologically positive pleural or pericardial fluid are not eligible. 
  • An active, known or suspected autoimmune disease. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
  • Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
  • History of allogeneic organ transplant
  • History of primary immunodeficiency.
  • Severe, active co-morbidity defined as follows: 
    • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease;
    • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications;
    • Active tuberculosis;
    • Active hepatitis B (chronic or acute) or hepatitis C infection.
      • Note that if hepatitis status is unknown, hepatitis B/C testing is required:
        • Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg]) test, a positive anti-HBc (antibody to hepatitis B core antigen), and a negative viral deoxyribonucleic acid (DNA) test (only obtained if HBsAg is found positive) are eligible.  Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). (The HCV RNA test must be performed for patients who have a positive HCV antibody test).
    • Known immunosuppressive disease, for example history of bone marrow transplant or chronic lymphocytic leukemia (CLL):
      • CD4 count < 200 cells/microliter.
        • Note that patients who are human immunodeficiency virus (HIV) positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol.
    • Chronic obstructive pulmonary disease (COPD) requiring chronic oral steroid therapy of > 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are not exclusionary. 
    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months. 
    • Transmural myocardial infarction within the last 3 months.
    • Clinically significant interstitial lung disease. 
  • A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception for the duration of study treatment and for 150 days after the last dose of study drug (Arm 2); this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
Drug, Other, Radiation, Administration of antineoplastic agent, Combined chemotherapy and radiation therapy, Drug therapy, Immunotherapy for cancer
Cancer, Lung cancer, Small cell lung cancer
1,2-Diaminocyclohexaneplatinum II citrate, Atezolizumab, Biological therapy for cancer, Cancer treatment, Carboplatin, Chemotherapy, Etoposide, Medical Oncology, Radiation therapy, Respiratory system, Small cell carcinoma of lung, atezolizumab, carboplatin, cisplatin, etoposide
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic Health System — Albert Lea, MN

Limited Stage Small Cell Lung Cancer (LS-SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab

Chemoradiation With or Without Atezolizumab in Treating Patients With Limited Stage Small Cell Lung Cancer

Amrit Singh
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
0000-101023-P01-MAIJ
19-005349
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Pathologically (histologically or cytologically) proven diagnosis of limited stage small cell lung cancer (Stage Tx, T1-T4, N0-3, M0, American Joint Committee on Cancer [AJCC] staging, 8th edition [Ed.]), within 60 days prior to registration.
  • Patients must have received one pre-registration cycle of platinum/etoposide chemotherapy prior to study entry, with study registration required within 21 days from day 1 of the pre-registration cycle of chemotherapy and protocol treatment designed to begin 21 days after. If patient has not recovered from pre-registration cycle chemotherapy toxicities, then an additional 14 days is permitted.
  • Patients must have had measurable disease (per Response Evaluation Criteria in Solid Tumors [RECIST], version 1.1) prior to the required cycle of platinum/etoposide chemotherapy.
  • Minimal staging requirements include:
    • History/physical examination within 30 days prior to registration;
    • Positron emission tomography (PET)/computed tomography (CT) scan for staging within 45 days prior to registration;
    • CT chest/abdomen with IV contrast (unless contraindicated based on kidney function) within 45 days prior to registration
      •this can be obtained as part of PET/CT if CT imaging is of diagnostic quality.
      • Note: If contrast allergy exists, premedication per institutional guidelines should be performed prior to obtaining CT with contrast. The only exception to this is a documented life-threatening allergy.
    • Magnetic resonance imaging (MRI) scan of the brain with contrast (preferred) or CT scan of the brain with contrast (allowable if there is a contraindication with MRI with contrast) within 30 days prior to registration. 
    • Eastern Cooperative Oncology Group (ECOG) performance status of 0-2 within 30 days prior to registration.
    • Absolute neutrophil count (ANC) ≥ 1, 500/cells/mm^3 (pre-registration cycle)
    • Platelet count ≥ 100,000 cells/mm^3 (pre-registration cycle).
    • Hemoglobin ≥ 9 g/dL (pre-registration cycle).
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (pre-registration cycle).
    • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.0 x ULN (pre-registration cycle).
    • Glomerular filtration rate (GFR) ≥ 50 mL/min/1.73 m^2 (within 30 days prior to registration).
    • Patients presenting with a pleural effusion will be eligible if thoracentesis is cytologically negative and non-bloody or if pleural fluid is too small a volume to effectively sample by thoracentesis and does not show increased metabolic activity on CT/PET imaging.
    • Negative serum pregnancy test within 14 days of registration for pre-menopausal women of childbearing potential.
    • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.


Exclusion Criteria:
 

  • Definitive clinical or radiologic evidence of metastatic disease.
  • Definitive surgical resection of small cell lung cancer.
  • Prior invasive malignancy (except non-melanomatous skin cancer, localized prostate cancer, or any early stage cancer treated with curative intent resection) unless disease free for a minimum of 2 years (carcinoma in situ of the breast, oral cavity, or cervix are all permissible).
  • More than 1 cycle of prior platinum-based chemotherapy for SCLC prior to enrollment; note that prior chemotherapy for a different cancer is allowable.
  • Any prior atezolizumab or other immunotherapy agent.
  • Prior radiotherapy to the lungs or mediastinum that would result in clinically significant overlap of radiation therapy fields; prior tangent fields for breast cancer with minimal overlap with target volumes are allowed per approval of study principal investigators (PIs).
  • Patients with cytologically positive pleural or pericardial fluid are not eligible. 
  • An active, known or suspected autoimmune disease. Patients are permitted to enroll if they have vitiligo, type I diabetes mellitus, residual hypothyroidism due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger.
  • Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).
  • History of allogeneic organ transplant
  • History of primary immunodeficiency.
  • Severe, active co-morbidity defined as follows: 
    • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease;
    • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpretation of the results or render the patient at high risk from treatment complications;
    • Active tuberculosis;
    • Active hepatitis B (chronic or acute) or hepatitis C infection.
      • Note that if hepatitis status is unknown, hepatitis B/C testing is required:
        • Patients with past or resolved hepatitis B infection (defined as having a negative hepatitis B surface antigen [HBsAg]) test, a positive anti-HBc (antibody to hepatitis B core antigen), and a negative viral deoxyribonucleic acid (DNA) test (only obtained if HBsAg is found positive) are eligible.  Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction (PCR) is negative for HCV ribonucleic acid (RNA). (The HCV RNA test must be performed for patients who have a positive HCV antibody test).
    • Known immunosuppressive disease, for example history of bone marrow transplant or chronic lymphocytic leukemia (CLL):
      • CD4 count < 200 cells/microliter.
        • Note that patients who are human immunodeficiency virus (HIV) positive are eligible, provided they are under treatment with highly active antiretroviral therapy (HAART) and have a CD4 count ≥ 200 cells/microliter within 30 days prior to registration. Note also that HIV testing is not required for eligibility for this protocol.
    • Chronic obstructive pulmonary disease (COPD) requiring chronic oral steroid therapy of > 10 mg prednisone daily or equivalent at the time of registration. Inhaled corticosteroids are not exclusionary. 
    • Unstable angina and/or congestive heart failure requiring hospitalization within the last 3 months. 
    • Transmural myocardial infarction within the last 3 months.
    • Clinically significant interstitial lung disease. 
  • A condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception for the duration of study treatment and for 150 days after the last dose of study drug (Arm 2); this exclusion is necessary because the treatment involved in this study may be significantly teratogenic.
Drug, Other, Radiation, Administration of antineoplastic agent, Combined chemotherapy and radiation therapy, Drug therapy, Immunotherapy for cancer
Cancer, Lung cancer, Small cell lung cancer
1,2-Diaminocyclohexaneplatinum II citrate, Atezolizumab, Biological therapy for cancer, Cancer treatment, Carboplatin, Chemotherapy, Etoposide, Medical Oncology, Radiation therapy, Respiratory system, Small cell carcinoma of lung, atezolizumab, carboplatin, cisplatin, etoposide
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic Health System — Mankato, MN

(ECTx) TG4050.01; A phase I trial evaluating a mutanome-directed immunotherapy in patients with high grade serous carcinoma (HGSC) of the ovary, fallopian tube or peritoneum who experience an asymptomatic relapse

A Study to Evaluate TG4050 in Ovarian Carcinoma

Matthew Block
Female
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-101028-P01-RST
19-005397
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:
 

Screening Period

  • Signed written informed consent in accordance to ICH-GCP and national/local regulation before any protocol-related procedures that are not part of normal patient care.
  • Female patients ≥ 18 years of age.
  • Histologically confirmed high grade, stage IIIC or stage IV (FIGO staging) serous ovarian, fallopian or primary peritoneal carcinoma with abnormal CA-125 at diagnosis.
  • Patients who have undergone primary debulking surgery or interval debulking surgery and completed a total of at least 5 cycles of taxane-platinum combination.
    • Note: patients may have received concurrent or maintenance bevacizumab or a PARP inhibitor.
  • Patients must have achieved a complete response to therapy, as demonstrated by no residual disease on most recent CT scan and normal CA-125 not increasing by both the following: > 25% from nadir AND ≥ 10 UI/mL from nadir.
  • Patient who remains disease free at least 6 months from last prior dose of cytotoxic chemotherapy (maintenance therapy with bevacizumab or a PARP inhibitor is allowed).
  • Available tumor tissue, banked from previous abdominal debulking surgery and/or from a core needle biopsy performed at diagnosis if the patient received neoadjuvant chemotherapy, and peripheral blood samples for exome and transcriptome sequencing.

Treatment Period

  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at treatment period initiation.
  • Patients who have developed an asymptomatic relapse as defined by:
    • Cohort A: CA-125 ≥ 2 times ULN on 2 occasions at least 1 week apart (GCIG criteria) or low volume radiological disease and CA-125 > ULN. Low volume radiological disease is defined as radiologically visible disease excluding intra-hepatic or splenic metastases, ascites or pleural effusion thought to require drainage;
    • Cohort B: patient asymptomatic with measurable disease, excluding intra-hepatic or splenic metastases, ascites or pleural effusion thought to require drainage, whatever serum CA-125 level and for whom further treatment is not planned within 2 months.
    • Longest diameter on CT-scan must not exceed 2 cm for non-nodal lesions and 2.5 cm in short axis for nodal lesions.
  • Adequate hematological, hepatic and renal functions:
    • Hemoglobin ≥ 9.0 g/dL;
    • Neutrophils count ≥ 1.5 x10^9 /L;
    • Lymphocytes count ≥ 0.9 x10^9 /L;
    • Platelets count ≥ 100 x10^9 /L;
    • Total bilirubin ≤ 1.5 x ULN (except for patients with Gilbert’s syndrome);
    • Aspartate aminotransferase (AST) ≤ 2.5 x ULN;
    • Calculated creatinine clearance ≤ 45 mL/min using the Cockroft & Gault formula or ≥ 45 mL/min/1.73m² using other methods.
  • Patients who received standard maintenance therapy will stop before initiation of TG4050 administration. A free-interval of at least 30 days will be respected before first dosing of TG4050 except for PARP inhibitor (at least 14 days).


Exclusion Criteria:
 

Screening Period

  • Patient having received any cancer immunotherapy including cancer vaccines, any antibody/drug targeting T cell co-regulatory proteins such as anti-PD1, anti-PDL1 or anti-CTLA-4.
  • Patients with other active malignancy ≤ 3 years prior to registration except non-melanoma skin cancer, stage 0 in situ carcinoma and recent early stage papillary thyroid cancer. If there is an history of prior malignancy, patient must not be receiving other specific treatment for their cancer.
  • Patient post-organ transplantation, including allogeneic stem cell or bone marrow transplantation. History of blood transfusion within 3 weeks prior to study entry visit.
  • Known history of positive testing for Human Immunodeficiency Virus (HIV) or known AIDS (Acquired Immune Deficiency Syndrome).
  • Any known allergy or reaction to eggs or attributed to compounds of similar chemical or biological composition to therapeutic vaccines/immunotherapeutic products.
  • Positive serology for Hepatis C Virus (HCV) or positive serum Hepatitis B surface antigen (HBsAg) within 3 months prior to or at study entry (tests required).

