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MC1841: Phase II Study of Niraparib and TSR-042 in Patients with Germline or Somatic BRCA1/2 and PALB2-related Pancreatic Cancer

A Study to Evaluate Niraparib and TSR-042 in Patients with Germline or Somatic BRCA1/2 and PALB2-related Pancreatic Cancer

Robert McWilliams
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-100409-P01-RST
18-003525
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Inclusion Criteria
•Registration:

  • Presence of either a germline deleterious mutation or somatic deleterious mutation in any one of the genes in our proposed gene-panel as determined by any of the commercially available or institutional testing platforms.
    • Note: The somatic mutation could be either on a tissue-based test or the circulating tumor DNA (ctDNA)-based assay. The 6 genes that would determine eligibility would be: BRCA1/2, PALB2, BARD1, RAD51c, RAD51d.
  • Provide written informed consent.
  • Age ≥ 18 years.
  • Histological/cytological confirmation of diagnosis of metastatic pancreatic ductal adenocarcinoma.
  • At least one but no more than two prior lines of systemic therapy for metastatic disease (maintenance therapy is not considered a line of treatment).
    • Note: Patients who have not had any prior chemotherapy can refuse chemotherapy and be considered eligible. This refusal and their reason for refusal would have to be documented.
  • Received a platinum agent as part of first or second line treatment (unless contraindicated).
  • ECOG performance status of 0 or 1.
  • Adequate hematologic and end-organ function as evidenced by the following ≤14 days prior to registration:
    • Serum creatinine ≤1.5 x ULN or eGFR ≥60mL/min using the Cockroft-Gault Equation;
    • Hemoglobin ≥9.0 g/dL;
    • Absolute neutrophil count ≥1500/μL;
    • Platelets ≥100x109/L;
    • Total bilirubin ≤1.5 x ULN, (2.0 x ULN for subjects with Gilbert’s disease);
    • Aspartate Transaminase (AST) and Alanine Transaminase (ALT) ≤2.5x ULN (for subjects with hepatic metastases ≤5 x ULN);
      • Note: One time repeat testing to meet eligibility is allowed. If more testing is required, discuss with PI.
    • International normalized ratio (INR) or prothrombin time (PT) ≤1.5× ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin (PTT) is within therapeutic range of intended use of anticoagulants. Activated partial thromboplastin time (aPTT) ≤1.5× ULN unless patient is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants.
  • Evaluable or measurable disease per iRECIST.
  • Life expectancy of ≥ 3 months.
  • Willingness to consent to translational studies.
  • Willingness to undergo repeat biopsies of tumor lesions amenable to biopsy.
  • Note: While biopsies are mandatory, subjects are allowed to participate if no lesions are amenable to biopsy, or if biopsy is not possible due to safety.
  • Willingness to not donate blood during the study or for 90 days after the last dose of study treatment.
  • Willingness to not breastfeed during the study or for 90 days after the last dose of study treatment.
  • Negative pregnancy test done ≤ 7 days prior to registration, for persons of childbearing potential only.

Exclusion Criteria
•Registration:

  • Known hypersensitivity to any component of study treatments (either niraparib and/or TSR-042 or similar medications).
  • Prior treatment with the combination of PARP inhibition and immunotherapy (either CTLA-4 or anti-PD1/PD-L1 therapies). Prior treatment consisting of monotherapy with either PARP inhibitors and/or with immunotherapy are allowed. Treatment with PARPi or PD1 inhibitor as the most recent treatment prior to enrollment is not allowed.  
  • Patient experienced ≥ Grade 3 immune-related AE with prior immunotherapy, with the exception of non-clinically significant lab abnormalities.
  • Radiotherapy ≤ 2 weeks prior to first study treatment or radionuclide treatment ≤ 4 weeks of first study treatment.
  • Live attenuated vaccine administration within 30 days prior to registration and/or expected during study period.
  • Known brain metastases, uncontrolled seizure disorder, or active neurologic disease which in the opinion of the investigator would impede participation within the trial. Subjects with treated brain metastases are allowed to enroll.
  • Allogenic bone marrow transplantation or high-dose chemotherapy requiring hematopoietic stem cell rescue.
  • Received a transfusion (platelets or red blood cells) ≤ 4 weeks prior to registration.
    • Note: patients are also deemed ineligible if they have received a transfusion ≤ 4 weeks prior to first dose of niraparib.
  • Received colony‑stimulating factors (e.g., granulocyte colony-stimulating factor, granulocyte macrophage colony‑stimulating factor, or recombinant erythropoietin) ≤ 4 weeks prior to registration.
    • Note: patients are also deemed ineligible if they have received colony‑stimulating factors ≤ 4 weeks prior to first dose of niraparib.
  • Known Grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment.
  • Known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) ≤ 4 weeks since receiving treatment with another investigational drug, or anti-cancer therapy, or within a time interval less than at least 5 half-lives of the investigational agent (whichever is shorter), or insufficient recovery (to the judgement of the investigator) from adverse events due to such a previously administered agent, except for alopecia prior to initiating protocol therapy. Bisphosphonate therapy and RANKL inhibitors are not considered anti-cancer therapy.
  • Inadequate recovery from toxicity and/or complications from previous interventions, including due to major surgery to the judgement of the investigator. Minor surgery allowed up to 3 weeks from registration.
  • Primary or secondary immunodeficiency, including immunosuppressive disease, and immunosuppressive doses of corticosteroids (e.g., prednisone > 20 mg per day during 2 weeks prior to first study treatment) or other immunosuppressive medications at dose levels that to the judgement of the investigator would preclude participation within the past 4 weeks prior to registration. Subjects with HIV who are stable on highly active antiretroviral therapy (HAART) will not be excluded.
  • Participant has known active hepatitis B (e.g., hepatitis B surface antigen [HBsAg] reactive) or hepatitis C (e.g., hepatitis C virus [HCV] ribonucleic acid [qualitative] is detected).
  • Pregnant or lactating.
  • Clinically significant, active, bacterial infections that, to the judgement of the investigator makes it undesirable for the subject to participate in the study.
  • Persons of childbearing potential (POCBP) or those capable of causing pregnancy whose sexual partners are POCBP who are unwilling or unable to use an effective method of contraception for at least 1 month prior to study entry, for the duration of the study, and for at least 180 days after the last dose of study drug.
  • Nonchildbearing potential is defined as follows (by other than medical reasons):
    • ≥ 45 years of age and has not had menses for >1 year;
    • Patients who have been amenorrhoeic for < 2 years without history of a hysterectomy and oophorectomy must have a follicle stimulating hormone value in the postmenopausal range upon screening evaluation;
    • Post-hysterectomy, post-bilateral oophorectomy, or post-tubal ligation. Documented hysterectomy or oophorectomy must be confirmed with medical records of the actual procedure or confirmed by an ultrasound. Tubal ligation must be confirmed with medical records of the actual procedure, otherwise the patient must be willing to use an adequate barrier method throughout the study, starting with the screening visit through 180 days after the last dose of study treatment. Information must be captured appropriately within the site’s source documents. Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.
  • History or active TB (Bacillus Tuberculosis) that in the investigator’s opinion would preclude participation within the study.
  • Any gastro-intestinal conditions that to the judgement of the investigator would interfere with the absorption of niraparib.
  • Active, known or suspected unstable auto-immune disease, are excluded from this study. Exceptions to this criterion are all auto-immune disease that have remained stable within the past 3 months on corticosteroids (≤ prednisone 20 mg or equivalent) prior to first study treatment are allowed to enroll. Patients with autoimmune diseases that do not require active immunosuppression are also allowed to enroll.
    • Note:   Paraneoplastic disease as a cause of auto-immune phenomenon will not be considered as auto-immune disease and are allowed to enroll.
  • Evidence of serious uncontrolled medical disorder, active infection or mental disorder that, to the judgement of the investigator, makes it undesirable for the subject to participate in the study or that would jeopardize compliance with the protocol. Examples include, but are not limited to, uncontrolled ventricular arrhythmia, recent (within 90 days) myocardial infarction, uncontrolled major seizure disorder, unstable spinal cord compression, superior vena cava syndrome, or any psychiatric disorder that prohibits obtaining informed consent.
  • Prior malignancy which required active systemic treatment within 2 years prior to first study treatment. Exceptions are: successfully treated squamous cell carcinoma of the skin, superficial bladder cancer, and in situ carcinoma of the cervix. Since patients with BRCA 1/2 or PALB2 can have other tumors, as long as they have been definitively treated, it would not be considered an exclusion.
Administration of antineoplastic agent, Chemotherapy, Drug therapy, Immunotherapy for cancer, Drug
Cancer, Pancreatic cancer
niraparib, Biological therapy for cancer, Cancer treatment, Chemotherapy, Digestive system, Dostarlimab [USAN], MDX-1106, Medical Oncology, Pancreatic ductal adenocarcinoma, Secondary malignant neoplasm of pancreatic duct, Somatic mutation, Targeted drug therapy
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Mayo Clinic — Rochester, MN

NRG-HN004, Randomized Phase II/III Trial of Radiotherapy With Concurrent MEDI4736 (Durvalumab) vs. Radiotherapy With Concurrent Cetuximab in Patients With Locoregionally Advanced Head and Neck Cancer With a Contraindication to Cisplatin (NRG-HN004)

Radiation Therapy with Durvalumab or Cetuximab to Treat Patients with Locoregionally Advanced Head and Neck Cancer who Cannot Take Cisplatin

Katharine Price
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
0000-100422-P01-RST
18-002902
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Inclusion Criteria:

PRIOR TO STEP 1 REGISTRATION INCLUSION CRITERIA

  • Patients must have pathologically confirmed, previously untreated, unresected squamous cell carcinoma of the larynx, hypopharynx, oropharynx, oral cavity, or carcinoma of unknown head/neck primary prior to step 1 registration; submission of hematoxylin and eosin (H&E) stained slides and formalin-fixed and paraffin-embedded (FFPE) tissue block (or punch biopsy of FFPE block) to the biospecimen bank at University of California, San Francisco (UCSF) for central review for oropharyngeal and unknown primaries and for p16 analysis for all other non-oropharyngeal primaries is mandatory for all patients; investigators should check with their pathology department regarding release of biospecimens before approaching patients about participation in the trial; for oropharyngeal and unknown primaries, submission of H&E and p16 stained slides (with the required block for PD-L1) to the biospecimen bank at UCSF for central review is also required prior to step 2 registration.
    • Note: fine needle aspirates (FNA) samples are not acceptable since they do not provide enough material for PD-L1 and p16 testing; however, if a cell block derived from the FNA is available, it is allowable if there are sufficient cells present in the block for PD-L1 testing; Dr. Jordan will determine this upon receipt; for sites submitting FNA cell blocks for ALL patients they must do so within 7-10 business days from registering the patient; sites must confirm with their cytology/pathology labs to make sure they can provide the required material as the bank must be able to retain these samples for the mandatory testing.
  • Patients must have locoregionally advanced head and neck squamous cell carcinoma (HNSCC).
  • For p16-positive oropharyngeal/unknown primaries, American Joint Committee on Cancer [AJCC] 8th edition stage III and selected stage I-II based on smoking status in pack-years.
  • For laryngeal, hypopharyngeal, and oral cavity primaries and p16-negative oropharyngeal/unknown primaries, AJCC 8th edition stage III-IVB.
  • Based on the following minimum diagnostic workup within 60 days prior to step 1 registration:
    • General history and physical examination by a radiation oncologist or medical oncologist or ear, nose and throat (ENT) or head & neck surgeon;
    • For larynx, hypopharynx, and base of tongue primaries, a laryngopharyngoscopy (mirror and/or fiberoptic and/or direct procedure) is required, unless the patient cannot tolerate or refuses;
    • Imaging of the head and neck with a neck CT or magnetic resonance imaging (MRI) (with contrast, unless contraindicated) or PET/CT; note that the CT portion of the PET/CT must be of diagnostic quality, including contrast administration unless contraindicated;
    • If the CT portion of the PET/CT study is low-dose (non-diagnostic), then an additional CT or MRI study with contrast (unless contraindicated) is required;
    • Chest imaging: chest CT with and without contrast (unless contraindicated) or PET/CT.
  • Patients must have a contraindication to cisplatin as defined in the following bullet points; sites must complete the online tool at comogram.org prior to step 1 registration to determine if the patient is eligible; the scores must be recorded on a case report form (CRF).
  • Age ≥ 70 with moderate to severe comorbidity or vulnerability to cisplatin, defined as having one or more of the following conditions within 30 days prior to step 1 registration:
    • Modified Charlson Comorbidity Index ≥ 1;
    • Adult Comorbidity Evaluation (ACE)-27 Index ≥ 1;
    • Generalized Competing Event Model for Cancer Risk (GCE) omega PFS score < 0.80;
    • Geriatric screening (G-8) score ≤ 14;
    • Cancer and Aging Research Group (CARG) toxicity score ≥ 30%;
    • Cumulative Illness Rating scale for Geriatrics (CIRS-G) score ≥ 4; OR
  • Age < 70 with severe comorbidity or vulnerability to cisplatin, defined as having two or more of the following conditions within 30 days prior to step 1 registration:
    • Modified Charlson Comorbidity Index ≥ 1;
    • ACE-27 Index ≥ 1;
    • GCE omega PFS-score < 0.80;
    • G-8 score ≤ 14;
    • CARG Toxicity score ≥ 30%;
    • CIRS-G score ≥ 4; OR
  • Age ≥ 18 with an absolute or relative contraindication to cisplatin, defined as one or more of the following within 30 days prior to step 1 registration:
    • Creatinine clearance (CC) > 30 and < 60 cc/min; for this calculation, use the Cockcroft-Gault formula;
    • For this calculation, use the Cockroft-Gault formula: CC = 0.85 (if female)* ((140–Age) / (Serum Creatinine)) * (Weight in kg / 72).
    • Patient must be greater than 18 years old;
    • Zubrod performance status 2 prior to Step 1 registration;
    • Pre-existing peripheral neuropathy grade ≥ 1;
    • History of hearing loss, defined as either:
      • Existing need of a hearing aid; OR ≥ 25 decibel shift over 2 contiguous frequencies on a pretreatment hearing test as clinically indicated.
  • Adequate hematologic function within 14 days prior to Step 1 registration defined as follows:
    • Absolute neutrophil count (ANC) ≥ 1,000 cells/mm^3 (within 14 days prior to step 1 registration);
    • Platelets ≥ 100,000 cells/mm^3 (within 14 days prior to step 1 registration);
    • Hemoglobin ≥ 9.0 g/dl (Note: the use of transfusion or other intervention to achieve hemoglobin [Hgb] ≥ 9.0 g/dl is acceptable) (within 14 days prior to step 1 registration).
  • Adequate hepatic and renal function within 14 days prior to Step 1 registration defined as follows:
    • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 times institutional upper limit of normal (within 14 days prior to step 1 registration);
    • Serum bilirubin ≤ 1.5 x institutional upper limit of normal (within 14 days prior to step 1 registration);
    • Measured creatinine clearance (CL) > 30 mL/min or calculated creatinine CL > 30 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance (within 14 days prior to step 1 registration).
  • For women of childbearing potential, a negative serum or urine pregnancy test within 14 days prior to step 1 registration.
    • Note: women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause; the following age-specific requirements apply:
    • Women < 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy);
    • Women ≥ 50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses > 1 year ago, had chemotherapy-induced menopause with last menses > 1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy or hysterectomy).
  • The patient or a legally authorized representative must provide study-specific informed consent prior to step 1 registration.

PRIOR TO STEP 2 REGISTRATION INCLUSION CRITERIA

  • For patients with oropharyngeal or unknown primaries: p16 determination by immuno-histochemistry (defined as greater than 70% strong nuclear or nuclear and cytoplasmic staining of tumor cells), confirmed by central pathology review.
    • Note: for patients with oral cavity, laryngeal, and hypopharyngeal primaries, analysis of p16 status prior to step 2 registration/ randomization is not required (p16 status will be analyzed centrally post-hoc); step 2 registration for these patients can be completed after step 1 registration.


Exclusion Criteria:

PRIOR TO STEP 1 REGISTRATION EXCLUSION CRITERIA

  • Prior invasive malignancy within the past 3 years (except for non-melanomatous skin cancer, and early stage treated prostate cancer); synchronous head and neck primaries are ineligible.
  • Prior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
    • Note: Prior external beam radiotherapy is excluded, but iodine 131 is allowed.
  • Prior immunotherapy.
  • Prior systemic therapy, including cytotoxic chemotherapy, biologic/targeted therapy, or immune therapy for the study cancer.
  • Major surgery within 28 days prior to step 1 registration.
  • Proven evidence of distant metastases.
  • If both of the following conditions are present, the patient is ineligible:
    • ≤ 10 pack-year smoking history;
    • p16-positive carcinoma of the oropharynx or unknown primary that are T0-3, N0-1 (AJCC 8th Edition);
    • Note: in the event that a registered patient with ≤ 10 pack-years has a p16-positive result on central review with the tumor and nodal stage T0-3, N0-1 (AJCC 8th Edition), then the site will be notified that the patient is ineligible.
  • Zubrod performance status ≥ 3.
  • Body weight ≤ 30 kg .
  • Patients with oral cavity cancer are excluded from participation if the patient is medically operable and resection of the primary tumor is considered technically feasible by an oral or head and neck cancers surgical subspecialist;(please consult the surgical oncology co-principal investigator [PI], Steven Chang, Doctor of Medicine [MD], if clarification is needed on an individual case).
  • Any of the following severe laboratory abnormalities within 14 days of Step 1 registration, unless corrected prior to Step 1 registration:
    • Sodium < 130 mmol/L or > 155 mmol/L (within 14 days of step 1 registration, unless corrected prior to step 1 registration);
    • Potassium < 3.5 mmol/L or > 6 mmol/L (within 14 days of step 1 registration, unless corrected prior to step 1 registration);
    • Fasting glucose < 40 mg/dl or > 400 mg/dl (within 14 days of step 1 registration, unless corrected prior to step 1 registration);
    • Serum calcium (ionized or adjusted for albumin) < 7 mg/dl or > 12.5 mg/dl (within 14 days of step 1 registration, unless corrected prior to step 1 registration);
    • Magnesium < 0.9 mg/dl or > 3 mg/dl (within 14 days of step 1 registration, unless corrected prior to step 1 registration);
  • Unstable angina and/or congestive heart failure requiring hospitalization within 3 months prior to step 1 registration
  • Transmural myocardial infarction within 3 months prior to step 1 registration
  • Respiratory illness requiring hospitalization at the time of step 1 registration
    • Note: if the respiratory illness is resolved and the patient meets the eligibility status above, then the patient can be considered for the trial
  • Idiopathic pulmonary fibrosis or other severe interstitial lung disease that requires oxygen therapy or is thought to require oxygen therapy within 1 year prior to step 1 registration
  • History of (non-infectious) pneumonitis that required steroids or current pneumonitis
  • Clinically apparent jaundice and/or known coagulation defects
  • Active or prior documented autoimmune or inflammatory disorders (including inflammatory bowel disease [e.g., 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 (e.g., 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 medical oncology study chair;
    • Patients with celiac disease controlled by diet alone;
    • History of active primary immunodeficiency including, but not limited to acquired immune deficiency syndrome (AIDS) based upon current Centers for Disease Control and Prevention (CDC) definition.
    • Note: human immunodeficiency virus (HIV) testing is not required for entry into this protocol; the need to exclude patients with AIDS from this protocol is necessary because the treatment involved in this protocol may be immunosuppressive; patients with known HIV, CD4 counts ≥ 200/uL, and undetectable viral loads who are stable on an antiretroviral regimen may be included.
  • Current or prior use of immunosuppressive medication within 14 days before step 1 registration, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid.
  • Receipt of live attenuated vaccination within 30 days prior to step 1 registration.
  • Medical or psychiatric illness which would compromise the patient's ability to tolerate treatment or limit compliance with study requirements.
  • Pregnancy or women of childbearing potential and men who are sexually active and not willing/able to use medically acceptable forms of contraception during treatment and for 6 months after the last dose of cetuximab or MEDI14736 (durvalumab); this exclusion is necessary because the treatment involved in this study may be significantly teratogenic; women who are breastfeeding are also excluded.
  • Prior allergic reaction or hypersensitivity to cetuximab or MEDI4736 (durvalumab) or any of study drug excipients.
  • History of allogenic organ transplantation.
  • Uncontrolled hypertension.
  • Uncontrolled cardiac arrhythmia.
  • Uncontrolled serious chronic gastrointestinal condition associated with diarrhea.
  • Active infection including tuberculosis (clinical evaluation that includes clinical history, physical examination and radiographic findings, and tuberculosis [TB] testing in line with local practice), hepatitis B (known positive hepatitis B virus [HBV] surface antigen [HBsAg] result), hepatitis C; patients with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible; patients positive for hepatitis C (hepatitis C virus [HCV]) antibody are eligible only if polymerase chain reaction is negative for HCV ribonucleic acid (RNA).
Biologic/Vaccine, Radiation, Other
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Mayo Clinic — Rochester, MN

A Phase 1b/2a Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab (PAVE-1)

A Dose Escalation and Confirmation Study of PT-112 in Advanced Solid Tumors in Combination With Avelumab

Brian Costello
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
0000-100431-P01-RST
18-001319
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Inclusion Criteria:

  • Signed informed consent obtained prior to initiation of any study-specific procedures and treatment.

For dose escalation phase:

  • Histologically or cytologically proven metastatic or locally advanced solid tumors for which no standard therapy known to confer clinical benefit exists OR standard therapy has failed recruited from among patients with squamous or non-squamous non-small cell lung cancer
  • (NSCLC), squamous cell carcinoma of the head and neck (SCCHN), urothelial carcinoma (UC), metastatic castrate resistant prostate cancer (mCRPC), and metastatic breast cancer (mBC).

For dose confirmation phase:

  • Cohort A will enroll patients with metastatic or locally advanced, squamous or non-squamous NSCLC (NSCLC) who had previously received no more than four prior lnes of therapy, including a PD-1/PD-L1 containing therapy and a platinum-containing regimen. Patients must have received no more than one taxane containing regimen and no more than one investigational agent.
  • Cohort B will enroll patients with histologically or cytologically confirmed transitional cell carcinoma of the urothelium including bladder, urethra, renal pelvis, or ureter (mUC). Patients must have received no more than three prior regimens, with PD-1 / PD-L1-containing therapy administered as their most recent therapy and have failed to achieve a PR or CR. Additionally for patients that did not progress while on the previous PD-1/PD-L1 containing therapy, the period of SD must be a minimum of four (4) months.
  • Patients with metastatic or locally advanced NSCLC, metastatic or locally advanced UC, metastatic or locally advanced SCCHN and mBC must have measurable disease by RECIST criteria, with at least one uni-dimensional measurable lesion.
  • Patients with mCRPC must meet PCWG3 criteria for disease progression at trial entry.
  • Availability of tumor specimens is optional for patients in dose escalation cohorts and mandatory for patients in the dose confirmation phase. In the dose confirmation phase, an archived formalin-fixed, paraffin-embedded tumor tissue block sufficient in size to allow for sectioning of at least 15 slides should be provided if available from the most recent primary or metastatic tumor biopsy or resection obtained within 3 months prior to start of study therapy. If such an archived sample is not available, a fresh tumor sample must be obtained prior to enrollment. If blocks cannot be provided, then at least 15 freshly prepared slides must be provided. Core needle or excision biopsies are required.
  • Male or female patients aged ≥ 18 years at time of informed consent.
  • ECOG Performance Status 0 to 1.
  • Estimated life expectancy of at least 3 months.
  • Adequate bone marrow reserve, hepatic, and renal function, defined by:
    • absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L;
    • platelet count ≥ 100 x 10^9/L;
    • hemoglobin ≥ 9 g/dL (may have been transfused);
    • alanine aminotransferase (ALT, SGPT) ≤ 3.5 x upper limit of normal (ULN);
    • aspartate aminotransferase (AST, SGOT) ≤ 2.5 x ULN;
    • total bilirubin ≤ 1.5 x ULN;
    • calculated creatinine clearance, estimated glomerular filtration rate 9eGFR ≥ 60 mL/min (MDRD formula).
    • normal bood urea nitrogen (BUN) unless considered unrelated to renal dysfunction as assessed by the investigator and Sponsor.
  • Female patients of child-bearing potential must have a negative pregnancy test and be nonlactating and use at least one form of contraception as approved by the Investigator for 4 weeks prior to initiating study treatment and continuing for 6 months after the last dose of study drug. For the purposes of this study, child-bearing potential is defined as “all female patients unless they are post-menopausal for at least 3 years or surgically sterile."
  • If the risk of conception exists, male patients must use a form of barrier contraception approved by the Investigator during the study and for 6 months after the last dose of study drug.
  • Willing and able to comply with study procedures and follow-up.


