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MC1935: A Phase III Trial of Hypofractionated Radiotherapy to the Whole Breast or Post-mastectomy Chest Wall Including Regional Nodal Irradiation

A Study to Evaluate Radiotherapy to the Whole Breast or Post-mastectomy Chest Wall Including Regional Nodal Irradiation

Robert Mutter
Female
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-101144-P01-RST
19-008858
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Histological confirmation of breast cancer.
  • Breast conserving surgery or mastectomy (reconstruction is allowed).
  • Clinical or pathologic T1-T4c, N0-3, M0 disease.
  • ECOG Performance Status (PS) 0 to 2.
  • Indications for breast or post mastectomy radiation with regional nodal radiotherapy per the discretion of the treating physician.
  • If uncertain of eligibility please consult the PI.


Exclusion Criteria:

  • Medical contraindication to receipt of radiotherapy.
  • Severe active co-morbid systemic illnesses or other severe concurrent disease which, in the judgment of the investigator or PI, 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.
  • 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 or providing informed consent.
  • Active systemic lupus or scleroderma.
  • Prior receipt of ipsilateral breast or chest wall radiation.
  • Persistent positive margins on ink after definitive surgery either for DCIS or invasive cancer.
  • No active metastatic disease from other origin.
  • Recurrent breast cancer.
  • Patient requires bilateral breast radiation treatment.
  • cT4d patients (inflammatory breast cancer).
  • Patients that may not be compliant or fit for the study at the discretion of the PI.
  • Male patients.

 

Hypofractionated whole breast radiation therapy, Radiotherapy to chest wall, Radiation
Breast cancer, Cancer
Breast cancer surgery, Cancer treatment, Malignant neoplasm of female breast, Mastectomy, Medical Oncology, Radiation therapy, Radiation therapy for breast cancer, Oncoplastic breast-conserving surgery
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Mayo Clinic — Rochester, MN

A Phase 1b Open-label, Multicenter Dose Escalation and Expansion Study of MT-5111 in Subjects With Previously Treated Advanced HER2-positive Solid Tumors (MT-5111)

A Study of MT-5111 in HER2-positive Solid Tumors

Joleen Hubbard
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-101152-P01-RST
19-010052
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Inclusion Criteria:

  • Subject must sign the written ICF before any screening procedure.
  • Subject must be aged ≥ 18 years (y) on the date of signing the informed consent.
  • Subject must have histologically confirmed, unresectable, locally advanced or metastatic solid cancers.
    • In Part A, all HER2-positive solid cancers are eligible;
    • In Part B, HER2-positive breast, GEA and other HER2- positive solid cancers are eligible for the respective expansion groups.
  • All subjects in both parts of the study must be HER2-positive in the latest tumor sample tested for HER2 (it is required that testing is done on a metastatic lesion in cases of metastatic cancers for subjects with metastatic disease), according to standard testing procedures. For the purpose of this study, HER2-positivity is defined as:
    • Tumors tested by IHC: must have an IHC status of 2+ or 3+, regardless of ISH result; OR
    • BC or GEA tumors tested by ISH only (no IHC available): must be HER2-positive.
    • Note: cancers other than BC and GEA must be tested via IHC and must have a status of 2+ or 3+, regardless of ISH result.
  • Subject should be relapsed or refractory to existing therapy(ies) known to provide clinical benefit for the underlying cancer or have been intolerant of such therapies.
    • Subjects with HER2-positive BC per American Society of Clinical Oncology-College of American Pathologists (ASCO-CAP) guidelines (Wolff et al, 2018) should have received at least 2 lines of HER2-directed therapy in the advanced setting and should have received at least 2 of the following: pertuzumab, trastuzumab emtansine, tucatinib or fam trastuzumab deruxtecan in either the early-stage or advanced setting. Subjects with tumors that are HER2 2+ by IHC and without gene amplification are not required to have received prior HER2-targeting therapy;
    • Subjects with HER2-positive gastric cancer per ASCO-CAP guidelines (Bartley et al, 2016) must have previously received trastuzumab or fam trastuzumab deruxtecan or have been intolerant of such therapy. Subjects with tumors that are HER2 2+ by IHC and without gene amplification are not required to have received prior HER2-targeting therapy.
  • Subject must have at least 1 measurable tumor lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 (APPENDIX D: Eisenhauer et al, 2009).
    • Subjects with evaluable disease only may be included in the dose escalation phase.
  • Subject must have Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1 (APPENDIX B).
  • Subject must have a life expectancy of at least 3 mo. 9. Subject must have adequate bone marrow function, as determined by:
    • ANC ≥ 1,000/mm^3;
    • Platelet count ≥ 75,000 mm³; and
    • Hemoglobin ≥ 8.0 g/dL. Red blood cell transfusion within 2 wk of study treatment start is allowed if hemoglobin levels remain stable (i.e., do not decrease by > 1 g/dL by C1D1).
  • Subject must have adequate kidney function, as determined by: a. Creatinine clearance ≥ 50 ml/min either measured or estimated using the Cockcroft-Gault formula.
  • Subject must have adequate hepatic function, as determined by:
    • Total bilirubin ≤ 1.5 x ULN, or ≤ 3 x ULN for subjects with Gilbert’s Syndrome; and
    • AST ≤ 3 x ULN (or ≤ 5 x ULN if liver metastasis); and
    • ALT ≤ 3 x ULN (or ≤ 5 x ULN if liver metastasis).
  • Subject must have adequate serum albumin, as determined by:
    • Albumin ≥ 2.5 g/dL.
  • Subject must have adequate coagulation, as determined by:
    • international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN; and
    • partial thromboplastin time ≤ 1.5 x ULN.
  • Subject must have adequate cardiac function, as determined by:
    • LVEF ≥ 55% assessed by ECHO (preferred), or multigated acquisition (MUGA) scan; and
    • QTcF ≤ 480 ms for women and QTcF ≤ 450 ms for men (average from 3 QTcF values on the triplicate 12-lead electrocardiogram) at baseline.
    • NOTE: Subjects with right bundle branch block and LVEF ≥ 55% will be eligible for participation.
  • Women of reproductive potential must have a negative pregnancy test during the screening period within 72 h before the start of treatment. Women not of reproductive potential are female subjects who are postmenopausal or permanently sterilized (e.g., tubal occlusion, hysterectomy, bilateral salpingectomy).
  • Subjects of reproductive potential must agree to either abstain continuously from heterosexual intercourse or to use a highly effective method of birth control between signing the informed consent until 90 d after last study treatment. The Investigator or Delegate should advise the subject to use a double barrier method to achieve adequate contraception. The following birth control methods will be considered as adequate:
    • Condoms (male or female) with a spermicidal agent;
    • Diaphragm or cervical cap with spermicide;
    • Condom with diaphragm;
    • Intrauterine device;
    • Hormone-based contraception: Established use of oral, injected, or implanted hormonal methods of contraception;
    • Vasectomy (for a male subject or male partner of a female subject).


Exclusion Criteria:
 

  • History or current evidence of neoplastic disease that is histologically distinct from the tumor under study, except cervical carcinoma in situ, superficial noninvasive bladder tumors, curatively treated Stage I-II non-melanoma skin cancer, or any other previous cancer curatively treated less than 2 y prior to enrollment in this study. Subjects with any other active malignancy may only be enrolled after discussion and approval by the Sponsor.
  • Current evidence of new or growing central nervous system (CNS) metastases during screening. Subjects with known CNS metastases will be eligible if they meet all the following criteria:
    • Had radiotherapy or another appropriate therapy for the CNS metastases;
    • Have no neurological symptoms > Grade 2, with approval by the Medical Monitor;
    • Have stable CNS disease on the Computed tomography (CT) or magnetic resonance imaging (MRI) scan within 4 wk before signing the informed consent compared with prior neuro-imaging;
    • Do not require steroid therapy.
  • Current evidence of CTCAE Grade > 1 toxicity before the start of treatment, except for hair loss and those Grade 2 toxicities listed as permitted in other eligibility criteria. Subjects with Grade 2 neurologic symptoms or other toxicities that are asymptomatic or adequately managed with stable medication may be eligible with approval by the Medical Monitor.
  • Current evidence of incomplete recovery from surgery or radiotherapy at screening, or planned surgery or radiotherapy from the start of treatment until the STFU Visit, except minor elective surgery deemed acceptable by the Investigator.
  • History or current evidence of significant (CTCAE Grade ≥ 2) infection or wound within 2 wk before the start of treatment.
  • history or current evidence of significant cardiovascular disease before the start of treatment, but not limited to the following conditions:
    • High sensitivity troponin I or T > ULN at screening;
    • Angina pectoris requiring anti-anginal medication, (chest pain: CTCAE Grade ≥ 2) or clinically significant valvular disease;
    • Myocardial infarction within 12 mo prior to the start of treatment;
    • Arterial thrombosis or pulmonary embolism within ≤ 6 mo before the start of treatment;
    • Pericarditis (any CTCAE grade), pericardial effusion (CTCAE Grade ≥ 2), non-malignant pleural effusion (CTCAE Grade ≥ 2) or malignant pleural effusion (CTCAE Grade ≥ 3) (subjects with pleural effusion that is manageable and stable > 3 mo prior to study are eligible);
    • Left bundle branch block;
    • History of Grade ≥ 2 symptomatic congestive heart failure or New York Heart Association (NYHA): Class ≥ II;
    • High-risk uncontrolled arrhythmias (i.e., atrial tachycardia with a heart rate > 100/min at rest, significant ventricular arrhythmia [CTCAE Grade ≥ 2] [ventricular tachycardia], or higher-grade atrioventricular [AV]-block [second degree AV-block Type 2 (Mobitz 2) or third degree AV-block]).
  • Current evidence of active, uncontrolled hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) (evidenced by detectable viral load by polymerase chain reaction or acquired immunodeficiency syndrome (AIDS) related illness.
    • Serology and virology measurements are not required to be performed at screening, but any previously-reported results should be used for eligibility purposes. Subjects with no previously reported results are eligible in the absence of history of HBV/HCV/HIV. Investigators will test per their discretion;
    • Subjects with a history of treated hepatitis C and non-quantifiable HCV-ribonucleic acid may be enrolled;
    • Subjects on treatment for HBV and/or HIV will be eligible if they have undetectable viral load.
    • Subjects with CD4+ T-cell (CD4+) counts ≥ 350 cells/µL may be enrolled;
    • Subjects taking atazanavir should be considered for alternate therapy given the risk of cardiac conduction abnormalities.
  • Known or suspected hypersensitivity to the study drug or excipients contained in the study drug formulation.
  • Current evidence of hypersensitivity requiring systemic steroids at doses > 20 mg/d prednisone equivalent.
  • History or current evidence of any other medical or psychiatric condition or addictive disorder, or laboratory abnormality that, in the opinion of the Investigator, will increase the risks associated with study participation, or require treatments that will interfere with the conduct of the study or the interpretation of study results.
  • Current evidence of ≥ Grade 2 underlying pulmonary disease.
  • Women who are pregnant or breastfeeding.
  • Subjects with unintentional weight loss greater than 10% of their body weight over the preceding 3 mo or less.
  • Therapeutic anticoagulation for a thromboembolic event within 2 wk before the start of treatment (prophylactic anticoagulation is allowed).
  • Received systemic therapy for the cancer under study or any investigational drug within 4 wk before the start of treatment.
  • Received immunosuppressive agents or other prescribed corticosteroids at doses ≥ 20 mg prednisone equivalent per d within 2 wk before the start of treatment.
  • For Part A (dose escalation phase): Received chemotherapy with doxorubicin (or another anthracycline) at any time. For Part B (dose expansion phase): Received chemotherapy with anthracycline or anthracenedione agents at the doxorubicin equivalent cumulative dose (sum total for all agents combined) of 550 mg/m^2 body surface area, or a lower total doxorubicin equivalent cumulative dose that, in the opinion of the Investigator, would increase the risk of cardiomyopathy in this study, or subjects who have received mitoxantrone at cumulative doses considered to increase the risk of cardiomyopathy. For subjects who have received a cumulative dose of an anthracycline of more than 300 mg/m^2 , approval must first be obtained from the Medical Monitor.
  • Received granulocyte colony–stimulating factor or granulocyte-macrophage colony–stimulating factor for the treatment of leukopenia within 2 wk before the start of treatment.

Eligibility last updated 8/11/21. Questions regarding updates should be directed to the study team contact.