Treatment Period

  • Measurable disease associated with the appearance of symptoms justifying initiation of further treatment.
  • Major surgery within 4 weeks prior to treatment start.
  • Treatment with another investigational agent within 30 days prior to TG4050 treatment initiation.
  • Patients under chronic treatment with systemic corticosteroids or other immunosuppressive drugs for a period of at least 4 weeks and whose treatment was not stopped 2 weeks prior to TG4050 treatment initiation planned date, with the exception of patients with adrenal insufficiency who may continue corticosteroids at physiological replacement dose, equivalent to ≤ 10 mg prednisone daily. Steroids with no or minimal systemic effect (topical, inhalation) are allowed.
  • Vaccination for the prevention of infectious diseases with a live vaccine during the four-week period prior to TG4050 treatment initiation planned date. Furthermore, patients should not receive any live vaccine during the period of study treatment administration.
  • Patient with any underlying medical condition, that in the opinion of the investigator, could make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety or toxicity of the study treatment.
  • Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric illness/social circumstances that could limit compliance with study requirements.
  • History of myocardial infarction ≤ 6 months.

Eligibility last updated 4/20/22. Questions regarding updates should be directed to the study team contact.

Drug, Administration of antineoplastic agent, Drug therapy, Immunotherapy for cancer
Cancer, Fallopian tube cancer, Ovarian cancer, Peritoneal cancer
Biological therapy for cancer, Cancer treatment, Extraovarian primary peritoneal carcinoma, Genetic mutation, Malignant tumor of fallopian tube, Malignant tumor of ovary, Medical Oncology, Primary adenocarcinoma of fallopian tube, Primary high grade serous adenocarcinoma of ovary, Reproductive system
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

A Phase 1 Study of TJ011133 Administered Alone or in Combination With Pembrolizumab or Rituximab in Subjects With Relapsed/Refractory Advanced Solid Tumors and Lymphoma

Study of TJ011133 in Participants With Relapsed/ Refractory Advanced Solid Tumors and Lymphoma

Alex Adjei
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-101036-P01-RST
19-005251
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:
 

Part 1 Dose Escalation:

  • Histological or cytological diagnosis of solid tumor or Hodgkin’s Lymphoma who have relapsed or progressed and who are ineligible for all therapies with demonstrated clinical benefit.
    • Note: there is no limit to the number of prior treatment regimens; or
  • Relapsed/refractory CD20 positive, B-cell NHL who have progressed following at least 2 prior systemic therapies. For aggressive histologies, frontline treatment must have included an alkylating agent; or
  • Relapsed/refractory classical Hodgkin’s Lymphoma who have progressed following at least 2 prior systemic therapies and have progressed on checkpoint inhibitors (for Part 1B only);
  • In Part 1A (45 mg/kg dose cohort only), Part 1B or Part 1C, archival tumor tissue and fresh post-treatment tumor biopsy obtained that allows preparation of the number of slides required in the separate study-specific specimen preparation instructions. Samples will be collected, processed and stored according to a separate laboratory manual.

Part 2 Dose Expansion for Combination Therapy with Rituximab:

  • Relapsed/refractory DLBCL including histologically confirmed de novo (NOS) or transformed DLBCL (including transformation from follicular lymphoma of any grade, gastric MALT lymphoma and non-gastric MALT lymphoma) expressing CD20 by IHC (immunohistochemistry) or flow cytometry, primary mediastinal large B‐cell lymphoma, or T‐cell rich large B cell lymphoma, which are relapsed after at least 2 prior lines of systemic therapy including at least one rituximab-containing regimen or refractory disease to rituximab without better available choices.
  • Confirmed marginal zone or follicular lymphoma (Grade 1-3a) expressing CD20+ by IHC or flow cytometry, relapsed after at least 2 prior line of systemic therapy including at least one rituximab-chemotherapy combination regimen or refractory to rituximab-containing regimen without better available choices; for indolent NHL histology, progression following prior treatment with an alkylating agent is allowed but not required.
    • NOTE: Refractory disease is defined as progression within 6 months of last dose of therapy. Relapsed disease is defined as disease recurrence or PD following a response after more than 6 months after last dose. Patients who received CAR-T therapy are allowed but cannot have progressive disease within 3 months of CAR-T therapy.
    • At least one measurable lesion as defined by Lugano criteria (version 2014).
    • Available fresh metastatic biopsy sample prior to study entry and one mandatory on-treatment tumor biopsy in US clinical sites, unless there is difficulty obtaining the sample (e.g., hard to reach tumors or biopsies requiring surgical intervention). Waiver of biopsy samples must be discussed with the medical monitor. Tumor biopsy samples collected should allow for sample preparation as detailed in the separate study-specific specimen preparation instructions. Mandatory archival pre-treatment or optional ontreatment FFPE tumor tissue that allow for sample preparation as detailed in the separate study-specific specimen preparation instructions will be collected from subjects enrolled at sites in China in the NHL cohort of Part 2.

Part 2 Dose Expansion for Combination Therapy with Pembrolizumab:

  • Locally advanced or metastatic NSCLC that expresses PD-L1 (Tumor Proportion Score (TPS) ≥1%) as determined by an FDA-approved test, with disease progression on or after platinum containing chemotherapy and checkpoint therapy.
  • Patients with NSCLC must have progressed on treatment with one prior PD1/L1 inhibitor administered either as monotherapy or in combination with other checkpoint inhibitors or other therapies.
  • Patients who have had more than 1 prior PD-(L)1 inhibitor may be considered after discussion with the Medical Monitor. PD-1/L1 inhibitor treatment progression is defined by meeting all of the following criteria:
    • has received at least 2 doses of the PD-1/L1 inhibitor (must be an approved PD-1/L1 inhibitor);
    • has been on a continuous regimen of the PD-1/L1 inhibitor for at least 4 months without disease progression;
    • has demonstrated radiographic disease progression after PD-1/L1.
  • Epithelial ovarian cancer, fallopian tube, or primary peritoneal cancer with any high-grade serous component and immune-oncology (IO) treatment naive subjects with metastases progressed on or after platinum-containing therapy and are not eligible for further platinum-containing treatment. Patients must meet the following criteria:
    • platinum-refractory, platinum-resistant disease defined by progression of disease on a platinum-containing regimen or recurrence of disease within 180 days of receiving the last dose of platinum-based treatment;
    • must not have progressed during the first 3 months of first line platinum-based therapy or must not have progressed within 3 months after completing first line platinum-based therapy;
    • must not have evidence of bowel obstruction requiring hospitalization and decompression within the past 30 days;
    • must not have ascites that requires therapeutic paracentesis in the last 30 days;
    • must not have tumors with low malignant potential (ie. borderline tumors) or mucinous tumors.
    • Prior lines of therapy to include:
      • Patients must have had 1 to 3 prior lines of therapy including at least one bevacizumab-containing regimen or ineligible for all other available therapies; Or
      • Patients must be in the 4th or 5th line of treatment, irrespective of bevacizumab or who are ineligible for all therapies with demonstrated clinical benefit; Or
      • Patients with known BRCA-positive associated cancer or mutation, prior therapy must include PARP inhibitors (unless contraindicated)
    • At least one measurable lesion as defined by RECIST 1.1 solid tumors.
    • Available fresh metastatic biopsy sample prior to study entry and one mandatory on-treatment tumor biopsy, unless there is difficulty obtaining the sample (e.g., hard to reach tumors or biopsies requiring surgical intervention). Waiver of biopsy samples must be discussed with the medical monitor. Tumor biopsy samples collected should allow for sample preparation as detailed in the separate study-specific specimen preparation instructions.

All Subjects:

  • Males or females, of any race, age ≥ 18 years;
  • Be willing and able to provide written informed consent for the trial.
  • Eastern Cooperative Oncology Group Performance Status 0 or 1.
  • Subjects able to follow the requirements of the study protocol and complete the trial.
  • Women of childbearing potential must:
    • Agree to use at least 2 effective contraceptive methods (1 highly effective method in combination with a barrier method; oral, injectable, or implantable hormonal contraceptive; tubal ligation; intra-uterine device; barrier contraceptive with spermicide; or vasectomized partner), one of which must be barrier, from signing the ICF, throughout the study, and for up to 8 weeks following the last dose of TJ011133;
    • If using treatment with rituximab, women of childbearing potential should continue to use effective contraceptive methods for 12 months following treatment with rituximab;
    • If using treatment with pembrolizumab, women of childbearing potential should continue to follow contraceptive guidance during the treatment period and for at least 120 days after the last dose of study treatment;
    • Have a negative serum pregnancy test (sensitivity of at least 25 mIU/mL) at Screening; and have a negative serum or urine pregnancy test (Investigator’s discretion) within 72 hours prior to Cycle 1 Day -1 of study treatment (note that the screening serum pregnancy test can be used as the test prior to Day -1 study treatment if it is performed within the prior 72 hours);
    • Avoid conceiving for 8 weeks after the last dose of TJ011133;
    • Avoid donation of ova from signing the ICF until 8 weeks after the last dose of TJ011133 (12 months after the last dose of rituximab);
    • Agree to ongoing urine pregnancy testing, if clinically indicated, during the course of the study.
  • Males must agree to use a condom (a latex condom is recommended) during sexual contact with a pregnant female or a female of childbearing potential and will avoid donation of sperm or having a female partner conceive from the time of signing the ICF, while participating in the study, during dose interruptions, and for at least 90 days after the last dose of study treatment, even if he has undergone a successful vasectomy.
  • Subject with a QT interval corrected for heart rate using Fridericia's formula (QTcF) and/or QT interval corrected for heart rate using Bazett's formula of ≤ 450 msec for males, ≤ 470 msec for females.
  • No systemic anti-cancer therapy within 4 weeks of starting study treatment or at least 5 half-lives (whichever is shorter) before study drug administration, and all AEs have either resolved or stabilized.
    • Note: Participants who have entered the follow-up phase of an investigational study may participate as long as it has been 4 weeks after the last dose of the previous investigational agent.
  • A 28-day washout period after the completion of programmed death-1 (PD-1)/PD-L1 therapy.
  • Adequate bone marrow function in subjects with solid tumors, including the following:
    • Part 1
    • Absolute neutrophil count ≥ 1500/μL (≥ 1.5 × 10^9 /L) without growth factor support for 7 days (14 days if on pegfilgrastim);
    • Platelet ≥ 100 × 10^3μL (≥ 100 ×10^9 /L) without transfusion within 2 weeks of the first study drug administration;
    • Hemoglobin ≥ 9 g/dL without transfusion within 2 weeks of the first study drug administration;
    • Part 2
    • Absolute neutrophil count ≥ 1500/μL (≥ 1.5 × 10^9 /L) without growth factor support for 7 days (14 days if on pegfilgrastim);
    • Platelet ≥ 75 × 10^3μL (≥ 75 × 109 /L) without transfusion within 2 weeks of the first study drug administration;
    • Hemoglobin ≥ 8 g/dL without transfusion within 2 weeks of the first study drug administration.
    • Adequate bone marrow function in subjects with NHL, including:
    • Part 1
    • Absolute neutrophil count ≥1000/μL (≥ 1.0 × 10^9 /L) without growth factor support for 7 days (14 days if on pegfilgrastim);
    • Platelet ≥ 100 × 10^3μL (≥ 100 × 10^9 /L) without transfusion within 2 weeks of the first study drug administration;
    • Hemoglobin ≥ 9 g/dL without transfusion within 2 weeks of the first study drug administration;
    • Part 2
    • Absolute neutrophil count ≥1000/μL (≥ 1.0 × 10^9 /L) without growth factor support for 7 days (14 days if on pegfilgrastim);
    • Platelet ≥ 50 × 10^3μL (≥ 50 ×10^9 /L) without transfusion within 2 weeks of the first study drug administration. For sites in China, Platelet ≥ 75 × 10^3μL (≥ 50 ×10^9 /L) without transfusion within 2 weeks of the first study drug administration;
    • Hemoglobin ≥ 8 g/dL without transfusion within 2 weeks of the first study drug administration. For sites in China, Hemoglobin ≥ 9 g/dL without transfusion within 2 weeks of the first study drug administration.
  • Adequate renal function and serum creatine ≤ 1.5 × ULN or estimated serum creatinine clearance of ≥60 mL/min using the Cockcroft-Gault equation.
  • Adequate liver function, including:
    • Total serum bilirubin ≤ 1.5 × ULN (≤ 3.0 × ULN if the subject has documented Gilbert syndrome);
    • AST and ALT ≤ 2.5 × ULN; ≤ 5.0 × ULN (if there is liver tumor present).
  • Normal parameters within the following (unless the subject is receiving anticoagulant therapy):
    • Prothrombin Time ≤ 1.5 ULN, or 11 to 15 seconds in the absence of a normal range;
    • Partial thromboplastin time or activated partial thromboplastin time ≤ 1.5 × ULN;
    • International normalized ratio ≤1.5 × ULN.
  • Resolved acute effects of any prior therapy to baseline severity or Grade ≤ 1 NCI CTCAE version 5.0 except for AEs not constituting a safety risk by Investigator judgment