Exclusion Criteria:

  • Concurrent cancer treatment with cytoreductive therapy, radiotherapy, cytokine therapy, cytotoxic agents, or targeted small molecule therapy within 2 weeks prior to the start of study treatment (except 5 weeks from last dose of nitrosourea compound) OR treatment with monoclonal antibodies within 4 weeks prior to the start of study treatment, with the following exceptions:
    • PD-1 / PD-L1 containing checkpoint inhibitor therapy is permitted;
    • palliative bone-directed radiotherapy is permitted unless involving an area of ≥ 25% of bone marrow reserves and occurring within 5 weeks prior to the start of study treatment;
    • erythropoietin and darbopoietin-α are permitted; and
    • hormonal therapies acting on the hypothalamic-pituitary-gonadal axis (i.e., LHRH agonist/antagonist) are permitted. No other hormonal therapy is permitted.
  • Known symptomatic central nervous system (CNS) metastases requiring steroids. Patients with previously diagnosed CNS metastases are eligible if they:
    • have completed their treatment and have recovered from the acute effects of radiation therapy and/or surgery prior to enrollment;
    • have discontinued corticosteroid treatment for these metastases for at least 14 days; and
    • are neurologically stable.
  • Persisting toxicity related to prior therapy is Grade >1 by NCI-CTCAE v4.03 criteria. However, alopecia or other Grade ≤ adverse events (AEs) not constituting a safety risk based on Investigator’s judgement are acceptable.
  • Diagnosis of any other malignancy within 2 years prior to enrollment. However, adequately treated basal cell or squamous cell skin cancer or non-invasive superficial bladder cancer or carcinoma in situ of the bladder, breast or cervix; or prostate cancer of low grade (Gleason ≤ 6) prostate cancer or surveillance without any plans for treatment intervention (e.g., surgery, radiation, or castration) are allowed.
  • Prior organ transplantation including allogeneic stem cell transplantation.
  • Major surgery (as deemed by the Investigator) for any reason OR not fully recovered from surgery within 4 weeks prior to the start of study treatment.
  • Vaccination within 4 weeks of the first dose of study treatment is prohibited except for administration of inactivated vaccines.
  • Current use of immunosuppressive medication at study entry, with the following exceptions:
    • intranasal, inhaled, or topical steroids or local steroid injections; (e.g., intra-articular injection) are permitted;
    • systemic corticosteroids at physiologic doses ≤ 10 mg/day of prednisone or equivalent are permitted; and
    • steroids as premedication for hypersensitivity reactions are permitted.
  • Active or prior autoimmune disease that might deteriorate with receiving an immunostimulatory agent. However, patients with diabetes type 1, vitiligo, psoriasis, or hypo- or hyper-thyroid disease not requiring immunosuppressive treatment are eligible.
  • Acute or chronic infections requiring systemic therapy, including, among others:
    • active infection requiring systemic therapy;
    • history of testing positive to human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome;
    • hepatitis B virus (HBV) or hepatitis C virus (HCV) infection at screening (positive HBV surface antigen or HCV RNA if anti-HCV antibody screening test is positive);
    • active tuberculosis (history of exposure or history of positive TB test with presence of clinical symptoms, physical or radiographic finding).
  • Clinically significant or active cardiovascular disease, including:
    • ongoing cardiac dysrhythmias of NCI CTCAE v4.03 grade ≥ 2 or prolongation of the QTcF interval to > 450 msec for males, and ≥ 470 msec for females;
    • cerebrovascular accident/stroke < 6 months prior to study entry;
    • myocardial infarction < 6 months prior to study entry;
    • unstable angina;
    • congestive heart failure (New York Heart Association Classification ≥ Class II);
    • symptomatic arrhythmia requiring medication (excluding anemia-related sinusal tachycardia grade ≤ 2 by NCI CTCAE v4.03 criteria). However, subjects with stable atrial fibrillation on treatment are allowed provided they do not meet any other cardiac or prohibited drug exclusion criterion.
  • Known history of autoimmune colitis, inflammatory bowel disease, pneumonitis, pulmonary fibrosis.
  • Uncontrolled intercurrent illness, including, but not limited to:
    • hypertension uncontrolled by standard therapies;
    • uncontrolled diabetes;
    • Known alcohol or drug abuse;
  • Other acute or chronic medical or psychiatric condition including recent (within the past year) or active suicidal ideation or behavior or laboratory abnormality that may increase the risk of study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgement of the Investigator, would make the patient inappropriate for entry into the study.
  • Known intolerance to checkpoint inhibitor therapy, defined by the occurrence of an AE leading to drug discontinuation.
  • Known prior severe hypersensitivity reaction to monoclonal antibodies (grade ≥ 3 by NCI CTCAE v4.03 criteria).
  • Known allergy or hypersensitivity to platinum (Pt)-containing agents, or known intolerance to prior Pt-containing agent which, in the judgement of the Principal Investigator, precludes exposure to Pt-containing agent.
  • Known allergic reaction to methotrexate (trace methotrexate may be present in the avelumab drug product).
  • Participation in other studies involving investigational drug(s) used to treat malignancy during study participation.
  • Legal incapacity or limited legal capacity or any psychiatric condition that would prohibit the understanding or rendering or informed consent or that might limit compliance with study requirements.
  • Abnormal blood urea nitrogen (BUN) due to renal compromise or dysfunction (e.g., hydronephrosis).
  • Any waiver of these exclusion criteria should be exceptional and justified and must be approved by the Investigator and the Sponsor on a case-by-case basis prior to enrolling the patient. Such waivers must be documented by both the Investigator and Sponsor.
Biologic/Vaccine, Drug, Administration of antineoplastic agent, Drug therapy
Cancer, Lung cancer, Non-small cell lung cancer, Recurrent cancer
Avelumab [USAN:INN], Biological therapy for cancer, Cancer treatment, Malignant neoplastic disease, Medical Oncology, Non-small cell lung cancer, Respiratory system, Solid tumor configuration, avelumab
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A Prospective, Phase II Study of Lutetium Lu 177 Dotatate (Lutathera®) in Patients with Inoperable, Progressive Meningioma after External Beam Radiation Therapy

A Study of Lutetium Lu 177 Dotatate (Lutathera®) in Patients with Inoperable, Progressive Meningioma after External Beam Radiation Therapy

Kenneth Merrell
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-100440-P01-RST
17-009927
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Inclusion Criteria

  • Age ≥ 18 years.
  • Previous treatment for meningioma including surgery, when possible, and radiation therapy (conventional fractionated or radiosurgery). Pathologic confirmation of meningioma is not required for patients who are not surgical candidates and received radiation therapy based on magnetic resonance imaging (MRI) consistent with meningioma. Patients with prior surgery will have pathologic confirmation of meningioma with either FFPE tumor block OR meningioma tissue slides available for submission to central pathology review.
  • Radiographic evidence of meningioma progression with measurable disease, defined as an increase in size of the measurable primary lesion on imaging by 15% or more (sum of the bidirectional measurements) or by the appearance of a new measurable lesion.
  • Previous treatment with either fractionated radiation therapy or stereotactic radiosurgery at the site of progressive meningioma, without safe option for further radiotherapy.
  • Willing to undergo 68Ga-DOTATATE PET imaging. 68Ga-DOTATATE PET imaging must be Krenning score must be a score of 2 or higher, suggesting somatostatin receptor expression, to be enrolled on the study.
  • ECOG Performance Status (PS) ≤ 2.
  • The following laboratory values obtained ≤ 14 days prior to registration.
  • Absolute neutrophil count (ANC) ≥1500/mm.
  • Platelet count ≥100,000/mm.
  • Hemoglobin ≥ 9.0 g/dL.
  • Direct bilirubin <1.5 x upper limit of normal (ULN) (or total bilirubin ≤ 3.0 x ULN with direct bilirubin ≤1.5 x ULN in patients with well-documented Gilbert’s Syndrome).
  • Aspartate transaminase (AST) ≤ 3 x ULN.
  • PT/INR/PTT ≤1.5 X ULN OR if patient is receiving anticoagulant therapy and PT or PTT is within therapeutic range of intended use of coagulants.
  • Calculated creatinine clearance must be ≥40 ml/min using the Cockcroft-Gault formula below:
    • Cockcroft-Gault Equation:
    • Creatinine clearance for males = (140
      •age)(weight in kg)                (72)(serum creatinine in
           mg/dL)
    • Creatinine clearance for females = (140
      •age)(weight in kg)(0.85)    (72)(serum creatinine in mg/dL)
  • Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
    • Note: A negative pregnancy test needs to be done within 48 hours of receiving LUTATHERA treatment.
    • Note: Patients with surgical sterilization or who have been post-menopausal for at least 2 years are excluded from pregnancy testing, but this must be documented.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Provide written informed consent.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).
  • Willing to sign consent onto the Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking study, IRB number 15-000136.
    • Note: The blood draw is optional.
  • Willing to undergo SPECT/CT imaging for dosimetry analysis.

Exclusion Criteria

  • Eligibility for surgical or radiation treatment with curative intent.
  • Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
    • Pregnant women;
    • Nursing women;
    • Men or women of childbearing potential who are unwilling to employ adequate contraception.
  • 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.
  • Contraindications to or intolerance of MRI.
  • Immunocompromised patients and patients known to be HIV positive and currently receiving antiretroviral therapy.
    • Note: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (NYHA II, III, IV), unstable angina pectoris, uncontrolled diabetes mellitus (fasting blood glucose >2 ULN), cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
    • Note: This includes treatment with Somatostatin LAR within 4 weeks prior to enrollment, or any patient receiving treatment with short-acting Octreotide that cannot be interrupted for greater than 24 hours before treatment.
  • Other active malignancy ≤ 2 years prior to registration.
  • Exceptions: Non-melanotic skin cancer or carcinoma-in-situ of the cervix.
    • Note: If there is a history of prior malignancy, they must not be receiving other specific treatment for their cancer.
  • History of myocardial infarction ≤6 months, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
  • Current spontaneous urinary incontinence making impossible the safe administration of LUTATHERA.
  • Significant toxicity related to previous radiation therapy including radiation necrosis, radiation optic neuropathy, or radiation retinopathy.
  • Optic nerve sheath meningioma, extracranial meningioma.
External beam radiation therapy procedure, Drug, Administration of antineoplastic agent, Drug therapy, Positron emission tomography of whole body using gallium (68-Ga) dotatate, Radionuclide therapy, Teleradiotherapy procedure
Brain tumor, Cancer, Meningioma, Recurrent cancer
Cancer treatment, Central nervous system, Dotatate lutenium Lu-177, Lu 177-DOTATATE therapy, Lutetium, Medical Oncology, Nervous system, Primary malignant meningioma, Radiation therapy, Recurrent malignant neoplastic disease, Tumor surgically unresectable, dotatate, lutetium
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AGCT1531, A Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients With Germ Cell Tumors (AGCT1531)

A Study to Evaluate Bleomycin, Carboplatin, Etoposide, or Cisplatin in Treating Pediatric and Adult Patients with Germ Cell Tumors

Wendy Allen-Rhoades
All
up to 49 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-100462-P01-RST
19-000336
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Inclusion Criteria:
 

  • There is no age limit for the low risk stratum (stage I ovarian immature teratoma and stage I non-seminoma or seminoma malignant GCT [all sites]).
  • Standard risk 1: Patient must be < 11 years of age at enrollment.
  • Standard risk 2: Patients must be ≥ 11 and < 25 years of age at enrollment.
  • Patients enrolling on one of the low risk arms must be newly diagnosed with a stage I germ cell tumor; for the standard risk arms, patients must be newly diagnosed with metastatic germ cell tumor (stage II or higher); histologic confirmation of a primary extracranial germ cell tumor in any of the categories outlined below is required of all patients at enrollment except for those who were initially diagnosed with stage I non-seminoma malignant GCT and later recur during observation post surgery off study; for these patients, if elevated tumor markers rise to > 5 x upper limit of normal (ULN) on at least 2 measurements taken at least 1 week apart, a diagnostic biopsy is not required for enrollment
  • Low risk stage I immature teratoma (IT); site: ovarian; stage: Children's Oncology Group (COG) stage I, Federation of Gynecology and Obstetrics (FIGO) stage IA and IB; grade: 2 or 3; histology: pure immature teratoma (may contain microscopic foci of yolk sac tumor), mixed immature and mature teratoma, (no pathological evidence of MGCT); tumor markers: alpha-FP ≤ 1,000 ng/mL, beta-HCG institutional normal; all ages.
  • Low risk stage I non-seminoma MGCT; site: ovarian, testicular, or extragonadal; stage: COG stage I, FIGO stage IA and IB, American Joint Committee on Cancer (AJCC) testicular stage IA, IB and IS; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma (pure or mixed); all ages.
  • Low risk stage I seminoma-MGCT; site: testicular; stage: COG stage I; AJCC testicular stage IA IB, and IS; histology: must contain at least one of the following: may contain immature/mature teratoma; may NOT contain yolk sac tumor, embryonal carcinoma, or choriocarcinoma; all ages.
  • Standard risk 1 (SR1); site: ovarian, testicular, or extragonadal; stage: COG stage II-IV, FIGO stage IC, FIGO stage II-IV (International Germ Cell Consensus Classification [IGCCC] criteria DO NOT apply); histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) < 11.
  • Standard risk 2 (SR2)
    • Site: ovarian; stage: COG stage II and III, FIGO stage IC, II and III; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) >= 11 and < 25;
    • Site: testicular; stage: COG stage II-IV, AJCC stage II, III, IGCCC good risk; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; tumor markers: must be IGCCC good risk; post op: alpha-FP < 1,000 ng/mL, beta-HCG < 5,000 IU/mL and lactate dehydrogenase (LDH) < 3.0 x normal; age (years) ≥ 11 and < 25;
    • Site: extragonadal; stage: COG stage II; histology: must contain at least one of the following: yolk sac tumor, embryonal carcinoma, or choriocarcinoma; age (years) ≥ 11 and < 25.
    • Notes:
      • IGCCC criteria only apply to SR2 patients with a testicular primary tumor;
      • Use post-op tumor marker levels to determine IGCCC risk group;
      • Stage 1 seminoma patients are not eligible for the standard risk arms of the study;
      • For the low risk stage I non-seminoma MGCT and the standard risk arms, components of yolk sac tumor, embryonal carcinoma, or choriocarcinoma can be mixed with other forms of GCT, such as seminoma or mature or immature teratoma; if yolk sac tumor is the only malignant component present, then it must be deemed by the pathologist to be greater than a "microscopic component" of yolk sac tumor.
  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, 2 or 3; use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age.
  • Organ function requirements apply ONLY to patients who will receive chemotherapy (SR1 and SR2 patients).
  • Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 mL/min/1.73 m^2.
  • A serum creatinine based on age/gender as follows: (mg/dL):
    • 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 female: 1;
    • 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.
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age.
  • Serum glutamic-oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) or serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) < 2.5 x upper limit of normal (ULN) for age (for the purpose of this study, the ULN for SGPT is 45 U/L).
  • Peripheral absolute neutrophil count (ANC) ≥ 1,000/mm^3.
  • Platelet count ≥ 100,000/mm^3.
  • Patients enrolling on the standard risk arms must be medically fit to receive protocol treatment and with no contraindications to protocol treatment.
  • Eligibility criteria to participate in the pilot study of the AYA-Hears instrument (patient reported outcomes [PROs] of ototoxicity).
    • Note: participants in group 1 will not receive AGCT1531 protocol-directed therapy; all other AYA-HEARS patients must be enrolled on the AGCT1531 SR2 arm in order to participate.
  • ≥ 11 and < 25 years old at enrollment.
  • Able to fluently speak and read English.
  • Has received prior cisplatin- or carboplatin-based chemotherapy regimen for malignancy including diagnoses other than germ cell tumor.
  • Followed for cancer or survivorship care at one of the following institutions:
    • Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center;
    • Dana Farber/Harvard Cancer Center;
    • Hospital for Sick Children;
    • Children's Hospital of Eastern Ontario;
    • Oregon Health and Science University;
    • Seattle Children's Hospital;
    • Yale University.


Exclusion Criteria:

  • Patients with any diagnoses not listed including:

    • Stage I testicular cancer patients who have undergone primary RPLND (retroperitoneal lymph node dissection);
    • Pure dysgerminoma;
    • Pure mature teratoma;
    • Pure immature teratoma COG stage I, grade I;
    • Pure immature teratoma COG stage I, grade 2,3 with alpha-fetoprotein (AFP) ≥ 1000 ng/mL;
    • Pure immature teratoma COG stage II
      •IV or FIGO stage IC to IV;
    • "Poor risk" GCT (age ≥ 11 years old and COG stage IV ovarian, COG stage III or IV EG, or IGCCC intermediate or poor risk testicular); or
    • Primary central nervous system (CNS) germ cell tumor;
    • Germ cell tumor with somatic malignant transformation;
    • Spermatocytic seminoma.
  • Patients must have had no prior systemic therapy for the current cancer diagnosis.
  • Patients must have had no prior radiation therapy with the exception of CNS irradiation of brain metastases; (this exception only applies to SR1 patients; any patients over age 11 with distant metastases to brain [stage IV disease] would be considered poor risk and therefore not eligible for this trial).
  • Patients with significant, pre-existing co-morbid respiratory disease that contraindicate the use of bleomycin, are ineligible for the standard risk arms of the trial.
  • 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; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients]).
  • Lactating females who plan to breastfeed their infants; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients]).
  • Sexually active patients of reproductive potential who have not agreed to use an effective contraceptive method for the duration of their study participation; (this criteria applies ONLY to patients who will receive chemotherapy [SR1 and SR2 patients]).

Eligibility last updated 11/29/21. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Drug, Other, Administration of antineoplastic agent, Chemotherapy, Drug therapy
Cancer, Germ cell tumor
1,2-Diaminocyclohexaneplatinum II citrate, Bleomycin, Cancer treatment, Carboplatin, Chemotherapy, Etoposide, Extragonadal teratoma, Malignant germ cell tumor of ovary, Malignant germ cell tumor of testis, Medical Oncology, Reproductive system, Teratoma of ovary, bleomycin, carboplatin, cisplatin, etoposide
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Comparative Effectiveness of Early Integrated Telehealth Versus In-Person Palliative Care for Patients With Advanced Lung Cancer (REACH PC)

Early Integrated Telehealth Versus In-Person Palliative Care for Patients With Lung Cancer

Konstantinos Leventakos
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-100466-P01-RST
18-001877
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Inclusion Criteria
•Patient:

  • Diagnosed with advanced NSCLC being treated with non-curative intent, and informed of advanced disease within the prior 8-12 weeks.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status from 0 (asymptomatic) to 3 (symptomatic and in bed >50% of the day).
  • The ability to read and respond to questions in English or Spanish.
  • Lives in a state where their institutions’ PC clinicians are licensed to practice.
  • Receiving primary cancer care at one of the participating sites.
  • Age > 18 years.

Inclusion Criteria
•Caregiver:

  • Relative or friend who is identified by the patient participant and lives with the patient or has contact with them at least twice per week.
  • The ability to read and respond to questions in English or Spanish.
  • Age ≥ or 18 years.

Exclusion Criteria
•Patient:

  • Already receiving PC or hospice services.
  • Cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participation.

Exclusion Criteria
•Caregiver:

  • Cognitive or psychiatric conditions as determined by the treating oncologist to prohibit study consent or participation.

Other, In-person encounter, Palliative care, Telehealth monitoring
Cancer, Lung cancer, Non-small cell lung cancer
Cancer treatment, Medical Oncology, Non-small cell lung cancer, Palliative care, Respiratory system
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MISP54450: A Phase II Study of Pembrolizumab Monotherapy in Recurrent Ovarian Cancer of the Immunoreactive Subtype Determined by NanoString Gene Expression Profiling

Pembrolizumab in Treating Participants With Recurrent Ovarian Cancer

Andrea Wahner Hendrickson
Female
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-100475-P01-RST
19-002924
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Inclusion Criteria:

  • Be willing and able to provide written informed consent/assent for the trial.
  • Be ≥ 18 years of age on day of signing informed consent.
  • Have received 1-5 prior chemotherapy lines for treating epithelial ROC (i.e., 2-6 total prior lines counting the front line).
  • Have measurable disease based on RECIST 1.1.
    • Note: Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • Have a performance status of 0 or 1 on the ECOG Performance Scale.
  • Have histologically diagnosed recurrent epithelial ovarian, fallopian or primary peritoneal ovarian cancer.
  • Have provided a tumor tissue sample from an archival tissue specimen collected from the primary ovarian tumor at the time of the initial debulking surgery. If primary ovarian cancer tissue is not available alternatively non lymph node tissue from a later biopsy may be used instead.
  • Have received a tumor tissue test result of NanoString gene expression profiling that is indicative of the immunoreactive molecular subtype.
  • Demonstrate adequate organ function as defined in Table 1, all screening labs should be performed within 28 days of treatment initiation.
  • Adequate Organ Function Laboratory Values:
  • Hematological
    • Absolute neutrophil count (ANC) ≥ 1,500 /mcL;
    • Platelets ≥ 100,000 / mcL;
    • Hemoglobin ≥ 9 g/dL or ≥ 5.6 mmol/L without transfusion or EPO dependency (within 7 days of assessment).
  • Renal
    • Serum creatinine OR Measured or calculated* creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤ 1.5 X upper limit of normal (ULN) OR ≥ 45 mL/min for subject with creatinine levels > 1.5 X institutional ULN.
  • Hepatic
    • Serum total bilirubin ≤ 1.5 X ULN OR Direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN
    • AST (SGOT) and ALT (SGPT) ≤ 2.5 X ULN OR ≤ 5 X ULN for subjects with liver metastases
    • * Creatinine clearance should be calculated per institutional standard.
  • Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Have received front line platinum-based chemotherapy (preoperative chemotherapy is allowed).
  • Female subjects of childbearing potential must be willing to use an adequate method of contraception.  Contraception, for the course of the study through 120 days after the last dose of study medication.
    • Note: Abstinence is acceptable if this is the usual lifestyle and preferred contraception for the subject.