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MC1974: A Study of Mucosal Sparing Adjuvant Radiotherapy After Surgical Exploration In HPV Head And Neck Cancer Of Unknown Primaries (HNCUP)

A Study to Evaluate Mucosal Sparing Adjuvant Radiotherapy After Surgical Exploration In HPV Head And Neck Cancer

Daniel Ma
All
18 years and over
Early Phase 1
This study is NOT accepting healthy volunteers
0000-101161-P01-RST
19-012222
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Patients meet criteria for IMPT treatment for Oropharyngeal Cancer as outlined in the procedure manual.
  • If IMPT is declined by patient’s insurance, they can be treated with standard of care IMRT using the same applicable standard of care procedures outlined in the procedures manual.
  • Meet criteria for adjuvant chemotherapy (if applicable).
  • Histological confirmation of HPV+ squamous cell carcinoma as defined by neck node pathology. HPV positivity will be defined as positive staining for p16 and HPV DNA ISH. (If discordant, RNA ISH will be run for confirmatory testing).
  • Clinical stage T0 N1-N3 and confirmed Pathologic stage T0 N1-N2 M0 (AJCC 8th edition) with one of the following risk factors:
    • lymph node ≥ 3cm;
    • ≥ positive lymph nodes;
    • presence of extracapsular extension;
    • > 1 nodal level involved.
  • Absence of distant metastases on standard diagnostic workup, prior to registration (Chest CT, CXR, or PET/CT).
  • Able to undergo pre-operative Q-clear series PET/CT head/neck for diagnostic workup of occult primary and nodal disease.
  • Able to undergo Transoral Surgery and neck dissection by their ENT oncologist.
  • Surgical exploration/sampling of all mucosal sites including ipsilateral wide field tonsillectomy and base of tongue resection.  Additional biopsies or surgical excision at the surgeon’s discretion. Any radiographic or clinically suspicious areas should be biopsied or removed. Bilateral neck dissection for high risk patients. Ipsilateral dissection only, for patients with contralateral cN0 necks and negative preoperative imaging.
  • Final pathologic evaluation demonstrating all benign samplings without discernible primary.
  • Documented smoking history.
  • ECOG Performance Status (PS) 0 or 1. 
  • Negative pregnancy test done ≤ 7 days prior to registration, for women of childbearing potential only.
  • Following laboratory values obtained ≤ 35 days prior to registration:
    • Absolute neutrophil count (ANC) ≥ 1500/mm^3;
    • Platelet count ≥100,000/mm^3;
    • Hemoglobin  ≥8.0g/dL;
    • Creatinine ≤ 1.5 mg/dL or creatinine clearance ≥ 50 mL/min;
    • Total or direct bilirubin < 2 x institutional upper limit of normal (ULN);
    • AST (SGOT) or ALT (SGPT) < 3 x institutional ULN.
  • Ability to complete questionnaire(s) by themselves or with assistance.
  • Able to provide written informed consent.
  • Willing to return to enrolling institution for follow-up (during the Active Monitoring Phase of the study).

 


Exclusion Criteria:

 

  • Any patient with positive retropharyngeal nodes on imaging.
  • 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.
  • 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.
  • Other active malignancy ≤ 5 years prior to registration.
    • EXCEPTIONS: Non-melanotic skin cancer, breast cancer, prostate cancer, well-differentiated thyroid cancer, carcinoma-in-situ of the cervix.
    • NOTE: If there is a history or prior malignancy, they must not be receiving other specific treatment for their cancer.
  • Immunocompromised patients and patients known to be HIV positive.
  • Receiving any other investigational agent which would be considered as a treatment for the primary neoplasm.
  • History of connective tissue disorders such as scleroderma, rheumatoid arthritis, lupus, or Sjogren’s disease.
  • Prior history of radiation therapy to the affected site.
Radiation
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ION-682884-CS3 A Phase 3 Global, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of ION-682884 in Patients With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy

NEURO-TTRansform: A Study to Evaluate the Efficacy and Safety of AKCEA-TTR-LRx in Participants With Hereditary Transthyretin-Mediated Amyloid Polyneuropathy

Morie Gertz
All
18 years to 82 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-101170-P01-RST
19-011570
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Inclusion Criteria:
1. Aged 18 to 82 years at the time of informed consent 2. Females must be non-pregnant and non-lactating, and either surgically sterile or post-menopausal or abstinent 3. Males must be surgically sterile or, abstinent or, if engaged in sexual relations with a woman of child-bearing potential, the subject or the subject''s non-pregnant female partner must be using a highly effective contraceptive method 4. Diagnosis of hereditary transthyretin-mediated polyneuropathy as defined by meeting all 3 of the following:
• Stage 1 or Stage 2 Familial Amyloid Polyneuropathy (FAP) or Coutinho Stage
• Documented genetic mutation in the TTR gene
• Symptoms and signs consistent with neuropathy associated with transthyretin amyloidosis, including NIS ≥ 10 and ≤ 130
Exclusion Criteria:
1. Clinically-significant (CS) abnormalities in medical history, screening laboratory results, physical or physical examination that would render a subject unsuitable for inclusion, including but not limited to abnormal safety labs 2. Karnofsky performance status ≤ 50 3. Other causes of sensorimotor or autonomic neuropathy (e.g., autoimmune disease), including uncontrolled diabetes 4. Prior liver transplant or anticipated liver transplant within 1-yr of Screening 5. New York Heart Association (NYHA) functional classification of ≥ 3 6. Acute coronary syndrome within 6 months of screening or major surgery within 3 months of Screening 7. Other types of amyloidosis 8. Have any other conditions, which, in the opinion of the Investigator or Sponsor would make the subject unsuitable for inclusion, or could interfere with the subject participating in or completing the Study 9. Current treatment with any approved drug for hereditary TTR amyloidosis such as Vyndaqel® / Vyndamax™ (tafamidis), Tegsedi™ (inotersen), Onpattro™ (patisiran), off-label use of diflunisal or doxycycline, and tauroursodeoxycholic acid (TUDCA). If previously treated with Vyndaqel® / Vyndamax™, diflunisal or doxycycline, and TUDCA, must have discontinued treatment for at least 2 weeks prior to Study Day 1 10. Previous treatment with Tegsedi™ (Inotersen) or Onpattro™ (patisiran), or other oligonucleotide or RNA therapeutic (including siRNA)
Drug therapy, Drug
Amyloidosis, Neuropathies, Polyneuropathy
Eplontersen [USAN], Hematopoietic system, Inotersen [USAN], Polyneuropathy in amyloidosis, Transthyretin related familial amyloid cardiomyopathy, inotersen
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KT-US-471-0119, A Phase 1/2 Open-label, Multicenter Study of Lenzilumab and Axicabtagene Ciloleucel in Subjects with Relapsed or Refractory Large B-cell Lymphoma (ZUMA-19)

Study of Lenzilumab and Axicabtagene Ciloleucel in Subjects with Relapsed or Refractory Large B-cell Lymphoma

Saad Kenderian
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
0000-101173-P01-RST
19-012798
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Inclusion Criteria:

  • Adult subjects with large B-cell lymphoma, including Diffuse large B-cell lymphoma (DLBCL) not otherwise specified, Primary mediastinal large B-cell lymphoma (PMBCL), High-grade B-cell lymphoma (HGBL), and Diffuse large B-cell lymphoma (DLBCL) arising from Follicular lymphoma (FL).
  • Subjects must have relapsed disease after 2 or more lines of systemic therapy, OR chemorefractory disease defined as the following: No response to first-line therapy, including the following: PD as best response to first therapy, SD as best response after ≥ 4 cycles of first-line therapy (eg, 4 cycles of R-CHOP), with SD duration no longer than 6 months from the last dose of therapy, Note: Subjects who are intolerant to first-line chemotherapy are excluded OR No response to ≥ 2 lines of therapy, including the following: PD as best response to most recent therapy, SD as best response after ≥ 2 cycles of last line of therapy.
  • Subjects must have received adequate prior therapy including at a minimum: Anti-CD20 monoclonal antibody unless investigator determines that tumor is CD20 negative, and An anthracycline-containing chemotherapy regimen, Subjects with transformed FL must have chemorefractory disease after transformation to DLBCL.
  • At least 1 measurable lesion according to the International Working Group (IWG) Lugano Classification {Cheson 2014}. Lesions that have been previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy.
  • Magnetic resonance imaging of the brain showing no evidence of CNS lymphoma.
  • At least 2 weeks or 5 half-lives, whichever is shorter, must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint therapy. At least 3 half-lives must have elapsed from any prior systemic inhibitory/stimulatory immune checkpoint molecule therapy at the time the subject is planned for leukapheresis (eg, ipilimumab, nivolumab, pembrolizumab, atezolizumab, OX40 agonists, 4-1BB agonists).
  • Toxicities due to prior therapy must be stable and recovered to Grade ≤ 1 (except for clinically nonsignificant toxicities such as alopecia).
  • Age 18 or older.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
  • Additional Inclusion Criteria may apply.


Exclusion Criteria:

  • History of malignancy other than nonmelanoma skin cancer or carcinoma in situ (eg, cervix, bladder, breast) or FL unless disease free for at least 3 years.
  • History of Richter’s transformation of chronic lymphocytic leukemia.
  • Autologous stem cell transplant (SCT) within 6 weeks of planned axicabtagene ciloleucel infusion.
  • History of allogeneic stem cell transplantation.
  • Prior CD19 targeted therapy or prior CAR T cell therapy.
  • History of PAP.
  • History of severe, immediate hypersensitivity reaction attributed to aminoglycosides.
  • Presence of fungal, bacterial, viral, or other infection that is uncontrolled or requiring intravenous antimicrobials for management. Simple urinary tract infection and uncomplicated bacterial pharyngitis are permitted if responding to active treatment and after consultation with the Kite medical monitor.
  • Known history of human immunodeficiency virus (HIV) infection, hepatitis B (HBsAg positive) or hepatitis C (anti-HCV positive) infection. A history of hepatitis B or hepatitis C infection is permitted if the viral load is undetectable per quantitative polymerase chain reaction (PCR) and/or nucleic acid testing.
  • Additional Exclusion Criteria may apply.
Biologic/Vaccine, Drug
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ME-522-001: A Phase 1, Open-label, Study of Voruciclib in Subjects with Relapsed and/or Refractory B-Cell Malignancies or Acute Myeloid Leukemia After Failure of Prior Standard Therapies and Voruciclib in Combination with Venetoclax in Subjects with Relapsed and/or Refractory Acute Myeloid Leukemia

A Phase 1 Study of Voruciclib in Subjects With B-Cell Malignancies or AML

Kebede Begna
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-101182-P01-RST
19-010929
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Inclusion Criteria:


- Age ≥18 years

- Histologically-confirmed diagnosis of Follicular lymphoma (FL), mantle cell lymphoma
(MCL), marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL), chronic
lymphocytic leukemia(CLL), diffuse large B-cell lymphoma (DLBCL), or AML

a. Subjects must have disease that has relapsed or is refractory to 2 or more prior
regimens and in need of treatment due to progressive disease

- Presence of measurable disease defined per the 2008 International workshop on CLL
guidelines, or by 2014 Lugano criteria for non-Hodgkin lymphoma (does not apply for
AML subjects)

- Adequate hematologic parameters unless clearly due to the disease under study

- Adequate renal and hepatic function, per laboratory reference range at screening


Exclusion Criteria:


- History of pneumonitis of any cause

- For CLL subjects: only known histological transformation to an aggressive lymphoma

- For AML subjects:

1. Acute promyelocytic leukemia

2. Peripheral blast count > 25 × 10 9/L

- Known central nervous system involvement

- Significant cardiovascular disease

- Significant screening ECG abnormalities

- Subjects who require warfarin, anti-cancer therapeutics or investigational agents

- Evidence of an ongoing systemic bacterial, fungal, or viral infection (including upper
respiratory tract infections) at the time of start of voruciclib therapy

- Prior solid organ transplantation

- Receipt of an allogeneic transplant within 6 months or an autologous transplant within
the preceding 3 months; evidence of ongoing graft-versus-host disease (GVHD)

- Prior therapy with a cyclin-dependent kinase (CDK9) inhibitor

- Symptomatic/uncontrolled HIV infection/AIDS, or currently taking contraindicated
medications for HIV control

- Ongoing immunosuppressive treatment including calcineurin inhibitors at the time of
the start of study treatment, including systemic or enteric corticosteroids except as
follows:

1. Prior to the start of study treatment, subjects may be using systemic
corticosteroids (≤20 mg/day of prednisone or equivalent), topical, or inhaled
corticosteroids

2. During study therapy, subjects may use systemic, topical, or enteric
corticosteroids, if needed

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

Eligibility last updated 10/6/22. Questions regarding updates should be directed to the study team contact.