Exclusion Criteria:

  • Has known active CNS metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable; i.e., without evidence of progression for at least 4 weeks by repeat imaging (note that the repeat imaging should be performed during study screening), clinically stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment.
  • Subjects with Burkitt’s lymphoma, lymphoblastic lymphoma, Richter's transformation, primary effusion lymphoma or chronic lymphocytic leukemia/small lymphocytic lymphoma.
  • Subjects with mantle cell lymphoma with blastoid and TP53 alterations (applies to Part 1 only, all types of mantle cell lymphoma are excluded in Part 2).
  • Impaired cardiac function or clinically significant cardiac diseases, including any of the following:
    • Left ventricular ejection fraction 25% of the bone marrow (non-lymphoma subjects only), or any subject who has received prior radiotherapy within 2 weeks of the start of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (≤ 2 weeks of radiotherapy) to non-CNS disease. For NSCLC subjects, radiation therapy to the lung that is > 30 Gy within 6 months of the first dose of trial treatment is not allowed (Parts 1B and Part 2 in combination with pembrolizumab only).
  • Prior treatment with CD47 or SIRPα inhibitors;
  • A woman of childbearing potential who has a positive urine pregnancy test (e.g., within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Pregnant or nursing females or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 8 weeks for TJ011133, 120 days for pembrolizumab and 12 months for rituximab after the last dose of study treatment.
  • Has a diagnosis of immunodeficiency (known active human immunodeficiency virus, hepatitis B virus/hepatitis C virus infection) or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior the first dose of study drug.
  • Blood product transfusions within 14 days of Cycle 1 Day 1.
  • Prior autologous stem cell transplant ≤3 months prior to starting TJ011133.
  • Prior allogeneic stem cell transplant with either standard or reduced intensity conditioning.
  • Has received chimeric antigen receptor (CAR) or chimeric antigen receptor T-cell (CAR-T) therapy within 90 days of starting TJ011133 OR has received prior CAR or CAR-T therapy and progressed within 90 days of infusion.
  • Has received any experimental antibodies or a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (e.g., FluMist®) are live attenuated vaccines and are not allowed.
  • Received any vaccine within 7 days of planned start of study therapy. Exceptions may apply with SARS-CoV-2 (COVID-19) vaccine, I-Mab Biopharma will provide up-to-date guidance based on evolving current practices.
  • History of AIHA or autoimmune thrombocytopenia.
  • Any bleeding history within 6 months of planned start of study therapy.
  • Any of the following in the previous 12 months: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, transient ischemic attack, deep venous thrombosis, or pulmonary embolism.
  • Any other significant medical condition, laboratory abnormality, or psychiatric illness that places the subject at unacceptable risk or that would prevent the subject from complying with the study.
  • Second malignancy within the last 3 years (Part 2 dose expansion cohort only) with the exception of cutaneous squamous cell carcinoma or cutaneous basal cell carcinoma or cervical carcinoma in situ.
  • Active graft versus host disease (GVHD) or ongoing immunosuppression for GVHD.
  • Donation of blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.
  • Has severe hypersensitivity (≥ Grade 3) to pembrolizumab or rituximab and/or any of its excipients;
  • Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment and is allowed.
  • Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease.
  • Has an active infection requiring systemic therapy.
  • Not recovered (i.e., to ≤ Grade 1 or to baseline) from AEs emerging from previous treatments (except alopecia or neuropathy).
  • Incomplete recovery from AEs and/or major surgery (must be ≤ Grade 1).
  • History of a ≥ Grade 3 irAE with prior immunotherapy with the exception of non-clinically significant laboratory abnormalities.
  • Unwilling or unable to comply with study procedures (including follow-up procedures).

Eligibility last updated 1/19/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Drug, Administration of antineoplastic agent, Drug therapy, Immunotherapy for cancer
Bladder cancer, Cancer, Diffuse large b-cell lymphoma, Fallopian tube cancer, Lung cancer, Lymphoma, Non-Hodgkin's lymphoma, Non-small cell lung cancer, Ovarian cancer, Peritoneal cancer, Tumors and masses
Biological therapy for cancer, Cancer treatment, Carcinoma of fallopian tube, Carcinoma of peritoneum, Diffuse non-Hodgkin's lymphoma, large cell (clinical), Hematopoietic system, Malignant epithelial tumor of ovary, Malignant tumor of fallopian tube, Malignant tumor of urinary bladder, Medical Oncology, Non-small cell lung cancer, Pembrolizumab [USAN:INN], Primary malignant neoplasm of bladder, Primary malignant neoplasm of the peritoneum, Reproductive system, Respiratory system, Rituximab, Secondary malignant neoplastic disease, Solid tumor configuration, Targeted drug therapy, Urinary system, pembrolizumab, rituximab
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

ICP-CL-00107: A Phase I/II, Multicenter, Open-Label, Study of a Novel Bruton's Tyrosine Kinase Inhibitor, Orelabrutinib, in Patients With B-Cell Malignancies

A Study of Tyrosine Kinase Inhibitor ICP-022 in Patients With r/r B-Cell Malignancies

Yucai Wang
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
0000-101044-P01-RST
19-011461
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Signed Informed Consent.
  • All subjects must meet criteria for requiring therapy at time of enrollment (see treatment indications below).
  • Age ≥ 18 years.
  • Patients with histologically confirmed relapsed or refractory B-cell malignancies, including only patients with Grades 1-3a FL, MZL, MCL, and CLL/SLL.
  • Patient must had received ≥1 or ≤ 4 prior therapies with documented failure to achieve at least partial response, or disease progression after the most recent systemic treatment.
  • Patient must have ≥ 1 measurable lesion site on CT scan (nodal lesions must have an LDi > 15 mm; extranodal lesions must have an LDi > 10 mm). Lesions in anatomical locations (such as extremities or soft tissue lesions) that are not well visualized by CT may be measured by MRI instead (Subjects with spleen-only disease are considered as not having measurable disease).
  • Electrocorticogram(ECOG) performance status of 0 ~1.
  • Life expectancy (in the opinion of the investigator) of ≥ 4 months.
  • Adequate liver function at time of screening: Total bilirubin ≤ 2.0 x Upper Limit of Normal (ULN) (Patients with documented history of Gilbert's Syndrome and in whom total bilirubin elevations are accompanied by elevated indirect bilirubin are eligible); Aspartate aminotransferase (AST)/ Alanine Aminotransferase (ALT) ≤ 2.5 × ULN.
  • Coagulation test: at time of screening, international normalized ratio (INR) ≤ 1.5, and the activated partial thromboplastin time (APTT) ≤ 1.5× ULN.
  • Adequate hematological function at time of screening: complete blood count tests should be independent of support therapies (i.e., growth factors, or transfusion) and fulfill these criteria: neutrophil count ≥ 1.5 × 10^9 /L, platelet count ≥ 75 × 10^9/L, hemoglobin ≥ 80 g/L; if presence of bone marrow infiltration, neutrophil count ≥ 1.0 × 10^9 /L and platelet count ≥ 50× 10^9 /L.
  • Adequate renal function at time of screening: serum creatinine ≤ 1.5 × ULN or creatinine clearance by Cockcroft-Gault formula ≥ 60 mL/min.
  • Negative test results for Hepatitis B Virus(HBV) ([HBsAg (-)] and non-active HBV or Hepatitis C Virus(HCV) infection:
    • Patients who are positive for anti-Hepatitis B Virus core(anti-HBc) antibody must be negative for HBV DNA by Polymerase Chain Reaction (PCR) to be eligible for study participation;
    • Patients who are positive for HCV antibody must be negative for HCV RNA by PCR to be eligible for study participation.
  • Negative serum pregnancy test within 7 days prior to study treatment in women of childbearing potential. Women who are not of childbearing potential and who are considered to be postmenopausal (≥ 12 months of non-therapy amenorrhea) or surgically sterile (absence of ovaries and/or uterus) are not required to have a pregnancy test.
  • Patients must agree to either remain completely abstinent or to use two effective contraceptive methods that result in a failure rate of < 1 % per year from screening until (a) 1 month if the patient is a male or (b) 2 months if patient is a female after the last dose of Innocare Pharma-022(ICP-022).


Exclusion Criteria:

  • Pregnant or breast-feeding or intending to become pregnant during the study.
  • Prior treatment with systemic immunotherapeutic agents, including but not limited to cytokine therapy and anti-CTLA4, anti-Programmed death 1(anti-PD1) and anti- Programmed cell death 1 ligand 1(anti-PDL1) therapeutic antibodies, within 12 weeks or five half-lives of the drug, whichever is shorter, before first dose of ICP-022.
  • Treatment with any Bruton's tyrosine kinase inhibitor(BTKi), phosphatidylinositol 3 kinase( PI3Ki) or B-cell lymphoma-2(BCL-2) inhibitor.
  • Patients with known allergies to ICP-022 or its excipients.
  • Treatment with any chemotherapeutic agent, or treatment with any other investigational therapies including but not limited to anti-cancer agent (defined as treatment for which there is currently no regulatory authority approved indication) within 4 weeks prior to first dose of ICP-022.
  • History of allogeneic stem-cell (or other organ) transplantation.
  • Any external beam radiation therapy within 6 weeks prior to the first dose of the study drug.
  • Concurrent use of warfarin or other vitamin K antagonists or anticoagulation therapies.
  • Concurrent use of a strong Cytochrome P450 3A (CYP3A) inhibitor. Subjects who have received a strong CYP3A inhibitor prior to entering the study must have discontinued therapy for at least 5 half-lives of the prohibited medication.
  • Active uncontrolled infections.
  • Recent infection requiring IV anti-infective treatment that was completed ≤14 days before the first dose of study drug.
  • Known infection with HIV, seropositive status.
  • Unresolved toxicities from prior anti-cancer therapy, defined as having not resolved to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v5.0) ≤ Grade 1, or to the levels dictated in the eligibility criteria with the exception of alopecia.
  • Patient with history of confirmed progressive multifocal leukoencephalopathy (PML).
  • Medically apparent central nervous system(CNS) lymphoma or leptomeningeal disease.
  • Current or past history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease:
    • Patients with a history of stroke who have not experienced a stroke or transient ischemic attack in the past 2 years and have no residual neurologic deficits as judged by the investigator, are allowed;
    • Evidence of significant, uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results, including diabetes mellitus, history of relevant pulmonary disorders, abusing of alcohol or illegal drugs including non-prescribed marijuana within last 6 months from screening.
  • Major surgery or significant traumatic injury < 28 days prior to the first dose of ICP-022 (excluding biopsies) or anticipation of the need for major surgery during study treatment.
  • Patients with another invasive malignancy in the last 2 years (with the exception of basal cell carcinoma and tumors deemed by the investigator to be of low likelihood for recurrence).
  • Significant cardiovascular disease such as New York Heart Association (NYHA) Class III or IV cardiac disease, myocardial infarction within the last 6 months, unstable arrhythmias, or unstable angina).
  • Significant active pulmonary disease (e.g., bronchospasm and/or obstructive pulmonary disease).
  • Administration of a live, attenuated vaccine within 28 days before Cycle 1, Day 1 or anticipation that such a live attenuated vaccine will be required during the study.
  • Received systemic immunosuppressive medications (including but not limited to cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor agents) with the exception of corticosteroid treatment < 20 mg/day prednisone or equivalent within 7 days prior to first dose of ICP-022:
    • Inhaled and topical steroids are permitted.
  • Unable to swallow tablets or disease significantly affecting gastrointestinal function such as malabsorption syndrome, resection of the stomach or small bowel, symptomatic inflammatory bowel disease, or partial or complete bowel obstruction.
  • Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug.

Eligibility last updated 2/1/22. Questions regarding updates should be directed to the study team contact.