Exclusion Criteria:
 

  • Is currently participating and receiving study therapy or has participated in a study of an investigational agent and received study therapy or used an investigational device within 2 weeks of the first dose of treatment.
  • Has had progression on or within 4 weeks of completing frontline platinum-based chemotherapy (primary platinum refractory).
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.
  • Has a known history of active TB (Bacillus Tuberculosis).
  • Hypersensitivity to pembrolizumab or any of its excipients.
  • Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier.
  • Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., ≤ Grade 1 or at baseline) from adverse events due to a previously administered agent.
    • Note: Subjects with ≤ Grade 2 neuropathy are an exception to this criterion and may qualify for the study.
    • Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  • Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging for at least four weeks prior to the first dose of trial treatment and any neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids for at least 7 days prior to trial treatment. This exception does not include carcinomatous meningitis which is excluded regardless of clinical stability.
  • Has active autoimmune disease that has required 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.
  • 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.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the subject’s participation for the full duration of the trial, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Is pregnant or breastfeeding, or expecting to conceive children within the projected duration of the trial, starting with the pre-screening or screening visit through 120 days after the last dose of trial treatment. 16. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent.
  • Has a known history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).
  • Has a known history of Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] reactive) or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
  • Has received a live vaccine or live-attenuated vaccine within 30 days of planned start of study therapy. Administration of killed vaccines is allowed.
    • Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed.

Eligibility last updated 8/31/21. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Genetic, 70-gene expression profile assay, Administration of antineoplastic agent, Drug therapy, Immunotherapy for cancer
Cancer, Fallopian tube cancer, Ovarian cancer, Peritoneal cancer, Recurrent cancer
Biological therapy for cancer, Cancer treatment, Extraovarian primary peritoneal carcinoma, Gene expression, Malignant tumor of fallopian tube, Malignant tumor of ovary, Medical Oncology, Pembrolizumab [USAN:INN], Recurrent malignant neoplastic disease, Recurrent ovarian cancer, Reproductive system, pembrolizumab
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DTRM-555_001, Phase II Expansion Cohorts Studies of a Novel Triple Combination Therapy, DTRM-555, in Patients with Relapsed/Refractory Chronic Lymphocytic Leukemia or Relapsed/Refractory Non-Hodgkin’s Lymphomas

Study of a Triple Combination Therapy, DTRM-555, in Patients With R/R CLL or R/R Non-Hodgkin's Lymphomas

Sameer Parikh
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-100487-P01-RST
18-002419
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Inclusion Criteria:

  • Patients must provide written informed consent.
  • Patients with a diagnosis of R/R CLL or other B-cell neoplasms (i.e., ABC DLBCL, GCB DLBCL, Richter's transformation and tFL) who have no available approved therapies, or patients with a diagnosis of non-Hodgkin's lymphoma, which has relapsed and/or is refractory to standard therapy.
    • Patients with R/R CLL must have been exposed to Bruton's tyrosine kinase (BTK) or B-Cell CLL/Lymphoma 2 (BCL2) inhibitor-based therapy in prior lines of therapy but must not have known Cys481 resistance mutation prior to study enrollment.
  • Age ≥ 18 years.
  • Life expectancy greater than 12 weeks.
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Ability to swallow and retain capsules and/or tablets.
  • Absence of uncontrolled intercurrent illnesses, including uncontrolled infections, cardiac conditions, or other organ dysfunctions.
  • If the patient consents to an optional tumor biopsy, he/she must have a tumor that can be safely biopsied and undergo a baseline tumor biopsy procedure, or be willing to provide available archival tissue collected within 6 months of signing the Informed Consent Form (ICF), and one post-Cycle 1 treatment biopsy.
  • Patients must have at least one target lesion according to Lugano Classification. Patients with R/R CLL are exempt from this requirement.
  • Women of child-bearing potential must have a negative serum or urine pregnancy test.
  • Women of child-bearing potential must agree to use 2 reliable methods of contraception beginning 4 weeks prior to the initiation of treatment, during therapy, and for at least 4 weeks after the last drug administration.
  • Men must agree to use a latex or synthetic condom during sexual contact with a pregnant female or a female of child-bearing potential, for the duration of the study and for at least 4 weeks after the last drug administration, even if they have undergone a successful vasectomy.


Exclusion Criteria:

  • Received prior systemic anticancer treatment within the following time frames:
    • Chemotherapy, immunotherapy, radiotherapy or any other investigational therapy within 21 days prior to starting study treatment;
    • Targeted therapies within 5 biological half-lives prior to starting study treatment.
  • Patients with active infections requiring therapy are not eligible for entry into the study until resolution of the infection; however, patients on prophylactic antibiotics, antifungals or antivirals are eligible for entry into the study.
  • Pregnant or lactating individuals.
  • Impaired hepatic or renal function as demonstrated by any of the following laboratory values:
    • Aspartate transaminase (AST) or alanine transaminase (ALT) > 2.5 x upper limit of normal (ULN); for patients with liver involvement, > 5 x ULN;
    • Total bilirubin > 1.5 x ULN (Patients with a history of Gilbert's syndrome may participate if total bilirubin is less than or equal to 3 x ULN and the AST/ALT and alkaline phosphatase meet the protocol-specified levels for eligibility);
    • Alkaline phosphatase > 2.5 x ULN;
    • Glomerular filtration rate < 50 mL/min, as assessed using the standard methodology at the investigating center (i.e., Cockcroft-Gault), or serum creatinine > 1.5 x ULN -International normalized ratio (INR) > 1.5 or other evidence of impaired hepatic synthesis function.
  • Absolute neutrophil count < 1.0 x 10^9/L or platelets < 100 x 10^9/L, unless due to disease-related bone marrow impairment as confirmed by bone marrow biopsy during screening or due to standard of care treatment within 2 months prior to signing of informed consent. Patients with bone marrow impairment will be excluded if their absolute neutrophil count (ANC) is < 0.5 x 10^9/L and platelets < 50 x 10^9/L.
  • Previous allogeneic bone marrow transplant is restricted, unless transplant was greater than 3 months prior and there is no evidence of acute or chronic graft versus host disease.
  • Central nervous system involvement with malignancy.
  • Patients who have poorly controlled diabetes mellitus or whose glucose values cannot be controlled with medical treatment.
  • Current malignancies of another type, with the exception of adequately treated in situ cervical cancer and basal cell skin cancer, squamous cell carcinoma of the skin or other malignancies with no evidence of disease for 2 years or more.
  • Known history of human immunodeficiency virus (HIV), hepatitis B virus (HBV), or hepatitis C virus (HCV) infection.
  • Documented or known bleeding disorder.
  • Requirement for anticoagulation treatment that increases INR or activated partial thromboplastin time above the normal range (low molecular weight heparin and heparin line flush allowed).
  • Patients requiring the use of strong CYP3A4, CYP1A2, or P-gp inhibitors.
  • Patients with a significant cardiovascular disease or condition, including:
    • Mmyocardial infarction within 6 months of study entry;
    • New York Heart Association Class III or IV heart failure;
    • Uncontrolled dysrhythmias or poorly controlled angina;
    • History of serious ventricular arrhythmia (ventricular fibrillation or ventricular tachycardia, ≥ 3 beats in a row) and/or risk factors (e.g., heart failure, hypokalemia, or family history of Long QT Syndrome);
    • Baseline prolongation of QT/QTc interval (repeated demonstration of corrected QT interval (QTc) ≥ 450 msec for men and 470 msec for women); and
    • Left ventricular ejection fraction (LVEF) < 45% by multiple gated acquisition (MUGA) and /or echocardiogram (ECHO).
Drug, Administration of antineoplastic agent, Drug therapy
Cancer, Chronic lymphocytic leukemia, Follicular lymphoma, Leukemia, Lymphoma, Non-Hodgkin's lymphoma
Cancer treatment, Chronic lymphoid leukemia, disease, Follicular non-Hodgkin's lymphoma, Hematopoietic system, Malignant lymphoma - small lymphocytic, Mantle cell lymphoma, Marginal zone lymphoma, Medical Oncology
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Mayo Clinic — Rochester, MN

A Phase III, Randomized, Double-blind Trial of Platinum Doublet Chemotherapy /-Pembrolizumab (MK-3475) as Neoadjuvant/Adjuvant Therapy for Participants With Resectable Stage IIB or IIIA Non-small Cell Lung Cancer (NSCLC) (KEYNOTE-671) (MK-3475)

Effectiveness and Safety of Pembrolizumab for Participants with Resectable Stage IIB or IIIA Non-small Cell Lung Cancer

Julian Molina
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100490-P01-RST
17-010993
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Inclusion Criteria:

  • ave previously untreated and pathologically confirmed resectable Stage II, IIIA, or IIIB (N2) NSCLC.
  • Be able to undergo protocol therapy, including necessary surgery. A positron emission tomography (PET) scan may be utilized as a surrogate for pathologic staging of N1 lymph nodes for participants with T2b and T4 tumors.
  • If male, must agree to use contraception or practice abstinence as well as refrain from donating sperm for at least 180 days after the last dose of neoadjuvant cisplatin.
  • If female, may participate if not pregnant or breastfeeding, and at least one of the following conditions apply: 1) not a woman of childbearing potential (WOCBP); or 2) a WOCBP who agrees to follow contraceptive guidance during the treatment period and for at least 180 days after the last dose of study treatment.
  • Have available formalin-fixed paraffin embedded (FFPE) tumor tissue sample blocks for submission. If blocks are not available, have unstained slides for submission for central programmed death-ligand 1 (PD-L1) testing.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 within 10 days of randomization.
  • Have adequate organ function.


Exclusion Criteria:

  • A WOCBP who has a positive urine pregnancy test within 24 hours before the first dose of study treatment.
  • Has one of the following tumor locations/types:1) NSCLC involving the superior sulcus; 2) Large cell neuro-endocrine cancer (LCNEC); or 3) Sarcomatoid tumor.
  • Has a history of (non-infectious) pneumonitis /interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease that requires steroids.
  • Has an active infection requiring systemic therapy.
  • Has had an allogenic tissue/sold organ transplant.
  • Has a known severe hypersensitivity (≥ Grade 3) to pembrolizumab, its active substance and/or any of its excipients.
  • Has a known severe hypersensitivity (≥ Grade 3) to any of the study chemotherapy agents and/or to any of their excipients.
  • Has an active autoimmune disease that has required systemic treatment in past 2 years.
  • Has a known history of human immunodeficiency virus (HIV) infection.
  • Has a known history of Hepatitis B or Hepatitis C.
  • Has a known history of active tuberculosis.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate.
  • Has known psychiatric or substance abuse disorders that would interfere with cooperating with the requirements of the trial.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor.
  • Has received prior systemic anti-cancer therapy including investigational agents for the current malignancy prior to randomization/allocation.
  • Has received prior radiotherapy within 2 weeks of start of trial treatment.
  • Has received a live vaccine within 30 days prior to the first dose of trial drug.
  • Is currently participating in or has participated in a trial of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of trial treatment.
  • Has a diagnosis of immunodeficiency or is receiving either systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior the first dose of trial drug.
  • Has a known additional malignancy that is progressing or requires active treatment within the past 5 years.
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 180 days after the last dose of trial treatment.

Eligibility last updated 11/10/21. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Drug, Administration of antineoplastic agent, Drug therapy, Immunotherapy for cancer
Cancer, Lung cancer, Non-small cell lung cancer
Biological therapy for cancer, Cancer treatment, Medical Oncology, Non-small cell lung cancer, Pembrolizumab [USAN:INN], Respiratory system, pembrolizumab
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Mayo Clinic — Rochester, MN

(ECTx) MC1811: An Open-Label Phase 1 Study of Metformin and Nelfinavir in Combination with Bortezomib in Patients with Relapsed and/or Refractory Multiple Myeloma

A Study to Evaluate the Safety and Effectiveness of Metformin and Nelfinavir with Bortezomib in Patients with Relapsed and/or Refractory Multiple Myeloma

Wilson Gonsalves
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-100522-P01-RST
18-000858
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Inclusion Criteria
•Registration:

  • Age ≥ 18 years.
  • Actively relapsing multiple myeloma.
  • Measurable disease of multiple myeloma as defined by at least ONE of the following:
    • Serum monoclonal protein ≥ 0.5 g/dL;
      • If IgA isotype, then IgA quantification > upper limit of normal.
    • ≥ 200 mg of monoclonal protein in the urine on 24-hour electrophoresis
    • Serum immunoglobulin free light chain ≥ 10 mg/dL AND abnormal serum immunoglobulin kappa to lambda free light chain ratio.
    • Monoclonal bone marrow plasmacytosis ≥ 10% (evaluable disease).
  • Patients must have received at least 2 prior regimens and patients should have been exposed to a PI, an IMiD and an anti-CD38 antibody.
    • NOTE: Induction therapy followed by an ASCT and maintenance therapy without any relapse counts as 1 regimen.
  • ECOG Performance Status (PS) 0, 1 or 2.
  • The following laboratory values obtained ≤14 days prior to registration:
    • Hemoglobin ≥ 8.0 g/dL (No red cell transfusion should have been administered within 4 days of registration);
    • Absolute neutrophil count (ANC) ≥ 1000/mm^3;
    • Platelet count 50,000/mm^3 or > 30,000/mm^3 if bone marrow plasma cells percentage > 50% by morphology. (No platelet transfusion should have been administered within 7 days of registration);
    • Total bilirubin ≤ 1.5 x ULN;
    • Alanine aminotransferase (ALT) and Aspartate transaminase (AST) 3 x ULN (≤ 5 x ULN for patients with liver involvement);
    • Calculated creatinine clearance ≥ 45 ml/min using the Cockcroft-Gault formula below:
    • Cockcroft-Gault Equation:
    • Creatinine clearance for males =  (140
      •age)(weight in kg)
    •                                                           (72)(serum creatinine in mg/dL)
    • Creatinine clearance for females =  (140
      •age)(weight in kg)(0.85)
    •                                                              (72)(serum creatinine in mg/dL)
  • Negative 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.
  • Provide written informed consent.
  • Able to swallow Metformin and Nelfinavir tablets.
  • Willingness to provide mandatory blood sample and bone marrow aspirate for research purposes.
  • Willingness to return to Mayo Clinic for follow-up (during the Active Monitoring Phase of the study).

Exclusion Criteria
•Registration:

  • Pregnant persons.
  • Nursing persons.
  • Persons of childbearing potential who are unwilling to employ adequate contraception.
  • Major surgery ≤ 14 days before study registration.
  • 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.
  • 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 situations that would limit compliance with study requirements.
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
  • Another active malignancy requiring therapy such as radiation, chemotherapy, or immunotherapy.
    • NOTE: Patients on hormonal therapy for treated breast or prostate cancer are permitted if they meet other eligibility criteria.
  • History of myocardial infarction ≤6 months prior to registration, or congestive heart failure requiring use of ongoing maintenance therapy for life-threatening ventricular arrhythmias.
  • Known allergy to any of the study medications, their analogues or excipients in the various formulations.
  • Subjects must not have conditions associated with increased risk of metformin associated lactic acidosis, including New York Heart Association Class III or IV congestive heart failure, history of acidosis of any type, alcoholic liver disease, or habitual intake of 3 or more alcoholic beverages per day.
  • Clinical history of Type I or Type II diabetes.
  • Currently on either metformin or a HIV-PI or both.
  • Elevated baseline lactate level > ULN (2.3 mmol/L).
  • Any of the following recent prior anti-myeloma therapy:
  • Alkylators (e.g., melaphalan, cyclophosphamide) and anthracyclines ≤ 14 days prior to registration.
  • High dose corticosteroids (equivalent to > 10 mg of predisone/day) and immunomodulatory drugs (thalidomide or lenalidomide) ≤ 7 days prior to registration.
  • Monoclonoal antibodies ≤ 14 days prior to registration.
  • Currently receiving any of the medications listed in Appendix III that cannot be discontinued 7 days prior to starting study and throughout study therapy.

 

 

Biologic/Vaccine, Drug, Administration of antineoplastic agent, Drug therapy
Cancer, Multiple myeloma
Cancer treatment, Hematopoietic system, Medical Oncology, Relapse multiple myeloma, bortezomib, metformin, nelfinavir
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Mayo Clinic — Rochester, MN

A Phase I Open Label Clinical Trial Evaluating the Safety and Anti-Tumor Activity of Autologous T Cells Expressing Enhanced TCRs Specific for Alpha Fetoprotein (AFPᶜ³³²T) in HLA-A2 Positive Subjects With Advanced Hepatocellular Carcinoma (HCC) or Other AFP Expressing Tumour Types

A Study to Evaluate AFPᶜ³³²T in Advanced HCC

Amit Mahipal
All
18 years to 75 years old
Phase 1
This study is NOT accepting healthy volunteers
0000-100527-P01-RST
18-004528
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Inclusion Criteria:

  • Subject is ≥ 18 years and ≤ 75 years of age and has voluntarily agreed to participate by giving written informed consent in accordance with ICH GCP Guidelines and applicable local regulations.
  • Histologically confirmed HCC, not amenable to transplant or resection. Subjects may undergo loco-regional therapy after enrolment but should not be amenable to further loco-regional therapy at the time of lymphodepletion; OR g-histologically confirmed diagnosis of another AFP expressing tumor (e.g., cholangiocarcinoma).
  • Measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria prior to lymphodepletion.
  • Progressive disease following or intolerant of or refuses standard of care systemic therapy prior to lymphodepletion.
  • Positive for HLA-A*02:01 (or any A*02:01 P group allele). The Sponsor will review the results of HLA typing for inclusion alleles, and will adjudicate subject eligibility based on HLA results.
  • Group 1, 2, 3, (HCC) Subjects must have biopsy tissue available for AFP expression evaluation prior to enrollment unless considered unsafe. Either an archival specimen (taken within the past 12 months from Screening) or a new biopsy will be required for AFP expression in tumor tissue. Non-cancerous biopsy is also required prior to enrolment. Subjects will be eligible for enrollment if they meet either one of these AFP expression criteria:
    • AFP expression of ≥ 1+ in ≥ 20% of tumor cells by immunohistochemistry and their non-cancerous liver tissue has ≤ 5% cells stained for AFP at any intensity by immunohistochemistry;
    • Serum AFP levels of ≥100ng/mL and their non-cancerous liver tissue has ≤ 5% cells stained for AFP at any intensity by immunohistochemistry. Subjects with serum AFP levels within the normal range at the time of screening are unlikely to have AFP expressing tumors and generally should not undergo new tumor biopsy for the purpose of participating in this study.
    • Group 4 (other AFP expressing tumor types) Subjects must have biopsy tissue available for AFP expression evaluation prior to enrollment unless considered unsafe. Either an archival specimen (taken within the past 12 months from Screening) or a new biopsy will be required for AFP expression in tumor tissue. Non-cancerous biopsy is also required prior to enrolment, for subjects with underlying liver disease. Subjects will be eligible for enrollment if they meet the following AFP expression criterion:
      • Serum AFP levels of ≥ 100ng/mL and their non-cancerous liver tissue (if applicable) has ≤ 5% cells stained for AFP at any intensity by immunohistochemistry. Subjects with serum AFP levels within the normal range at the time of screening are unlikely to have AFP expressing tumors and generally should not undergo new tumor biopsy for the purpose of participating in this study.
  • Life expectancy of > 4 months.
  • Child-Pugh score ≤ 6.
  • Eastern Cooperative Oncology Group (ECOG) 0-1.
  • Female subjects of childbearing potential (FCBP) must have a negative serum pregnancy test.
  • NOTE: FCBP is defined as premenopausal and not surgically sterilized. FCBP must agree to use effective birth control or to abstain from heterosexual activity throughout the study, starting at the first dose of chemotherapy for at least 12 months thereafter or 4 months after there is no evidence of persistence or gene modified cells are in the subject’s blood, whichever is longer. FCBP must also agree to refrain from egg donation, storage, or banking during these same time periods. Effective contraceptive methods include intra-uterine device, oral and injectable hormonal contraception, or 2 adequate barrier methods (e.g., diaphragm with spermicide, cervical cap with spermicide, or female condom with spermicide). Spermicides alone are not an adequate method of contraception; OR male subjects must be surgically sterile or agree to use a double barrier contraception method or abstain from heterosexual activity with a female of childbearing potential starting at the first dose of chemotherapy and for at least 6 months thereafter. Male subjects must also agree to refrain from sperm donation, storage, or banking during these same time periods.
    Abstinence (relative to heterosexual activity) can be used as the sole method of contraception if it is consistently employed as the subject’s preferred and usual lifestyle and if considered acceptable by local Regulatory Agencies and ERCs/IRBs. Periodic abstinence (e.g., calendar, ovulation, sympto-thermal, post-ovulation methods, etc.) and withdrawal are not acceptable methods of contraception.