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ADVL1823, Larotrectinib (LOXO-101, NSC# 788607) for Previously Untreated TRK Fusion Pediatric Solid Tumors and TRK Fusion Relapsed Pediatric Acute Leukemias (ADVL1823)

A Study to Evaluate Larotrectinib to Treat Patients with Previously Untreated TRK Fusion Solid Tumors and TRK Fusion Relapsed Acute Leukemia

Carola Arndt
All
up to 30 years old
Phase 2
This study is NOT accepting healthy volunteers
0000-101183-P01-RST
19-010273
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Inclusion Criteria:
 

  • Patients must be ≤ 30 years of age at the time of study entry.

COHORT A

  • Patients must have a histologic diagnosis of infantile fibrosarcoma with an NTRK1, NTRK2, or NTRK3 fusion identified in a Clinical Laboratory Improvement Amendments/College of American Pathologists (CLIA/CAP) certified laboratory. Fusions may be identified by fluorescence in situ hybridization (FISH) or molecular techniques (reverse transcriptase-polymerase chain reaction [RT-PCR] using primers flanking the fusion junction or next generation sequencing). For fusions identified by FISH, an ETV6 rearrangement is sufficient for eligibility in Cohort A. Identification of the upstream TRK fusion partner is not required. 

COHORT B

  • Patients must have a histologic diagnosis of any solid tumor other than infantile fibrosarcoma, including central nervous system (CNS) tumors but excluding high grade gliomas. An NTRK1, NTRK2, or NTRK3 fusion must be identified in a CLIA/CAP certified laboratory. Fusions may be identified by FISH or molecular techniques (RT-PCR using primers flanking the fusion junction or next generation sequencing). For fusions identified by FISH, there must be an identified rearrangement in NTRK1, NTRK2, or NTRK3 (e.g., an ETV6 rearrangement is not sufficient for eligibility) unless the patient has a diagnosis of congenital mesoblastic nephroma in which case an ETV6 rearrangement is sufficient for eligibility. Identification of the upstream TRK fusion partner is not required. 

COHORT C

  • Patients must have a histologic diagnosis of relapsed or refractory acute leukemia with an NTRK1, NTRK2, or NTRK3 fusion identified in a CLIA/CAP certified laboratory. Fusions may be identified by FISH or molecular techniques (RT-PCR using primers flanking the fusion junction or next generation sequencing). For fusions identified by FISH, there must be an identified rearrangement in NTRK1, NTRK2, or NTRK3 (e.g., an ETV6 rearrangement is not sufficient for eligibility). Identification of the upstream TRK fusion partner is not required.

SOLID TUMORS (COHORTS A AND B)

  • Patients must have measurable disease. Patients must have disease that cannot be completely resected without a predicted functional, neurologic, or significant cosmetic deficit in the opinion of the investigator. 

LEUKEMIA (COHORT C)

  • Patients must have ≥ 5% blasts in the bone marrow. Extramedullary disease is permitted. 
  • Patients must have a Lansky or Karnofsky performance status score of ≥ 50, corresponding to Eastern Cooperative Oncology Group (ECOG) categories 0, 1 or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age.
    • Note: Neurologic deficits in patients with CNS tumors must have been stable for at least 7 days prior to study enrollment. Patients who are unable to walk because of paralysis, but who are up in a wheelchair, will be considered ambulatory for the purpose of assessing the performance score. 

COHORTS A AND B

  • No prior anti-cancer therapy, including radiotherapy, other than surgical resection is permitted.
  • Patients who experience recurrence after surgery alone and no other anti-cancer therapy will be eligible.
  • If not eligible due to prior anticancer therapy, patients may be eligible for the larotrectinib arm of Pediatric MATCH (APEC1621A) or treatment with commercial larotrectinib off study. 

COHORT C

  • Patients with relapsed leukemia (Cohort C) must have fully recovered from the acute toxic effects of all prior anti-cancer therapy and must meet the following minimum duration from prior anti-cancer directed therapy prior to enrollment. If after the required timeframe, the numerical eligibility criteria are met; e.g., blood count criteria, the patient is considered to have recovered adequately. 
  • Cytotoxic chemotherapy or other anti-cancer agents known to be myelosuppressive. The duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment. 
  • A waiting period prior to enrollment is not required for patients receiving standard cytotoxic maintenance chemotherapy (i.e., corticosteroid, vincristine, thioguanine [6MP], and/or methotrexate). 
  • A waiting period is not required for patients receiving a single dose of intrathecal methotrexate, hydrocortisone, and/or cytarabine within 7 days prior to enrollment.
  • ≥ 14 days must have elapsed after the completion of other cytotoxic therapy, with the exception of hydroxyurea, for patients not receiving standard maintenance therapy. Additionally, patients must have fully recovered from all acute toxic effects of prior therapy. 
    • Note: Cytoreduction with hydroxyurea must be discontinued ≥ 24 hours prior to the start of protocol therapy. 
    • Anti-cancer agents not known to be myelosuppressive (e.g., not associated with reduced platelet or absolute neutrophil [ANC] counts): ≥ 7 days after the last dose of agent. The duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment. 
    • Antibodies: ≥ 21 days must have elapsed from infusion of last dose of antibody, and toxicity related to prior antibody therapy must be recovered to grade ≤ 1. There is an exception for blinatumomab infusions, for which patients must have been off for at least 3 days and all drug related toxicity must have resolved to grade 2 or lower as outlined in the inclusion/exclusion criteria. 
    • Corticosteroids: If used to modify immune adverse events related to prior therapy, ≥ 14 days must have elapsed since last dose of corticosteroid. A waiting period prior to enrollment is not required for patients receiving corticosteroid for leukemia therapy/cytoreduction. 
    • Hematopoietic growth factors: >= 14 days after the last dose of a long-acting growth factor (e.g., pegfilgrastim) or 7 days for short-acting growth factor. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair and the study-assigned research coordinator.
      •Interleukins, interferons and cytokines (other than hematopoietic growth factors): ≥ 21 days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors ).
    • Stem cell infusions (with or without total body irradiation [TBI]): 
    • Allogeneic (non-autologous) bone marrow or stem cell transplant, or any stem cell infusion including donor lymphocyte infusion (DLI) or boost infusion: ≥ 84 days after infusion and no evidence of graft versus host disease (GVHD). 
    • Autologous stem cell infusion including boost infusion: ≥ 42 days. 
    • Cellular therapy: ≥ 42 days after the completion of any type of cellular therapy (e.g., modified T cells, natural killer [NK] cells, dendritic cells, etc.) 
    • Radiation therapy (XRT)/external beam irradiation including protons: ≥ 14 days after local XRT; ≥ 150 days after TBI, craniospinal XRT or if radiation to ≥ 50% of the pelvis; ≥ 42 days if other substantial BM radiation. 
    • Radiopharmaceutical therapy (e.g., radiolabeled antibody): ≥ 42 days after systemically administered radiopharmaceutical therapy. 
    • Patients must not have received prior exposure to TRK inhibitors (including larotrectinib, LOXO-195, entrectinib, lorlatinib, crizotinib, or lestaurtinib). 
    • For patients with solid tumors without known bone marrow involvement: 
      • Peripheral absolute neutrophil count (ANC) ≥ 1000/mm^3 (within 7 days prior to enrollment);
      • Platelet count ≥ 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment);
      • Hemoglobin ≥ 8.0 g/dL at baseline (may receive red blood cell [RBC] transfusions).
    • Patients with solid tumors with known bone marrow metastatic disease will be eligible for study provided they meet the blood counts (may receive transfusions provided they are not known to be refractory to red cell or platelet transfusions). These patients will not be evaluable for hematologic toxicity. 
    • For patients with leukemia: 
      • Platelet count ≥ 20,000/mm^3 (may receive platelet transfusions) (within 7 days prior to enrollment); 
      • Hemoglobin ≥ 8.0 g/dL at baseline (may receive RBC transfusions).
    • These patients must not be known to be refractory to red cell or platelet transfusion. 
    • Creatinine clearance or radioisotope glomerular filtration rate (GFR) ≥ 70 mL/min/1.73 m^2 or a serum creatinine based on age/gender as follows (within 7 days prior to enrollment): 
      • 1 month to < 6 months (male 0.4 mg/dL, female 0.4 mg/dL);
      • 6 months to < 1 year (male 0.5 mg/dL, female 0.5 mg/dL);
      • 1 to < 2 years (male 0.6 mg/dL, female 0.6 mg/dL);
      • 2 to < 6 years (male 0.8 mg/dL, female 0.8 mg/dL);
      • 6 to < 10 years (male 1 mg/dL, female 1 mg/dL); 
      • 10 to < 13 years (male 1.2 mg/dL, female 1.2 mg/dL); 
      • 13 to < 16 years (male 1.5 mg/dL, female 1.4 mg/dL);
      • ≥ 16 years (male 1.7 mg/dL, female 1.4 mg/dL);
      • For patients < 1 month of age, serum creatinine levels must be < 1.5 x the treating institution's creatinine upper limit of normal (ULN) for patients < 1 month of age or the creatinine clearance or radioisotope GFR must be > 70 mL/min/1.73 m^2. 
    • Patients with solid tumors: 
      • Bilirubin (sum of conjugated + unconjugated) ≤ 1.5 x upper limit of normal (ULN) for age. After approval of the study chair or designee, infants with a higher total bilirubin due to physiologic or breast milk jaundice are eligible if the conjugated (direct) bilirubin is ≤ 2 mg/dL (within 7 days prior to enrollment). 
      • Serum glutamate pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) ≤ 135 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L (within 7 days prior to enrollment). 
      • Serum albumin ≥ 2 g/dL (within 7 days prior to enrollment). 
    • Patients with leukemias: 
      • Conjugated (direct) bilirubin ≤ 1.5 x upper limit of normal (ULN) for age (within 7 days prior to enrollment).
      • SGPT (ALT) ≤ 225 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L (within 7 days prior to enrollment).
      • Serum albumin ≥ 2 g/dL (within 7 days prior to enrollment). 
    • Patients with seizure disorder may be enrolled if on anticonvulsants and well controlled. 
    • Nervous system disorders (Common Terminology Criteria for Adverse Events [CTCAE] version [v] 5) except tendon reflex decreased resulting from prior therapy must be ≤ grade 2.


Exclusion Criteria:
 

  • Pregnant or breast-feeding women will not be entered on this study due to risks of fetal and teratogenic adverse events as seen in animal/human studies, OR because there is yet no available information regarding human fetal or teratogenic toxicities. Pregnancy tests must be obtained in girls who are post-menarchal. Patients of reproductive potential may not participate unless they have agreed to use an effective contraceptive method for the duration of study therapy. This criterion does not exclude infants who are breast fed. 
  • Patients with solid tumors, including CNS tumors, requiring corticosteroids who have not been on a stable or decreasing dose of corticosteroid for at least 7 days prior to enrollment are not eligible. Patients with leukemia may receive systemic corticosteroids for cytoreduction up to 24 hours prior to the start of protocol therapy. If used to modify immune adverse events related to prior therapy, ≥ 14 days must have elapsed since last dose of corticosteroid. 
  • Patients who are currently receiving another investigational drug are not eligible.
  • Patients who are currently receiving other anti-cancer agents are not eligible [except leukemia patients receiving corticosteroids or hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy].
  • Patients with leukemia should receive a single dose of intrathecal cytarabine, hydrocortisone, and/or methotrexate within 7 days prior to Day 1 of Cycle 1 at the time of the baseline lumbar puncture. 
  • Patients who are receiving cyclosporine, tacrolimus or other agents to prevent graft-versus-host disease post bone marrow transplant are not eligible for this trial. 
  • Patients currently receiving a strong CYP3A4 inducer or inhibitor are not eligible. Strong inducers or inhibitors of CYP3A4 should be avoided from 14 days prior to enrollment to the end of the study.
    • Note: CYP3A4 inducing anti-epileptic drugs and dexamethasone for CNS tumors or metastases, on a stable dose, are allowed.
  • Patients with malabsorption syndrome or other conditions that significantly limit enteral absorption are not eligible. 
  • Patients who are unable to swallow capsules or liquid and do not have gastric access via a nasogastric or gastrostomy tube are not eligible. 
  • Patients who have an uncontrolled infection are not eligible. 
  • Patients who have received prior solid organ transplantation are not eligible. 
  • Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study are not eligible.
  • Patients with high grade gliomas (HGG) are not eligible.
Drug, Administration of antineoplastic agent, Drug therapy
Cancer, Leukemia
Acute leukemia, Cancer treatment, Hematopoietic system, Larotrectinib [USAN:INN], Medical Oncology, Solid neoplasm with neurotrophic receptor tyrosine kinase gene fusion, Targeted drug therapy, larotrectinib
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Mayo Clinic — Rochester, MN