Drug
I'm interested
Share via email
Show 1 location
Hide all locations

Location Contacts
Mayo Clinic — Rochester, MN

Open label, multi-center, Phase 1b/2 clinical trial to evaluate the safety and efficacy of autologous CAR-BCMA T cells (CT053) in patients with relapsed and/or refractory multiple myeloma

Open-label, Multi-center, Phase 1b/2 Clinical Trial to Evaluate the Safety and Efficacy of Autologous CAR-BCMA T-cells (CT053) in Patients

Shaji Kumar
All
18 years to 80 years old
Phase 1/2
This study is NOT accepting healthy volunteers
0000-101045-P01-RST
19-007047
Show full eligibility criteria
Hide eligibility criteria

Inclusion Criteria:

  • Voluntarily signed consent.
  • Age of ≥ 18 and ≤ 80 years.
  • Received sufficient prior lines of myeloma therapy.
  • Received treatment with at least one proteasome inhibitor, one IMiD and daratumumab.
  • The patients should have measurable disease per IMWG definition.
  • Estimated life expectancy > 12 weeks.
  • ECOG performance score 0-1.
  • Patients should have reasonable CBC counts, renal and hepatic functions.
  • Sufficient venous access for leukapheresis collection, and no other contraindications to leukapheresis.
  • Women of childbearing age must undergo a serum pregnancy test with negative results before screening, and are willing to use effective and reliable method of contraception for at least 6 months after T cell infusion.
  • Men must be willing to use effective and reliable method of contraception for at least 6 months after T cell infusion.


Exclusion Criteria:

  • Pregnant or lactating women.
  • HIV, active hepatitis C virus (HCV), or active hepatitis B virus (HBV) infection.
  • Any uncontrolled active infection.
  • AEs from previous treatment that have not recovered.
  • Patients who have had anti-BCMA therapy.
  • Patients who have graft versus host disease (GvHD).
  • Patients have received stem cell transplantation less than 12 weeks before leukapheresis.
  • Patients have received any anti-cancer treatment before leukapheresis.
  • Patients have received steroids before leukapheresis or lymphodepletion.
  • Patients have plasma cell leukemia, Waldenström macroglobulinemia, POEMS (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes) syndrome or clinically significant symptomatic immunoglobulin light chain (AL) amyloidosis with evidence of end-organ damage.
  • Patients have been administered live attenuated vaccine before leukapheresis or lymphodepletion.
  • Patients allergic to Flu, Cy, tocilizumab, dimethyl sulfoxide (DMSO) or CT053 CAR BCMA T cell.
  • Patients have clinical significant cardiac conditions that researchers believe that participating in this clinical trial may endanger the health of the patients.
  • Patients have clinical significant pulmonary conditions.
  • Patients are known to have active autoimmune diseases including but not limited to psoriasis, rheumatoid arthritis and other needs of long-term immunosuppressive therapy.
  • Patients with second malignancies in addition to MM are not eligible.
  • Patients have central nervous system (CNS) metastases or CNS involvement.
  • Patients have significant neurologic disorders.
  • Patients are unable or unwilling to comply with the requirements of clinical trial.

Eligibility last updated 11/24/21. Questions regarding updates should be directed to the study team contact.

 

    Biologic/Vaccine, Administration of antineoplastic agent, Drug therapy, Immunotherapy for cancer
    Cancer, Multiple myeloma, Plasma cell disorders
    Biological therapy for cancer, Cancer treatment, Hematopoietic system, Immune system, Medical Oncology, Ningetinib, Relapse multiple myeloma, Cellular therapy
    I'm interested
    Share via email
    Show 1 location
    Hide all locations

    Location Contacts
    Mayo Clinic — Rochester, MN

    EAA173, Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)

    A Study to Evaluate Lenalidomide and Dexamethasone, with or without Daratumumab, in Treating High-Risk Smoldering Myeloma Patients

    Taxiarchis Kourelis
    All
    18 years and over
    Phase 3
    This study is NOT accepting healthy volunteers
    0000-101050-P01-RST
    19-006110
    Show full eligibility criteria
    Hide eligibility criteria

    Inclusion Criteria:
     

     

    • Patient must be ≥ 18 years of age.                    
    • Patient must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 12 months. High-risk is defined by the presence of 2 or more of the following factors:
      • Abnormal serum free light chain (FLC) ratio of involved to uninvolved >20, but less than 100 if the involved FLC is >10 mg/dL by serum FLC assay;
      • Serum M-protein level > 2 gm/dL;
      • Presence of t(4;14) or del 17p or 1q gain by conventional cytogenetics or FISH studies;
      • > 20% plasma cells on biopsy or aspirate;
    • A bone marrow aspirate and/or biopsy is required to be performed within 28 days prior to randomization and must demonstrate 10-59% clonal plasma cells.
      1.  
    • Patient must have measureable disease as defined by having one or more of the following, obtained within 28 days prior to randomization:
      • ≥ 1 g/dL on serum protein electrophoresis;
      • ≥ 200 mg of monoclonal protein on a 24 hour urine protein electrophoresis.
    • NOTE: In the rare situation where the SPEP is felt to be unreliable, then quantitative immunoglobulin levels on nephelometry or turbidometry can be accepted. SPEP, UPEP, and serum FLC are required to be performed within 28 days prior to randomization.
    • NOTE:      UPEP (on a 24-hour collection) is required; no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is ≥ 200 mg/24 hr, and urine in addition to serum must be followed in order to confirm a VGPR or higher response.
    • Patient must have no lytic lesions, no known plasmacytoma, and no unexplained hypercalcemia (i.e., > 11 mg/dL or 1mg/dL above ULN). Specifically, local interpretation of MRI and PET scans will be used to exclude lytic lesions or plasmacytomas and must be obtained within 60 days prior to randomization.
    • Patient must not have known COPD with FEV1 < 50% or known moderate or severe persistent asthma within 2 years prior to randomization.
    • Patient must have adequate organ and marrow function as defined below (obtained within 28 days prior to randomization):
      • Hemoglobin ≥ 11 g/dL;
      • Platelet count ≥ 100,000 cells/mm^3;
      • Absolute neutrophil count ≥ 1500 cells/mm^3;
      • Calculated creatinine clearance ≥ 30 mL/min;
      • Bilirubin ≤ 1.5 mg/dL;
      • SGPT (ALT) and SGOT (AST) ≤ 2.5 times the upper limit of normal.
    • Patient must not have any prior or concurrent systemic or radiation therapy for the treatment of myeloma. Patient must also not have contraindication to DVT prophylaxis/aspirin.
    • Patient must not have more than one focal marrow lesion on MRI of either pelvis or spine.
    • Concurrent use of erythropoietin is not allowed while on study therapy.
    • Prior or glucocorticosteroid therapy for the treatment of multiple myeloma is not permitted.
    • Prior systemic glucocorticosteroid use for the treatment of non-malignant disorders is permitted; concurrent use after registration on the study should be restricted to the equivalent of prednisone 10 mg per day. Prior or concurrent topical or localized glucocorticosteroid therapy to treat non-malignant comorbid disorders is permitted.
    • Patient must not have active, uncontrolled seizure disorder. Patient must not have had a seizure in the last 6 months.
    • Patient must not have uncontrolled intercurrent illness including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would limit compliance with the study, or a prior history of Stevens Johnson Syndrome.
    • Patient must have an ECOG performance status 0, 1, or 2.
    • Patients with monoclonal gammopathy of undetermined significance are not eligible.
    • Patient must not have Grade 2 or higher peripheral neuropathy per CTCAE.
    • Patient must not have active, uncontrolled infection.
    • Patient may have a history of current or previous deep vein thrombosis or pulmonary embolism but are required to take some form of anti-coagulation as prophylaxis if they are not currently on full- dose anticoagulation.
    • Patient should not have New York Heart Association classification III or IV heart failure at baseline.
    • Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for cure of the specific cancer.
    • Patient must agree to register into the mandatory REMS program and be willing and able to comply with the requirements of REMS.
    • Women must not be pregnant due to potential harm to the fetus from Daratumumab and Lenalidomide. All females of childbearing potential (FCBP) must have a blood test or urine study with a sensitivity of at least 25 mIU/mL within 10-14 days prior to the first dose of lenalidomide and again within 24 hours prior to the first dose of lenalidomide. FCBP must also agree to ongoing pregnancy testing while on treatment. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
      • has achieved menarche at some point;
      • has not undergone a hysterectomy or bilateral oophorectomy; or
      • has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
      • Females of childbearing potential (FCBP) must either abstain from sexual intercourse for the duration of their participation in the study or agree to use TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for 1) at least 28 days before starting study treatment; 2) while participating in the study; 3) during dose interruptions; and 4) for at least 28 days after the last dose of protocol treatment (FCBP who are assigned to Arm A and receive daratumumab must extend this contraception requirement to 3 months after the last dose of protocol treatment). Women must also agree to not breastfeed during this same time period. Men must agree to either abstain from sexual intercourse for the duration of their participation in the study or use a latex condom during sexual contact with a FCBP while participating in the study and for 28 days after the last dose of protocol treatment even if they have had a successful vasectomy (Men assigned to Arm A and receive daratumumab must extend this contraception requirement to 3 months after the last dose of protocol treatment).
      • Men must also agree to abstain from donating sperm while on study treatment and for 28 days after the last dose of protocol treatment even if they have had a successful vasectomy. Both women and men must both agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment.
      • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial. 
      • Patient should not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to daratumumab, lenalidomide, or dexamethasone.
      • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
      • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.

     

    Biologic/Vaccine, Drug, Other, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Immunotherapy for cancer
    Cancer, Multiple myeloma, Plasma cell disorders
    Biological therapy for cancer, Cancer treatment, Chemotherapy, Daratumumab [USAN:INN], Dexamethasone, Hematopoietic system, Immune system, Lenalidomide, Medical Oncology, Smoldering myeloma, Targeted drug therapy, daratumumab, dexamethasone, lenalidomide
    I'm interested
    Share via email
    Show 1 location
    Hide all locations

    Location Contacts
    Mayo Clinic — Rochester, MN

    EAA173, Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER-SMM)

    A Study to Evaluate Lenalidomide and Dexamethasone, with or without Daratumumab, in Treating High-Risk Smoldering Myeloma Patients

    Mina Hanna
    All
    18 years and over
    Phase 3
    This study is NOT accepting healthy volunteers
    0000-101050-P01-ALCL
    19-006110
    Show full eligibility criteria
    Hide eligibility criteria

    Inclusion Criteria:
     

     