Exclusion Criteria:

  • Positive for any HLA-A*02 allele other than HLA-A*02:01 P Group, HLA-A*02:03 P group or null alleles, or positive for the following alleles: HLA-C*04:04 or HLA-B*51:03. The Sponsor will review the results of HLA typing for exclusion alleles, and will adjudicate subject eligibility based on HLA results.
  • Prior liver transplant.
  • Received the following prior to leukapheresis:
    • Cytotoxic chemotherapy, immune therapy and biological therapy within 3 weeks;
    • Corticosteroids or any other immunosuppressive therapy within 2 weeks.
    • NOTE: Use of inhaled or topical steroids is not exclusionary.
    • Sorafenib/Regorafenib/Lenvatinib within 1 week;
    • Cabozantinib within 2 weeks;
    • Duration of treatment free intervals for any other anti-cancer therapies must be discussed with Adaptimmune Study Physician.
  • Received the following prior to lymphodepleting chemotherapy:
    • Cytotoxic chemotherapy or loco-regional therapy within 3 weeks, liver directed radiation therapy within three months;
    • Corticosteroids or any other immunosuppressive therapy within 2 weeks.
    • NOTE: Use of inhaled or topical steroids is not exclusionary.
    • Bone/soft tissue directed palliative radiotherapy within 4 weeks;
    • Investigational treatment or clinical trial within 4 weeks;
    • Sorafenib/Regorafenib/Lenvatinib within 1 week;
    • Cabozantinib within 2 weeks;
    • Prior cancer-directed immunotherapy within 4 weeks, including monoclonal antibodies against PD-1 receptor or ligand;
    • Use of an experimental vaccine within 2 months in the absence of tumor response. The subject should be excluded if their disease is responding to an experimental vaccine given within 6 months;
    • Any previous gene therapy using an integrated vector;
    • Duration of treatment free intervals for any other anti-cancer therapies must be discussed with Adaptimmune Study Physician.
  • Toxicity persisting from previous anti-cancer therapy of ≥ Grade 2 (except for non-clinically significant toxicities; e.g., alopecia, vitiligo). Subjects with Grade 2 toxicities that are deemed stable or irreversible (e.g. peripheral neuropathy) can be enrolled on a case-by-case basis with prior consultation and agreement with the Sponsor Study Physician.
  • Major surgery within 4 weeks prior to lymphodepletion; subjects should have been fully recovered from any surgical related toxicities.
  • Bleeding ≥ Grade 2 in the past 3 months prior to lymphodepletion.
  • Therapeutic anticoagulation from lymphodepletion until platelet count recovery (prophylactic heparin allowed).
  • Clinically or radiographically detectable ascites (beyond trace/rim of ascites) or ascites requiring medication.
  • Clinically detectable hepatic encephalopathy or hepatic encephalopathy requiring medication.
  • Active viral hepatitis.  
  • Subjects positive for hepatitis B surface antigen not on antiviral treatment/prophylaxis or subjects with detectable hepatitis B DNA:
    • Subjects with resolved (surface antigen negative, core antibody positive) or chronic stable (surface antigen positive) hepatitis B on antiviral treatment/prophylaxis with DNA levels of ≤ 100 IU/mL are allowed with HBV DNA monitoring after treatment;
    • Subjects with hepatitis C allowed provided they meet all other eligibility criteria.
  • Positive serology for HIV.
  • Positive serology for HTLV 1 or 2.
  • History of chronic or recurrent (within the last year) severe autoimmune or immune mediated disease requiring steroids or other immunosuppressive treatments. Subjects with history of idiopathic autoimmune hepatitis are excluded. Subjects who experienced hepatitis during treatment with check point inhibiting antibodies are not excluded.
  • Subject has brain metastases.
  • Other active malignancy besides HCC or other eligible AFP expressing tumor types within 3 years:
    • Subjects must be in complete remission from prior malignancy in order to be eligible to enter the study;
    • Adequately treated malignancies not likely to require therapy (e.g., completely resected non-melanomatous skin carcinoma or successfully treated in situ carcinoma) are eligible to enter the study.
  • Electrocardiogram (ECG) showing clinically significant abnormality at Screening or showing a QTc interval ≥ 450 msec in males and ≥ 470 msec in females (≥ 480 msec for subjects with Bundle Branch Block (BBB) over consecutive ECGs).
  • Bacterial or opportunistic infection within 3 months of treatment (upper respiratory infection and uncomplicated urinary tract infection allowed).
  • Uncontrolled intercurrent illness considered by the Investigator to add appreciable risk to study participation, including but not limited to:
    • Clinically significant cardiac disease defined by CHF New York Heart Association (NYHA) > Class 1; uncontrolled clinically significant arrhythmia in last 6 months; Acute Coronary Syndrome (ACS) (angina or myocardial infarction) in last 6 months;
    • Oxygen dependent lung disease;
    • Clinically significant psychiatric illness/social situations that would limit compliance with study requirements;
    • History of stroke or central nervous system bleeding; transient ischemic attack (TIA) or reversible ischemic neurologic deficit (RIND) in last 6 months.
  • Pregnant or breastfeeding.
  • Alcohol or illicit drug dependency.
  • Known contraindication to cyclophosphamide, fludarabine, mesna, G-CSF or other agents associated with study treatment.

Eligibility last updated 12/30/21. Questions regarding updates should be directed to the study team contact.

Genetic, Administration of antineoplastic agent, Drug therapy, Immunotherapy for cancer
Cancer, Hepatocellular carcinoma, Liver cancer
Biological therapy for cancer, Cancer treatment, Digestive system, Liver cell carcinoma, Medical Oncology, Cellular therapy
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Mayo Clinic — Rochester, MN

A Phase IB/II Study of Venetoclax (ABT-199) in Combination With Liposomal Vincristine in Patients With Relapsed or Refractory T-Cell or B-Cell Acute Lymphoblastic Leukemia

Venetoclax and Vincristine Liposomal in Treating Patients With Relapsed or Refractory T-cell or B-cell Acute Lymphoblastic Leukemia

Hassan Alkhateeb
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
0000-100539-P01-RST
18-005870
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Inclusion Criteria:
-ELIGIBILITY CRITERIA
•PHASE I (ARMS A, B, C): Relapsed or refractory ALL after multi-agent chemotherapy (>= 5% marrow lymphoblasts, assessed by morphology and flow cytometry; flow cytometry will be used to confirm immunophenotype and percentage of blasts will be assessed by morphology) -ELIGIBILITY CRITERIA
•PHASE I (ARMS A, B, C): Eastern Cooperative Oncology Group (ECOG) performance status 0-2 -ELIGIBILITY CRITERIA
•PHASE I (ARMS A, B, C): Adequate liver function with aspartate aminotransferase (AST)/alanine aminotransferase (ALT) less than 3 X upper limit of normal and total bilirubin less than 2 mg/dL within 7 days prior to first dose of study agent -ELIGIBILITY CRITERIA
•PHASE I (ARMS A, B, C): Circulating white blood cell (WBC) count must not be above 20 x10^9/L within 7 days prior to first dose of study agent -Patients with WBC count above 20 x 10^9/L may be eligible if they start steroids or hydroxyurea per institutional guidelines, but they must discontinue before day 1 of study drug -ELIGIBILITY CRITERIA
•PHASE I (ARMS A, B, C): Creatinine clearance of at least 50 mL/min within 7 days prior to first dose of study agent -ELIGIBILITY CRITERIA
•PHASE I (ARMS A, B, C): Women must not be pregnant or breast-feeding -ELIGIBILITY CRITERIA
•PHASE I (ARMS A, B, C): All females of childbearing potential must have a blood test or urine study within 2 weeks 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: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) -ELIGIBILITY CRITERIA
•PHASE I (ARMS A, B, C): Women of childbearing potential and sexually active males must use an accepted and highly effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for 30 days after the last dose of venetoclax; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately -ELIGIBILITY CRITERIA
•PHASE I (ARMS A, B, C): No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma, or any surgically- or radiation-cured malignancy continuously disease free for >= 5 years so as not to interfere with interpretation of radiographic response -ELIGIBILITY CRITERIA
•PHASE I (ARMS A, B, C): No evidence of isolated extramedullary relapse (i.e., testicular or central nervous system [CNS]) -ELIGIBILITY CRITERIA
•PHASE I (ARMS A, B, C): Patient must not have Burkitt?s lymphoma/leukemia based on the World Health Organization (WHO) criteria -ELIGIBILITY CRITERIA
•PHASE I (ARMS A, B, C): Patients must not have active central nervous system (CNS) leukemia, as defined by unequivocal morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF), use of CNS-directed local treatment for active disease within the prior 28 days; previously treated CNS disease with documented cleared CSF will be allowed -ELIGIBILITY CRITERIA
•PHASE I (ARMS A, B, C): Patient will not be enrolled if they received prior chemotherapy within 2 weeks before enrollment with the following exceptions: to reduce the circulating lymphoblast count or palliation (i.e., steroids or hydroxyurea) or for ALL maintenance (mercaptopurine, methotrexate, vincristine, thioguanine, and/or tyrosine kinase inhibitors) -ELIGIBILITY CRITERIA
•PHASE I (ARMS A, B, C): Patient may be enrolled with a prior allogeneic hematopoietic stem cell transplant (HSCT) but the transplant date must be at least 90 days before date of enrollment; patient must be off immunosuppression and without active graft versus host disease (GVHD) prior to enrollment if previous HSCT -ELIGIBILITY CRITERIA
•PHASE I (ARMS A, B, C): Patient cannot have poorly controlled human immunodeficiency virus (HIV), or CD4 < 400; HIV positive patients are allowed on this study if they have a CD4 count >= 400, and are on a stable antiviral regimen -ELIGIBILITY CRITERIA
•PHASE I (ARMS A, B, C): Patients with New York Heart Association (NYHA) class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia may not be enrolled -ELIGIBILITY CRITERIA
•PHASE I (ARMS A, B, C): Patients with serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolled -ELIGIBILITY CRITERIA
•PHASE I (ARMS A, B, C): Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration -ELIGIBILITY CRITERIA
•PHASE I (ARMS A, B, C): Patients should not have received the following within 7 days prior to the first dose of study drug: -Steroid therapy for anti-neoplastic intent; -Strong and moderate CYP3A inhibitors; -Strong and moderate CYP3A inducers -ELIGIBILITY CRITERIA
•PHASE I (ARMS A, B, C): Patients must not have grade 3 or higher peripheral neuropathy -ELIGIBILITY CRITERIA
•PHASE II (ARM D): Relapsed or refractory ALL after multi-agent chemotherapy (>= 5% marrow lymphoblasts, assessed by morphology and flow cytometry; flow cytometry will be used to confirm immunophenotype and percentage of blasts will be assessed by morphology) -ELIGIBILITY CRITERIA
•PHASE II (ARM D): ECOG performance status 0-2 -ELIGIBILITY CRITERIA
•PHASE II (ARM D): Adequate liver function with AST/ALT less than 3 X upper limit of normal and total bilirubin less than 2 mg/dL within 7 days prior to first dose of study agent -ELIGIBILITY CRITERIA
•PHASE II (ARM D): Circulating WBC count must not be above 20 x10^9/L within 7 days prior to first dose of study agent -Patients with WBC count above 20 x10^9/L may be eligible if they start steroids or hydroxyurea per institutional guidelines, but they must discontinue before day 1 of study drug -ELIGIBILITY CRITERIA
•PHASE II (ARM D): Creatinine clearance of at least 50 mL/min within 7 days prior to first dose of study agent -ELIGIBILITY CRITERIA
•PHASE II (ARM D): Women must not be pregnant or breast-feeding -ELIGIBILITY CRITERIA
•PHASE II (ARM D): All females of childbearing potential must have a blood test or urine study within 2 weeks 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: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) -ELIGIBILITY CRITERIA
•PHASE II (ARM D): Women of childbearing potential and sexually active males must use an accepted and highly effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for 30 days after the last dose of venetoclax; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately -ELIGIBILITY CRITERIA
•PHASE II (ARM D): No evidence of prior malignancy except adequately treated non-melanoma skin cancer, in situ cervical carcinoma, or any surgically- or radiation-cured malignancy continuously disease free for >= 5 years so as not to interfere with interpretation of radiographic response -ELIGIBILITY CRITERIA
•PHASE II (ARM D): No evidence of isolated extramedullary relapse (i.e., testicular or CNS) -ELIGIBILITY CRITERIA
•PHASE II (ARM D): Patient must not have Burkitt?s lymphoma/leukemia based on the WHO criteria -ELIGIBILITY CRITERIA
•PHASE II (ARM D): Patients must not have active central nervous system (CNS) leukemia, as defined by unequivocal morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF), use of CNS-directed local treatment for active disease within the prior 28 days; previously treated CNS disease with documented cleared CSF will be allowed -ELIGIBILITY CRITERIA
•PHASE II (ARM D): Patient will not be enrolled if they received prior chemotherapy within 2 weeks before enrollment with the following exceptions: to reduce the circulating lymphoblast count or palliation (i.e., steroids or hydroxyurea), for ALL maintenance (mercaptopurine, methotrexate, vincristine, thioguanine, and/or tyrosine kinase inhibitors) -ELIGIBILITY CRITERIA
•PHASE II (ARM D): Patient may be enrolled with a prior allogeneic hematopoietic stem cell transplant (HSCT) but the transplant date must be at least 90 days before date of enrollment; patient must be off immunosuppression and without active GVHD prior to enrollment if previous HSCT -ELIGIBILITY CRITERIA
•PHASE II (ARM D): Patient cannot have poorly controlled HIV, or CD4 < 400; HIV positive patients are allowed on this study if they have a CD4 count >= 400, and are on a stable antiviral regimen -ELIGIBILITY CRITERIA
•PHASE II (ARM D): Patients with NYHA class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia may not be enrolled -ELIGIBILITY CRITERIA
•PHASE II (ARM D): Patients with serious medical or psychiatric illness that in the opinion of the primary investigator is likely to interfere with study participation may not be enrolled -ELIGIBILITY CRITERIA
•PHASE II (ARM D): Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration -ELIGIBILITY CRITERIA
•PHASE II (ARM D): Patients should not have received the following within 7 days prior to the first dose of study drug: -Steroid therapy for anti-neoplastic intent; -Strong and moderate CYP3A inhibitors; -Strong and moderate CYP3A inducers -ELIGIBILITY CRITERIA
•PHASE II (ARM D): Patients must not have grade 3 or higher peripheral neuropathy
Drug, Other, Administration of antineoplastic agent, Drug therapy
Cancer, Leukemia, Recurrent cancer
B-cell acute lymphoblastic leukemia, Cancer treatment, Hematopoietic system, Medical Oncology, T-cell acute lymphoblastic leukemia, venetoclax, vincristine liposome
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Mayo Clinic — Rochester, MN

A Randomized Phase II Study of Nivolumab After Combined Modality Therapy (CMT) in High Risk Anal Cancer (CMT)

Nivolumab After Combined Modality Therapy in Treating Patients With High Risk Stage II-IIIB Anal Cancer

Joleen Hubbard
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100540-P01-RST
18-004936
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REGISTRATION TO STEP 1
•ELIGIBILITY CRITERIA:

  • Age ≥ 18 years.
  • Patients must have histologically proven stage IIB (T3N0M0 only), IIIA (T2N1M0), IIIB (T4N0M0), or IIIC (T3N1M0, T4N1M0) invasive squamous cell carcinoma of the anus or anorectum, according to the AJCC 8th edition. This may include tumors of non-keratinizing histology such as basoloid, transitional cell, or cloacogenic histology. 
  • Individuals with squamous cell carcinoma of the anal margin are eligible if there is evidence of extension of the primary tumor into the anal canal.
  • For patients registering to Arm T, patients must not have received prior chemoradiotherapy for anal cancer.
  • Patients must have ECOG performance status of 0-2.
  • Adequate hematologic function must be documented within 2 weeks prior to registration:
    • Patients must have hemoglobin levels of > 9g/dL;
    • Patient must have a platelet count of > 100,000/mm3;
    • Patient’s ANC level must be > 1500/mm3.
  • Serum creatinine must be ≤ 1.5X ULN.
  • Adequate hepatic function must be documented within 2 weeks prior to registration:
    • Total bilirubin must be < 2 X ULN. AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional upper limit of normal;
    • Albumin ≥ 3.0 g/dL.
  • Patients known to be Human immunodeficiency virus (HIV)+ are permitted. Patients with CD4>200 and Serum HIV viral load of < 200 copies/mm3 are eligibile, and in addition:
    • Participants must be PPD negative. Alternatively, the QuantiFERON-TB Gold In-Tube (QFT-GIT) assay (Cellestis Limited, Carnegie, Australia) can be used. An individual is considered positive for M. tuberculosis infection if the IFN-γ response to TB antigens is above the test cut-off (after subtracting the background IFN-γ response in the negative control). The result must be obtained within 20 weeks prior to enrollment. PPD positive (or Quantiferon assay positive) participants are permitted if prophylaxis has been completed prior to enrollment.
  • No history of AIDS-related complications within past year other than a history of low CD4+ T-cell count >200/mm3 prior to initiation of combination antiretroviral therapy. On study CD4+ T-cell count may not be informative due to chemoradiotherapy and should not be used as an exclusion criterion if low.
  • Patient must be healthy on the basis of HIV disease with high likelihood of near normal life span were it not for the anal cancer
  • Participants MUST receive appropriate care and treatment for HIV infection, including antiretroviral medications when clinically indicated, and should be under the care of a physician experienced in HIV management. Participants will be eligible regardless of antiretroviral medication (including no antiretroviral medication) provided there is no intention to initiate therapy or the regimen has been stable for at least 4 weeks with no intention to change the regimen within 12 weeks following enrollment.
  • Patient must have ≤ grade 2 diarrhea (participants with grade 1 diarrhea are eligible provided stool for ova/parasites and stool cryptosporidium studies are negative
    • NOTE: HIV testing is not required for eligibility.
  • For patients registering prior to start of chemoradiotherapy, baseline scans must have been completed within 4 weeks prior to registration.
  • Patients with an allogenic bone marrow/stem, cell or solid organ transplant are excluded.
  • Women of child bearing potential and sexually active males must use accepted and effective method(s) of contraception and/or abstain from sexual intercourse while on protocol treatment and for at least 5 months after the last dose of nivolumab (for female patients) and for at least 7 months after the last dose of nivolumab (for male patients).
  • Women MUST NOT be pregnant or breast-feeding due to the potential teratogenic harm or abortifacient effectsto an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients must also not expect to conceive or father children from study registration and throughout their time on study treatment . For female patients this must continue until at least 5 months after the last dose of nivolumab and for male patients until at least 7 months after the last dose of nivolumab. 
  • All females of child bearing potential must have a serum or urine pregnancy test to rule out pregnancy within 2 weeks prior to registration.
  • A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy, or 3) 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).
    • Female of child bearing potential? ______ (Yes or No)
    • Date of blood test or urine study: ___________
  • Patients will be excluded if they have any T1 or M1, and T2N0 cancer.
  • Patients must not have had prior potentially curative surgery (abdominal, peritoneal resection) for carcinoma of the anus.
  • Participants may not be receiving any other standard anti-cancer therapy or experimental agent concurrently with the study drugs.
  • Any surgery must have been completed ≥ 4 weeks prior to starting study treatment.
  • No 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 situations that would limit compliance with study requirements.
  • Individuals with a history of a different malignancy are ineligible except if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
  • Patient must not have active autoimmune disease Rev. Add2 in the past 2 years.
    • NOTE: This does not include patients with autoimmune disease controlled by medication, such as hypothyroidism.
  • No prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 monoclonal antibody).
  • No patients with immunodeficiency or receiving Nivolumab equivalent to > 10 mg prednisone per day or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication. Topical corticosteroid or occasional inhaled corticosteroids are allowed.
  • No live vaccines within 30 days prior to registration. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, 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.
    • NOTE: No live vaccines may be administered while participating in the trial
  • Patients must not have known interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.
  • Previously irradiated patients (Arm S) must have received radiation per NCCN guidelines. Details of the prior radiation are captured in Rave. Radiation therapy delivered on protocol (Arm T) will be reviewed.

REGISTRATION TO STEP 2
•ELIGIBILITY CRITERIA:

  • Patients will be registered within 63 days following completion of standard chemoradiation for anal cancer. Standard chemoradiation therapy is as defined in Appendix VII.
  • Patients must have histologically proven stage IIB (T3N0M0 only), IIIA (T2N1M0), IIIB (T4N0M0), or IIIC (T3N1M0, T4N1M0) invasive squamous cell carcinoma of the anus or anorectum, according to the AJCC 8th edition. This may include tumors of non-keratinizing histology such as basoloid, transitional cell, or cloacogenic histology.
  • Individuals with squamous cell carcinoma of the anal margin are eligible if there is evidence of extension of the primary tumor into the anal canal.
  • Patients must have received at least 54 Gy of radiation to the PTVp (primary) and 45 Gy to PTVn (elective nodal region) for the treatment of the anal cancer.
  • Patients must have ECOG performance status of 0-2.
  • Adequate hematologic function must be documented within 2 weeks prior to registration:
  • Patients must have hemoglobin levels of > 10g/dL.
  • Patient must have a platelet count of > 100,000/mm3.
  • Patient’s ANC level must be > 1500/mm3.
  • Serum creatinine must be ≤ 1.5 X ULN.
  • Adequate hepatic function must be documented within 2 weeks prior to registration:
    • Total bilirubin must be < 2 X ULN. AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional upper limit of normal;
    • Albumin ≥ 3.0 g/dL.
  • Patients known to be Human immunodeficiency virus (HIV)+ are permitted. Patients with CD4 > 200 and Serum HIV viral load of < 200 copies/mm3 are eligible. In addition:
    • Participants must be PPD negative. Alternatively, the QuantiFERON-TB Gold In-Tube (QFT-GIT) assay (Cellestis Limited, Carnegie, Australia) can be used. An individual is considered positive for M. tuberculosis infection if the IFN-γ response to TB antigens is above the test cut-off (after subtracting the background IFN-γ response in the negative control). The result must be obtained within 20 weeks prior to enrollment. PPD positive (or Quantiferon assay positive) participants are permitted if prophylaxis has been completed prior to enrollment.
    • NOTE: If patient completed chemoradiation on Step 1, PPD testing does not need to be performed again.
  • No history of AIDS-related complications within past year other than a history of low CD4+ T-cell count >200/mm3 prior to initiation of combination antiretroviral therapy. On study CD4+ T-cell count may not be informative due to chemoradiotherapy should not be used as an exclusion criterion if low.
  • Patient must be healthy on the basis of HIV disease with high likelihood of near normal life span were it not for the anal cancer.
  • Participants MUST receive appropriate care and treatment for HIV infection, including antiretroviral medications when clinically indicated, and should be under the care of a physician experienced in HIV management. Participants will be eligible regardless of antiretroviral medication (including no antiretroviral medication) provided there is no intention to initiate therapy or the regimen has been stable for at least 4 weeks with no intention to change the regimen within 12 weeks following enrollment.
  • Patient must have ≤ grade 2 diarrhea (participants with grade 1 diarrhea are eligible provided stool for ova/parasites and stool cryptosporidium studies are negative).
    • NOTE: HIV testing is not required for eligibility
  • Scans done within 4 weeks of randomization to Step 2.
  • Patient must be able to have recovered from all toxicities associated with chemoradiotherapy for anal cancer, to Grade ≤ 1 with the exception of alopecia.
  • Patients with an allogenic bone marrow/stem, cell or solid organ transplant are excluded.
  • Women of child bearing potential and sexually active males must use accepted and effective method(s) of contraception and/or abstain from sexual intercourse while on protocol treatment and for at least 5 months after the last dose of nivolumab (for female patients) and for at least 7 months after the last dose of nivolumab (for male patients).
  • Women MUST NOT be pregnant or breast-feeding due to the potential teratogenic harm or abortifacient effectsto an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. All patients must also not expect to conceive or father children from study registration and throughout their time on study treatment . For female patients this must continue until at least 5 months after the last dose of nivolumab and for male patients until at least 7 months after the last dose of nivolumab.
  • All females of child bearing potential must have a serum or urine pregnancy test to rule out pregnancy within 2 weeks prior to registration.
  • 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).
      • Female of child bearing potential? ______ (Yes or No)
      • Date of blood test or urine study: ___________
  • Patients must not have had prior potentially curative surgery (abdominal, peritoneal resection) for carcinoma of the anus.
  • Participants may not be receiving any other standard anti-cancer therapy or experimental agent concurrently with the study drugs.
  • No 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 situations that would limit compliance with study requirements.
  • Individuals with a history of a different malignancy are ineligible except if they have been disease-free for at least 2 years and are deemed by the investigator to be at low risk for recurrence. Individuals with the following cancers are eligible if diagnosed and treated within the past 5 years: cervical cancer in situ, and basal cell or squamous cell carcinoma of the skin.
  • Patient must not have active autoimmune disease that has required systemic treatment in past 2 years.
  • No prior treatment with an immune checkpoint inhibitor (anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA4 monoclonal antibody).
  • No patients with immunodeficiency or receiving systemic steroid therapy equivalent to > 10 mg prednisone per day or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication. Topical corticosteroid or occasional inhaled corticosteroids are allowed.
  • No live vaccines within 30 days prior to the first dose of trial treatment and while participating in the trial. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, chicken pox, yellow fever, rabies, 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.
  • Patients must not have known interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicity.
  • Patients must not have a history of allergic reactions attributed to compounds of similar chemical or biologic composition to nivolumab.