MS200647_0055: A Phase II/III, Multicenter, Randomized, Placebo-controlled Study of Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) as First-line Treatment of Biliary Tract Cancer

Gemcitabine Plus Cisplatin With or Without Bintrafusp Alfa (M7824) in Participants With 1L Biliary Tract Cancer (BTC)

Amit Mahipal
All
18 years and over
Phase 2/3
This study is NOT accepting healthy volunteers
0000-101188-P01-RST
19-012227
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Inclusion Criteria:

  • Are ≥ 18 (or ≥ 20 in Japan and Taiwan or age legally considered to be an adult) years of age at the time of signing the informed consent. In Japan, a participant aged < 20 years of age but ≥ 18 years of age may participate if written informed consent from his/her parent or guardian is provided in addition to the participant’s written informed consent.
  • Are participants with histologically or cytologically confirmed locally advanced or metastatic BTC, including intrahepatic CCA, extrahepatic CCA, gallbladder cancer, and ampulla of Vater’s cancer. The histological origin of ampullary carcinomas (intestinal, pancreaticobiliary, or other) will be collected.
  • Naïve to chemotherapy, immunotherapy, and interventional radiological treatment (transarterial chemo-embolization, transarterial embolization, transarterial infusion) for locally advanced or metastatic BTC. Participants whose disease has recurred ≥ 6 months after completion of neoadjuvant or adjuvant treatments will be considered eligible.
  • Availability of tumor tissue (primary or metastatic) (fresh or archival biopsies) before the first administration of study intervention. Availability of tumor tissue is mandatory except for the safety run-in part. Brush cytology and cell blocks are not acceptable. Tumor tissue (fresh or archival) must be suitable for biomarker assessment as described in the Laboratory Manual.
  • At least 1 measurable lesion according to RECIST 1.1. Participants in the safety run-in part do not require a measurable lesion at baseline.
  • ECOG PS of 0 or 1 at study entry and at Week 1, Day 1 prior to dosing.
  • Life expectancy of ≥ 12 weeks, as judged by the Investigator.
  •  Adequate hematological function defined by white blood cell count ≥ 2.0 × 10^9 /L with absolute neutrophil count ≥ 1.5 × 10^9 /L, lymphocyte count ≥ 0.5 × 10^9 /L, platelet count ≥ 100 × 10^9 /L, and hemoglobin (Hgb) ≥ 9 g/dL (participants may have been transfused) at study entry and at Week 1 Day 1 prior to dosing.
    • Previously transfused participants are allowed in the study with a stable Hgb of ≥ 9 g/dL at the time of study entry.
  • Adequate hepatic function defined by a total bilirubin level ≤ 1.5 × upper limit of normal (ULN), an aspartate aminotransferase level ≤ 3.0 × ULN, and an alanine aminotransferase level ≤ 3.0 × ULN. For participants with liver involvement, aspartate aminotransferase ≤ 5.0 × ULN and alanine aminotransferase ≤ 5.0 × ULN are acceptable.
  • Adequate renal function defined by an estimated creatinine clearance (CrCl) > 50 mL/min according to the Cockcroft-Gault formula or by measure of CrCl from 24-hour urine collection.
    • CrCl (mL/min) = (140-age) × weight (kg) / (72 × serum creatinine Cr[jaffe]);
    • If female, × 0.85 ;
    • If creatinine is measured by the enzymatic method, add 0.2 and use as Cr[jaffe] = 0.2 + Cr[enzyme].
  • Albumin ≥ 2.8 g/dL.
  • Adequate coagulation function defined as prothrombin time or international normalized ratio ≤ 1.5 × ULN unless the participant is receiving anticoagulant therapy.
  • Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive participants must be treated and on a stable dose of antivirals (e.g., entecavir, tenofovir, or lamivudine; adefovir or interferon is not allowed) at study entry and with planned monitoring and management including baseline HBV DNA quantity according to appropriate labeling guidance. Participants receiving active hepatitis C virus (HCV) therapy must be on a stable dose at study entry and with planned monitoring and management according to appropriate labeling guidance of approved antiviral.
  • Are male or female:
    • Male Participants Agree to the following during the intervention period and for at least 4 months after the last dose of study intervention (35 days corresponding to the time needed to eliminate any study interventions; e.g., 5 terminal half-lives plus 90 days for spermatogenic cycle):
      • Refrain from donating sperm PLUS, either:  Abstain from any activity that allows for exposure to ejaculate; OR
      • Use a male condom:  When having sexual intercourse with a woman of childbearing potential who is not currently pregnant, and advise her to use a highly effective contraceptive method with a failure rate of < 1% per year since a condom may break or leak;
      • When engaging in any activity that allows for exposure to ejaculate.
    • Female participants are not pregnant or breastfeeding and at least 1 of the following conditions applies: Not a woman of childbearing potential; OR
    • If a woman of childbearing potential, agree to use a highly effective contraceptive method (i.e., with a failure rate of < 1% per year), preferably with low user dependency for the following time periods: 
      Before the first dose of study intervention(s), if using hormonal contraception:
      • Has completed at least one 4-week cycle of an oral contraceptive pill and has either had or has begun her menses; OR
      • Has used a depot contraceptive or extended-cycle contraceptive for at least 28 days and has a documented negative pregnancy test using a highly sensitive assay;
      • During the intervention period;
      • After the study intervention period (i.e., after the last dose of study intervention is administered) for at least 65 days (time needed to eliminate any study interventions, eg, 5 terminal half-lives plus 30 days for a menstrual cycle), and as indicated in the respective label (Summary of Product Characteristics [SmPC]) for gemcitabine and cisplatin. Participants have to agree to the following:
        • Women of childbearing potential should refrain from donating eggs from the start of dosing until 2 months after discontinuing study intervention.
        • The Investigator evaluates the effectiveness of the contraceptive method in relationship to the first dose of study intervention.
      • Have a negative serum or highly sensitive urine pregnancy test, as required by local regulations, within 24 hours before the first dose of study intervention. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required.
      • The Investigator reviews the medical history, menstrual history, and recent sexual activity to decrease the risk for inclusion of a female with an early, undetected pregnancy.
  • Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the Informed Consent Form (ICF) and this protocol.


Exclusion Criteria:

  • Previous and/or intercurrent cancers. With the exception of: curatively-treated cancers with no recurrence in > 3 years or early cancers treated with curative intent, including but not limited to cervical carcinoma in situ, superficial, noninvasive bladder cancer, basal cell carcinoma, squamous cell carcinoma in situ, or endoscopically resected gastrointestinal cancers limited in mucosal layer.
  • Rapid clinical deterioration not related to malignancy which, in the opinion of the Investigator, may predispose to inability to tolerate treatment or study procedures at study entry and at Week 1 Day 1 prior to dosing.
  • Participants with symptomatic central nervous system (CNS) metastases are excluded. Participants with a history of treated CNS metastases (by surgery or radiation therapy) are not eligible unless they are judged to have fully recovered from treatment.
  • Receipt of any organ transplantation, including allogeneic stem-cell transplantation, but with the exception of transplants that do not require immunosuppression (e.g., corneal transplant, hair transplant).
  • Significant acute or chronic infections including:
    • Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (testing at Screening is not required). If an Investigator has a strong suspicion of HIV infection without known history for a participant in screening, but the participant refuses testing, discuss with Medical Monitor to assess eligibility.
      • Note: HIV testing is not mandated for study inclusion; however, if it is performed at any point in screening or while on study, a site must consent the participant for HIV testing as per local standard guidance.
      • Active tuberculosis (presence of clinical symptoms, physical or radiographic findings of active tuberculosis).
      • Uncontrolled biliary infection. Biliary tract obstruction should be released by stenting or percutaneous transhepatic biliary drainage (PTBD). Participants with biliary obstruction should have adequate biliary drainage with no evidence of ongoing infection without antibiotics treatment at the time of enrollment as well as on Cycle 1 Day 1.
      • Active bacterial, fungal, or viral infection (with the exception of hepatitis B and hepatitis C) requiring systemic therapy at study entry and at Week 1 prior to dosing.
  • Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent:
    • Participants with type 1 diabetes, vitiligo, alopecia, psoriasis, hypo- or hyperthyroid disease not requiring immunosuppressive treatment are eligible. 
    • Participants requiring hormone replacement with corticosteroids are eligible if the steroids are administered only for the purpose of hormonal replacement and at doses ≤ 10 mg of prednisone or equivalent per day.
    • Administration of steroids for other conditions through a route known to result in a minimal systemic exposure (topical, intranasal, intra-ocular, or inhalation) is acceptable.
  • History of, or concurrent, interstitial lung disease.
  • Known history of hypersensitivity reactions to bintrafusp alfa or its products or known severe hypersensitivity reactions to monoclonal antibodies (Grade ≥ 3 National Cancer Institute [NCI]-Common Terminology Criteria for Adverse Events [CTCAE] Version 5.0), any history of anaphylaxis, or recent (within 5 months) history of uncontrolled asthma.
  • Clinically significant cardiovascular/cerebrovascular disease as follows: cerebral vascular accident/stroke (< 6 months prior to enrollment), myocardial infarction (< 6 months prior to enrollment), unstable angina, congestive heart failure (New York Heart Association Classification ≥ Class II), or serious cardiac arrhythmia.
  • Other severe, acute, or chronic medical conditions, including immune colitis, inflammatory bowel disease, immune pneumonitis, or psychiatric conditions, including recent (within the past year) or active suicidal ideation or behavior. Participants with history of bleeding diathesis or recent major bleeding events considered by the Investigator as high risk for study intervention are also excluded.
  • Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization or precluding study therapy within 30 days before randomization.
  • Participants who are candidates for liver transplantation and who can receive the transplantation within a medically acceptable period.
  • Concurrent treatment with nonpermitted drugs. Participants who have completed prior adjuvant therapy > 6 months prior to randomization are eligible.
  • Prior therapy with any antibody/drug targeting T-cell coregulatory proteins (immune checkpoints), including but not limited to anti-PD-1, anti-PD-L1, anti-cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4) antibody, or anti-4-1BB antibody is not allowed, inclusive of localized administration of such agents.
  • Prior therapy with any antibody/drug targeting TGFβ/TGFβ receptor.
  • Radiation within 28 days other than focal palliative bone-directed radiotherapy.
  • Systemic therapy with immunosuppressive agents within 7 days before the start of study intervention; or use of any investigational drug within 28 days before the start of study intervention.
  • Live vaccine administration within 4 weeks of study intervention administration.
  • Unable to tolerate CT or magnetic resonance imaging (MRI) in the opinion of the Investigator and/or allergy to contrast material.