    • Patient must be ≥ 18 years of age.                    
    • Patient must be diagnosed with asymptomatic high-risk smoldering multiple myeloma (SMM) within the past 12 months. High-risk is defined by the presence of 2 or more of the following factors:
      • Abnormal serum free light chain (FLC) ratio of involved to uninvolved >20, but less than 100 if the involved FLC is >10 mg/dL by serum FLC assay;
      • Serum M-protein level > 2 gm/dL;
      • Presence of t(4;14) or del 17p or 1q gain by conventional cytogenetics or FISH studies;
      • > 20% plasma cells on biopsy or aspirate;
    • A bone marrow aspirate and/or biopsy is required to be performed within 28 days prior to randomization and must demonstrate 10-59% clonal plasma cells.
      1.  
    • Patient must have measureable disease as defined by having one or more of the following, obtained within 28 days prior to randomization:
      • ≥ 1 g/dL on serum protein electrophoresis;
      • ≥ 200 mg of monoclonal protein on a 24 hour urine protein electrophoresis.
    • NOTE: In the rare situation where the SPEP is felt to be unreliable, then quantitative immunoglobulin levels on nephelometry or turbidometry can be accepted. SPEP, UPEP, and serum FLC are required to be performed within 28 days prior to randomization.
    • NOTE:      UPEP (on a 24-hour collection) is required; no substitute method is acceptable. Urine must be followed monthly if the baseline urine M-spike is ≥ 200 mg/24 hr, and urine in addition to serum must be followed in order to confirm a VGPR or higher response.
    • Patient must have no lytic lesions, no known plasmacytoma, and no unexplained hypercalcemia (i.e., > 11 mg/dL or 1mg/dL above ULN). Specifically, local interpretation of MRI and PET scans will be used to exclude lytic lesions or plasmacytomas and must be obtained within 60 days prior to randomization.
    • Patient must not have known COPD with FEV1 < 50% or known moderate or severe persistent asthma within 2 years prior to randomization.
    • Patient must have adequate organ and marrow function as defined below (obtained within 28 days prior to randomization):
      • Hemoglobin ≥ 11 g/dL;
      • Platelet count ≥ 100,000 cells/mm^3;
      • Absolute neutrophil count ≥ 1500 cells/mm^3;
      • Calculated creatinine clearance ≥ 30 mL/min;
      • Bilirubin ≤ 1.5 mg/dL;
      • SGPT (ALT) and SGOT (AST) ≤ 2.5 times the upper limit of normal.
    • Patient must not have any prior or concurrent systemic or radiation therapy for the treatment of myeloma. Patient must also not have contraindication to DVT prophylaxis/aspirin.
    • Patient must not have more than one focal marrow lesion on MRI of either pelvis or spine.
    • Concurrent use of erythropoietin is not allowed while on study therapy.
    • Prior or glucocorticosteroid therapy for the treatment of multiple myeloma is not permitted.
    • Prior systemic glucocorticosteroid use for the treatment of non-malignant disorders is permitted; concurrent use after registration on the study should be restricted to the equivalent of prednisone 10 mg per day. Prior or concurrent topical or localized glucocorticosteroid therapy to treat non-malignant comorbid disorders is permitted.
    • Patient must not have active, uncontrolled seizure disorder. Patient must not have had a seizure in the last 6 months.
    • Patient must not have uncontrolled intercurrent illness including uncontrolled hypertension, symptomatic congestive heart failure, unstable angina, uncontrolled cardiac arrhythmia, uncontrolled psychiatric illness or social situation that would limit compliance with the study, or a prior history of Stevens Johnson Syndrome.
    • Patient must have an ECOG performance status 0, 1, or 2.
    • Patients with monoclonal gammopathy of undetermined significance are not eligible.
    • Patient must not have Grade 2 or higher peripheral neuropathy per CTCAE.
    • Patient must not have active, uncontrolled infection.
    • Patient may have a history of current or previous deep vein thrombosis or pulmonary embolism but are required to take some form of anti-coagulation as prophylaxis if they are not currently on full- dose anticoagulation.
    • Patient should not have New York Heart Association classification III or IV heart failure at baseline.
    • Patients with a history of prior malignancy are eligible provided they were treated with curative intent and have been free of disease for the time period considered appropriate for cure of the specific cancer.
    • Patient must agree to register into the mandatory REMS program and be willing and able to comply with the requirements of REMS.
    • Women must not be pregnant due to potential harm to the fetus from Daratumumab and Lenalidomide. All females of childbearing potential (FCBP) must have a blood test or urine study with a sensitivity of at least 25 mIU/mL within 10-14 days prior to the first dose of lenalidomide and again within 24 hours prior to the first dose of lenalidomide. FCBP must also agree to ongoing pregnancy testing while on treatment. A female of childbearing potential is defined as any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria:
      • has achieved menarche at some point;
      • has not undergone a hysterectomy or bilateral oophorectomy; or
      • has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).
      • Females of childbearing potential (FCBP) must either abstain from sexual intercourse for the duration of their participation in the study or agree to use TWO acceptable methods of birth control, one highly effective method and one additional effective method AT THE SAME TIME for 1) at least 28 days before starting study treatment; 2) while participating in the study; 3) during dose interruptions; and 4) for at least 28 days after the last dose of protocol treatment (FCBP who are assigned to Arm A and receive daratumumab must extend this contraception requirement to 3 months after the last dose of protocol treatment). Women must also agree to not breastfeed during this same time period. Men must agree to either abstain from sexual intercourse for the duration of their participation in the study or use a latex condom during sexual contact with a FCBP while participating in the study and for 28 days after the last dose of protocol treatment even if they have had a successful vasectomy (Men assigned to Arm A and receive daratumumab must extend this contraception requirement to 3 months after the last dose of protocol treatment).
      • Men must also agree to abstain from donating sperm while on study treatment and for 28 days after the last dose of protocol treatment even if they have had a successful vasectomy. Both women and men must both agree to abstain from donating blood during study participation and for at least 28 days after the last dose of protocol treatment.
      • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial. 
      • Patient should not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to daratumumab, lenalidomide, or dexamethasone.
      • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
      • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.

     

    Biologic/Vaccine, Drug, Other, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Immunotherapy for cancer
    Cancer, Multiple myeloma, Plasma cell disorders
    Biological therapy for cancer, Cancer treatment, Chemotherapy, Daratumumab [USAN:INN], Dexamethasone, Hematopoietic system, Immune system, Lenalidomide, Medical Oncology, Smoldering myeloma, Targeted drug therapy, daratumumab, dexamethasone, lenalidomide
    I'm interested
    Share via email
    Show 1 location
    Hide all locations

    Location Contacts
    Mayo Clinic Health System — Albert Lea, MN

    GOG-3026: A Phase II Trial of Ribociclib (LEE011) Plus Letrozole in Women With Recurrent Low-Grade Serous Carcinoma of the Ovary, Fallopian Tube or Peritoneum

    A Study to Evaluate Ribociclib Plus Letrozole to Treat Cancer of the Ovary, Fallopian Tube or Peritoneum

    Saravut Weroha
    Female
    18 years and over
    Phase 2
    This study is NOT accepting healthy volunteers
    0000-101051-P01-RST
    19-007632
    Show full eligibility criteria
    Hide eligibility criteria

    Inclusion Criteria:

    • Patient has signed the Informed Consent (ICF) prior to any screening procedures being performed and is able to comply with protocol requirements. 
    • Age > 18 years at time of study entry. 
    • Willingness and ability to comply with study and follow-up procedures. 
    • Histological confirmation of diagnosis of low-grade serous carcinoma of ovary, fallopian tube or peritoneum; original diagnosis of de novo low-grade serous carcinoma or original diagnosis of serous borderline tumor with subsequent diagnosis of low-grade serous carcinoma:
      • In order to prevent inclusion of patients with high-grade serous carcinoma, diagnosis of low-grade serous carcinoma will be verified as part of screening review by a gynecologic pathologist. Tissue for confirmation can be from primary tumor or recurrence.
    • Patient must have recurrent, measurable disease by RECIST v1.1. 
    • There are no restrictions on number of prior therapies. 
    • Patient cannot have previously received a prior cyclin dependent kinase inhibitor (CDKi). Patients who were treated with letrozole or another aromatase inhibitor for other indications must have not taken the drug for 6 months prior to initiating letrozole for this trial and may not have progressed on treatment.
    • Patients must not have remaining ovarian function to be included. In women who have at least one retained ovary, menopause must be confirmed with laboratory confirmation. Women who have ovarian function are eligible but must be placed on hormonal suppression. Menopause must be confirmed with laboratory confirmation, to include an estradiol level as this is assessed within 8 weeks of patient having been on tamoxifen. 
    • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-2.
    • Resolution of all acute toxic effects of prior therapy or surgical procedures to National Cancer Institute (NCI) CTCAE Grade ≤ 1. 
    • Patient has adequate bone marrow and organ function as defined by the following laboratory values at screening:
      • Absolute neutrophil count ≥ 1.5 × 10^9/L;
      • Platelets ≥ 100 × 10^9/L;
      • Hemoglobin ≥ 9.0 g/dL;
      • Potassium, total calcium (corrected for serum albumin), magnesium, sodium and phosphorus within normal limits for the institution or corrected to within normal limits with supplements before first dose of study medication;
      • INR ≤ 1.5;
      • Serum creatinine < 1.5 mg/dL or creatinine clearance ≥ 50 mL/min;
      • In the absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN. If the patient has liver metastases, ALT and AST < 5 x ULN;
      • Total bilirubin < ULN or total bilirubin ≤ 3.0 x ULN or direct bilirubin ≤ 1.5 x ULN in patients with well-documented Gilbert's Syndrome.
    • Patient with available standard 12-lead ECG with the following parameters at screening: 
      • QTcF interval at screening < 450msec (using Fridericia's correction);
      • Resting heart rate 50-90 bpm.
    • Must be able to swallow ribociclib and letrozole capsules/tablets.
    • Patients receiving tamoxifen or toremifine must have washout period of 5 half-lives prior to randomization.


    Exclusion Criteria:

    • Patient has a known hypersensitivity to any of the excipients of ribociclib or letrozole. 
    • Patient has a concurrent malignancy or malignancy within 3 years prior to starting study drug, with the exception of adequately treated, basal or squamous cell carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer. Patients with known brain metastases are excluded.
    • Patients with central nervous system (CNS) involvement unless they meet ALL of the following criteria:
      • At least 4 weeks from prior therapy completion (including radiation and/or surgery) to starting the study treatment;
      • Clinically stable CNS tumor at the time of screening and not receiving steroids and/or enzyme inducing anti-epileptic medications for brain metastases.
    • Patient has impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of the study drugs (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
    • Patient has a known history of HIV infection (testing not mandatory).
    • Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the investigator’s judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical study or compromise compliance with the protocol (e.g., chronic pancreatitis, chronic active hepatitis, active untreated or uncontrolled fungal, bacterial or viral infections, etc.). 
    • Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormalities, including any of the following:
      • History of acute coronary syndromes (including myocardial infarction, unstable angina, coronary artery bypass grafting, coronary angioplasty, or stenting) or symptomatic pericarditis within 6 months prior to screening;
      • History of documented congestive heart failure (New York Heart Association functional classification III-IV);
      • Documented cardiomyopathy;
      • Left Ventricular Ejection Fraction (LVEF) < 50% as determined by Multiple Gated acquisition (MUGA) scan or echocardiogram (ECHO);
      • Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia), complete left bundle branch block, high-grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block);
      • Long QT syndrome or family history of idiopathic sudden death or congenital long QT syndrome, or any of the following: 
        • Risk factors for Torsades de Pointe (TdP) including uncorrected hypocalcemia, hypokalemia or hypomagnesemia, history of cardiac failure, or history of clinically significant/symptomatic bradycardia;
        • Concomitant use of medication(s) with a known risk to prolong the QT interval and/or known to cause Torsades de Pointe that cannot be discontinued (within 5 halflives or 7 days prior to starting study drug) or replaced by safe alternative medication;
        • Inability to determine the QT interval on screening (QTcF, using Fridericia’s correction);
        • Systolic blood pressure (SBP) >160 mmHg or <90 mmHg at screening;
    • Patient is currently receiving any of the following medications and cannot be discontinued 7 days prior to starting study drug:
      • Known strong inducers or inhibitors of CYP3A4/5, including grapefruit, grapefruit hybrids, pummelos, star-fruit, and Seville oranges;
      • That have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5;
      • Herbal preparations/medications, dietary supplements.
    • Participation in other studies involving investigational drug(s) within 30 days prior to randomization or within 5 half-lives of the investigational product (whichever is longer) or participation in any other type of medical research judged not to be scientifically or medically compatible with this study. If the patient is
      enrolled or planned to be enrolled in another study that does not involve an investigational drug, the agreement of Novartis study medical lead is required to establish eligibility.
    • Patient is currently receiving warfarin or other coumadin-derived anticoagulant for treatment, prophylaxis or otherwise. Therapy with heparin, low molecular weight heparin (LMWH) or fondaparinux is allowed. Direct-Acting Oral Anticoagulants (DOACS) are permitted. 
    • Patient is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting study drug, or who have not fully recovered from side effects of such treatment. The following uses of corticosteroids are permitted: a short duration (<5 days) of systemic corticosteroids; any duration of topical applications (e.g., for rash), inhaled sprays (e.g., for obstructive airways diseases), eye drops or local injections (e.g., intra-articular).
    • Patient who has received radiotherapy ≤ 4 weeks or limited field radiation for palliation ≤ 2 weeks prior to starting study drug, and who has not recovered to grade 1 or better from related side effects of such therapy (exceptions include alopecia) and/or in whom ≥25% of the bone marrow (Ellis, 1961) was irradiated.
    • Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major side effects (tumor biopsy is not considered as major surgery).
    • Patient with a Child-Pugh score B or C.
    • Patients who are pregnant or breastfeeding. 
    • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception throughout the study and for 3 weeks after study drug discontinuation. Highly effective contraception methods include:
      • Total abstinence when this is in line with the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of
        contraception;
      • Female sterilization (have had surgical bilateral oophorectomy with or without hysterectomy), total hysterectomy, or tubal ligation at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment.
    • Women are considered post-menopausal and not of child bearing potential if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., age appropriate, history of vasomotor symptoms) or have had surgical bilateral oophorectomy (with or without hysterectomy) or tubal ligation at least six weeks ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment is she considered not of child bearing potential.
    • Current use of food or drugs known to be potent CYP3A4 inhibitors, drugs known to be potent CYP3A4 inducers, and drugs that are known to prolong the QT interval unless the prohibited concomitant medication can be replaced by other drugs of less potential to inhibit or induce CYP3A4 or prolong QT interval
    • Patients whose tumors contain both low-grade serous carcinoma (LGSC) and high-grade serous carcinoma (HGSC).
    • Patients with history of haemopoietic stem cell or bone marrow transplant.
    Drug, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Hormone therapy
    Cancer, Fallopian tube cancer, Ovarian cancer, Peritoneal cancer, Recurrent cancer
    Cancer treatment, Chemotherapy, Extraovarian primary peritoneal carcinoma, Letrozole, Malignant tumor of fallopian tube, Medical Oncology, Primary low grade serous adenocarcinoma of ovary, Recurrent ovarian cancer, Reproductive system, Ribociclib [USAN:INN], letrozole, ribociclib
    I'm interested
    Share via email
    Show 1 location
    Hide all locations