 

Biologic/Vaccine, Other, Administration of antineoplastic agent, Drug therapy, Immunotherapy for cancer
Anal cancer, Anal squamous cell carcinoma, Cancer
Biological therapy for cancer, Cancer treatment, Digestive system, MDX-1106, Medical Oncology, Squamous cell carcinoma of anal margin, nivolumab
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A Multicenter, Open-label, Phase 3 Study to Evaluate the Long-term Safety and Efficacy in Participants Who Are Currently on Treatment or in Follow-up in Studies That Include Pembrolizumab (MK3475-587)

Long-term Safety and Effectiveness Study for Participants with Advanced Tumors who are Currently on Treatment or in Follow-up in a Pembrolizumab Trial

Matthew Block
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100558-P01-RST
18-005766
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Inclusion Criteria
Participants are eligible to be included in the study only if all of the following criteria apply:
Type of Participants
1. Participants that are currently enrolled in MSD-sponsored pembrolizumab trials and are receiving trial treatment or in a Follow-up Phase at the time KN587 is open. The parent trials must have completed all regulatory requirements and submissions, if any, or have fully addressed their primary endpoint(s) before all their participants roll over into KN587.
Informed Consent
2. The participant (or legally acceptable representative if applicable) provides informed consent for the trial and agrees to follow study procedures.

Exclusion Criteria
There are no exclusion criteria to participate in KN587.

Biologic/Vaccine, Drug, Administration of antineoplastic agent, Drug therapy
Cancer
Cancer treatment, Malignant neoplastic disease, Medical Oncology, pembrolizumab
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INCB54828-302 A Phase 3, Open-Label, Randomized, Active-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Pemigatinib Versus Gemcitabine Plus Cisplatin Chemotherapy in First-Line Treatment of Participants With Unresectable or Metastatic Cholangiocarcinoma With FGFR2 Rearrangement (FIGHT-302) (FIGHT-302)

A Study to Evaluate the Effectiveness and Safety of Pemigatinib Versus Chemotherapy in Unresectable or Metastatic Cholangiocarcinoma

Nguyen Tran
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100571-P01-RST
18-003888
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Inclusion Criteria:
 

  • Ability to comprehend and willingness to sign a written ICF for the study.
  • Male and female participants at least 18 years of age at the time of signing the ICF; a legally minor participant from Japan needs written parental consent.
  • Histologically or cytologically confirmed cholangiocarcinoma that is previously untreated and considered unresectable and/or metastatic (Stage IV per the AJCC Cancer Staging Manual [AJCC 2002]).
  • Radiographically measurable or evaluable disease by CT or MRI per RECIST v1.1 criteria (Eisenhauer et al 2009).
  • ECOG performance status 0 to 1.
  • Documented FGFR2 rearrangement.


Exclusion Criteria:
 

  • Received prior anticancer systemic therapy for unresectable and/or metastatic disease (not including adjuvant/neo-adjuvant treatment completed at least 6 months prior to enrollment, and participants that have received treatment for locally advanced disease with trans-arterial chemoembolization or selective internal radiation therapy, if clear evidence of radiological progression is observed before enrollment).
  • Child-Pugh B and C.
  • Toxicities related to prior therapy(ies) must be CTCAE v5.0 ≤ Grade 1 at the time of screening.
  • Concurrent anticancer therapy (eg, chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, hormonal therapy, investigational therapy, or tumor embolization), other than the therapies being tested in this study.
  • The participant must not be a candidate for potentially curative surgery.
  • Current evidence of clinically significant corneal (including but not limited to bullous/band keratopathy, corneal abrasion, inflammation/ulceration, and keratoconjunctivitis) or retinal disorder (including but not limited to central serous retinopathy, macular/retinal degeneration, diabetic retinopathy, retinal detachment) as confirmed by ophthalmologic examination
  • Radiation therapy administered within 4 weeks of enrollment/randomization/first dose of study treatment. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis. Evidence of fibrosis within a radiation field from prior radiotherapy is permitted with medical monitor approval. A 2-week washout is permitted for palliative radiation to non-CNS disease.
  • Known CNS metastases or history of uncontrolled seizures. Participants with treated brain metastases are eligible if there is no evidence of progression for at least 4 weeks after CNS-directed treatment, as ascertained by clinical examination and brain imaging (MRI or CT scan) during the screening period, and they are on stable or decreasing dose of corticosteroids for at least 1 week.
  • Known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
  • Participants with laboratory values at screening defined below:
  • Hematology
    • Platelets | ≤ 75/100 × 109/L (transfusion allowed with 2-week washout period);
    • Hemoglobin | ≤ 9.0 g/dL (transfusion allowed with 2-week washout period);
    • ANC | ≤ 1.5 × 109/L.
  • Hepatic 
    • ALT | > 2.5 × ULN (> 5 × ULN if related to underlying disease or the presence of liver metastases);
    • AST | > 2.5 × ULN (> 5 × ULN if related to underlying disease or the presence of liver metastases);
    • Total bilirubin | ≥ 1.5 × ULN (≥ 2.5 × ULN if Gilbert syndrome).
    • NOTE: Participants with biliary drainage to improve liver function tests to meet above criteria are allowed.
  • Renal 
    • < 60 mL/min based on Cockcroft-Gault formula.
  • Chemistry 
    • Serum phosphate | > ULN;
    • Serum calcium | Outside of normal range or serum albumin-corrected calcium outside of the normal range when serum albumin is outside of the normal range.
  • History of calcium and phosphate hemostasis disorder or systemic mineral imbalance with ectopic calcification of soft tissues (exception: commonly observed calcifications in soft tissues, such as the skin, kidney, tendons or vessels due to injury, disease, and aging, in the absence of systemic mineral imbalance).
  • Gastrointestinal conditions/disorders that may raise gastric and/or small intestinal pH that could interfere with absorption, metabolism, or excretion of pemigatinib.
  • Inability of the participant to swallow and retain oral medication
  • Clinically significant or uncontrolled cardiac disease, including unstable angina, acute myocardial infarction within 6 months from Day 1 of study treatment administration, New York Heart Association Class III and IV congestive heart failure, and uncontrolled arrhythmia (participants with pacemaker or with atrial fibrillation and well controlled heart rate are allowed).
  • History or presence of an abnormal ECG, which, in the investigator's opinion, is clinically meaningful. A screening QTcF interval > 480 milliseconds is excluded. For participants with an interventricular conduction delay (QRS interval >120 ms), the JTc interval may be used in place of the QTc with sponsor approval (the JTc must be ≤ 340 milliseconds if JTc is used in place of the QTc).
  • Chronic or current active infectious disease requiring systemic antibiotics or antifungal or antiviral treatment within 2 weeks prior to enrollment (participants with asymptomatic chronic infections on prophylactic treatment are allowed). Note: HIV-positive participants are allowed if all of the following criteria are met: CD4+ count > 300/uL, undetecable viral load, receiving antiretroviral therapy that does not interact with study drug, and no HIV/AIDS-associated opportunistic infection in the last 12 months. 
  • Current use of prohibited medication.
  • Use of any potent CYP3A4 inhibitors or inducers or moderate CYP3A4 inducers within 14 days or 5 half-lives (whichever is longer) before the first dose of study treatment. Note: Moderate CYP3A4 inhibitors are not prohibited.
  • Known hypersensitivity or severe reaction to pemigatinib, gemcitabine, cisplatin, or their excipients (refer to the IB and commercially available product information sheets).
  • Inability or unlikeliness of the participant to comply with the dose schedule and study evaluations in the opinion of the investigator.
  • Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
  • For NA, EU, and ROW participants, women who are pregnant or breastfeeding or participants expecting to conceive or father children within the projected duration of the study, starting with the screening visit through completion of safety follow-up or through 90 days from the date of last dose of pemigatinib and 6 months after the last dose of gemcitabine and/or cisplatin for male participants.
  • For Japanese participants, pregnant or breastfeeding women or participants expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 90 days after last dose of pemigatinib (men; based on the spermatogenetic cycle) and 30 days after last dose of pemigatinib (women; based on menstrual cycle) and 6 months after the last dose of gemcitabine and/or cisplatin (men and women). Female participants who are breastfeeding and wish to enroll must discontinue breastfeeding before receiving study drug and must not resume breastfeeding until at least 30 days after last dose of study treatment, which exceeds 5 times the half-life of pemigatinib.
  • Any condition that would, in the investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
  • Inability of the participant (or parent, guardian, or legally authorized representative) to comprehend or unwilling to sign the ICF.
  • Any contraindication to gemcitabine or cisplatin as per each SmPC or product insert.
  • History of hypovitaminosis D requiring supraphysiologic doses (e.g., 50,000UI/weekly) to replenish the deficiency. Participants receiving vitamin D supplements are allowed.

 

Drug, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Experimental therapeutic procedure
Cancer, Cholangiocarcinoma
1,2-Diaminocyclohexaneplatinum II citrate, Cancer treatment, Chemotherapy, Cholangiocarcinoma of biliary tract, Digestive system, Gemcitabine [USAN:INN:BAN], Medical Oncology, Pemigatinib, cisplatin, gemcitabine
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A Phase 3, Multicenter, Randomized, Open Label Study of Venetoclax and Dexamethasone Compared with Pomalidomide and Dexamethasone in Subjects with t(11;14)-Positive Relapsed or Refractory Multiple Myeloma

Study Comparing Venetoclax and Dexamethasone to Pomalidomide and Dexamethasone in Patients with t(11;14)-Positive Relapsed or Refractory Multiple Myeloma

Prashant Kapoor
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100572-P01-RST
18-005416
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Inclusion Criteria:

  • Subjects must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures.
  • Adult male or female, ≥ 18 years old.
  • Laboratory values meeting the following criteria within the screening period prior to the first dose of study drug:
    • Absolute neutrophil count (ANC) ≥ 1000/μL.  Subject may use growth factor support to achieve ANC eligibility criteria;
    • Platelets: ≥ 50,000/mm^3.  For subjects with > 50% myeloma involvement in the marrow, a platelet count of ≥ 30,000 mm^3 is allowed. Subjects may not have received a platelet transfusion within 72 hours prior to the platelet count used for eligibility;
    • Hemoglobin ≥ 8.0 g/dL; subject may receive red blood cell (RBC) transfusions in accordance with institutional guidelines to meet this criteria;
    • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN);
    • Total bilirubin ≤ 1.5 × ULN (subjects with documented Gilbert's syndrome may have bilirubin > 1.5 × ULN);
    • Creatinine Clearance (CrCl) ≥ 30 mL/min, measured by 24-hour urine collection or calculated using the Cockcroft-Gault formula;
    • Serum calcium corrected for albumin ≤ 14.0 mg/dL (≤ 3.5 mmol/L).
  • Are willing or able to comply with procedures required in this protocol.
  • Are willing and able to receive antithrombotic prophylactic treatment. Documented diagnosis of MM based on standard IMWG criteria.
  • Subject has an Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
  • Subject has documented disease progression on or within 60 days of completion of their last therapy. 
  • Subject has received at least 2 prior lines of therapy. 
    • A line of therapy consists of at least 1 complete cycle of a single agent, a regimen consisting of a combination of several drugs, or a planned sequential therapy of various regimens.
  • Subject must have received at least 2 consecutive cycles of lenalidomide and be refractory to lenalidomide as defined by one of the following:
    • Subject experienced PD on or within 60 days of completing treatment;
    • Subject exhibited PR or better but relapsed within 6 months after stopping treatment.
  • Subject must have received at least 2 consecutive cycles of a proteasome inhibitor (bortezomib, carfilzomib or ixazomib).
  • Subject has measurable disease at Screening, defined by at least 1 of the following:
    • Serum M-protein ≥ 1.0 g/dL (≥ 10 g/L); OR
    • Urine M-protein ≥ 200 mg/24 hours; OR
    • Serum immunoglobulin free light chain (FLC) ≥ 10 mg/dL (100 mg/L), provided serum FLC ratio is abnormal.
  • Subject has MM positive for t(11;14) as determined by an analytically validated fluorescent in situ hybridization (FISH) assay per centralized laboratory testing.
  • No history of treatment with venetoclax or another BCL-2 inhibitor or pomalidomide.
  • No history of other active malignancies, including myelodysplastic syndromes (MDS), within the past 3 years with the following exceptions:
    • Adequately treated in situ carcinoma of the cervix uteri or the breast;
    • Basal cell carcinoma of the skin or localized squamous cell carcinoma of the skin;
    • Prostate cancer Gleason grade 6 or lower AND with stable Prostate Specific Antigen (PSA) levels off treatment; or
    • Previous malignancy with no current evidence of disease, and which was confined and surgically resected (or treated with other modalities) with curative intent and unlikely to impact survival during the duration of the study.
  • No evidence of ongoing graft-versus-host disease (GvHD) if prior stem cell transplant (SCT).
  • No prior treatment with any of the following:
    • Allogeneic or syngeneic SCT within 16 weeks prior to randomization; or
    • Autologous SCT within 12 weeks prior to randomization.
  • No known meningeal involvement of MM.
  • No history of clinically significant renal, neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary or hepatic disease within the last 6 months that, in the Investigator's opinion, would adversely affect the subject's participation in the study.
  • No history of known allergies, hypersensitivities, or intolerance to any of the study drug or excipients, or thalidomide derivatives.
  • None of the following conditions:
    • Nonsecretory MM;
    • Active plasma cell leukemia; i.e., either 20% of peripheral white blood cells or > 2.0 × 10^9/L circulating plasma cells by standard differential;
    • Waldenström's macroglobulinemia;
    • Primary amyloidosis;
    • POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes);
    • Known human immunodeficiency virus (HIV) infection;
    • Active hepatitis B or C infection based on screening blood testing;
    • Significant cardiovascular disease, including uncontrolled angina, arrhythmia, recent myocardial infarction within 6 months of first dose, congestive heart failure New York Heart Association (NYHA) Class ≥ 3;
    • Major surgery within 4 weeks prior to first dose or planned during study participation;
    • Acute infections within 14 days prior to first dose of study drug requiring therapy (antibiotic, antifungal, or antiviral);
    • Uncontrolled diabetes or hypertension within 14 days prior to first dose; or
    • Peripheral neuropathy ≥ Grade 3 or ≥ Grade 2 with pain within 2 weeks prior to first dose.
  • A negative serum pregnancy test for all female subjects (except those of non-childbearing potential) within 10 to 14 days prior to initiating therapy and a negative urine pregnancy test within 24 hours for all female subjects (except those of non-childbearing potential) at baseline prior to the first dose of study drug.
  • If female, subject must be either postmenopausal, OR permanently surgically sterile OR for women of childbearing potential practicing at least 2 protocol-specified methods of birth control that are effective from at least 30 days before starting study drugs through at least 30 days after the last dose of any study drug.
  • If male, and subject is sexually active with female partner(s) of childbearing potential, he must agree, from Study Day 1 through 30 days after the last dose of study drug, to practice the protocol-specified contraception.
  • Female who is not pregnant, breastfeeding, or considering becoming pregnant during the study and for at least 30 days after the last dose of study drug.
  • Male who is not considering fathering a child or donating sperm and/or semen during the study and for at least 30 days after the last dose of study drug.
  • Subject must not have been treated with any systemic anti-myeloma therapies within 5 half-lives or 2 weeks prior to randomization, whichever is longer (or 2 weeks if half-life unknown), and through the last dose of  any study drug. For anti-myeloma monoclonal antibodies, subjects should observe a washout period of 30 days prior to randomization.
  • Subject must not have been treated with anti-myeloma radiotherapy within 2 weeks prior to randomization.
  • Subject must not have received corticosteroid therapy at a dose equivalent to > 4 mg daily of dexamethasone or a single dose of corticosteroid equivalent dose > 40 mg of dexamethasone within 2 weeks prior to randomization.
  • Subject must not have used systemic strong or moderate inhibitor or inducer of cytochrome P450 (CYP)3A (Appendix B in the Operations Manual) within 1 week prior to the first dose of study drugs.
  • Subject must not have used systemic strong inhibitor of CYP1A2 within 1 week before the first dose of study drugs.
  • Subject must not have consumed grapefruit, grapefruit products, Seville oranges (including marmalade containing Seville oranges), or starfruit within 3 days prior to the first dose of study drugs.
  • Subject must not have received any live vaccines within 8 weeks prior to randomization.
  • Subject must not anticipate the use of prohibited medications or foods during study participation.


Exclusion Criteria:

  • Anything other than a positive response to the questions below will result in exclusion from study participation.
Other, Administration of antineoplastic agent, Drug therapy
Cancer, Multiple myeloma, Plasma cell disorders
3-Aminophthalimidoglutarimide, 4-(4-((2-(4-chlorophenyl)-4,4-dimethylcyclohex-1-en-1-yl)methyl)piperazin-1-yl)-N-((3-nitro-4-((tetrahydro-2H-pyran-4-ylmethyl)amino)phenyl)sulfonyl)-2-(1H-pyrrolo(2,3-b)pyridin-5-yloxy)benzamide, Cancer treatment, Chemotherapy, Dexamethasone, Hematopoietic system, Immune system, Medical Oncology, Relapse multiple myeloma, dexamethasone, pomalidomide, venetoclax
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A Phase 1/2 Study of Oral Selpercatinib LOXO-292 in Patients With Advanced Solid Tumors, Including RET Fusion-Positive Solid Tumors, Medullary Thyroid Cancer, and Other Tumors With RET Activation (LIBRETTO-001) (LIBRETTO-001)

A Study of LOXO-292 in Patients with Advanced Solid Tumors, RET Fusion-Positive Solid Tumors, and Medullary Thyroid Cancer

Mabel Ryder
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
0000-100577-P01-RST
18-008859
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Inclusion Criteria:

For Phase 1 

  • Patients with a locally advanced or metastatic solid tumor who:
    • have progressed on or are intolerant to standard therapy, or
    • no standard therapy exists, or in the opinion of the Investigator, are not candidates for or would be unlikely to tolerate or derive significant clinical benefit from standard therapy, or
    • decline standard therapy.
  • Prior MKIs with anti-RET activity are allowed. Refer to Appendix A for examples of MKIs with anti-RET activity. The specific agent(s), duration of treatment, clinical benefit, and reason for discontinuation (e.g., PD, drug toxicity, or intolerance) should be documented for all kinase inhibitors the patient has been exposed to.
  • A RET gene alteration is not required initially. Once adequate PK exposure is achieved (see below), evidence of RET gene alteration in tumor and/or blood is required (e.g., gene rearrangement and/or mutation, excluding synonymous, frameshift, or nonsense mutations) as identified through molecular assays, as performed for clinical evaluation. The RET alteration result should be generated from a laboratory with CLIA, ISO/IEC, CAP or other similar certification. The Sponsor should be contacted to discuss test results from labs where such certification is not clearly demonstrated to determine eligibility.
  • Notes:
    • During Phase 1, a RET gene alteration is not required initially. The Sponsor’s preclinical data indicates that a LOXO-292 plasma level of 70 ng/mL is equivalent to the IC50 for RET (corrected for human plasma protein binding). Therefore, once a dose level is achieved that: (1) is associated with a DLT rate of < 33%; (2) is deemed safe by the SRC; and (3) is associated with a Cmin of > 70 ng/mL at steady state in ≥ 70% of patients in the same dosing cohort (e.g., 3/3, 3/4, 4/5, 5/6 patients, etc.), enrollment to subsequent dose levels during Phase 1 will be restricted to patients with: (1) RET fusion-positive solid tumors; (2) MTC; (3) an advanced solid tumor that harbors a RET gene alteration (excluding synonymous, frameshift, or nonsense mutations); or (4) with prior Sponsor approval, an advanced solid tumor with other evidence of RET activation (refer to Section 4).
    • A positive germline test for a RET mutation is acceptable for patients with MTC.
    • Local testing in a CLIA, ISO/IEC, CAP, or other similar certified laboratory is sufficient.
    • In all cases, an anonymized/redacted Molecular Pathology Report or other report(s) describing tumor RET (and other) alteration analysis should be submitted to the Sponsor or designee during/prior to eligibility.
  • Measurable or non-measurable disease as determined by RECIST 1.1 or RANO as appropriate to tumor type.
  • At least 18 years of age.
    • For countries and sites where approved, patients as young as 12 years of age may be enrolled. (Canada is excluded from enrolling minors [patients under 18 years of age] into the study).
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1, or 2 (age ≥ 16 years) or Lansky Performance Score (LPS) ≥ 40% (age < 16 years) with no sudden deterioration 2 weeks prior to the first dose of study treatment.
  • Life expectancy of at least 3 months.
  • Archived tumor tissue sample available.
  • Notes:
    • Patients who do not have adequate archival tumor tissue available (refer to specific archival tissue requirements in Section 7.8.5.1) should undergo a fresh tumor biopsy, if it is considered safe to perform, prior to treatment (requirement may be waived with Sponsor approval).
    • If archived tumor tissue was obtained prior to progression on the last MKI with anti-RET activity, the patient should undergo a fresh tumor biopsy, if it is considered safe to perform prior to treatment (optional).
  • Adequate hematologic status, defined as:
    • Absolute neutrophil count (ANC) ≥ 1.0 × 109/L not requiring growth factor support for at least 7 days prior to treatment, and
    • Platelet count ≥ 75 × 109/L not requiring transfusion support for at least 7 days prior to treatment, and
    • Hb ≥ 9 g/dL not requiring transfusion support or erythropoietin for at least 7 days prior to treatment.
  • Adequate hepatic function, defined as:
    • ALT and AST ≤ 2.5 × the upper limit of normal (ULN) or ≤ 5 × ULN with documented liver involvement (such as liver metastasis or a primary biliary tumor); and
    • Total bilirubin ≤ 1.5 × ULN or ≤ 3 × ULN with documented liver involvement (patients with Gilbert’s Disease may be enrolled with prior Sponsor approval).
  • Adequate renal function, with estimated glomerular filtration rate ≥ 30 mL/minute (up to 6 patients with an estimated glomerular filtration rate (eGFR) ≥ 15 and < 30 mL/minute will be allowed to enroll with Sponsor approval).
  • Ability to swallow capsules and comply with outpatient treatment, laboratory monitoring, and required clinic visits for the duration of study participation. If the liquid formulation is widely available, this requirement may be waived with Sponsor approval.
  • Willingness of men and women of reproductive potential to observe conventional and effective birth control for the duration of treatment and for 3 months following the last dose of study treatment; this may include barrier methods such as condoms or diaphragms with spermicidal gel.
  • Notes:
    • A postmenopausal woman will be defined as having no menses for 12 months without an alternative medical cause. Male sterility will be defined as only men sterilized surgically. For male patients with a pregnant partner, a condom should be used for contraception. For male patients with a non-pregnant female partner of child-bearing potential and woman of child-bearing potential one of the following birth control methods with a failure rate of less than 1% per year when used consistently and correctly are recommended:
      • Combined estrogen and progesterone containing hormonal contraception associated with inhibition of ovulation given orally, intravaginally, or transdermally
      • Progesterone-only hormonal contraception associated with inhibition of ovulation given orally, by injection, or by implant
      • Intrauterine device (IUD)
      • Intrauterine hormone-releasing system (IUS)
      • Bilateral tubal occlusion
      • Vasectomized partner
      • Sexual abstinence
  •  Birth control methods unacceptable for this clinical trial are:
    • Periodic abstinence (calendar, symptothermal, or post-ovulation methods)
    • Withdrawal (coitus interruptus)
    • Spermicide only
    • Lactational amenorrhea method

For Phase 2

Inclusion Criteria are the same as for Phase 1, with the following modifications:

  • Cohorts 1 and 3: failed or intolerant to standard of care.
  • Cohorts 2 and 4: without prior standard-first line therapy.