Other Exclusions:

  • Major surgery within 28 days before the start of study intervention (excluding prior diagnostic biopsy and stenting/PTBD for the purpose of releasing biliary tract obstruction).
  • Pregnancy or breastfeeding.
  • Known alcohol or drug abuse.
  • Legal incapacity or limited legal capacity.
Drug, Other, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Immunotherapy for cancer
Ampullary cancer, Cancer, Cholangiocarcinoma, Gallbladder cancer
1,2-Diaminocyclohexaneplatinum II citrate, Bintrafusp alfa, Biological therapy for cancer, Cancer treatment, Chemotherapy, Digestive system, Gemcitabine [USAN:INN:BAN], Medical Oncology, Primary cholangiocarcinoma of intrahepatic biliary tract, Primary malignant neoplasm of ampulla of Vater, Primary malignant neoplasm of extrahepatic bile duct, Primary malignant neoplasm of gallbladder, Secondary malignant neoplasm of biliary tract, cisplatin, gemcitabine
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2015LS095: Phase II Trial of Exemestane in Previously Treated Post-Menopausal Women With Advanced Non-Small Cell Lung Cancer

A Study to Evaluate Exemestane in Post-Menopausal Women with Non-Small Cell Lung Cancer (NSCLC)

Mina Hanna
Female
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-101198-P01-ALCL
19-008976
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Inclusion Criteria:

  • Recurrent or progressive advanced stage non-small cell lung cancer (no small cell component) with most recent treatment being an FDA approved immune checkpoint inhibitor (pembrolizumab, atezolizumab, or nivolumab).
    • NOTE: Pathology reports documenting the diagnosis of NSCLC are required to be reviewed to confirm outside diagnosis.
  • Sufficient tumor tissue available from original diagnosis or subsequent biopsy for analysis of estrogen receptor and aromatase.
  • Tumor block or a minimum of 5 unstained slides.
  • Failed at least 1 prior FDA approved treatment for advanced NSCLC. 
  • Measureable disease by RECIST version 1.1.
  • Post-menopausal defined as:
    • Age ≥ 55 years and 1 year or more of amenorrhea;
    •  Age < 55 years and 1 year or more of amenorrhea with an estradiol assay < 20 pg/mL;
    • Surgical menopause with bilateral oophorectomy.
  • ECOG performance status 0, 1 or 2.
  • Life expectancy of 3 months or more in the opinion of the enrolling investigator and documented in the medical record. 
  • Adequate organ function within 14 days of study enrollment defined as: 
  • Hematology:
    • Absolute neutrophil count (ANC) ≥ 1500/mm³;
    • Platelets ≥ 100,000/mm³;
    • Hemoglobin ≥ 8 g/dL.
  • Biochemistry: 
    • Total Bilirubin within normal institutional limits.
    • AST/SGOT and ALT/SGPT ≤ 2.5 x upper limit of normal (ULN), except if there is known hepatic metastasis, wherein transaminases may be ≤ 5 x institutional ULN.
    • Serum creatinine ≤ 1.5 mg/dl or glomerular filtration rate > 50 ml/min.
  • Must have recovered to CTCAE v 4 Grade 1 or better from the acute effects of any prior surgery, chemotherapy or radiation therapy. Chronic residual toxicity (i.e., peripheral neuropathy) is permitted. 
  • A minimum time period must elapse between the end of a previous treatment and start of study therapy: 
    • 1 week from the completion of radiation therapy for brain metastases;
    • 4 weeks from the completion of chemotherapy or any experimental therapy;
    • 4 weeks from prior major surgery (such as open biopsy or significant traumatic injury).
  • Voluntary written consent before any research related procedures or therapy.


Exclusion Criteria:

  • Known active CNS disease.
  • If patient has history of brain metastases, the brain lesions must have been treated with radiation and/or surgery.
  • Patients should be neurologically stable and requiring ≤ 10mg oral prednisone equivalence of steroids per day.
  • Any toxicity from immune-related toxicity from prior immune therapy that would preclude further treatment with anti-PD-1/PDL-1 inhibitor or ongoing IR toxicity ≥ Grade 2.
  • Requiring > 10 mg prednisone equivalence of steroids per day for immune-related toxicity.
  • Inability or unwilling to swallow study drug.
  • Any gastrointestinal condition causing malabsorption or obstruction (e.g., celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome).
  • Currently using hormone replacement therapy (oral or patch) or/and phytoestrogen supplements (i.e., black cohosh).
  • Known hypersensitivity to exemestane or its excipients.
  • Any serious underlying medical condition that, in the opinion of the enrolling physician, would impair the ability of the patient to receive protocol treatment.
  • Prior malignancy, with the exception of curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer, unless there is a 3-year disease-free interval.
  • Concomitant use of strong CYP3A4 inducers such as rifampicin, phenytoin, carbamazepine, phenobarbital, or St. John's wort as these may significantly reduce the availability of exemestane.
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Mayo Clinic Health System — Albert Lea, MN

2015LS095: Phase II Trial of Exemestane in Previously Treated Post-Menopausal Women With Advanced Non-Small Cell Lung Cancer

A Study to Evaluate Exemestane in Post-Menopausal Women with Non-Small Cell Lung Cancer (NSCLC)

Stephan Thome
Female
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-101198-P01-MAIJ
19-008976
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Inclusion Criteria:

  • Recurrent or progressive advanced stage non-small cell lung cancer (no small cell component) with most recent treatment being an FDA approved immune checkpoint inhibitor (pembrolizumab, atezolizumab, or nivolumab).
    • NOTE: Pathology reports documenting the diagnosis of NSCLC are required to be reviewed to confirm outside diagnosis.
  • Sufficient tumor tissue available from original diagnosis or subsequent biopsy for analysis of estrogen receptor and aromatase.
  • Tumor block or a minimum of 5 unstained slides.
  • Failed at least 1 prior FDA approved treatment for advanced NSCLC. 
  • Measureable disease by RECIST version 1.1.
  • Post-menopausal defined as:
    • Age ≥ 55 years and 1 year or more of amenorrhea;
    •  Age < 55 years and 1 year or more of amenorrhea with an estradiol assay < 20 pg/mL;
    • Surgical menopause with bilateral oophorectomy.
  • ECOG performance status 0, 1 or 2.
  • Life expectancy of 3 months or more in the opinion of the enrolling investigator and documented in the medical record. 
  • Adequate organ function within 14 days of study enrollment defined as: 
  • Hematology:
    • Absolute neutrophil count (ANC) ≥ 1500/mm³;
    • Platelets ≥ 100,000/mm³;
    • Hemoglobin ≥ 8 g/dL.
  • Biochemistry: 
    • Total Bilirubin within normal institutional limits.
    • AST/SGOT and ALT/SGPT ≤ 2.5 x upper limit of normal (ULN), except if there is known hepatic metastasis, wherein transaminases may be ≤ 5 x institutional ULN.
    • Serum creatinine ≤ 1.5 mg/dl or glomerular filtration rate > 50 ml/min.
  • Must have recovered to CTCAE v 4 Grade 1 or better from the acute effects of any prior surgery, chemotherapy or radiation therapy. Chronic residual toxicity (i.e., peripheral neuropathy) is permitted. 
  • A minimum time period must elapse between the end of a previous treatment and start of study therapy: 
    • 1 week from the completion of radiation therapy for brain metastases;
    • 4 weeks from the completion of chemotherapy or any experimental therapy;
    • 4 weeks from prior major surgery (such as open biopsy or significant traumatic injury).
  • Voluntary written consent before any research related procedures or therapy.


Exclusion Criteria:

  • Known active CNS disease.
  • If patient has history of brain metastases, the brain lesions must have been treated with radiation and/or surgery.
  • Patients should be neurologically stable and requiring ≤ 10mg oral prednisone equivalence of steroids per day.
  • Any toxicity from immune-related toxicity from prior immune therapy that would preclude further treatment with anti-PD-1/PDL-1 inhibitor or ongoing IR toxicity ≥ Grade 2.
  • Requiring > 10 mg prednisone equivalence of steroids per day for immune-related toxicity.
  • Inability or unwilling to swallow study drug.
  • Any gastrointestinal condition causing malabsorption or obstruction (e.g., celiac sprue, gastric bypass surgery, strictures, adhesions, history of small bowel resection, blind loop syndrome).
  • Currently using hormone replacement therapy (oral or patch) or/and phytoestrogen supplements (i.e., black cohosh).
  • Known hypersensitivity to exemestane or its excipients.
  • Any serious underlying medical condition that, in the opinion of the enrolling physician, would impair the ability of the patient to receive protocol treatment.
  • Prior malignancy, with the exception of curatively treated squamous cell or basal carcinoma of the skin or in situ cervical cancer, unless there is a 3-year disease-free interval.
  • Concomitant use of strong CYP3A4 inducers such as rifampicin, phenytoin, carbamazepine, phenobarbital, or St. John's wort as these may significantly reduce the availability of exemestane.
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Mayo Clinic Health System — Mankato, MN

EA4181, A Randomized 3-Arm Phase II Study Comparing 1.) Bendamustine, Rituximab and High Dose Cytarabine (BR/CR) 2.) Bendamustine, Rituximab, High Dose Cytarabine and Acalabrutinib (BR/CR-A), and 3.) Bendamustine, Rituximab and Acalabrutinib (BR-A) in Patients ≤ 70 Years Old With Untreated Mantle Cell Lymphoma

A Study to Compare Three Chemotherapy Regimens for the Treatment of Patients with Newly- diagnosed Mantle Cell Lymphoma

Jonas Paludo
All
18 years to 70 years old
Phase 2
This study is NOT accepting healthy volunteers
0000-101203-P01-RST
19-011161
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Inclusion Criteria:
 

  • Baseline measurements and evaluations must be obtained within 6 weeks of randomization to the study. Abnormal PET or CT scans may constitute evaluable disease. Patient must have at least one objective measurable disease parameter. Measurable disease in the liver is required if the liver is the only site of lymphoma. 
  • MIPI score must be calculated and entered in Oncology Patient Enrollment Network (OPEN). 
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. 
  • Patients must have untreated histologically confirmed mantle cell lymphoma, with cyclin D1 (BCL1) expression by immunohistochemical stains and/or t(11;14) by cytogenetics or fluorescent in situ hybridization (FISH). The diagnosis must be confirmed by formal hematopathology review at the enrolling center.
  • Patients being treated with gastric reducing agents proton pump inhibitors must be switched to an alternative drug before starting acalabrutinib. 
    • Absolute neutrophil count (ANC) ≥ 1,000/mcL (obtained with 14 days of randomization). If disease includes marrow involvement or hypersplenism, please reference the below revised ANC requirement: 
      • ANC ≥ 500/mcL. 
    • Platelets ≥ 75,000 mcL (obtained with 14 days of randomization). If disease includes involvement or hypersplenism, please reference the below revised platelet requirement: 
      • Platelets ≥ 25,000/mcL.
    • Total bilirubin ≤ 2 x institutional upper limit of normal (ULN) (obtained with 14 days of randomization). If disease includes hepatic infiltration or is causing biliary obstruction, or if elevated bilirubin is due to Gilbert's disease, please reference the below revised bilirubin requirements: 
      • Bilirubin ≤ 3 x institutional ULN.
    • Aspartate aminotransferase (AST) and alanine transaminase (ALT) ≤ 2.5 x institutional ULN (obtained with 14 days of randomization). If disease includes hepatic infiltration or is causing biliary obstruction, or if elevated bilirubin is due to Gilbert's disease, please reference the below revised AST/ALT requirements: 
      • AST/ALT ≤ 5 x institutional ULN.
  • Prothrombin time (PT)/international normalized ratio (INR) or partial thromboplastin time (aPTT) in the absence of lupus anticoagulant) < 2 x institutional ULN (obtained with 14 days of randomization).
  • Patients receiving anticoagulant therapy (other than warfarin or equivalent vitamin K antagonists which are excluded), higher INR/aPTT may be permitted to enroll to this study after discussion with the primary investigator (PI). 
  • Creatinine ≤ institutional ULN, OR glomerular filtration rate (GFR) ≥ 40 mL/min/1.73 m^2 (obtained with 14 days of randomization). 
  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. 
  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated. 
  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load. 
  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. 
  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional classification. To be eligible for this trial, patients should be class 2B or better. 
  • Patients must have a QT interval (QTc) ≤ 480 msec obtained within 14 days of randomization. 
  • Women must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. Patients must also not expect to conceive or father children from the time of registration, while on study treatment, and until 12 months after the last dose of study treatment. All females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy. A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: has achieved menarche at some point, has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months). 
  • Women of childbearing potential and sexually active males must agree to use accepted and effective method(s) of contraception or to abstain from sexual intercourse for the duration of their participation in the study and for 12 months after treatment ends. 