    Location Contacts
    Mayo Clinic — Rochester, MN

    (ECTx) HPN536-2001: A Phase 1/2a Open-label, Multicenter, Dose Escalation and Dose Expansion Study of the Safety, Tolerability, and Pharmacokinetics of HPN536 in Patients with Advanced Cancers Associated with Mesothelin Expression Who Have Failed Standard Available Therapy

    Study of HPN536 in Patients with Advanced Cancers Associated With Mesothelin Expression

    Andrea Wahner Hendrickson
    All
    18 years and over
    Phase 1/2
    This study is NOT accepting healthy volunteers
    0000-101055-P01-RST
    19-006158
    Show full eligibility criteria
    Hide eligibility criteria

    Inclusion Criteria:

    • Patients ≥ 18 years of age.
    • One of the following progressive advanced or metastatic cancers:
      • Epithelial ovarian, fallopian tube, or primary peritoneal cancer (Part 1 and Part 2, Group 1 only) that is platinum refractory or platinum resistant;
      • Pancreatic adenocarcinoma (Part 2, Group 2 only) that is locally advanced, and now with progressive disease on or after front-line treatment;
      • Malignant mesothelioma with epithelioid histology, pleural or primary peritoneal (Part 2, Group 3 only) that is progressive disease following frontline platinum-based chemotherapy;
      • For Part 2 only
        •Measurable disease according to RECIST v1.1 for patients with epithelial ovarian, fallopian tube, or primary peritoneal cancer, pancreatic adenocarcinoma, and peritoneal mesothelioma, and mRECIST v1.1 for patients with pleural mesothelioma;
      • Available archival tissue sample or fresh biopsy tissue sample must be obtained prior to enrollment;
      • For patients previously treated with systemic chemotherapy, targeted therapy, immunotherapy, or treatment with an investigational anticancer agent, discontinuation must have occurred ≥ 2 weeks, or at least 5 half-lives, whichever is longer, prior to start of study drug. The maximum washout period will not exceed 4 weeks;
      • ECOG performance status of 0 or 1;
      • Adequate bone marrow function, including:
        • Absolute neutrophil count (ANC) ≥ 1500/mm^3 or ≥ 1.5 x 10^9/L;
        • Platelets ≥ 100,000/mm3 or ≥ 100 x 10^9/L;
        • Hemoglobin (Hgb) ≥ 0 g/dL.
      • Adequate renal function, including estimated creatinine clearance ≥ 50 mL/min;
      • Adequate liver function, including:
        • Total serum bilirubin ≤ 1.5 x upper limit of normal (ULN) unless the patient has documented Gilbert syndrome in which case the maximum total serum bilirubin should be < 5 mg/dL;
        • Aspartate and alanine transaminase (AST and ALT) ≤ 2.5 x ULN or AST/ALT ≤ 5 x ULN for patients with liver metastases.
      • Serum albumin ≥ 30 mg/mL.


    Exclusion Criteria:

    • Previously treated or current brain metastases.
      • Note: Patients with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry and have no evidence of new or enlarging brain metastases.
    • Concurrent treatment with anti- TNFα therapies, systemic corticosteroids, or other immune suppressive drugs within the 2 weeks prior to Screening.
    • History of or known or suspected autoimmune disease.
    • History of clinically significant cardiovascular disease.
    • Second primary malignancy that has not been in remission for greater than 3 years.
    • Pulmonary, hematologic, renal, hepatic, gastrointestinal, neurological or psychiatric disease that would limit compliance with study requirements
    Biologic/Vaccine, Administration of antineoplastic agent, Drug therapy
    Cancer
    Biological therapy for cancer, Cancer treatment, Gene expression, Malignant neoplastic disease, Medical Oncology, Cellular therapy
    I'm interested
    Share via email
    Show 1 location
    Hide all locations

    Location Contacts
    Mayo Clinic — Rochester, MN

    J2G-MC-JZJB A Multicenter, Randomized, Open-label, Phase 3 Trial Comparing Selpercatinib to Physicians Choice of Cabozantinib or Vandetanib in Patients With Progressive, Advanced, Kinase Inhibitor Naïve, RET-Mutant Medullary Thyroid Cancer (LIBRETTO-531) (J2G-MC-JZJB)

    A Study of Selpercatinib to Treat Participants with RET-Mutant Medullary Thyroid Cancer

    John Morris
    All
    12 years and over
    Phase 3
    This study is NOT accepting healthy volunteers
    0000-101059-P01-RST
    19-006266
    Show full eligibility criteria
    Hide eligibility criteria

    Inclusion Criteria:

    • Are of an acceptable age to provide informed consent according to local regulations and are at least 18 years of age (patients as young as 12 years of age will be allowed if permitted by local regulatory authorities and institutional review boards).
      • All patients of 12 years of age and older, after giving assent / legally designated representative/ participant written consent.
    • Histologically or cytologically confirmed, unresectable, locally advanced and/or metastatic MTC and no prior history of treatment with kinase inhibitors for advanced/metastatic disease. Patients with mixed histology (e.g., incidental papillary thyroid cancer identified at the time of resection) are eligible if MTC is the dominant histology. Prior systemic or radiation therapy in the adjuvant setting may be allowed with discussion and approval by the Lilly medical team.
    • Radiographic progressive disease per RECIST 1.1 (Eisenhauer et al. 2009) at screening compared with a previous image taken within the prior 14 months as assessed by the BICR. Patients with measurable or non-measurable but evaluable disease are eligible; however, patients with non-measurable disease may not have disease limited to bone sites only.
    • A RET gene alteration identified in a tumor, germline DNA or blood sample (e.g., cfDNA). The RET alteration result should be generated from a laboratory with CLIA, ISO/IEC, CAP, or other similar certification. Lilly should be contacted to discuss test results from labs where such certification is not clearly demonstrated to determine eligibility; if certification is not required in the patient’s country, the Sponsor may allow enrollment using a result from a non-certified lab if sufficient evidence can be provided as to the accuracy of the result. A positive germline test for a RET mutation is acceptable given the test was determined by internal institutional quality standards and performed for clinical evaluation. In all cases, a redacted Molecular Pathology Report or other report(s) describing RET (and any co-occurring findings, if applicable) alteration analysis should be submitted to Lilly or designee during/prior to eligibility.
      • Mandatory provision of an unstained, archived tumor tissue sample in a quantity sufficient to allow for retrospective central analysis of RET mutation status (for confirmation). 
    • Eastern Cooperative Oncology Group (ECOG) performance status score (Oken et al. 1982) of zero to two.
    • Ability to swallow capsules and comply with treatment, laboratory monitoring, and required clinic visits for the duration of study participation.
    • Patients must have discontinued from previous treatments as shown below and fully recovered.  Consult with the Lilly medical team for the appropriate length of time prior to the first dose of study treatment on additional therapies not mentioned.
    • Patients must have normal serum potassium, calcium, and magnesium levels (may be receiving supplements.
    • Men with partners of childbearing potential or women of childbearing potential must agree to use a highly effective contraceptive method (for example, intrauterine device [IUD], birth control pill, or barrier method) during treatment with study drug and for 4 months following the last dose of study drug.
      • Note: Unless not allowed by local regulations, women of childbearing potential who are abstinent (if this is complete abstinence, as their preferred and usual lifestyle) or in a same-sex relationship (as part of their preferred and usual lifestyle) must agree to either remain abstinent or stay in a same-sex relationship without sexual relationships with males unless they agree to use contraceptive method known to be highly effective. Periodic abstinence (e.g., calendar, ovulation, symptothermal, postovulation methods), declaration of abstinence just for the duration of a trial, and withdrawal are not acceptable methods of contraception.
    • Women of childbearing potential must:
      • have a negative pregnancy test (serum or urine, consistent with local regulations) documented within 24 hours prior to treatment with study drug;
      • not be breast-feeding during treatment and for at least 4 months after the last dose of study drug.
    • Capable of giving signed informed assent/consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.


    Exclusion Criteria:

    • An additional validated oncogenic driver in MTC if known that could cause resistance to selpercatinib treatment. Examples include, but are not limited to RAS or BRAF gene mutations and NTRK gene fusions.
    • Symptomatic CNS metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression. Patients are eligible if neurologically stable and without increase in steroid dose for 14 days prior to the first dose of study treatment and no CNS surgery or radiation has been performed for 28 days, 14 days if stereotactic radiosurgery (SRS).
    • Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of study treatment, history of Torsades de pointes, or prolongation of the QT interval corrected for heart rate using Fridericia’s formula (QTcF) > 470 msec on more than one ECG during Screening. Correction of suspected drug-induced QTcF prolongation may be attempted at the investigator’s discretion if clinically safe to do so.  Patients who are intended to receive vandetanib if randomized to the control arm ineligible if QTcF is > 450 msec.
      • Note: Patients with implanted pacemakers may enter study without meeting QTc criteria due to nonevaluable measurement if QT changes are considered monitorable;
      • Note:  Patients with bundle branch block may be considered for study entry if QTc is appropriate by a formula other than Fridericia’s and if QT changes are considered monitorable.
    • Active uncontrolled systemic bacterial, viral, or fungal infection or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment, a clinical diagnosis or symptoms of interstitial lung disease, or other serious medical conditions which in the medical judgment of the investigator would prevent the patient from safely participating (screening for chronic conditions is not required).
    • Clinically significant active malabsorption syndrome or other condition likely to affect gastrointestinal absorption of the study drug.
    • Uncontrolled symptomatic hyperthyroidism or hypothyroidism
    • Uncontrolled symptomatic hypercalcemia or hypocalcemia
    • Active hemorrhage or at significant risk for hemorrhage.
    • Other malignancy unless nonmelanoma skin cancer, carcinoma in situ or malignancy diagnosed ≥ 2 years previously and not currently active.  Patients receiving adjuvant hormone therapy for breast or prostate cancer with no evidence of disease are eligible. Participants with MEN2-associated pheochromocytoma are eligible if the pheochromocytoma is, in the opinion of the investigator, documented to be stable or has been resected (and patient has fully recovered from surgery).
    • Prior systemic treatment with kinase inhibitor(s)
    • Are taking a concomitant medication that is known to cause QTc prolongation.
    • Have participated, within the last 30 days (4 months for studies conducted in Japan; 3 months for studies conducted in the UK), in a clinical study involving an investigational product.  If the previous investigational product has a long half-life, 5 half-lives or 30 days (4 months for studies conducted in Japan; 3 months for studies conducted in the UK) (whichever is longer) should have passed.  Exceptions will be considered on a case by case basis by the Lilly medical team.
    • Life expectancy ≤ 3 months
    • Have a known hypersensitivity to any of the excipients of selpercatinib, cabozantinib, or vandetanib.

    Eligibility last updated 10/27/21.  Questions regarding updates should be directed to the study team contact.