Exclusion Criteria:

 Phase 1 and Phase 2

  • Phase 2 Cohorts 1-4: an additional validated oncogenic driver that could cause resistance to LOXO-292 treatment.
  • Cohorts 1-5: prior treatment with a selective RET inhibitor(s) (including investigational selective RET inhibitor[s]).
    • Notes: Patients otherwise eligible for Cohorts 1-5 who discontinued another selective RET inhibitor may be eligible for Phase 2 Cohort 6 with prior Sponsor approval.
  • Investigational agent or anticancer therapy (including chemotherapy, biologic therapy, immunotherapy, anticancer Chinese medicine or other anticancer herbal remedy) within 5 half-lives or 2 weeks (whichever is shorter) prior to planned start of LOXO-292. In addition, no concurrent investigational anti-cancer therapy is permitted.
    • Note: Potential exception for this exclusion criterion will require a valid scientific justification and approval from the Sponsor.
  • Major surgery (excluding placement of vascular access) within 4 weeks prior to planned start of LOXO-292.
  • Radiotherapy with a limited field of radiation for palliation within 1 week of the first dose of study treatment, with the exception of patients receiving radiation to more than 30% of the bone marrow or with a wide field of radiation, which must be completed at least 4 weeks prior to the first dose of study treatment.
  • Any unresolved toxicities from prior therapy greater than CTCAE Grade 1 at the time of starting study treatment with the exception of alopecia and Grade 2, prior platinum-therapy related neuropathy.
  • Symptomatic primary CNS tumor, metastases, leptomeningeal carcinomatosis, or untreated spinal cord compression.
    • Exception: Patients are eligible if neurological symptoms and CNS imaging are stable and steroid dose is stable for 14 days prior to the first dose of LOXO-292 and no CNS surgery or radiation has been performed for 28 days, 14 days if stereotactic radiosurgery (SRS).
    • Note:  During the Phase 2 portion of the study, all prior local treatments for CNS disease (e.g., surgery, whole brain radiation [WBRT], SRS), the start and stop dates for each prior local therapy, the specific lesions treated (if SRS and/or surgery), whether the patient developed intracranial progression after the last prior local treatment, and which lesions progressed since completion of the local therapy must be documented.
  • Clinically significant active cardiovascular disease or history of myocardial infarction within 6 months prior to planned start of LOXO-292 or prolongation of the QT interval corrected for heart rate using Fridericia’s formula (QTcF) interval > 470 msec during Screening. Correction of suspected drug-induced QTcF prolongation may be attempted at the Investigator’s discretion if clinically safe to do so.
  • Active uncontrolled systemic bacterial, viral, or fungal infection, or serious ongoing intercurrent illness, such as hypertension or diabetes, despite optimal treatment. 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.
  • Current treatment with certain strong CYP3A4 inhibitors or inducers (outlined in Appendix D) and certain prohibited concomitant medications.
  • Current treatment with PPIs (refer to Appendix E).
    • Note: Treatment with PPIs must be stopped 1 or more weeks prior to the first dose of LOXO-292.
  • Pregnancy or lactation.
  • Active second malignancy other than minor treatment of indolent cancers.
  • History of hypersensitivity to any of the study drug capsule components.
Drug, Administration of antineoplastic agent, Drug therapy
Cancer, Medullary thyroid carcinoma, Thyroid cancer
Cancer treatment, Endocrine system, Medical Oncology, Medullary thyroid carcinoma
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A Phase III Trial of Stereotactic Radiosurgery Compared With Whole Brain Radiotherapy (WBRT) for 5-15 Brain Metastases (HA-WBRT)

A Study to Compare Stereotactic Radiosurgery to Hippocampal-Avoidant Whole Brain Radiotherapy

Elizabeth Yan
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100586-P01-RST
18-006060
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Inclusion Criteria:
 

  • Patients must have 5 or more brain metastases as counted on a T1 contrast enhanced MRI obtained ≤ 30 days from randomization (maximum 15 brain metastases).
  • Patients must have a pathological diagnosis (cytological or histological) of a non-hematopoietic malignancy.
  • The largest brain metastasis must measure < 2.5 cm in maximal diameter. The total tumour volume must be 30 cm3 or less. Lesion volume will be approximated by measuring the lesion’s three perpendicular diameters on contrast-enhanced, T1-weighted MRI and the product of those diameters will be divided by 2 to estimate the lesion volume (e.g., xyz/2). Alternatively, direct volumetric measurements via slice by slice contouring on a treatment planning software package can be used to calculate the total tumour volume.
  • Centre must either have the ability to treat patients with either a Gamma Knife, Cyberknife, or a linear accelerator-based radiosurgery system, or access to a centre at which the trial is open which can treat with using one of these systems.
  • Patient must be ≥ 18 years of age.
  • Patient is able (i.e., sufficiently fluent) and willing to complete the quality of life questionnaires in either English or French either alone or with assistance. The baseline assessment must be completed within required timelines, prior to randomization.
  • Patient must also be able and willing to complete the neurocognitive testing without assistance from family and companions. Because this is one of the primary goals of this study, patients must be fluent in English or French, and fully testable in one of those languages.
  • A patient that is able but unwilling to complete the questionnaires will be considered ineligible.
  • ECOG performance status 0, 1, or 2.
  • Creatinine clearance must be ≥ 30 ml/min within 28 days prior to registration.
  • The Neurocognitive Testing examiner must have credentialing confirming completion of the neurocognitive testing training.
  • The enrolling facility is credentialed by IROC to perform SRS and HA-WBRT
    •or have access to a centre where these treatments are credentialed and the study is open. The treating centre must have completed stereotactic radiosurgery credentialing of the specific system(s) to be used in study patients. The treating centre must have completed IMRT credentialing of the specific IMRT system(s) to be used in study patients for the purposes of HA-WBRT.
  • Patient consent must be appropriately obtained in accordance with applicable local and regulatory requirements. Each patient must sign a consent form prior to enrolment in the trial to document their willingness to participate. A similar process must be followed for sites outside of Canada as per their respective cooperative group’s procedures.
  • Patients must be accessible for treatment and follow-up. Investigators must assure themselves the patients randomized on this trial will be available for complete documentation of the treatment, adverse events, and follow-up.
  • In accordance with CCTG policy, protocol treatment is to begin within 14 days of patient enrolment.
  • Women/men of childbearing potential must have agreed to use a highly effective contraceptive method. A woman is considered to be of "childbearing potential" if she has had menses at any time in the preceding 12 consecutive months. In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy or bilateral tubal ligation, or vasectomy/vasectomized partner. However, if at any point a previously celibate patient chooses to become heterosexually active during the time period for use of contraceptive measures outlined in the protocol, he/she is responsible for beginning contraceptive measures.
  • Women of childbearing potential will have a pregnancy test to determine eligibility as part of the Pre-Study Evaluation; this may include an ultrasound to rule-out pregnancy if a false-positive is suspected. For example, when beta-human chorionic gonadotropin is high and partner is vasectomized, it may be associated with tumour production of hCG, as seen with some cancers. Patient will be considered eligible if an ultrasound is negative for pregnancy.


Exclusion Criteria:
 

  • Pregnant or nursing women.
  • Men or women of childbearing potential who are unwilling to employ adequate contraception.
  • Inability to complete a brain MRI.
  • Known allergy to gadolinium.
  • Prior cranial radiation therapy.
  • Planned cytotoxic chemotherapy within 48 hours prior or after the SRS or HA-WBRT.
  • Primary germ cell tumour, small cell carcinoma, or lymphoma.
  • Widespread definitive leptomeningeal metastasis. This includes cranial nerve palsy, leptomeningeal carcinomatosis, ependymal involvement, cranial nerve involvement on imaging, suspicious linear meningeal enhancement, or cerebrospinal fluid (CSF) positive for tumour cells.
  • A brain metastasis that is located ≤ 5 mm of the optic chiasm or either optic nerve.
  • Surgical resection of a brain metastasis (stereotactic biopsies will be allowed).
  • More than 15 brain metastases on a volumetric T1 contrast MRI (voxels of 1mm3 or smaller) performed within the past 14 days, or more than 10 metastases in the case of a non-volumetric MRI.
  • Prior allergic reaction to memantine, or hypersensitivity to any excipients of memantine.
  • Current alcohol or drug abuse.
  • Current use of NMDA antagonists, such as amantadine, ketamine, or dextromethorphan.
  • Diagnosis of chronic liver disease/cirrhosis of the liver (e.g., Child-Pugh class B or C).
  • Clinically significant untreated or uncontrolled cardiovascular conditions, and/or symptomatic cardiac dysfunction (i.e., unstable angina, congestive heart failure, myocardial infarction within the previous year, cardiac ventricular arrhythmias requiring medication, history of 2nd or 3rd degree atrioventricular conduction defects, uncontrolled hypertension).
  • Current active or uncontrolled urinary tract infections (UTI).
  • History of epilepsy or seizures, and not currently taking anti-epileptic medication.
  • Any other serious intercurrent illness or medical condition judged by the local investigator to compromise the patients safety, preclude safe administration of the planned protocol treatment, or would not permit the patient to be managed according to the protocol guidelines.
  • Patients with architectural distortion of lateral ventricular systems which, in the opinion of the local investigator, makes hippocampal delineation challenging.

 

Drug, Procedure/Surgery, Radiation, Stereotactic radiosurgery of brain tissue, Whole brain radiation therapy
Brain metastasis, Brain tumor, Cancer
Brain stereotactic radiosurgery, Cancer treatment, Medical Oncology, Nervous system, Radiation therapy, Secondary malignant neoplasm of brain, Stereotactic radiosurgery
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MK-3475-756 - A Randomized, Double-Blind, Phase III Study of Pembrolizumab Versus Placebo in Combination With Neoadjuvant Chemotherapy and Adjuvant Endocrine Therapy for the Treatment of High-Risk Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER/HER2-) Breast Cancer (KEYNOTE-756)

A Study of Pembrolizumab (MK-3475) Versus Placebo in Combination with Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer

Minetta Liu
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100591-P01-RST
19-002820
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Inclusion Criteria:

  • Participant has a localized invasive breast ductal adenocarcinoma, confirmed by the local pathologist, that includes either T1c-T2 (tumor size ≥ 2 cm), clinical node stage (cN)1-cN2, or T3-T4, cN0-cN2.
    • Note: Multifocal tumors defined as the presence of 2 or more foci of cancer within the same quadrant are allowed; at least 1 of the tumors needs to be ≥ 2 cm.
  • ER+/HER2– status needs to be confirmed for each focus.
    • Note: Inflammatory breast cancer is allowed.
    • Note: Participants with node negative disease will be capped at 20% of the total population.
  • Has centrally confirmed ER+/HER2–, Grade 3 breast cancer of ductal histology, according to the most recent American Society of Clinical Oncology/College of American Pathologist guidelines. Refer to Appendix 6 for country-specific requirements.
  • Provides a new or recently obtained core needle biopsy, consisting of multiple cores, taken from the primary breast tumor(s) for central determination of HR status (ER and progesterone receptor), HER2, grade, and PD-L1 status.
    • Note: Adequacy of the biopsy specimen for the above analyses must be confirmed by the central laboratory. Submission of another tumor specimen may be required, if adequate tumor tissue was not provided the first time.
    • Note: Sponsor agreement is required for formalin-fixed paraffin-embedded (FFPE) tumor tissue sample or slides that were obtained greater than 60 days prior to the date that the informed consent was signed.
  • Is a male or female ≥ 18 years of age on the day of signing informed consent.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, as assessed within 10 days prior to initiation of study treatment.
  • A male participant must agree to use a contraception during the treatment period and for at least 12 months (for participants who received cyclophosphamide) or 6 months (for participants who did not receive cyclophosphamide) after the last dose of study treatment 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); OR
  • A WOCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 12 months (for participants who received cyclophosphamide) or 6 months (for participants who did not receive cyclophosphamide) after the last dose of study treatment with pembrolizumab or placebo. 
  • The participant (or legally acceptable representative if applicable) provides written informed consent for the study. The participant may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research.
  • Has adequate organ function; all screening laboratory tests should be performed within 10 days prior to initiation of study treatment:
  • Hematological
    • Absolute neutrophil count ≥ 1,500 cells/μL;
    • Platelets* ≥ 100,000 cells/μL;
    • Hemoglobin* ≥ 9 g/dL or ≥ 5.6 mmol/L.
  • Renal
    • Creatinine ≤ 1.5 × ULN; OR
    • Measured or calculated** creatinine clearance (GFR can also be used instead of CrCl) ≥ 50 mL/min for participants with creatinine levels ≥ 1.5 × institutional ULN.
  • Hepatic
    • Total bilirubin ≤ 1.5 × ULN; OR
    • Direct bilirubin ≤ ULN for participants with total bilirubin levels ≥ 1.5 × ULN;
    • AST (SGOT) and ALT (SGPT) ≤ 2.5 × ULN.
  • Coagulation
    • INR or PT ≤ 1.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT/PTT is within therapeutic range of intended use of anticoagulants;
    • Activated partial thromboplastin time (aPTT) or partial thromboplastin time (PTT).
  • Abbreviations: ALT = alanine aminotransferase; AST = aspartate aminotransferase; CrCl = creatinine clearance; GFR = glomerular filtration rate; INR = international normalized ratio; PT = prothrombin time; SGOT = serum glutamic oxaloacetic transaminase; SGPT = serum glutamic pyruvic transaminase; ULN = upper limit of normal.
  • *  Platelet and hemoglobin requirements cannot be met by use of recent transfusion or growth factor support (granulocyte colony stimulating factor [G-CSF], granulocyte-macrophage colony stimulating factor [GM-CSF], or erythropoietin) within 2 weeks prior to initiation of study treatment.
  • ** Creatinine clearance should be calculated per institutional standard.


Exclusion Criteria:
 

 

  • Has a history of non-infectious pneumonitis that required treatment with steroids or has current pneumonitis.
  • Has breast cancer with lobular histology.
  • Has bilateral invasive breast cancer.
  • Has metastatic (Stage IV) breast cancer.
  • Has multi-centric breast cancer (presence of more than 1 tumor in different quadrants of the breast).
  • Has any of the following clinical lymph node staging per current AJCC staging criteria for breast cancer staging based on radiological and/or clinical assessment:
    • cN3, cN3a, cN3b, or cN3c.
  • Has ER–, progesterone receptor positive breast cancer.
  • Participants who have undergone excisional biopsy of the primary tumor and/or axillary lymph nodes or have undergone sentinel lymph node biopsy prior to study treatment.
  • Has a known additional, invasive, malignancy that is progressing or required active treatment in the last 5 years.
    • Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, breast ductal carcinoma in situ, or cervical carcinoma in situ that has undergone potentially curative therapy are not excluded.
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study treatment.
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids, or immunosuppressive drugs).
    • Note: Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
  • Has a known history of active tuberculosis (Bacillus tuberculosis).
  • Has an active infection requiring systemic therapy.
  • Has a history or current evidence of any condition (e.g., transfusion-dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that is specifically contraindicated per the current locally-approved labeling, that might confound the results of the study, interfere with the participant’s involvement for the full duration of the study, or is not in the best interest of the participant to be involved, in the opinion of the treating investigator.
  • Has known psychiatric or substance abuse disorders that would may interfere with cooperation with the requirements of the study.
  • Has left ventricular ejection fraction (LVEF) of < 50% or below the institution limit of normal, as assessed by echocardiogram (ECHO) or multigated acquisition (MUGA) scan performed at screening.
  • Has other significant cardiac disease, such as:
    • History of myocardial infarction, acute coronary syndrome, or coronary angioplasty/stenting/bypass within the last 6 months;
    • Congestive heart failure (CHF) New York Heart Association (NYHA) Class II-IV or history of CHF NYHA Class III or IV.
  • Has a known history of human immunodeficiency virus (HIV) infection.
    • Note: No HIV testing is required unless mandated by local health authority.
  • Has a known history of hepatitis B (defined as hepatitis B surface antigen [HbsAg] reactive) or known active hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.
    • Note: No testing for hepatitis B or hepatitis C is required unless mandated by local health authority.
  • A WOCBP who has a positive urine pregnancy test within 72 hours before the first dose of study treatment. If the urine test cannot be confirmed as negative, a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive.

 

Biologic/Vaccine, Drug, Procedure/Surgery, Radiation, Administration of antineoplastic agent, Drug therapy, Excision of malignant tumor of breast, Hormone therapy, Immunotherapy for cancer
Breast cancer, Cancer, Male breast cancer
Biological therapy for cancer, Breast cancer surgery, Cancer treatment, Chemotherapy, Chemotherapy for breast cancer, Estrogen receptor positive tumor, High risk tumor, Hormone therapy for breast cancer, Human epidermal growth factor 2 negative carcinoma of breast, Infiltrating duct carcinoma of breast, Medical Oncology, Pembrolizumab [USAN:INN], pembrolizumab
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Phase 1 Study with Expansion Cohorts to Assess the Safety, Tolerability, and Activity of Oraxol (Paclitaxel HM30181A) in Combination with Pembrolizumab in Subjects with Advanced Solid Malignancies

Study of Oraxol and Pembrolizumab in Subjects with Advanced Solid Tumors

Konstantinos Leventakos
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-100599-P01-RST
18-006041
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Inclusion Criteria:


Eligible subjects must have/be:

- Able to understand and sign an informed consent form

- Age ≥ 18 years

- Dose Escalation: Histologically confirmed metastatic or unresectable solid tumors for which pembrolizumab is an FDAapproved therapy

- Dose Expansion: Histologically confirmed diagnosis of advanced or metastatic NSCLC or gastric/gastro-esophageal adenocarcinoma:

NSCLC:

- Subjects with actionable mutations or alterations must have progressed on prior FDA approved therapy for these aberrations.

- Subjects must have progressed on a prior FDA-approved single agent immunotherapy (antiPD1/anti-PD-L1) in first line (1L) or progressed on a prior FDA approved
immunotherapy + chemotherapy combination therapy in 1L, as long as the chemotherapy did not include a taxane.

Gastric/Gastro-esophageal

- Histologically confirmed diagnosis of advanced or metastatic gastric/gastro-esophageal adenocarcinoma or esophageal squamous cell carcinoma.

- Subjects must have progressed on previous anti-PD-1 therapy as single agent or combination therapy.

- Must have at least one measurable site of disease as defined as per RECIST v1.1 criteria

- ECOG Performance Status ≤ 1

- The following laboratory values obtained ≤14 days prior to Cycle 1/Day 1 dosing:

- Absolute neutrophil count (ANC) ≥ 1.5 x 10^9/L

- Platelet count ≥ 100 x 10^9/L

- Hemoglobin ≥ 9.0 g/dL

- Total and direct bilirubin within normal range

- Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 3 x upper limit of
normal (ULN)

- Gamma-glutamyl transferase (GGT) ≤ 5 x ULN

- Alkaline phosphatase ≤ 3 x ULN or ≤ 5 x ULN if bone or liver metastasis is present

- Serum creatinine ≤ 2 x ULN, or 24-hr urine creatinine clearance calculation ≥ 50 mL/min

- Prothrombin time (PT)/international normalized ratio (INR)/partial thromboplastin time (PTT) ≤1.5 x ULN OR if a subject is receiving anticoagulant therapy and PT or PTT is
within therapeutic range of intended use of coagulants for 7 days prior to receiving study treatment

- Willing and able to comply with scheduled visits, treatment plan and laboratory tests

- No concurrent malignancy except curatively treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix, breast, or bladder

- Subjects receiving warfarin who are otherwise eligible and who may be appropriately managed with low molecular weight heparin, in the opinion of the Investigator, may be
enrolled in the study provided they are switched to low molecular weight heparin at least 7 days prior to receiving study treatment.

- Men who are sterile (including vasectomy confirmed by post vasectomy semen analysis) OR agree to use a condom with spermicide and to not donate sperm during the study and for at least 30 days following last dose of Oraxol

- Female subjects must be postmenopausal (>12 months without menses) or surgically sterile (ie, by hysterectomy and/or bilateral oophorectomy) or must be using effective
contraception (ie, oral contraceptives, intrauterine device, double barrier method of condom and spermicide) and agree to continue use of contraception for 30 days after
their last dose of assigned study treatment. Abstinence is also an acceptable form of contraception.

- Subjects who are of childbearing potential must have a negative serum pregnancy test at Screening and within 96 hours before Week 1 dosing.

- Willing to return for follow-up

- Willing to provide blood samples for correlative research purposes

- Life expectancy of at least 3 months


Exclusion Criteria:


- Eligible subjects must not have/be:

- Subjects with history of prior treatment with taxanes (eg, paclitaxel, docetaxel, cabazitaxel) in expansion cohorts only

- History of prior significant toxicity from anti-PD-1 or anti-PD-L1 therapy requiring discontinuation of treatment

- Subjects who have received recent anti-cancer therapy defined by:

- Chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies (but excluding nitrosurea, mitomycin-C, targeted therapy, and radiation) ≤ 28 days prior to starting
study drug, or who have not recovered from side effects of such therapy

- Last administration of nitrosurea or mitomycin-C ≤ 42 days prior to starting study drug, or who have not recovered from the side effects of such therapy

- Targeted therapy (e.g., sunitinib, sorafenib, pazopanib) ≤ 14 days prior to starting study drug, or who have not recovered from the side effects of such therapy; or

- Radiotherapy ≤ 28 days prior to starting study drug, or ≤ 14 days prior to starting study drug in the case of localized radiotherapy (eg, for analgesic purpose or for lytic lesions at risk of fracture), or who have not recovered from radiotherapy toxicities.

- Current or prior use of immunosuppressive medication within 14 days before the first dose of pembrolizumab. The following are exceptions to this criterion: Intranasal,
inhaled, topical corticosteroids, or local corticosteroid, injections (e..g, intra-articular injection), systemic corticosteroids at doses not to exceed 10 mg/day
of prednisone or its equivalent.

- Vaccinated with live, attenuated vaccines within 28 days of the first dose of the study drug

- Active or prior documented autoimmune or inflammatory disorders (including but not limited to inflammatory bowel disease [eg, colitis, Crohn's disease], celiac disease,
or other serious gastrointestinal (GI) chronic conditions associated with diarrhea; type 1 diabetes mellitus; multiple sclerosis; systemic lupus erythematosus; Wegener's
granulomatosis; myasthenia gravis; Graves' disease; rheumatoid arthritis; hypophysitis; uveitis; etc) within the past 3 years prior to the start of treatment.

The following are exceptions to this criterion:

- Subjects with vitiligo or alopecia

- Subjects with hypothyroidism (eg, following Hashimoto's thyroiditis) stable on hormone replacement therapy or psoriasis not requiring systemic treatment

- Subject has impairment of GI function or GI disease that may significantly alter the absorption of study drugs (including gastric bypass surgery and total gastrectomy).
Subjects with partial gastrectomy may be included in the trial.

- Subjects who have undergone major surgery (eg, intra-thoracic, intra-abdominal or intra-pelvic), open biopsy or significant traumatic injury ≤ 28 days prior to starting
study treatment, or subjects who have had minor procedures, percutaneous biopsies or placement of vascular access device ≤ 7 days prior to starting study drug, or who have not recovered from side effects of such procedure or injury

- Uncontrolled concurrent illness, including but not limited to ongoing or active serious infection requiring systemic antimicrobials (within 14 days prior to first
dose of Oraxol), arterial hypertension (> 160/100 mm/Hg on antihypertensive medications), uncontrolled endocrine diseases, altered mental status or psychiatric illness/social situations that would limit compliance with protocol requirements and/or obscure study results.