Exclusion Criteria:

  • Patients are not eligible if they require treatment with a strong cytochrome P450 (CYP) 3A inhibitor. 
  • Patients may not have received the following within 7 days prior to the first dose of study drug: 
    • Strong and moderate CYP3A inhibitors;
    • Strong and moderate CYP3A inducers.
  • Patients are ineligible if they have any of the following:
    • Malabsorption syndrome or disease significantly affecting gastrointestinal function;
    • Active bleeding or history of bleeding diathesis (e.g., hemophilia or von Willebrand disease);
    • Uncontrolled AIHA (autoimmune hemolytic anemia) or ITP (idiopathic thrombocytopenia purpura).;
    • Requires or receiving anticoagulation with warfarin or equivalent vitamin K antagonists (e.g., phenprocoumon) within 7 days of first dose of study drug;
    • History of significant cerebrovascular disease/event, including stroke or intracranial hemorrhage, within 6 months before the first dose of study drug;
    • Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infections at study enrollment (defined as exhibiting ongoing signs/symptoms related to the infection and without improvement, despite appropriate antibiotics or other treatment);
    • History of severe allergic reaction attributed to compounds of similar chemical or biologic composition to rituximab, bendamustine, cytarabine, or acalabrutinib. 
  • Patients must be able to fulfill one of the following eligibility requirements pertaining to biospecimen availability for submission following randomization: 
    • Archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen from the original diagnostic biopsy is available for submission; or
    • If tumor tissue is not available, peripheral blood collected prior to initiation of protocol therapy will be submitted.
      • NOTE: Biospecimens must be submitted within 60 days following randomization to Adaptive Biotechnologies for ClonoSEQ ID molecular marker identification of unique clonal immunoglobulin deoxyribonucleic acid (DNA) sequence. If peripheral blood will be submitted, Adaptive Biotechnologies should be contacted prior to patient randomization for guidance pertaining to collection and submission requirements.
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PDS0101-HNC-201: A Phase 2, Open-Label, Multi-Center Study of PDS0101 (R-DOTAP [Versamune] + HPVmix) and Pembrolizumab (KEYTRUDA®) Combination Immunotherapy in Subjects with Recurrent and/or Metastatic Head and Neck Cancer and High-Risk Human Papillomavirus-16 (HPV16) Infection (VERSATILE002)

A Study to Evaluate PDS0101 and Pembrolizumab Combination to Treat Subjects with HPV16 + Recurrent and/or Metastatic Head and Neck Squamous Cell Carcinoma

Katharine Price
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-101209-P01-RST
20-001688
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Inclusion Criteria:

  • The subject (or legally acceptable representative if applicable) provides written informed consent for the study.
  • Be ≥ 18 years of age on the day of signing the informed consent.
  • Checkpoint-naïve subjects: Have a history of histologically- confirmed diagnosis of squamous cell cancer of the head and neck (HNSCC) that is recurrent, metastatic, or persistent with:
    • Confirmed HPV16 infection;
    • Confirmed tumor PDL1 expression defined as a combined positive score (CPS) ≥ 1 using the FDA- approved Dako PD-L1 IHC 22C3 PharmDx Assay;
    • No prior receipt of any immunological therapy for metastatic disease.
  • Checkpoint experienced subjects have a history of histologically-confirmed diagnosis of HNSCC that is recurrent, metastatic, or persistent with:
    • Confirmed HPV16 infection;
    • Characterization of tumor PDL1 expression using the FDA-approved PD-L1 IHC 22C3 PharmDx Assay;
    • Receipt of prior treatment with checkpoint inhibitors as a single agent or in combination, and have received at least 2 doses of the agent or a minimum of 6 weeks on treatment;
    • Have documented clinical progression or recurrence that has been radiologically confirmed.
  • Have recurrent and/or metastatic measurable disease based on RECIST 1.1 as assessed by the local PI/radiology. There must be confirmation that the subject’s imaging shows at least 1 lesion that is appropriate for selection as a target.
  • Llesion per RECIST 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
  • Have adequate organ function as defined in:
  • Hematological:
    • ANC ≥ 1500/µL;
    • Platelets ≥100 000/µL; Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L;
  • Renal:
    • ​​​​​​​Creatinine ≤ 1.5 × ULN or >1.5 × institutional ULN;
  • Hepatic:
    • ​​​​​​​Total bilirubin ≤ 1.5 × ULN or direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 × ULN;
    • AST and ALT ≤ 2.5 ULN (5 × ULN for subjects with liver metastases);
  • Coagulation:
    • ​​​​​​​INR, PT or PTT 1.5 × ULN. S
    • Specimens must be collected within 10 days prior to the start of study combination treatment.
  • If subject received major surgery or radiation therapy of > 30 Gy, they must have recovered from the toxicity and/or complications from the intervention.
  • For female subjects defined as women of childbearing potential (WOCBP), a negative urine pregnancy test must be obtained during screening. Women who are surgically sterile or at least 2 years postmenopausal do not require pregnancy testing.​​​​​​​
    • Note: Female subjects of childbearing potential must be willing to use an effective method of contraception for the course of the study through 120 days after the last dose of study medication.
  • Male subjects of childbearing potential must agree to use an effective method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
  • Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.


Exclusion Criteria:

Subjects are excluded from study if any of the following criteria apply:

  • A female subject defined as a WOCBP who has a positive urine pregnancy test (within 72 hours) prior to treatment. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.
  • Has received prior therapy with an anti-PD-1, anti-PD- L1, or anti-PD-L2 agent with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX40, CD137) and was discontinued from that treatment due to a Grade 3 or higher adverse events (AE).
  • Has received prior systemic anticancer therapy including investigational agents within 30 days prior to treatment. Note: Subjects must have recovered from all AEs due to previous therapies to <Grade 1 or baseline. Subjects with
  • < Grade 2 neuropathy and < Grade 2 alopecia are an exception to this criterion and may qualify for therapy.
    • Note: If subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting treatment.
  • Coordination and timing of COVID-19 vaccination should be based on local Investigator clinical assessment and judgment.
    • Note: Whenever possible, it is recommended to avoid COVID vaccination on the day of PDS0101 and/or pembrolizumab dosing because it may be difficult to attribute certain AEs (e.g., fever, infusion reaction) to the study drug(s) or the COVID vaccine if they are both administered on the same day.
  • Has received prior radiotherapy within 2 weeks of start of study treatment. Subjects must have recovered from all- radiation-related toxicities, not require corticosteroids and not have had radiation pneumonitis. A 1-week washout is permitted for palliative radiation (< 2 weeks of radiotherapy) to non-CNS disease.
  • Has received a live vaccine within 30 days prior to the first dose of 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-Guerin (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.
  • Received immunotherapy/immunomodulatory or immunosuppressive agents (eg, IFNs, tumor necrosis factor, interleukins, immunoglobulins or other biological response modifiers [GM-CSF, granulocyte colony-stimulating factor, macrophage colony- stimulating factor]) within 6 weeks prior to administration of the first study combination treatment.
  • Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 30 days prior to the first dose of study treatment.
    • Note: Subjects who entered the follow-up phase of an investigational study may participate as long as it has been 30 days after the last dose of the previous investigational agent.
  • Has undergone prior allogeneic hematopoietic stem cell transplantation within the last 5 years. (Subjects who have had a transplant greater than 5 years ago are eligible as long as there are no symptoms of graft-versus-host disease [GVHD]).
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immuno-suppressive therapy within 7 days prior to the first dose of study drug. Current or recent use of physiologic doses of intra-articular, topical, or inhaled corticosteroids is acceptable.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
    • Note: Subjects with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) or other malignant tumors that have undergone potentially curative therapy are not excluded.
  • Has known active central nervous system (CNS) metastases and/or carcinomatosis meningitis. Subjects with previously treated brain metastases may participate provided they are radiologically stable, ie, without evidence of progression for at least 4 weeks by repeat imaging (note that repeat imaging should be performed during study screening clinical stable and without requirement of steroid treatment for at least 14 days prior to first dose of study treatment).
  • Has severe hypersensitivity (> Grade 3) to pembrolizumab and/or any of its excipients.
  • 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). Replacement therapy (e.g., thyroxine, insulin or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not consider a form of systemic treatment and is allowed.
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • Has an active infection requiring systemic therapy.
  • Subjects with known HIV and/or history of hepatitis B or C infections or known to be positive for hepatitis B antigen (HBsAg)/ hepatitis B virus (HBV) DNA or hepatitis C antibody or RNA. Active hepatitis C is defined by a known positive hepatitis C Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay.
  • Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject’s participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating Investigator.
  • Has a known psychiatric or substance abuse disorder that would interfere with the subject’s ability to cooperate with the requirements of the study.
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of any study treatment.
  • Has had an allogenic tissue/solid organ transplant.
  • Has received administration of colony-stimulating factors (including G-CSF, GM-CSF or recombinant erythropoietin) within 30 days prior to Day 1.
  • Has a history of interstitial lung disease.
  • Female subjects defined as WOCBP unwilling or unable to use highly effective contraception method(s) for the duration of the study:
    • Combined hormonal contraception;
    • Progestogen-only hormonal contraception;
    • Intrauterine device;
    • Intrauterine hormone-releasing system;
    • Bilateral tubal occlusion;
    • Vasectomized partner.
  • Any prior Grade ≥ 3 immune-related adverse event (irAE) while receiving any previous checkpoint inhibitor or immunotherapy agent, or any unresolved irAE > Grade 1 except for endocrine AEs managed with replacement therapy.
  • Developed immune-related toxicity while on prior checkpoint inhibitor therapy that has not yet returned to
  • Grade 1 or better.

Eligibility last updated 9/1/21. Questions regarding updates should be directed to the study team contact.

 

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A Multicenter, Pivotal Phase 3 Study of Iomab-B Prior to Allogeneic Hematopoietic Cell Transplantation Versus Conventional Care in Older Subjects With Active, Relapsed or Refractory Acute Myeloid Leukemia (SIERRA)

Study of Iomab-B Prior to HCT vs. Conventional Care in Older Subjects With Active, Relapsed or Refractory AML

Mark Litzow
All
55 years and over
Phase 3
This study is NOT accepting healthy volunteers
0000-101210-P01-RST
16-001301
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Inclusion Criteria:

  • Have active, relapsed or refractory AML. Active, relapsed or refractory AML is defined as any one of the following:
    • primary induction failure (PIF) after 2 or more cycles of therapy; or
    • first early relapse after a remission duration of fewer than 6 months; or
    • relapse refractory to salvage combination therapy; or
    • second or subsequent relapse (Schmid, 2006).
  • Have documented CD45 expression by leukemic cells via flow cytometry (a “blast gate” on CD45 vs. side scatter analysis consist.nt with AML);
  • Be ≥ 55 years of age.
  • Have a circulating blast count of less than 10,000/mm^3 (control with hydroxyurea is allowed).
  • Have a calculated creatinine clearance (Cockroft-Gault equation) > 50 mL/min.
  • Have adequate hepatic function (direct bilirubin, aspartate aminotransferase (AST), and alanine aminotransferase (ALT), defined as ≤ 2 times the upper limit of normal [ULN]).
  • Have a Karnofsky score ≥ 70.
  • Have an expected survival of > 60 days.
  • Have a central venous catheter line in place prior to study treatment administration.
  • Have 8/8 allele-level, related or unrelated, HSC donor matching at human leukocyte antigen (HLA)-A, HLA-B, HLA-C, and DRB1 with a donor who is medically cleared.
  • Syngeneic donors that meet these criteria are allowed.
  • Women of childbearing potential, be surgically sterile or agree to practice abstinence or utilize acceptable contraception (intrauterine, injectable, transdermal, or combination oral contraceptive) through 1-year post transplant; Males who are sexually active with women of childbearing potential must be surgically sterile or using an acceptable method of contraception (defined as barrier methods in conjunction with spermicides) from time of screening through 12 weeks after last dose of study drug.
  • Be able to understand the study procedures, agree to participate in the study program, and voluntarily provide written Informed Consent.

Exclusion Criteria

  • Have circulating HAMA noted on initial screening.
  • Have received prior radiation to maximally tolerated levels to any critical normal organ.
  • Have active leukemic central nervous system (CNS) involvement, as defined by any leukemic blasts detected in the cerebrospinal fluid (CSF) by morphology or flow cytometry and/or any chloromas detected by CNS imaging.
  • Have previously received a HCT (includes both allogeneic and autologous HCT).
  • Clinically significant cardiac disease (NYHA Class III or IV); clinically significant arrhythmia; i.e., ventricular tachycardia, ventricular fibrillation, or “Torsade de Pointes”. Myocardial infarction with uncontrolled angina within 6 months, congestive heart failure, or clinically significant cardiomyopathy.
  • Have abnormal QTcF (> 450 milliseconds) after electrolytes have been corrected (at least two different ECG readings and at least 15 minutes between readings). Subjects with paced rhythm or prolonged QTcF may be exempt from this exclusion if considered eligible for transplant per treating physician clinical judgment, with optional cardiology consultation.
  • Have current or prior positive test results for human immunodeficiency virus (HIV) or hepatitis B (HBV) or C. Subjects who have positive HBV test results due to having been previously vaccinated against hepatitis B, as evidenced by negative hepatitis B surface antigen (HBsAg), negative anti- hepatitis B core protein (HBc) and positive antibody to the HBsAg (anti-HBs) are not excluded; Subjects who have positive hepatitis test results with adequate organ function as defined in the protocol are not excluded.
  • Have active serious infection uncontrolled by antibiotics or antifungals.
  • Have acute promyelocytic leukemia and the associated cytogenetic translocation t(15;17).
  • Have active malignancy within 2 years of entry. Active malignancy is defined as those malignancies requiring treatment with anti-cancer therapy or in the event of indolent malignancies, having measurable disease.  Exceptions to this exclusion include:
    • myelodysplastic syndrome;
    • treated non-melanoma skin cancer;
    • completely resected Stage 0 or 1 melanoma no less than 1 year from resection;
    • carcinoma in situ or cervical intraepithelial neoplasia;
    • successfully treated organ-confined prostate cancer with no evidence of progressive disease based on prostate specific antigen (PSA) levels and are not on active therapy;
  • Have a perceived inability to tolerate diagnostic or therapeutic procedures, particularly treatment in radiation isolation.
  • Currently receiving any other active investigational agents.