    Drug
    I'm interested
    Share via email
    Show 1 location
    Hide all locations

    Location Contacts
    Mayo Clinic — Rochester, MN

    S1803, Phase III Study of Daratumumab/rHuPH20 (NSC-810307) Lenalidomide or Lenalidomide as Post-Autologous Stem Cell Transplant Maintenance Therapy in Patients With Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study) (DRAMMATIC)

    A Study to Evaluate Daratumumab/rHuPh20 +/- Lenalidomide as Post-ASCT Maintenance for Multiple Myeloma with Minimal Residual Disease (MRD) to Direct Therapy Duration

    Rahma Warsame
    All
    18 years to 75 years old
    Phase 3
    This study is NOT accepting healthy volunteers
    0000-101060-P01-RST
    19-009968
    Show full eligibility criteria
    Hide eligibility criteria

    Registration Step 1
    •Study Entry Post-Induction and Pre-Maintenance

    • Except where otherwise indicated below that test is required in a shorter timeframe, all tests for establishing baseline disease status must be completed within 60 days prior to registration. All test results must be documented on the Baseline Tumor Assessment Form for Multiple Myeloma and the Onstudy Form.

    Inclusion Criteria:

    • Patients must have had a confirmed diagnosis of symptomatic multiple myeloma that required systemic induction therapy prior to autologous stem cell transplantation (ASCT). Patients with smoldering myeloma are not eligible. Patients with purely nonsecretory MM as measured by electrophoresis and immunofixation and the absence of Bence Jones proteins in the urine are not eligible.
    • Patients must have measurable M protein in the serum (defined as ≥ 0.5g/dL) or urine (defined as ≥ 200 mg/24h). Patients with plasma cell leukemia are not eligible. Patients with disease measurable by serum light chain assay alone are eligible (defined as ≥ 100 mg/L on involved light chain).
    • Patients must not have any organ involvement by amyloidosis or evidence of amyloidosis related organ dysfunction.
    • Patients must not have progressive disease at any time prior to registration.
    • Patients must not be refractory to either lenalidomide or daratumumab/rHuPH20. 
    • Patients must not be intolerant to either lenalidomide or daratumumab/rHuPH20.
    • Patients must have initiated induction therapy within 12 months prior to registration Step 1 and have received at least two cycles of induction therapy.
    • Patients must be registered to Step 1 prior to registration to Step 2. Registration to Step 1 may take place prior to or after autologous stem cell transplant (ASCT), but after completion of induction therapy.
    • Patients must not have received any investigational agents within 14 days prior to registration.
    • Patients must be willing and able to take DVT prophylaxis (aspirin, low molecular weight heparin, warfarin, or equivalent oral anticoagulation).
    • Patients must be ≥ 18 and ≤ 75 years of age at time of registration to Step 1.
    • Patients must have history and physical exam within 28 days prior to registration.
    • Patients must have Zubrod Performance Status ≤ 2.
    • Patients must have evidence of adequate renal function, as defined by:
      • creatinine clearance (CrCl) ≥ 30 mL/min., as measured by a 24-hour urine collection, or estimated by the Cockcroft and Gault formula; or
      • serum creatinine < 2.5 mg/dL. Values must be obtained within 28 days prior to registration. Estimated creatinine clearance = (140
        •age) x wt (kg) x 0.85 (if female) 72 x creatinine (mg/dl).
    • Patients must have adequate hepatic function defined by the following within 42 days prior to registration:
      • Total bilirubin ≤ 1.5 x IULN (institutional upper limit of the norm); AND
      • AST and ALT ≤ 3.0 x IULN o. Patients must not have chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) < 50% of predicted normal. FEV1 is required for patients suspected of having chronic obstructive pulmonary disease and are not eligible if FEV1 is < 50% of predicted normal. p. Patients must not have moderate or severe persistent asthma within the past 2 years and must not have currently uncontrolled asthma of any classification.
    • Patients must meet one of the following criteria:
      • Be acceptable for transplant per institutional guidelines and the criteria evidencing this must be documented on the S1803 Onstudy Form; OR
      • Note that these are guidelines and not required criteria.)
      • Have completed autologous stem cell transplant within 180 days prior to registration.
    • Patients must not have had prior autograft or allograft, or prior organ transplant requiring immunosuppressive therapy.
    • Patient’s with human immunodeficiency virus (HIV) are eligible providing they are on effective antiretroviral therapy and have undetectable viral load at their most previous viral load test and within 6 months prior to registration.
    • Patients must not have known allergy to any of the study drugs.
    • Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment are not eligible.
    • Patients must not have known central nervous system (CNS) involvement with multiple myeloma, defined as CSF positivity for plasma cells at any time or a parenchymal CNS plasmacytoma at time of enrollment. Lumbar puncture is not required.
    • Patients must not be seropositive for hepatitis C (except in the setting of sustained virologic response, defined as undetectable viral load at least 12 weeks after completion of antiviral therapy). HCV testing is only required if clinically indicated or if the patient has a history of HCV.
    • Patients must be able to take and swallow oral medication (capsules) whole. Patients may not have any known impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of study drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
    • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years. 
    • Patients must not have any uncontrolled intercurrent illness including (not limited to):
      • Symptomatic CHF (NYHA III/IV), unstable angina pectoris or coronary angioplasty, or stenting within 6 months prior to registration, Unstable cardiac arrhythmia (ongoing cardiac dysrhythmias of NCI CTCAE v5.0 Grade ≥ 2), intracardiac defibrillators, known cardiac metastases, or abnormal cardiac valve morphology (≥ Grade 3), or known psychiatric illness that would limit study compliance.
    • For patients who have not yet received transplant:
      • Patients must be willing and able to return to the transplant center for their assigned treatment after randomization. Note that patients need not have a direct relationship with the transplant center in order to register.
    • Patients must submit specimens for MRD.  Note that patients are not ineligible based solely on archival specimens being unavailable.
    • Patients must be offered participation in specimen banking for future research. 
    • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
    • As a part of the OPEN registration process the treating institution's identity is provided in order to ensure that the current (within 365 days) date of institutional review board approval for this study has been entered in the system.


    Exclusion Criteria:

    • Patients with smoldering myeloma are not eligible. Patients with purely non-secretory MM as measured by electrophoresis and immunofixation and the absence of Bence Jones proteins in the urine are not eligible. Patients must have measurable M protein in the serum (defined as ≥ 0.5g/dL) or urine (defined as ≥ 200 mg/24h). Patients with plasma cell leukemia are not eligible.
    • Patients must not have any organ involvement by amyloidosis or evidence of amyloidosis related organ dysfunction.
    • Patients must not have progressive disease at any time prior to registration.
    • Patients must not be refractory to either lenalidomide or daratumumab/rHuPH20.
    • Patients must not be intolerant to either lenalidomide or daratumumab/rHuPH20.
    • Patients must not have received any investigational agents within 14 days prior to registration.
    • Patients must not have chronic obstructive pulmonary disease with a forced expiratory volume in 1 second (FEV1) < 50% of predicted normal. FEV1 is required for patients suspected of having chronic obstructive pulmonary disease and are not eligible if FEV1 is < 50% of predicted normal.
    • Patients must not have moderate or severe persistent asthma within the past 2 years and must not have currently uncontrolled asthma of any classification.
    • Patients must not have had prior autograft or allograft, or prior organ transplant requiring immunosuppressive therapy.
    • Patients must not have known allergy to any of the study drugs.
    • Patients with uncontrolled bacterial, viral or fungal infections (currently taking medication and with progression or no clinical improvement) at time of enrollment are not eligible.
    • Patients must not have known central nervous system (CNS) involvement with multiple myeloma, defined as CSF positivity for plasma cells at any time or a parenchymal CNS plasmacytoma at time of enrollment. Lumbar puncture is not required.
    • Patients must not be seropositive for hepatitis C (except in the setting of sustained virologic response, defined as undetectable viral load at least 12 weeks after completion of antiviral therapy). HCV testing is only required if clinically indicated or if the patient has a history of HCV.
    • No other prior malignancy is allowed except for the following: adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, adequately treated Stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for three years.
    • Patients must not have any uncontrolled intercurrent illness including (not limited to): Symptomatic CHF (NYHA III/IV), unstable angina pectoris or coronary angioplasty, or stenting within 6 months prior to registration, Unstable cardiac arrhythmia (ongoing cardiac dysrhythmias of NCI CTCAE v5.0 Grade ≥ 2), intra-cardiac defibrillators, known cardiac metastases, or abnormal cardiac valve morphology (≥ Grade 3), or known psychiatric illness that would limit study compliance.

    Registration Step 2 - First Randomization (Post-ASCT, Pre-Maintenance)

    Inclusion Criteria:

    • Patients must have completed ASCT within 180 days prior to registering to Step 2.
    • Patients must not have received any other maintenance therapy post-ASCT and prior to Step 2 registration.
    • Patients must not have had progressive disease between induction and registration to Registration Step 2.
    • Patients must have one of the following performed within 60 days prior to registration for disease assessment: diagnostic quality skeletal survey, whole body CT scan, MRI, or PET.
    • Patients must have Zubrod Performance Status ≤ 2 f. Patients must have adequate bone marrow function as evidenced by platelets ≥ 75,000/mm^3 and ANC ≥ 1,000/mm^3 within 28 days prior to first randomization:
    • Patients must have adequate hepatic function defined by the following within 28 days prior to first randomization:
      • Total bilirubin ≤ 1.5 x IULN (institutional upper limit of the norm) AND 2. AST and ALT ≤ 3.0 x IULN.
    • Patients must have evidence of adequate renal function, as defined by creatinine clearance (CrCl) ≥ 30 mL/min., as measured by a 24-hour urine collection, or estimated by the Cockcroft and Gault formula, or have a serum creatinine < 2.5 mg/dL within 28 days prior to first randomization. Estimated creatinine clearance = (140
      •age) x wt (kg) x 0.85 (if female) 72 x creatinine (mg/dl).
    • All ASCT-related toxicities must have recovered to ≤ Grade 1 (except for alopecia, fatigue and amenorrhea) prior to first randomization. 
    • Mucositis and gastrointestinal symptoms must have resolved to ≤ Grade 1.
    • Females of childbearing potential (FCBP) must have a negative serum or urine pregnancy test with a sensitivity of at least 25 mIU/mL within 10-14 days prior to registration. FCBP must agree to have a second pregnancy test within 24 hours prior to starting Cycle 1. Further, FCBP must either commit to continued abstinence from heterosexual intercourse or begin TWO acceptable methods of birth control: one highly effective method and one additional effective method AT THE SAME TIME, at least 28 days before starting lenalidomide. FCBP must also agree to ongoing pregnancy testing and must agree to not become pregnant for at least 3 months after the last dose of study treatment. A FCBP is a female who:
      • has achieved menarche (first menstrual cycle) at some point;
      • has not undergone a hysterectomy (the surgical removal of the uterus) or bilateral oophorectomy (the surgical removal of both ovaries); or
      • has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time during the preceding 24 consecutive months). Men must agree to use a latex condom during sexual contact with a FCBP, even if they have had a successful vasectomy, during the study treatment and for 3 months after the last dose of study treatment.
    • Patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.


    Exclusion Criteria:

    • Patients must not have received any other maintenance therapy post-ASCT and prior to Step 2 registration.
    • Patients must not have had progressive disease between induction and registration to Registration Step 2.