- Known or suspected diagnosis of human immunodeficiency virus (HIV) or chronic active Hepatitis B or C, or cirrhosis.

- Clinically significant pulmonary illness resulting in Grade ≥2 hypoxia (National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE, v4.03]) or
any requirement for supplemental oxygen, or pulse oximetry less than 90% saturation on room air

- Symptomatic or uncontrolled brain metastases requiring current treatment (less than 28 days from last cranial radiation or 28 days from last steroids use).

- Impaired cardiac function or clinically significant cardiac disease including the following:

- Clinically significant arrhythmias (except chronic well controlled atrial fibrillation)

- New York Heart Association (NYHA) Class III or IV congestive heart failure

- Angina pectoris ≤ 6 months

- Myocardial infarction within the last 12 months

- Subjects with a healing or open wound

- Lack of recovery of prior AEs to Grade ≤1 severity (NCI CTCAE v4.03) (except alopecia) due to medications administered prior to the first dose of the trial drugs.

- Any other condition or finding (including social situation) that in the opinion of the Investigator may render the patient at excessive risk for treatment complications or
may not be able provide evaluable outcome information.

- Pregnant or breast-feeding women

- Known allergy to any of the formulation components of Oraxol (oral paclitaxel or HM30181A) or pembrolizumab

- Currently taking following prohibited concomitant medication:

- Medication known to be strong inhibitors (gemfibrozil) or inducers (rifampin) of cytochrome P450 (CYP)2C8. Subjects who are currently taking such medications but who are otherwise eligible may be enrolled if they discontinue the medication 14 days before dosing and remain off that medication during treatment with Oraxol.

- Strong CYP3A4 inducer (e.g., rifampin or St. John's Wort) or a strong CYP3A4 inhibitors (e.g., ketoconazole) or a moderate CYP3A4 inhibitor including neurokinin 1 (NK1) inhibitors (e.g., aprepitant and rolapitant) within 14 days prior to treatment administration

- Medication known to be strong P-gp inhibitors or inducers. Subjects who are taking such medications but who are otherwise eligible may be enrolled if they discontinue the medication 7 days before dosing and remain off that medication during treatment with Oraxol.

- An oral medication with a narrow therapeutic index known to be a P-gp substrate (e.g., digoxin, dabigatran) within 1 day prior to start of Oraxol dosing in the study

Eligibility last updated from clinicaltrials.gov 7/21/22. Questions regarding updates should be directed to the study team contact.

Biologic/Vaccine, Drug, Radiation, Administration of antineoplastic agent, Drug therapy
Cancer, Lung cancer, Non-small cell lung cancer, Stomach cancer
Biological therapy for cancer, Cancer treatment, Chemotherapy, Digestive system, Infinnium, Malignant neoplasm of cardio-esophageal junction of stomach, Malignant tumor of stomach, Medical Oncology, Non-small cell lung cancer, Pembrolizumab [USAN:INN], Primary urothelial carcinoma of overlapping lesion of urinary organ, Respiratory system, Solid tumor configuration, Zoledronic acid, paclitaxel, pembrolizumab, zoledronic acid, Primary urothelial carcinoma of overlapping sites of urinary organs, Paclitaxel
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ACCRU-GI-1809, A Randomized Phase II Study of Regorafenib Followed by Anti-EGFR Monoclonal Antibody Therapy Versus the Reverse Sequencing for Metastatic Colorectal Cancer Patients Previously Treated With Fluoropyrimidine, Oxaliplatin and Irinotecan (REVERCE II)

A Study to Evaluate Regorafenib with Cetuximab or Panitumumab to Treat Unresectable, Locally Advanced, or Metastatic Colorectal Cancer

Zhaohui Jin
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-100600-P01-RST
20-000071
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Inclusion Criteria:

  • Histologically proven, unresectable distant metastatic or locally advanced colorectal adenocarcinoma.
  • KRAS, NRAS wild type.
  • BRAF v600E wildtype.
  • Measurable disease.
  • Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0, 1, or 2.
  • Life expectancy of ≥ 3 months per estimation of treating physician.
  • Absolute neutrophil count (ANC) ≥ 1200/mm^3 (obtained ≤ 7 days prior to randomization).
  • Platelet count ≥ 75,000/mm^3 (obtained ≤ 7 days prior to randomization).
  • Hemoglobin ≥ 9.0 g/dL (obtained ≤ 7 days prior to randomization).
  • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) (obtained ≤ 7 days prior to randomization).
  • Alanine aminotransferase (ALT) and aspartate amino-transferase (AST) ≤ 2.5 x ULN (≤ 5 x ULN for subjects with liver involvement of their cancer) (obtained ≤ 7 days prior to randomization).
  • Serum creatinine ≤ 1.5 x ULN (obtained ≤ 7 days prior to randomization).
  • International normalized ratio (INR)/partial thromboplastin time (PTT) ≤ 1.5 x ULN (obtained ≤ 7 days prior to randomization).
    • Note: Patients who are therapeutically treated with an agent such as warfarin or heparin will be allowed to participate provided that no prior evidence of underlying abnormality in coagulation parameters exists. Close monitoring of at least weekly evaluations will be performed until INR/PTT is stable based on a measurement that is pre-dose as defined by the local standard of care.
  • Alkaline phosphatase limit ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement of their cancer) (obtained ≤ 7 days prior to randomization).
  • Negative serum pregnancy test done ≤ 7 days prior to randomization for women of childbearing potential only.
    • Note: Post-menopausal women (defined as no menses for at least 1 year) and surgically sterilized women are not required to undergo a pregnancy test. The definition of adequate contraception will be based on the judgment of the treating physician.
  • Provide informed written consent.
  • Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study).
  • Disease progression on or intolerable to any of the following: fluoropyrimidine, oxaliplatin and irinotecan.
  • Able to swallow and retain oral medication.
  • Willing to provide tissue and blood samples for correlative research purposes.
  • Willing to allow transfer of tissue and blood samples, clinical information, and outcome data collected from this trial for future research.


Exclusion Criteria:
 

  • Prior treatment with regorafenib, cetuximab or panitumumab.
  • Major surgical procedure, open biopsy, or significant traumatic injury ≤ 28 days prior to randomization.
  • Congestive heart failure > New York Heart Association (NYHA) class 2.
    • Note: Class 3 is defined as marked limitation in activity due to symptoms, even during less-than-ordinary activity; e.g., walking short distances (20-100m). They are comfortable at rest. Class 4 is defined as patients with severe limitations. Experiences symptoms even while at rest. Mostly bed bound.
  • Unstable angina (angina symptoms at rest), new-onset angina (begun ≤ 3 months prior to randomization) or myocardial infarction ≤ 6 months prior to randomization.
  • Cardiac arrhythmias requiring anti-arrhythmic therapy. Note: Pace makers, beta blockers or digoxin are permitted.
  • Uncontrolled hypertension. (Systolic blood pressure > 140 mmHg or diastolic pressure > 90 mmHg despite optimal medical management).
  • History of or current pheochromocytoma.
  • Arterial or venous thrombotic or embolic events such as cerebrovascular accident (including transient ischemic attacks), deep vein thrombosis or pulmonary embolism ≤ 6 months prior to randomization.
  • Ongoing infection > grade 2 National Cancer Institute (NCI)-Common Terminology Criteria for Adverse Events (CTCAE) version (v)5.0.
  • Known history of chronic hepatitis B or C.
  • Patients with seizure disorder requiring medication.
  • Symptomatic metastatic brain or meningeal tumors unless the patient is > 6 months from definitive therapy, has a negative imaging study within 4 weeks of randomization and is clinically stable with respect to the tumor at the time of randomization.
    • Note: Patient must not be undergoing acute steroid therapy or taper (chronic steroid therapy is acceptable provided that the dose is stable for one month prior to and following screening radiographic studies).
  • History of organ allograft (including corneal transplant).
  • Evidence or history of bleeding diathesis or any hemorrhage or bleeding event > CTCAE v5.0 grade 3 ≤  4 weeks prior to randomization.
  • Non-healing wound, ulcer, or bone fracture.
  • Substance abuse, medical, psychological or social conditions that may interfere with the patient's participation in the study or evaluation of the study results.
  • High-frequency microsatellite instability (MSI-H) patients who have not received prior PD-1 monoclonal antibody (mAb) therapy.
  • Concurrent anti-cancer therapy ≤ 3 weeks from randomization (chemotherapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization).
  • Known hypersensitivity to any of the study drugs, study drug classes, or excipients in the formulation
    •Interstitial lung disease with ongoing signs and symptoms at the time of informed consent.
  • History of known persistent proteinuria of CTCAE v5.0 grade 3 or higher (≥ 3.5 g/24 hrs).
  • Any malabsorption condition.
  • Unresolved toxicity greater than CTCAE v5.0 grade 1 attributed to any prior therapy/procedure excluding alopecia and oxaliplatin induced neurotoxicity ≤ grade 2.
  • Albumin levels < 2.5 g/dl
  • Any of the following because this study involves an agent that has known genotoxic, mutagenic and teratogenic effects:
    • Pregnant women.
    • Nursing women.
    • Men or women of childbearing potential who are unwilling to employ adequate contraception.
    • Note: Men and women of childbearing potential must agree to use adequate contraception beginning at the signing of the informed consent form (ICF) until at least 3 months after the last dose of study drug. The definition of adequate contraception will be based on the judgment of the principal investigator or a designated associate.
  • Co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the treating physician, 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.
  • Known history of human immunodeficiency virus (HIV) infection or active hepatitis B or C infection requiring treatment with antiviral therapy.
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
  • Previous or concurrent cancer that is distinct in primary site or histology from colorectal cancer ≤ 3 years prior to randomization EXCEPT for cervical cancer in-situ, treated ductal carcinoma in situ of the breast, curatively treated nonmelanoma skin carcinoma, noninvasive aerodigestive neoplasms, or superficial bladder tumor (Ta [Non-invasive tumor], Tis [carcinoma in situ] and T1 [Tumor invades lamina propria]).
    • Note: All cancer treatments for cancers that were distinct in a primary site other than colorectal must be completed at least 3 years prior to randomization (i.e., signature date of the informed consent form).
  • Pleural effusion or ascites that causes respiratory compromise (≥ CTCAE v5.0 grade 2 dyspnea).
  • Any condition which, in the treating physician's opinion, makes the subject unsuitable for trial participation.
Biologic/Vaccine, Drug
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Utility of Gallium-68-DOTA-Octreotate PET/CT in the Characterization of Pediatric Neuroendocrine Tumors

Utility of Gallium-68-DOTA-Octreotat PET/CT in the Characterization of Pediatric Neuroendocrine Tumors

Nadia Laack
All
up to 30 years old
ERROR
This study is NOT accepting healthy volunteers
0000-100616-P01-RST
16-010137
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Inclusion Criteria:

  • Age ≤ 30 years.
  • Histological confirmation of neuroblastoma, ganglioneuroblastoma, or ganglioneuroma.
  • High-risk neuroblastoma requiring consolidative RT, as determined by the treating radiation oncologist.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-3.
  • Planned for radiation planning and RT at enrolling institution.
  • Documented negative pregnancy test prior to induction chemotherapy, for women of childbearing age within ≤ 7 days prior to registration.
  • Signed written informed consent from patient, parent, and/or legal guardian.
  • Willing to return to enrolling institution for follow-up imaging and clinical evaluation, or willing to send follow-up imaging and clinical notes to enrolling institution (during the Observation Phase of the study).

 


Exclusion Criteria:

  • Pregnant women, nursing women who refuse to stop breastfeeding, or men/women of childbearing age who are unwilling to use an effective birth control method.
  • 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 human immunodeficiency virus positive and currently receiving antiretroviral therapy.  
    • NOTE:  Patients known to be human immunodeficiency virus positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.

 

 

Drug, Procedure/Surgery, Nuclear medicine imaging procedure, Positron emission tomography with computed tomography of whole body using gallium (68-Ga) dotatate
Cancer, Neuroblastoma, Neuroendocrine carcinoma, Neuroendocrine tumor
Cancer treatment, Ganglioneuroblastoma, Ganglioneuroma, Medical Oncology, Metastatic neuroblastoma, Nervous system, Neuroendocrine carcinoma, metastatic, Secondary malignant neoplastic disease
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A Phase II Randomized Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Unilateral Head and Neck Cancer

A Study of Proton Versus Photon Beam Radiotherapy in the Treatment of Unilateral Head and Neck Cancer

Scott Lester
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-100655-P01-RST
17-005766
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Inclusion Criteria:


- Age greater than or equal to 18.

- Histopathologically confirmed diagnosis of one the following cancer types:

- Salivary gland cancer

- Skin cancer

- Melanoma

- HNSCC that require ipsilateral radiation

- Patients must be a candidate for ipsilateral radiation therapy.

- Karnofsky performance status ≥70.

- Negative pregnancy test for women of childbearing potential (<51 years of age) as per
institutional policy.


Exclusion Criteria:


- Any prior head or neck irradiation.

- Physician recommendation of bilateral neck radiation.

- Non-resectable disease

- Physician recommendation of mucosal radiation

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Eligibility last updated 9/19/22. Questions regarding updates should be directed to the study team contact.

Radiation, Intensity modulated radiation therapy, Proton therapy
Cancer, Head and neck cancer, Melanoma, Salivary gland tumor, Skin cancer
Cancer treatment, Digestive system, IMRT, Integumentary system, Malignant melanoma of head and neck, Malignant neoplasm of skin head and neck, Malignant tumor of salivary gland, Medical Oncology, Mucositis following radiation therapy, Proton therapy, Radiation therapy, Intensity-modulated radiation therapy
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Mayo Clinic — Rochester, MN

61186372EDI1001: A Phase 1, First-in-Human, Open-Label, Dose Escalation Study of Amivantamab (JNJ-61186372), a Human Bispecific EGFR and cMet Antibody, in Subjects With Advanced Non-Small Cell Lung Cancer

A Dose Escalation Study of Amivantamab in Participants with Advanced Non-Small Cell Lung Cancer

Aaron Mansfield
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-100656-P01-RST
18-006628
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Inclusion Criteria:

  • Participant must have histologically or cytologically confirmed non-small cell lung cancer (NSCLC) that is metastatic or unresectable. Participants must have either progressed after prior standard of care therapy (Cohort C and hepatocyte growth factor receptor gene [MET]-1: epidermal growth factor receptor [EGFR] tyrosine kinase inhibitor [TKI]; Cohort D and MET-2: platinum-based chemotherapy) for metastatic disease, or be ineligible for, or have refused all other currently available therapeutic options. In cases where participants refuse currently available therapeutic options, this must be documented in the study records.
  • For Part 1 Chemotherapy Combination Cohort only:
    • Participants must have histologically or cytologically confirmed NSCLC that is metastatic or unresectable and be eligible for treatment with combination carboplatin and pemetrexed, in accordance with standard of care, and be willing to receive additional investigational therapy with Amivantamab
  • For Part 1 Combination Dose Escalation with lazertinib only:
    • Participants must have been diagnosed with EGFR Exon 19del or L858R activating mutation and (a) be treatment naïve for metastatic disease, without access to third generation TKI in the front-line setting, or (b) have progressed after front-line treatment with first (erlotinib or gefitinib) or second generation (afatinib) TKI and are ineligible for Cohort MET-1, or (c) have been treated with a third generation TKI (eg, osimertinib) in either the front line or second-line setting, and are not eligible for enrollment in either Cohort C or MET-1.
  • For Part 1 Chemotherapy Combination Cohort:
    • Participants may be diagnosed with EGFR mutated or EGFR wild type NSCLC. For Part 2 only: Participants must also have disease with a previously diagnosed activating epidermal growth factor receptor (EGFR) mutation (includes both inhibitor sensitive primary mutations such as Exon 19 deletion and L858R (Cohort C, E, and MET-1), as well as marketed TKI-resistant mutations such as Exon 20 insertion (Cohort C, D and MET-1) or activating cMet Exon 14 skipping mutation (Cohort MET-2). Documentation of primary activating EGFR or cMet mutation eligibility by CLIA-certified laboratory (or equivalent) testing is required.
  • For Part 1:
    • Participant must have evaluable disease. For Part 2: Participant must have measurable disease according to Response Criteria in Solid Tumors (RECIST) v1.1
  • For Part 2: Cohorts A and B:
    • Participants EGFR mutated disease must have most recently progressed following treatment with a marketed EGFR inhibitor. Exception: In participants diagnosed with mutations associated with de novo EGFR inhibitor resistance (for example, Exon 20 insertions), only previous treatment with combination platinum-based chemotherapy is required.
  • Cohort C:
    • Participants with primary EGFR mutated disease, with a documented EGFR alteration (example, C797S) mediating resistance to previous treatment with a third generation EGFR TKI (for example, osimertinib), in participants with primary Exon 20ins disease, the documented EGFR alteration may arise following treatment with a TKI with known activity against Exon 20ins disease (for example, poziotinib).
  • Cohort D:
    • Pparticipants must have been previously diagnosed with an EGFR Exon 20 insertion and have not been previously treated with a TKI with known activity against Exon 20ins disease (exampe, poziotinib).
  • Cohort MET-1:
    • Participants with documented primary EGFR mutated disease and documented MET amplification or MET mutation after progression on any EGFR TKI. Participants with disease characterized by both MET amplification and EGFR resistance mutations to prior third generation EGFR TKI will be preferentially enrolled into Cohort C. Participants may have received or have been intolerant to prior platinum-based chemotherapy.
  • Cohort MET-2:
    • Participants with documented primary MET Exon 14 skipping mutation non-small cell lung cancer (NSCLC).
  • Cohort E (combination Amivantamab and lazertinib):
    • Participants must have been diagnosed with EGFR Exon 19del or L858R activating mutation, and have progressed after first or second-line treatment with a third generation TKI (e.g., osimertinib).
  • Participant must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.


Exclusion Criteria:

  • Participant has uncontrolled inter-current illness, including but not limited to poorly controlled hypertension, or diabetes, ongoing or active infection, (that is, has discontinued all antibiotics for at least one week prior to first dose of study drug), or psychiatric illness/social situation that would limit compliance with study requirements. Participants with medical conditions requiring chronic continuous oxygen therapy are excluded.
  • For Part 1 Chemotherapy Combination Cohort only:
    • additionally, participants with active bleeding diathesis.
  • Participant has had prior chemotherapy, targeted cancer therapy, immunotherapy, or treatment with an investigational anticancer agent within 2 weeks or 4 half-lives whichever is longer, before the first administration of study drug. For agents with long half-lives, the maximum required time since last dose is 4 weeks. Toxicities from previous anti-cancer therapies should have resolved to baseline levels or to Grade 1 or less, (except for alopecia [any grade], Grade less than or equal to [≤] 2 peripheral neuropathy, and Grade less than [<] 2 hypothyroidism stable on hormone replacement).
  • For Part 1 Combination Dose Escalation:
    • Any previous treatment with systemic anti cancer immunotherapy, including but not limited to anti-PD-1, anti-PD-L1, and anti-CTLA-4 agents.
  • For Part 1 Chemotherapy Combination Cohort only:
    • Any previous treatment with systemic anti cancer immunotherapy in the past 3 months or localized radiotherapy to lung within the past 6 months.
  • For Part 2 only:
    • Cohorts A and B: Prior treatment with chemotherapy for metastatic disease is not allowed unless the tumor mutation carries de-novo resistance to EGFR TKI (example, Exon 20 insertions). Cohort C and MET-1: Prior treatment with more than 2 lines of cytotoxic chemotherapy for metastatic disease (maintenance therapy is not included).
  • Cohort D:
    • Previous treatment with an EGFR TKI with activity against EGFR Exon 20 insertions (such as poziotinib).
  • Cohort E (combination Amivantamab and lazertinib):
    • Any previous treatment in the metastatic setting with other than a first, second, or third generation EGFR TKI
  • Participants with untreated brain metastases. Participants with definitively, locally-treated metastases that are clinically stable and asymptomatic for at least 2 weeks and who are off or receiving low-dose corticosteroid treatment (≤ 10 mg prednisone or equivalent) for at least 2 weeks prior to study treatment are eligible. Exception: participants with asymptomatic, untreated brain metastases, each less than 1 cm in diameter, may be eligible for Amivantamab and lazertinib combination therapy in the Part 1 Combination Dose Escalation or Part 2 Combination Expansion Cohort E.
  • Participant has a history of malignancy other than the disease under study within 3 years before Screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy that in the opinion of the investigator, with concurrence with the sponsor's medical monitor, is considered cured with or minimal risk of recurrence within a year from Screening).
  • Participant has not fully recovered from major surgery or significant traumatic injury prior the first dose of study drug or expects to have major surgery during the study period or within 6 months after the last dose of study drug.
Drug, Administration of antineoplastic agent, Drug therapy
Cancer, Lung cancer, Non-small cell lung cancer
Amivantamab, Cancer treatment, Medical Oncology, Non-small cell lung cancer, Respiratory system
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A Phase 2 Precision Oncology Study of Biomarker-Directed, Pembrolizumab-(MK-3475, SCH 900475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (KEYNOTE-495; KeyImPaCT)

A Study of Biomarker-Directed, Pembrolizumab (MK-3475) Based Combination Therapy for Advanced Non-Small Cell Lung Cancer (MK-3475-495)

Aaron Mansfield
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-100671-P01-RST
18-004855
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Inclusion Criteria:
 

  • Has a histologically- or cytologically-confirmed diagnosis of Stage IV (American Joint Committee on Cancer [AJCC] v 8) NSCLC and has not had prior systemic therapy for advanced disease.
  • Has confirmation that epidermal growth factor receptor- (EGFR-), anaplastic lymphoma kinase- (ALK-), c-ros oncogene 1- (ROS1-), or B isoform of rapidly accelerated fibrosarcoma- (B-Raf-) directed therapy is not indicated as primary therapy (documentation of absence of tumor activating EGFR or B-Raf mutations AND absence of ALK or ROS1 gene rearrangements).
  • Has measurable disease per RECIST 1.1 as assessed by the local site investigator/radiology.
  • Male/female participants who are at least 18 years of age on the day of signing the informed consent.
  • Male participants must agree to use contraception during the treatment period and for ≥ 120 days, after the last dose of study treatment and refrain from donating sperm during this period. Male participants with pregnant partners must agree to use a condom.
  • Female participants eligible to participate if not pregnant, not breastfeeding, and not a woman of childbearing potential (WOCBP) or is a WOCBP who agrees to follow contraceptive guidance during the treatment period and for ≥ 120 days after the last dose of study treatment.
  • The participant (or legally acceptable representative if applicable) provides written informed consent for the study. The participant may also provide consent for Future Biomedical Research. However, the participant may participate in the main study without participating in Future Biomedical Research.
  • Provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously irradiated. 
    • Note:  If sending newly cut slides, they should be submitted to the testing laboratory within 14 days from the date slides are cut (details pertaining to tumor tissue submission can be found in the Procedures Manual).
  • Participants must have adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP ≤150/90 mm Hg with no change in antihypertensive medications within 1 week prior to randomization.
  • Has an Eastern Cooperative  Oncology Group (ECOG) performance status of 0 to 1.
  • Has adequate organ function as defined below:
  • Hematological
    • Absolute neutrophil count (ANC) ≥1500/μL;
    • Platelets ≥00 000/μL;
    • Hemoglobin ≥.0 g/dL or ≥.6 mmol/L*.
  • Renal
    • Creatinine OR Measured or calculated** creatinine clearance (GFR can also be used in place of creatinine or CrCl);
    • ≤1.5 × ULN OR ≥0 mL/min for participant with creatinine levels >1.5 × institutional ULN.
  • Hepatic
    • Total bilirubin ≤.5 ×ULN OR direct bilirubin ≤LN for participants with total bilirubin levels >1.5 × ULN;
    • AST (SGOT) and ALT (SGPT) ≤.5 × ULN (≤ × ULN for participants with liver metastases).
  • Coagulation
    • International normalized ratio (INR) OR prothrombin time (PT);
    • Activated partial thromboplastin time (aPTT) ≤.5 × ULN unless participant is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants
    • ALT (SGPT)=alanine aminotransferase (serum glutamic pyruvic transaminase); AST (SGOT)=aspartate aminotransferase (serum glutamic oxaloacetic transaminase); GFR=glomerular filtration rate; ULN=upper limit of normal;
  • Specimens must be collected within 10 days prior to the start of study treatment.

* Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.

** Creatinine clearance (CrCl) should be calculated per institutional standard.


Exclusion Criteria:
 

  • Has significant cardiovascular impairment within 12 months of the first dose of study drug: history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident (CVA) stroke, or cardiac arrhythmia associated with hemodynamic instability, significant cardiovascular impairment, or a left ventricular ejection fraction (LVEF) below the institutional normal range as determined by multigated acquisition scan (MUGA) or echocardiogram.
  • Prolongation of QTc interval to > 480 milliseconds (ms).
  • Has symptomatic ascites or pleural effusion. A participant who is clinically stable following treatment for these conditions (including therapeutic thoraco- or paracentesis) is eligible.
  • Has had an allogenic tissue/solid organ transplant.
  • A WOCBP who has a positive urine pregnancy test within 24 hours before the first dose of study treatment (see Appendix 5). If the urine test cannot be confirmed as negative, a serum pregnancy test will be required.
    • Note: in the event that 24 hours have elapsed between the screening pregnancy test and the first dose of study treatment, another pregnancy test (urine or serum) must be performed and must be negative in order for participant to start receiving study medication.
  • Participants with proteinuria >1+ on urine dipstick testing will undergo 24-hour urine collection for quantitative assessment of proteinuria. Participants with urine protein ≥ 1 g/24 h will be ineligible.
  • Participants who have not recovered adequately from any toxicity and/or complications from major surgery prior to starting therapy. Participants who have had major surgery within 3 weeks prior to first dose of study intervention.
    • Note: Adequate wound healing after major surgery must be assessed clinically, independent of time elapsed for eligibility.
  • Has preexisting ≥Grade 3 gastrointestinal or non-gastrointestinal fistula, gastrointestinal malabsorption, gastrointestinal anastomosis, or any other condition that might affect the absorption of lenvatinib.
  • Radiographic evidence of major blood vessel invasion/infiltration. The degree of tumor invasion/infiltration of major blood vessels should be considered because of the potential risk of severe hemorrhage associated with tumor shrinkage/necrosis following lenvatinib therapy.
  • Clinically significant hemoptysis or tumor bleeding within 2 weeks prior to the first dose of study drug.
  •  Has received prior systemic chemotherapy treatment for metastatic/recurrent NSCLC.
    • Note: Prior treatment with chemotherapy and/or radiation as part of neoadjuvant/adjuvant therapy is allowed as long as therapy was completed at least 6 months prior to the diagnosis of metastatic/recurrent NSCLC.
  • Has current NSCLC disease that can be treated with curative intent with surgical resection, localized radiotherapy, or chemoradiation.
  • Is expected to require any other form of systemic or localized antineoplastic therapy while on study (including maintenance therapy with another agent for NSCLC, radiation therapy, and/or surgical resection).
  • Has received prior therapy with an anti–PD-1, anti–PD-L1, or anti–PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T cell receptor (e.g., CTLA-4, OX 40, CD137).
  • Has received previous treatment with another agent targeting the LAG-3 receptor.
  • Has received previous treatment with another agent targeting VEGF or the VEGF receptor.
  • Has received prior anticancer therapy including investigational agents within 4 weeks prior to randomization.
    • Note: Participants must have recovered from all AEs due to previous therapies to ≤ Grade 1 or baseline. Participants with ≤Grade 2 neuropathy may be eligible.
    • Note: If participant received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting study treatment.
  • Has received prior radiotherapy within 2 weeks of start of study treatment or received lung radiation therapy of >30 Gy within 6 months prior to the first dose of study intervention. Participants must have recovered from all radiation-related toxicities to Grade ≤1, 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.
  • Has received a live vaccine within 30 days prior to the first dose of study treatment.
    • 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 (eg, FluMist®) are live attenuated vaccines and are not allowed.
Biologic/Vaccine, Drug, Administration of antineoplastic agent, Drug therapy, Immunotherapy for cancer
Cancer, Lung cancer, Non-small cell lung cancer
Biological therapy for cancer, Cancer treatment, Lenvatinib, Medical Oncology, Non-small cell lung cancer, Pembrolizumab [USAN:INN], Respiratory system, lenvatinib, pembrolizumab
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bb2121-MM-003: A Phase 3, Multicenter, Randomized, Open-label Study to Compare the Efficacy and Safety of bb2121 Versus Standard Regimens in Subjects with Relapsed and Refractory Multiple Myeloma (RRMM) (KarMMa-3) (KarMMa-3)

A Study to Compare the Effectiveness and Safety of bb2121 Versus Standard Regimens in Subjects with Relapsed and Refractory Multiple Myeloma (RRMM)

Yi Lin
All
18 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-100675-P01-RST
18-008956
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Inclusion Criteria:

  • Subjects must satisfy the following criteria to be enrolled in the study:
    • Subject is ≥ 18 years of age at the time of signing the informed consent form (ICF).
    • Subject has documented diagnosis of MM and measurable disease
    • Subject has received at least 2 but no greater than 4 prior MM regimens.
    • Subject has received prior treatment with DARA, a proteasome inhibitor and an immunomodulatory compound-containing regimen for at least 2 consecutive cycles.
    • Subject must be refractory to the last treatment regimen. Refractory is defined as documented progressive disease during or within 60 days (measured from the last dose of any drug within the regimen) of completing treatment with the last anti-myeloma regimen before study entry.
    • Subject achieved a response (minimal response [MR] or better) to at least 1 prior treatment regimen.
    • Subject has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
    • Recovery to Grade 1 or baseline of any non-hematologic toxicities due to prior treatments, excluding alopecia and Grade 2 peripheral neuropathy.


Exclusion Criteria:

  • Subject has nonsecretory multiple myeloma (MM). 
  • Subject has inadequate pulmonary function defined as oxygen saturation (SaO2) < 92% on room air. 
  • Subject has prior history of malignancies, other than MM, unless the subject has been free of the disease for ≥ 5 years. 
  • Subject has active or history of plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome or amyloidosis. 
  • Subject with known central nervous system (CNS) involvement with myeloma. 
  • Subject has clinical evidence of pulmonary leukostasis and disseminated intravascular coagulation. 
  • Subject has known chronic obstructive pulmonary disease (COPD) with a forced expiratory volume in 1 second (FEV1) 50% of predicted normal. 
  • Subject has a history or presence of clinically relevant CNS pathology. 
  • Subject was treated with DARA in combination with POM with or without dex (DP±d) as part of their most recent anti-myeloma treatment regimen, cannot receive DPd as bridging therapy but may receive DVd or IRd as bridging as per Investigator's discretion if randomized to Treatment Arm A. 
  • Subject was treated with DP±d as part of their most recent anti-myeloma treatment regimen, cannot receive DPd if randomized to Treatment Arm B but may receive DVd or IRd as per Investigator's discretion. 
  • Subject was treated with DARA in combination with BTZ with or without dex (DV±d) as part of their most recent anti-myeloma treatment regimen, cannot receive DVd as bridging therapy but may receive DPd or IRd as bridging as per Investigator's discretion if randomized to Treatment Arm A. 
  • Subject was treated with DV±d as part of their most recent anti-myeloma treatment regimen, cannot receive DVd if randomized to Treatment Arm B but may receive DPd or IRd as per Investigator's discretion. 
  • Subject was treated with IXA in combination with LEN with or without dex (IR±d) as part of their most recent anti-myeloma treatment regimen, cannot receive IRd as bridging therapy but may receive DPd or DVd as bridging as per Investigator's discretion if randomized to Treatment Arm A. 
Biologic/Vaccine, Drug, 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, Relapse multiple myeloma, Cellular therapy
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Mayo Clinic — Rochester, MN

MC1893, Nasal Vestibulitis Natural History Evaluation (MC1893)

A Study to Evaluate Nasal Vestibulitis Symptoms in Patients Undergoing Systemic Antineoplastic Therapy

Stephan Thome
All
18 years and over
This study is NOT accepting healthy volunteers
0000-100681-P01-MAIJ
18-000065
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Inclusion Criteria:

  • ≥ 18 years of age and be diagnosed with cancer.
  • Provide informed consent.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Planned use of one of the defined systemic, antineoplastic therapies.
  • Willingness to complete questionnaires with each dose of therapy.
  • Plan to receive chemotherapy for the following 3-4 months OR a minimum of 4 cycles of chemotherapy given at intervals of 2 weeks or longer.
  • No prior chemotherapy over the previous 3 months.


Exclusion Criteria:

  1. Predisposition to frequent nosebleeds (more than once per month).
  2. Verbal baseline nasal dryness, pain, bleeding, or scabbing ≥ 2 on a 10 point scale (from mild=1 to severe=10).
  3. Planned receipt of two of the studied agents concurrently (e.g., abraxane and bevacizumab).
  4. Planned participation in a placebo-controlled trial.

 

Cancer, Vestibular disorder
Bevacizumab, Cancer treatment, Chemotherapy, Docetaxel, Infinnium, Malignant neoplastic disease, Medical Oncology, Nasal vestibulitis, bevacizumab, docetaxel, paclitaxel
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Mayo Clinic Health System — Mankato, MN

ALTE1631, A Randomized Web-Based Physical Activity Intervention Among Children and Adolescents With Cancer (ALTE1631)

A Study to Evaluate Web-Based Physical Activity Intervention in Children and Adolescents with Newly Diagnosed Acute Lymphoblastic Leukemia in First Remission

Wendy Allen-Rhoades
All
8 years to 15 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-100686-P01-RST
18-007584
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Inclusion Criteria:

  • Patient must be ≥ 8 years of age and ≤ 16 years of age at time of enrollment.
  • All cancer cases with an ICD-O histologic behavior code of two "2" (carcinoma in situ) or three "3" (malignant), in remission.
  • Patient must have completed curative chemotherapy within past 12 months at a Childrens Oncology Group (COG) institution.
  • Patients must have a performance status corresponding to Eastern Cooperative Oncology Group (ECOG) scores of 0, 1, or 2; use Lansky for patients ≤ 16 years of age.
  • At the time of consent, patient or parent/guardian reports less than 420 minutes of moderate to vigorous physical activity over the last week.
  • Patient must have access to a smart phone with Android 4.3 or later or iOS 7.1 or later or computer (laptop/desktop) with a connection to the internet to create an account and be able to sync the Sqord device (accelerometer).
  • Patient and at least one parent/guardian are able to read and write English; at least 1 parent/guardian must be able to read and write English in order to assist the patient with using their Sqord account.
  • All patients and/or their parents or legal guardians must sign a written informed consent.
  • All institutional, FDA, and NCI requirements for human studies must be met.


Exclusion Criteria:

  • Patients with previous hematopoietic stem cell transplant (HSCT).
  • Patients with significant concurrent disease, illness, psychiatric disorder or social issue that would compromise patient safety or compliance with protocol therapy, or interfere with consent, study participation, follow up, or interpretation of study results.
  • Female patients who are pregnant are not eligible; women of childbearing potential require a negative pregnancy test.
  • Female patient who is postmenarcheal and has not agreed to use an effective contraceptive method (including abstinence) for the duration of study participation.
  • Patients with a cognitive, motor, visual or auditory impairment that prevents computer use (e.g., unresolved posterior fossa syndrome) are not eligible.
Device, Other
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AURORA US: Prospective Biospecimen Repository in Metastatic Breast Cancer

A Study to Collect Clinical Data, Blood Samples, and Tissue Specimens from Patients with Metastatic Breast Cancer

Karthik Giridhar
All
18 years and over
This study is NOT accepting healthy volunteers
0000-100687-P01-RST
18-001910
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Inclusion Criteria

  • Histologically confirmed or suspected invasive breast cancer.
  • Radiographic evidence of distant metastatic disease.
  • Clinical or radiographic evidence of disease progression OR presenting with de novo stage IV disease.
  • Available archived tissue from the initial breast primary (formalin fixed paraffin embedded [FFPE] tissue is acceptable; fresh frozen tissue is preferred if available).
  • Accessible lesion representative of recurrent or metastatic breast cancer for biopsy:
    • Type 1 specimen collection: Patients undergoing a clinically directed tissue biopsy or tissue collection who are willing to have additional specimens taken for research during the same procedure. Sites for tissue acquisition may include the breast, skin/chest wall, lymph node/soft tissue, liver, bone, lung, brain, pleural fluid, and ascites as needed for routine clinical care;
    • Type 2 specimen collection: Patients underging a tissue biopsy or tissue collection for research purposes only. Sites for tissue acquisition include the breast, skin/chest wall, lymph node/soft tissue, liver, bone, pleural fluid, and ascites. Research directed lung biopsies and brain biopsies are not permitted. Procedures for tissue acquisition are restricted to those performed under local anesthesia or IV conscious sedation; biopsies that require general anesthesia are not permitted in this situation.
  • Previous cytologic confirmation of malignant pleural effusion or ascites if that is the planned source of fresh specimen collection for study participation.
  • Age 18 years or older.
  • ECOG performance status 0-2.
  • Ability to understand and the willingness to sign an informed consent document.

Exclusion Criteria

  • Concurrent disease or condition that in the opinion of the treating oncologist or the provider performing the biopsy procedure renders the patient inappropriate for study participation.
  • Concurrent serious medical or psychiatric disorder that may interfere with the subject’s safety during the biopsy or tissue collection procedure.
  • Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.
  • History of a serious or life-threatening allergic reaction to local anesthetics (e.g., lidocaine, xylocaine) used during a biopsy procedure.
  • Pregnancy (due to the risk of conscious sedation or anesthesia to mother and fetus).
  • Any condition or laboratory finding that in the opinion of the treating oncologist or the provider performing the biopsy procedure would make participation in this protocol hazardous for the patient.
Breast cancer, Cancer
Malignant tumor of breast, Medical Oncology, Secondary malignant neoplastic disease
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Mayo Clinic — Rochester, MN

NRG-DT001, A Phase Ib Trial of Neoadjuvant AMG 232 Concurrent With Preoperative Radiotherapy in Wild-Type P53 Soft Tissue Sarcoma (STS)

MDM2 Inhibitor AMG-232 and Radiation Therapy in Treating Patients With Soft Tissue Sarcoma

Scott Okuno
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-100689-P01-RST
18-008045
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INCLUSION CRITERIA
•Prior to Step 1 Registration:

 

  • Patients with pathologically proven diagnosis of grade 2-3 (intermediate or high grade) soft tissue sarcoma with size ≥ 5 cm are eligible to enroll if the intention to treat is curative. They must have sufficient tissue to submit to central  laboratory for review as well as for NGS sequencing (see submission requirement). Biopsy should be obtained within 180 days prior to registration.
  • Availability of tumor tissue is mandatory for study eligibility. The patient must have consented to provide archived formalin-fixed paraffin-embedded tumor tissue for future central pathology review, NGS sequencing and/or translational research.
  • Appropriate stage for study entry based on the following diagnostic workup:
    • History/physical examination within 30 days prior to registration;
    • Imaging of the primary tumor by MRI and/or CT with or without contrast and/or PET/CT within 30 days prior to registration;
    • Staging workup evaluated by chest CT and/or PET/CT showing no distant metastasis within 30 days prior to registration.
  • There is a planned definitive surgical resection of the primary tumor.
  • Age ≥ 18 years old.
  • ECOG or Zubrod performance status of 0-1 within 30 days prior to registration.
  • Adequate hematologic function within 30 days prior to registration defined as follows:
    • Absolute neutrophil count ≥ 1500/μL;
    • Platelet count ≥ 100,000/μL;
    • Hemoglobin: ≥ 10 g/dL (transfuse as necessary to raise levels; no transfusions within 7 days of start).
  • Adequate renal and hepatic function within 30 days prior to registration defined as follows:
    • Calculated Creatinine Clearance ≥ 60 ml/min (by Cockroft-Gault formula) within 30 days prior to registration;
    • The patient has an adequate coagulation function as defined by International Normalized Ratio (INR) ≤1.5 x ULN or prothrombin time (PT) ≤1.5 x ULN, and partial thromboplastin time (PTT or aPTT) ≤1.5 x ULN (those receiving anticoagulation therapy except low molecular weight heparin are excluded);
    • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) appropriate for age (except for patients with Gilbert’s Syndrome, who must have a total bilirubin <3 mg/dL);
    • SGOT (AST) or SGPT (ALT) < 2.5 x upper limit of normal (ULN) appropriate for age.
  • Females of child-bearing potential must have a negative serum pregnancy test within 7 days prior to registration.
    • Exceptions: Females not of child-bearing potential due to surgical sterilization (at least 6 weeks following tubal ligation, hysterectomy, or surgical bilateral oophorectomy with or without hysterectomy) confirmed by medical history, or female after menopause:
  • A “postmenopausal woman” is a woman meeting either of the following criteria:
    • spontaneous amenorrhea for at least 12 months, not induced by a medical condition such as anorexia nervosa and not taking medications during the amenorrhea that induced the amenorrhea (for example, oral
    • contraceptives, hormones, gonadotropin releasing hormone, antiestrogens, selective estrogen receptor modulators [SERMs], or chemotherapy);
    • spontaneous amenorrhea for 6 to 12 months and a follicle-stimulating hormone (FSH) level >40 mIU/mL.
  • Females of child-bearing potential and males must agree to use highly effective contraceptive precautions during the trial and up to 12 months following the last dose of study treatment. A highly effective method of birth control is defined as one that results in a low failure rate (that is, <1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner.
  • The patient or a legally authorized representative must provide study-specific informed consent prior to study entry.

INCLUSION CRITERIA
•Prior to Step 2 Registration:

  • TP53 sequencing by NGS performed by central pathology lab.

EXCLUSION CRITERIA
•Prior to Step 1 Registration:

 

  • Well- differentiated liposarcoma or other low grade STS; Kaposi sarcoma, bone sarcomas, cartilage sarcomas and GIST. 
  • Definitive clinical or radiologic evidence of metastatic disease; indeterminate lung nodules less than 8mm are acceptable.
  • The patient has history of another primary malignancy, with the exception of:
    •  curatively treated non-melanomatous skin cancer; 
    • curatively treated cervical carcinoma in situ;
    • non-metastatic prostate cancer;
    • other primary non-hematologic malignancies or solid tumor treated with curative intent, no known active disease, and no treatment administered during the last 3 years prior to registration.
  • The patient has a serious cardiac condition, such as congestive heart failure; New York Heart Association Class II/ III/IV heart disease; unstable angina pectoris, cardiac stenting within 6 months of enrollment; myocardial infarction within the last 3 months; valvulopathy that is severe, moderate, or deemed clinically significant; or arrhythmias that are symptomatic or require treatment.
  • Females who are pregnant or breastfeeding.
  • Prior systemic chemotherapy for the study cancer (sarcoma); note that prior chemotherapy for a different cancer is allowable. However, unresolved toxicities from prior anti-tumor therapy, defined as not having resolved to Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade 0 or 1, or to levels dictated in the eligibility criteria with the exception of alopecia (Grade 2 or 3 toxicities from prior antitumor therapy that are considered irreversible [defined as having been present and stable for > 6 months], such as ifosfamide-related proteinuria, may be allowed if they are not otherwise described in the exclusion criteria AND there is agreement to allow by both the investigator and sponsor).
  • P rior radiotherapy to the region of the study cancer that would result in overlap of radiation therapy fields.
  •  Clinically significant bleeding within 4 weeks of screening, current use of warfarin, factor Xa inhibitors, and direct thrombin inhibitors unless these medications can be safely discontinued 14 days prior to AMG-232 administration.
    • Note: Low molecular weight heparin and prophylactic low dose warfarin are permitted. PT/PTT must meet the inclusion criteria. Subjects taking warfarin must have their INR followed closely. History of allergic reactions attributed to  compounds of similar chemical or biologic composition to AMG 232.
  • Medication use:
    • All subjects must agree to stop the use of all herbal medicines (e.g., St. John’s wort), and supplements, within the 10 days prior to receiving the first dose of AMG 232, and during the protocol AMG 232 treatment (Weeks 1-5). Subjects may renew the use of the above at week 6. Standard adult multi-vitamin is allowed;
    • All subjects must agree to stop the use of any known CYP3A4 substrates with narrow therapeutic window (such as alfentanil, astemizole, cisapride, dihydroergotamine, pimozide, quinidine, sirolimus, or terfanide; within the 14 days prior to receiving the first dose of AMG 232 and during protocol AMG 232 treatment (Weeks 1-5). Other medications (such as fentanyl and oxycodone) may be allowed per investigator’s assessment/evaluation;
    • All subjects must agree to stop the use of any known CYP2C8 substrates with a narrow therapeutic window within the 14 days prior to receiving the first dose of AMG 232 and during protocol AMG 232 treatment (Weeks 1-5);
    • All subjects are required to submit a list of medications consumed within 14 days prior to receiving the first dose of AMG232 and during the protocol AMG232 treatment (Weeks 1-5).
  • Patients with GI tract disease causing the inability to take oral medication, malabsorption syndrome, requirement for intravenous alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g.,  Crohn’s disease, ulcerative colitis), therefore could affect the absorption of AMG 232 at the discretion of treating physician.
  • Patients with active infection requiring IV antibiotics within 2 weeks of registration.
  • Patients with known Positive Hepatitis B Surface Antigen (HepBsAg) (indicative of chronic Hepatitis B), positive Hepatitis total core antibody with negative HBsAG (suggestive of occult hepatitis B), or detectable Hepatitis C virus RNA by a polymerasechain reaction (PCR) assay (indicative of active Hepatitis C – screening is generally done by Hepatitis C Antibody (HepCAb), followed by Hepatitis C virus RNA by PCR if HepCAb is positive).
  • Patients known to be positive for human immunodeficiency virus (HIV) are NOT excluded from this study, but HIV-positive patients must have:
    • 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 test HIV testing is not required.
  • Treatment with medications known to cause QTc interval prolongation within 7 days of study day 1 is not permitted unless approved by the sponsor. Use of ondansetron is permitted for treatment of nausea and vomiting.

  

Drug, Other, Administration of antineoplastic agent, Drug therapy, Radiation therapy procedure or service
Cancer, Sarcoma, Soft tissue sarcoma
Cancer treatment, Medical Oncology, Musculoskeletal system, Radiation therapy, Sarcoma of soft tissue
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Mayo Clinic — Rochester, MN