 

Drug, Procedure/Surgery, Administration of antineoplastic agent, Allogeneic peripheral blood stem cell transplant, Drug therapy, Immunosuppressive therapy for transplant
Acute myelogenous leukemia, Cancer, Leukemia, Recurrent cancer
Acute myeloid leukemia, disease, Allogeneic stem cell transplant, Bone marrow transplant, Cancer treatment, Hematopoietic system, Medical Oncology, Myeloid leukemia in relapse, Therapy related acute myeloid leukemia due to and following administration of antineoplastic agent
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10183: A Pilot Study of Tazemetostat and MK-3475 (Pembrolizumab) in Advanced Urothelial Carcinoma

A Study to Evaluate Tazemetostat and Pembrolizumab to Treat Advanced Urothelial Carcinoma

Brian Costello
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
0000-101223-P01-RST
19-011951
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Inclusion Criteria:

  • Patients in Arm A may begin treatment after this registration.
  • Patients in Arm B will be required to undergo a second registration by meeting PD-L1  eligibility criteria. A tissue sample must be submitted for central analysis of PD-L1  after eligibility are confirmed.
  • Patients must have pathologically confirmed urothelial carcinoma.
    • Note: patients with mixed histology (with predominant urothelial carcinoma) are eligible.
  • Patients must have locally advanced or metastatic disease with either:
  • Arm A:  Disease progression during or following (within 12 months) platinum-based chemotherapy (cisplatin or carboplatin).
    • Note: no minimum number of cycles on platinum-based chemotherapy are required.
  • Patients who have had multiple rounds of platinum-based  chemotherapy with events of intermittent progressive disease (PD) are eligible as long as progression has been confirmed while on or within 12 months from platinum based therapy OR
  • Arm B:  Cisplatin ineligible as defined.
  • Patients in Arm B must also: 
    • Undergo central analysis of tissue for PD-L1 status; Be positive for PD-L1; 
    • If archival tissue is unavailable or insufficient for PD-L1 central analysis, a new biopsy must be performed;
    • Alternatively, patients who previously have had PD-L1 testing performed as standard of care via the Food and Drug Administration (FDA)-approved Dako PD-L1 immunohistochemistry (IHC) 22C3 PharmDx Assay companion diagnostic test and who have a combined positive score (CPS) of >= 10 may be eligible. In these cases, PD-L1 testing does not need to be repeated, and tissue does not need to be sent for central analysis.
  • All patients must have measurable disease in accordance with RECIST criteria version  (v) 1.1.
    • Note: radiological evaluation should occur within 28 days prior to study registration.
  • Patients must be naive to prior PD-L1 or EZH2 inhibitors.
    • Note: patients in Arm A should have received platinum-based chemotherapy only.  
  • Patients ≥ 18 years of age.
  • ECOG performance status ≤ 2.
  • Patients must have a blood smear or manual differential performed at screening showing  no significant morpholic abnormalities on complete blood count (CBC) testing.  
  • Leukocytes ≥ 3000/mcL (performed within 14 days prior to registration).  
  • Absolute neutrophil count (ANC) ≥ 1500/mcL (performed within 14 days prior to  registration).
  • Platelets ≥ 100 000/mcL (performed within 14 days prior to registration).
  • Hemoglobin ≥ 9 g/dL or ≥ 4.9 mmol/L (performed within 14 days prior to registration).
  • Creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine  clearance (CrCl) ≥ 30 mL/min for patient with creatinine levels > 1.5 x institutional  ULN (performed within 14 days prior to registration).
  • Creatinine clearance (CrCl) should be calculated per institutional standard.  
  • Glomerular filtration rate (GFR) can also be used in place of creatinine or CrCl. 
  • Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for patients with total  bilirubin levels > 1.5 x ULN (performed within 14 days prior to registration).
  • Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT]) and  alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) ≤ 2.5 x  ULN OR ≤ 5 x ULN for patients with liver metastases (performed within 14 days prior  to registration).
  • International normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 x ULN unless patient is receiving anticoagulant therapy as long as PT or partial thromboplastin  time (PTT) is within therapeutic range of intended use of anticoagulants (performed  within 14 days prior to registration)  
  • Activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless patient is receiving  anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants (performed within 14 days prior to registration).
  • The effects of MK-3475 and tazemetostat on the developing human fetus are unknown. For  this reason and because PD-1 inhibitors as well as EZH2 inhibitors are known to be  teratogenic, women of child-bearing potential and men must agree to use adequate  contraception (hormonal or barrier method of birth control; abstinence) prior to study  entry and for the duration of study participation. 
  • Female patients of childbearing potential must have a negative urine or serum pregnancy test 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.
  • Female patients of childbearing potential must be willing to use an adequate method of 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 patient. 
  • Male patients of childbearing potential must agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.
    • Note: abstinence is acceptable if this is the usual lifestyle and preferred contraception for the patient.
  • Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of MK-3475 or tazemetostat administration.
  • Participants who have the ability to understand and the willingness to sign an  Institutional Review Board (IRB) approved written informed consent document are  eligible OR Participants with impaired decision-making capacity (IDMC) who have a  legally authorized representative (LAR) or caregiver are eligible.  


Exclusion Criteria:
 

  • Patients with disease that is suitable for local therapy administered with curative intent are not eligible.
  • Patients who have had chemotherapy, targeted small molecule therapy, or radiotherapy  within 4 weeks prior to entering the study are not eligible.
  • Patients who have not recovered from adverse events due to prior anti-cancer therapy  (i.e., have residual toxicities > grade 1 per Common Terminology Criteria for Adverse Events [CTCAE] v.5 ) are not eligible.
    • Note: patients with ≤ grade 2 neuropathy or ≤ grade 2 alopecia or ≤ grade 3 audiometric hearing loss are an exception to this criterion and may qualify for the study.
    • Note: if patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
  • Patients are not eligible who are currently participating and receiving study therapy  or have participated in a study of an investigational agent and received study therapy or used an investigational device within 4 weeks of the first dose of treatment.
  • Patients who have received transfusion of blood products (including platelets or red  blood cells) or administration of colony stimulating factors (including granulocyte  colony-stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor  [GM-CSF], or recombinant erythropoietin) within 4 weeks prior to the first dose of  treatment are not eligible.
  • Patients with a diagnosis of immunodeficiency or are receiving systemic steroid  therapy or any other form of immunosuppressive therapy within 7 days prior to the  first dose of trial treatment are not eligible.  
    • Note: the use of physiologic doses of corticosteroids may be approved after consultation with the study principal investigator (PI).
  • Patients with thrombocytopenia, neutropenia, or anemia of grade 3 (per CTCAE 5.0 criteria) or any prior history of myeloid malignancies, including myelodysplastic  syndrome (MDS) are not eligible. 
  • Patients with abnormalities known to be associated with MDS (e.g., del 5q, chr 7 abn)  and myeloproliferative neoplasms (MPN, e.g. JAK2 V617F) observed in cytogenetic  testing and deoxyribonucleic acid (DNA) sequencing are not eligible.
  • Patients with a prior history of T-cell lymphoblastic lymphoma (T-LBL) or T-cell acute  lymphoblastic leukemia (T-ALL) are not eligible.
  • Patients who have received prior PD-L1/PD-1/PD-L2 or EZH2 inhibitor therapy are not eligible.
  • Patients who have had a prior monoclonal antibody within 4 weeks prior to study day 1 are not eligible.
  • Patients with a known additional malignancy that is progressing or requires active  treatment are not eligible. Exceptions include basal cell carcinoma of the skin,  squamous cell carcinoma of the skin that has undergone potentially curative therapy,  or in situ cervical cancer.
  • Patients with known brain metastases or carcinomatous meningitis are excluded from  this clinical trial because of their poor prognosis and because they often develop  progressive neurologic dysfunction that would confound the evaluation of neurologic  and other adverse events.  
    • Note: patients with previously treated brain metastases may participate provided they are stable (without evidence of progression by imaging using the identical imaging modality for each assessment, either magnetic resonance imaging [MRI] or computed tomography [CT] scan, for at least 4 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.
  • Patients with a history of allergic reactions attributed to compounds of similar  chemical or biologic composition to MK-3475 or tazemetostat are not eligible.
  • Patients with 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) are not eligible.
    • Note: replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.
    • Patients with a history of (non-infectious) pneumonitis that required steroids or  current pneumonitis are not eligible.
  • Patients with a prolongation of corrected QT interval (Fridericia's correction formula  [QTcF]) of > 450 msec are not eligible.
  • Patients with major surgery within 3 weeks before the first dose of study drugs.  
    • Note: minor surgery (e.g., minor biopsy of an extracranial site, central venous catheter placement, shunt revision) has no restriction.
  • Patients must not have a history or current evidence of any condition, therapy, or  laboratory abnormality that might confound the results of the trial, interfere with  the patient's participation for the full duration of the trial, or is not in the best  interest of the patient to participate, in the opinion of the treating investigator.
  • Patients receiving any medications or substances that are strong inhibitors or  inducers of CYP3A =< 14 days prior to study treatment are not eligible .
    • Note: The study team should check a frequently-updated medical reference for a list of drugs to avoid or minimize use of. As part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product.
  • Patients who are unable to take oral medication OR have malabsorption syndrome or any  other uncontrolled gastrointestinal condition (e.g., nausea, diarrhea, vomiting) that  might impair the bioavailability of tazemetostat are not eligible.
  • Patients with uncontrolled intercurrent illness including, but not limited to, ongoing  or active infection, interstitial lung disease or active, non-infectious pneumonitis,  symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia,  uncontrolled arterial hypertension, stroke within 6 months prior to starting study  treatment, or psychiatric illness/social situations that would limit compliance with  study requirements are not eligible.
  • Pregnant women are excluded from this study because MK-3475 and tazemetostat are  agents with the potential for teratogenic or abortifacient effects. Because there is  an unknown but potential risk for adverse events in nursing infants secondary to  treatment of the mother with MK-3475 and tazemetostat, breastfeeding should be  discontinued if the mother is treated with MK-3475 or tazemetostat.
  • MK-3475 may have adverse effects on a fetus in utero. Furthermore, it is not known if MK-3475 has transient adverse effects on the composition of sperm. Patients are excluded from this study if pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 120 days after the last dose of trial treatment.
  • Patients who are human immunodeficiency virus (HIV) positive may participate IF they  meet the following eligibility requirements:
    • They must be stable on their anti-retroviral regimen, and they must be healthy from an HIV perspective;
    • They must have a CD4 count of greater than 250 cells/mcL; 
    • They must not be receiving prophylactic therapy for an opportunistic infection.
  • Patients with a known history of hepatitis B (defined as hepatitis B surface antigen  [HBsAg] reactive) or known hepatitis C virus (defined as HCV ribonucleic acid [RNA]  [qualitative] is detected) infection are not eligible   -Note: no testing for hepatitis B and hepatitis C is required unless mandated by local health authority.
  • Patients who have received a live vaccine within 30 days of planned treatment start  are not eligible.
    • Note: seasonal flu vaccines that do not contain live virus are permitted.