    Registration Step 3
    •Second Randomization (Post 24 Months Maintenance)

      Inclusion Criteria:

      • Patients must have completed 24 cycles of protocol maintenance with either lenalidomide or lenalidomide + daratumumab/rHuPH20.
      • Patients must have 24-month MRD by NGS test results available and must be MRD negative. Patients whose PCR results are indeterminable will be considered to have positive results.
      • Patients must be in very good partial remission (VGPR) or better by IMWG response criteria.
      Biologic/Vaccine, Drug
      I'm interested
      Share via email
      Show 1 location
      Hide all locations

      Location Contacts
      Mayo Clinic — Rochester, MN

      TED16132, An Open-label, First-in-human, Single Agent, Dose-escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR442085 in Patients With Relapsed or Refractory Multiple Myeloma (RRMM)

      A Study of SAR442085 in Relapsed or Refractory Multiple Myeloma

      Prashant Kapoor
      All
      18 years and over
      Phase 1
      This study is NOT accepting healthy volunteers
      0000-101086-P01-RST
      19-008701
      Show full eligibility criteria
      Hide eligibility criteria

      Inclusion Criteria:
       

      • Participant must be at least 18 years of age or of the country's legal age of majority if the legal age is >18 years old at the time of signing the informed consent. 
      • Participant has given voluntary written informed consent. 
      • Participant has been previousy diagnosed with multiple myeloma based on standard criteria. 
      • Part A:
        • Participant has received at least 3 prior lines of therapy for multiple myeloma, or at least 2 prior lines of therapy if at least 1 of those lines consisted of 2 or more multi-agent regimens (eg, multi-agent induction regimen with autologous stem cell transplantation, followed by maintenance regimen). 
        • Prior therapy for multiple myeloma has included at least 1 proteasome inhibitor (bortezomib, carfilzomib, ixazomib), at least 1 immunomodulatory agent (lenalidomide, thalidomide, pomalidomide), at least 1 anti-CD38 monoclonal antibody and at least 1 steroid. 
        • Participant had at least a minimal response (MR) to the anti-CD38 antibody containing regimen and had last dose of anti-CD38 monoclonal antibody at least 9 months prior to study entry, except the last cohort(s) of Part A who are anti CD38 naïve. 
      • Part B and the last cohort(s) of Part A:
        • Participant has received at least 3 prior lines of therapy for multiple myeloma, or at least 2 prior line of therapy if at least 1 of those lines consisted of 2 or more multi-agent regimens (eg, multi-agent induction regimen with autologous stem cell transplantation, followed by maintenance regimen).
        • Prior therapy for multiple myeloma has included at least 1 proteasome inhibitor (bortezomib, carfilzomib, ixazomib), at least 1 immunomodulatory agent (lenalidomide, thalidomide, pomalidomide) and at least 1 steroid.
        • Prior therapy has not included an anti-CD38 monoclonal antibody. 
      • Participant has myeloma disease progression on or after last therapy. 
      • Participant must have measurable disease as defined as at least one of the following: 
        • Serum M protein ≥0.5 g/dL (≥5 g/L);
        • Urine M protein ≥200 mg/24 hours;
        • Serum FLC assay: Involved FLC assay ≥10 mg/dL (≥100 mg/L) and an abnormal serum;
        • FLC ratio (<0.26 or >1.65). 
      • A male participant must agree to use contraception during the intervention period and for at least 150 days after the last dose of study drug and refrain from donating sperm during this period.
      • A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies: 
        • Not a woman of childbearing potential (WOCBP);
        • A WOCBP who agrees to follow the contraceptive guidance during the intervention period and for at least 150 days after the last dose of study intervention.


      Exclusion Criteria:
       

      • Participant is diagnosed or treated for another malignancy within 3 years prior to enrollment, with the exception of basal cell carcinoma or squamous cell carcinoma of the skin, an in situ malignancy, superficial bladder carcinoma or low risk prostate cancer. 
      • Participant has an Eastern Cooperative Oncology Group (ECOG) performance status score > 2.
      • Participant has a history of Chronic obstructive pulmonary disease (COPD) or asthma. 
      • Participant has not recovered from adverse reactions to prior myeloma treatment or procedures (chemotherapy, immunotherapy, radiation therapy) to NCI CTCAE Grade ≤1 or baseline (exception: alopecia).
      • Participant has congestive heart failure (New York Heart Association) Grade ≥ II; cardiac myopathy, active ischemia, or any other uncontrolled cardiac condition such as angina pectoris, clinically significant arrhythmia requiring therapy including anticoagulants, or clinically significant uncontrolled hypertension, QT interval corrected by the Fridericia method > 480 msec (Grade ≥ 2). 
      • Participant has had acute myocardial infarction within 6 months before first dose of study medication. 
      • Participant has ongoing sensory or motor neuropathy of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade ≥ 3. 
      • Participant has active autoimmune disease including autoimmune hemolytic anemia, idiopathic thrombocytopenic purpura, inflammatory bowel syndrome, pneumonitis or any chronic condition requiring a higher corticosteroid systemic equivalent than prednisone 10 mg daily.
      • Known acquired immunodeficiency syndrome (AIDS) or related illnesses or human immunodeficiency virus (HIV) disease requiring antiretroviral treatment, or to have active hepatitis A, B (defined as a known positive hepatitis B surface antigen (HBsAg) result or positive HepB DNA), or C (defined as a known quantitative hepatitis C [HCV] ribonucleic acid RNA results greater than the lower limits of detection of the assay or positive HCV antigen) infection.
      • Participant has positive Coombs test at baseline. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
      Drug, Administration of antineoplastic agent, Drug therapy
      Cancer, Multiple myeloma, Plasma cell disorders
      Cancer treatment, Hematopoietic system, Immune system, Medical Oncology, Relapse multiple myeloma, Targeted drug therapy
      I'm interested
      Share via email
      Show 1 location
      Hide all locations

      Location Contacts
      Mayo Clinic — Rochester, MN

      NRG-GY018, A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475, NSC #776864) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer

      A Study to Test the Addition of the Immunotherapy Drug Pembrolizumab to the Usual Chemotherapy Treatment (Paclitaxel and Carboplatin) in Stage III-IV or Recurrent Endometrial Cancer

      Andrea Wahner Hendrickson
      Female
      18 years and over
      Phase 3
      This study is NOT accepting healthy volunteers
      0000-101089-P01-RST
      19-007266
      Show full eligibility criteria
      Hide eligibility criteria

      Inclusion Criteria:
       

      • Women and minorities may be included.
      • Measurable stage III, measurable stage IVA, stage IVB (with or without measurable disease) or recurrent (with or without measurable disease) endometrial cancer.
      • Pathology report showing results of institutional MMR IHC testing.
      • Histologic confirmation of the original primary tumor is required (submission of pathology report[s] is required). Patients with the following histologic types are eligible:
        • Endometrioid adenocarcinoma, serous adenocarcinoma, undifferentiated carcinoma, clear cell adenocarcinoma, mixed epithelial carcinoma, adenocarcinoma not otherwise specified (N.O.S.). 
      • Submission of tumor specimens for centralized MMR IHC testing is required after Step 1 and before Step 2 registration.
      • In patients with measurable disease (stage III and IVA), lesions will be defined and monitored by RECIST version (v) 1.1. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded). Each lesion must be ≥ 10 mm when measured by computed tomography (CT) or magnetic resonance imaging (MRI). Lymph nodes must be 15 mm in short axis when measured by CT or MRI. 
      • Patients may have received:
        • NO prior chemotherapy for treatment of endometrial cancer; OR 
        • Prior adjuvant chemotherapy (e.g., paclitaxel/carboplatin alone or as a component of concurrent chemotherapy and radiation therapy [with or without cisplatin]) provided adjuvant chemotherapy was completed  ≥ 12 months prior to STEP 2 registration. 
      • Patients may have received prior radiation therapy for treatment of endometrial cancer. Prior radiation therapy may have included pelvic radiation therapy, extended field pelvic/para aortic radiation therapy, and/or intravaginal brachytherapy. All radiation therapy must be completed at least 4 weeks prior to STEP 2 registration. 
      • Patients may have received prior hormonal therapy for treatment of endometrial cancer. All hormonal therapy must be discontinued at least three weeks prior to STEP 2 registration. 
      • Age ≥ 18 years.
      • Performance status of 0, 1 and 2. 
      • Hematologic Function:
        • Platelets ≥ 100,000/mcl;
        • Absolute neutrophil count (ANC) ≥ 1,500/mcl.
      • Renal Function:
        • Creatinine ≤ 1.5 x institutional/laboratory upper limit of normal (ULN).
      • Hepatic Function:
        • Total serum bilirubin level ≤ 1.5 x upper limit of normal (ULN) (patients with known Gilbert's disease who have bilirubin level ≤ 3 x ULN may be enrolled);
        • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 x ULN. 
      • Thyroid stimulating hormone (TSH) within normal limits (TSH < ULN allowed in euthyroid patients on thyroid replacement therapy). 
      • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of Step 2 registration are eligible for this trial. 
      • For patients of child bearing potential: negative urine or serum pregnancy test within 72 hours prior to Step 2 registration. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test is required. 
      • Administration of study drugs (pembrolizumab, paclitaxel, carboplatin) may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality. Women of childbearing potential (WOCBP) must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) from up to 14 days prior to Step 2 registration (for oral contraceptives), during treatment, and for 120 days after the last dose of study medication. Should a woman become pregnant or suspect she is pregnant while she is participating in this study, she should inform her treating physician immediately. Patients will be considered of nonreproductive potential if they are either: 
        • Postmenopausal (defined as at least 12 months with no menses without an alternative medical cause; in women < 45 years of age, a high follicle stimulating hormone (FSH) level in the postmenopausal range may be used to confirm a postmenopausal state in women not using hormonal contraception or hormonal replacement therapy;In the absence of 12 months of amenorrhea, a single FSH measurement is insufficient); OR 
        • Have a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy or bilateral tubal ligation/occlusion, at least 6 weeks prior to Step 2 registration; OR 
        • Have a congenital or acquired condition that prevents childbearing. 
      • Patients with a prior or current malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessent of the investigational regimen are eligible for this trial
      • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry and, for patients treated in the United States (U.S.), authorization permitting release of personal health information.


      Exclusion Criteria:
       

      • Patients with prior treatment with anti-PD-1, anti-PD-L1 or anti-CTLA-4 therapeutic antibody or other similar agents.
      • Patients who have a history of a severe hypersensitivity reaction to monoclonal antibody or pembrolizumab (MK-3475) and/or its excipients.
      • Patients who are currently participating and receiving cancer-directed study therapy or have participated in a study of an investigational agent and received cancer-directed study therapy within 4 weeks prior to Step 2 registration.
      • Patients who have a diagnosis of immunodeficiency or are receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to Step 2 registration:
        • Patients who have received steroids as CT scan contrast premedication may be enrolled;
        • The use of inhaled or topical corticosteroids is allowed;
        • The use of mineralocorticoids (e.g., fludrocortisone) for patients with orthostatic hypotension or adrenocortical insufficiency is allowed;
        • The use of physiologic doses of corticosteroids may be approved after consultation with the study chair.
      • Patients with treated brain metastases are eligible if follow-up brain imaging after central nervous system (CNS)-directed therapy shows no evidence of progression, and they have been off steroids for at least 4 weeks prior to Step 2 registration and remain clinically stable.
      • Patients with active autoimmune disease or history of autoimmune disease that might recur, which may affect vital organ function or require immune suppressive treatment including systemic corticosteroids. This includes, but is not limited to, patients with a history of immune related neurologic disease, multiple sclerosis, autoimmune (demyelinating) neuropathy, Guillain-Barre syndrome, myasthenia gravis; systemic autoimmune disease such as systemic lupus erythematosus (SLE), connective tissue diseases, scleroderma, inflammatory bowel disease (IBD), Crohn's, ulcerative colitis, hepatitis; and patients with a history of toxic epidermal necrolysis (TEN), Stevens-Johnson syndrome, or phospholipid syndrome because of the risk of recurrence or exacerbation of disease.
      • Patients with vitiligo, endocrine deficiencies including type I diabetes mellitus, thyroiditis managed with replacement hormones including physiologic corticosteroids are eligible.
      • Patients with rheumatoid arthritis and other arthropathies, Sjogren's syndrome and psoriasis controlled with topical medication and patients with positive serology, such as antinuclear antibodies (ANA), anti-thyroid antibodies should be evaluated for the presence of target organ involvement and potential need for systemic treatment but should otherwise be eligible.
      • Patients who have a history of (non-infectious) pneumonitis that required steroids, or current pneumonitis.
      • Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection (except for uncomplicated UTI), interstitial lung disease or active, non-infectious pneumonitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
      • Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; and cirrhosis:
        • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated;
        • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
      • Pregnant or lactating patients.
      Biologic/Vaccine, Drug, Other, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Immunotherapy for cancer
      Cancer, Endometrial cancer, Recurrent cancer
      Biological therapy for cancer, Cancer treatment, Carboplatin, Chemotherapy, Infinnium, Medical Oncology, Pembrolizumab [USAN:INN], Primary malignant neoplasm of endometrium, Recurrent malignant neoplastic disease, Reproductive system, carboplatin, paclitaxel, pembrolizumab
      I'm interested
      Share via email
      Show 1 location
      Hide all locations

      Location Contacts
      Mayo Clinic — Rochester, MN