PD-L1 ELIGIBILITY (ARM B ONLY):

  • Patients in Arm B must have positive PD-L1 status as confirmed by central analysis  prior to second step registration and treatment initiation.
    • Note: positive PD-L1 expression is defined as a combined positive score (CPS) ≥ 10 and will be confirmed in a report from HistoGeneX.  Alternatively, patients who previously have had PD-L1 testing performed as standard of care via the FDA-approved Dako PD-L1 IHC 22C3 PharmDx Assay companion diagnostic test and who have a combined positive score (CPS) of ≥ 10 may be eligible. In these cases, PD-L1 testing does not need to be repeated, and tissue does not need to be sent for central analysis.
Biologic/Vaccine, Drug
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ASTX727-06: An Open-Label, Multicenter, Extension Study for Subjects Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)

A Study for Subjects Who Participated in Prior Clinical Studies of ASTX727 (Standard Dose)

Aref Al-Kali
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-101227-P01-RST
19-012633
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Inclusion Criteria:

  • Adult patients, 18 years or older.
  • Previous participation in an Astex-sponsored ASTX727 clinical trial (including, but not limited to studies ASTX727-01, ASTX727-02, and ASTX727-04) in which the subject was treated with ASTX727 and was still on active treatment with ASTX727 at the time of study completion as determined by Astex. 
  • Subject is considered to be benefitting from ASTX727 treatment in the opinion of the treating investigator at the time of parent study completion (subjects must not be withdrawn from the parent study until eligibility for this study is confirmed). 
  • Subject is able to understand and comply with the study procedures and understands the risks involved in the study. 
  • Subject provides written informed consent before undergoing any study-specific procedure.
  • Women of childbearing potential must not be pregnant or breastfeeding and must have a negative pregnancy test at screening. Women of childbearing potential must agree to practice 2 highly effective contraceptive methods of birth control and must agree not to become pregnant for 6 months after completing treatment; men with female partners of childbearing potential must agree to practice 2 highly effective contraceptive measures and must agree not to father a child while receiving ASTX727 and for at least 3 months after completing ASTX727 treatment.


Exclusion Criteria:

  • Any subject who, in the opinion of the investigator, may have other conditions, organ dysfunction, or for whom safety data from parent study participation suggests the risks of continuing treatment with ASTX727 may outweigh the benefits.
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A Prospective Study of Heated Intra-peritoneal Chemotherapy (H.I.P.E.C.) with Doxorubicin and Cisplatin in Pediatric Patients with Pelvic and Abdominal Tumors: The T.O.A.S.T. I.T. Trial (Trial Of Adjuvant Surgical Treatment with Intraperitoneal chemoTherapy)

A Study of Heated Intra-peritoneal Chemotherapy (H.I.P.E.C.) with Doxorubicin and Cisplatin in Pediatric Patients with Pelvic and Abdominal Rhabdomyosarcoma

Patricio Gargollo
All
1 years to 25 years old
Early Phase 1
This study is NOT accepting healthy volunteers
0000-101239-P01-RST
18-010108
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Inclusion Criteria:

  • Patients must have resectable, primary refractory or recurrent intra-abdominal or pelvic tumors based on imaging studies with measurable disease (≥ 1 cm in 2 perpendicular planes), or primary tumor with peritoneal implants in whom no known other curative treatment exists, and/or patients not on up-front clinical trial.
  • PCI ≤ 20 and surgeons deem high likelihood of complete R0 resection.
  • No evidence of distant metastases at the time of enrollment.
  • Patients must be 1-25 years of age at the time of entry into the study.
  • Patients may be included in the study independent of the regimen of previous surgical, radiation, or chemotherapy treatments administered.
  • Given the increased risk of entero-cutaneous fistulae observed in patients treated with HIPEC AFTER radiation therapy, patients may be excluded based on the assessment of risk by our radiation oncology team.
  • Karnofsky / Lansky Performance Score of ≥ 40 or ECOG Performance score of 3 or less.
  • Laboratory studies should be performed no later than 14 days before surgery:
    • Platelet count ≥ 50,000 (independent of transfusion);
    • Prothrombin and Partial Thromboplastin Times ≤ 1.2 xnormal;
    • Total bilirubin, SGOT, SGPT, LDH, alkaline phosphatase ≤ 2 x normal;
    • Neutrophil count ≥ 750.
  • Patients must have adequate renal function defined as creatinine clearance or radioisotope GFR (glomerular filtration rate) ≥ 70mL/min/1.73m^2 or a serum creatinine based on age/gender less than the following values: 1 to < 2 years 0.6mg/dL for both males and females, 2 to < 6 years 0.8mg/dL for both males and females, 6 to < 10 years 1.0mg/dL for both males and females.
  • A signed informed consent form (and assent form when appropriate) approved by the Mayo Clinic (IRB) will be required for patient enrollment into the study.
  • Patients must be able to read and understand the informed consent document and must sign the informed consent indicating that they are aware of the investigational nature of this study.


Exclusion Criteria:

  • Pregnancy.
  • Females who are pregnant or breast-feeding during the study period will be excluded.
  • Distant metastatic disease not limited to peritoneum:
    • Solid organ metastases (liver, central nervous system, lung);
    • Known bone marrow involvement.
  • No critical cumulative dose of previous chemotherapy (total anthracycline dose not ≥ 435 mg / m2).
  • Prior HIPEC within 3 months.
  • Patients with an active infection requiring treatment or having an unexplained febrile illness (Tmax > 99.5 F).
  • Patients with known immune deficiency disorder or known human immunodeficiency virus infection.
  • Patients must not have any systemic illness which precludes them from being an operative candidate as determined by anesthesia preoperative evaluation. This includes, but is not limited to, sepsis, liver failure, renal failure, cardiovascular failure, pulmonary failure.
  • Subjects deemed unable to comply with study and/or follow-up procedures.
  • Subjects with a known hypersensitivity to protocol systemic chemotherapy that was life-threatening, required hospitalization or prolongation of existing hospitalization, or resulted in persistent or significant disability or incapacitation.
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SGNTGT-001: A Phase 1 Study of SEA-TGT (SGN-TGT) in Subjects With Advanced Malignancies

A Safety Study of SEA-TGT (SGN-TGT) in Patients With Advanced Cancer

Stephen Ansell
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-101243-P01-RST
20-002632
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Monotherapy Inclusion Criteria (Parts A and B)

- Histologically- or cytologically-confirmed advanced or metastatic malignancy, defined
as:

- One of the following tumor types:

- Unresectable locally-advanced or metastatic non-small cell lung cancer
(NSCLC), gastric/gastroesophageal (GE) junction carcinoma, cutaneous
melanoma, head and neck squamous cell carcinoma (HNSCC), bladder cancer,
cervical cancer, ovarian cancer, or triple negative breast cancer (TNBC)

- Lymphomas, including:

- Classical Hodgkin lymphoma (cHL)

- Diffuse large B-cell lymphoma (DLBCL)

- Peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS)

- Lymphoma: Participants should have disease progression on or after treatment
with standard therapies expected to provide benefit in the judgement of the
investigator.

- cHL: Participants must have received at least 3 prior systemic
therapies. Participants should have had disease recurrence or
progression following brentuximab vedotin therapy or have been
ineligible to receive brentuximab vedotin. Participants who have not
received autologous stem cell transplant (SCT) must have refused or
been deemed ineligible. Participants should have received or not be
eligible to have received an anti-PD-1 agent.

- DLBCL: Participants must have received at least 2 prior systemic
chemo-immunotherapy regimens, including an anti-CD20 agent and
combination chemotherapy. Unless clinically contraindicated,
participants should have had disease that has relapsed after or be
refractory to intensive salvage chemotherapy, including autologous SCT.

- PTCL-NOS: Participants must have had at least 1 prior systemic therapy.
Participants must have received or have been ineligible to receive the
combination of cyclophosphamide, doxorubicin, vincristine, and
prednisone (CHOP) or CHOP-like therapy. Participants with CD30-positive
disease must have received or be ineligible to receive brentuximab
vedotin. Participants must have also received intensive salvage therapy
(defined as combination chemotherapy ± autologous SCT) unless they
refused or were deemed ineligible.

- Measurable disease defined as:

- Solid tumors: Measurable disease according to RECIST V1.1

- Lymphomas: Fluorodeoxyglucose (FDG)-avid disease by positron emission tomography
(PET) and measurable disease of ≥15 mm in the greatest transverse diameter by
computed tomography (CT) scan, as assessed by the site radiologist.

- A representative archival tumor tissue sample should be available as follows:
Participants must provide archived tumor tissue, if available, from the most recent
biopsy (≤12 months from screening). If archived tissue is not available, a fresh
baseline tumor biopsy will be requested for any participant enrolled in Part B whose
tumors are considered accessible and appropriate in the opinion of the investigator.

- ECOG Performance Status score of 0 or 1

Combination Inclusion Criteria (Part C)

- ECOG Performance Status score of 0 or 1

- NSCLC: histological or cytological confirmed metastatic disease. Participants must
have received no prior anti-PD-1/PD-L1 therapy allowed.

- HNSCC: histological or cytological confirmed metastatic disease. Participants must
have received no prior exposure to anti-PD-1/PD-L1 therapy.

- Cutaneous Melanoma: histological or cytological confirmed metastatic disease.
Participants must not have received anti-PD-1/PD-L1 targeted therapy.

- Measurable disease by CT or magnetic resonance imaging (MRI) as defined by RECIST V1.1

- Participants must provide archived tumor tissue, if available, from the most recent
biopsy (≤12 months from screening). If archived tissue is not available, a fresh
screening tumor biopsy will be requested for any participant whose tumors are
considered accessible and appropriate in the opinion of the investigator.

Monotherapy Exclusion Criteria (Parts A and B)

- History of another malignancy within 2 years before the first dose of study drug, or
any evidence of residual disease from a previously diagnosed malignancy. Exceptions
are malignancies with a negligible risk of metastasis or death.

- Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment that has not
been completed before the first dose of study drug within the timeframe as follows:

- Chemotherapy, small molecule inhibitors, radiation, and/or other investigational
anticancer agents (excluding investigational monoclonal antibodies): 2 weeks

- Palliative radiotherapy (≤2 weeks of radiotherapy to non-central nervous
system [CNS] disease): ≤7 days prior to start of SEA-TGT

- Immune-checkpoint inhibitors: 4 weeks

- Monoclonal antibodies, antibody-drug conjugates, or radioimmunoconjugates: 4
weeks (2 weeks with documented disease progression)

- T-cell or other cell-based therapies: 12 weeks

- Known CNS metastases

- Participants with a history of CNS metastases are allowed if they have undergone
treatment for the CNS disease, symptoms have resolved, and steroids have been
discontinued.

- Leptomeningeal involvement by malignant disease is excluded regardless of prior
treatment.

- Previous allogeneic SCT. Participants with prior autologous SCT may be eligible if
they are >100 days from autologous SCT and fulfill all other inclusion criteria.

- Prior use of any anti-TIGIT mAb.

- Participants with a condition requiring systemic treatment with either corticosteroids
(>10 mg daily prednisone or equivalent) or other immunosuppressive medications within
14 days of enrollment. Inhaled or topical steroids and adrenal replacement steroid
doses >10 mg daily prednisone or equivalents are permitted in the absence of active
immune disease.

- Known hypersensitivity to any excipient contained in the drug formulation of SEA-TGT

Combination Exclusion Criteria (Part C)

- History of another malignancy within 2 years before the first dose of study drug, or
any evidence of residual disease from a previously diagnosed malignancy. Exceptions
are malignancies with a negligible risk of metastasis or death.

- Active, non-infectious pneumonitis, pulmonary fibrosis, or known history of immune
mediated pneumonitis.

- Previous therapy with an anti-PD-1 or anti-PD-L1 inhibitor.

- Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment that has not
been completed before the first dose of study drug within the timeframe as follows:

- Chemotherapy, small molecule inhibitors, radiation, and/or other investigational
anticancer agents (excluding investigational monoclonal antibodies): 2 weeks

- Palliative radiotherapy (≤2 weeks of radiotherapy to non-CNS disease): ≤7
days prior to start of SEA-TGT.

- Immune-checkpoint inhibitors: 4 weeks

- Monoclonal antibodies, antibody-drug conjugates, or radioimmunoconjugates: 4
weeks (2 weeks with documented disease progression)

- T-cell or other cell-based therapies: 12 weeks

- Known active CNS metastases.

- Participants with a history of CNS metastases are allowed if they have undergone
treatment for the CNS disease, symptoms have resolved, and steroids have been
discontinued.

- Leptomeningeal involvement by malignant disease is excluded regardless of prior
treatment.

- Known hypersensitivity to any excipient contained in the drug formulation of SEA-TGT
or sasanlimab

- Participants with active known or suspected autoimmune disease or significant
autoimmune-related toxicity from prior immuno-oncology-based therapy (prior autoimmune
colitis, pneumonitis, transaminitis); Participants with vitiligo, controlled type 1
diabetes mellitus, residual hypothyroidism requiring hormone replacement, or
conditions not expected to recur in the absence of an external trigger are permitted
to enroll.

- History of interstitial lung disease

- Participants with a condition requiring systemic treatment with either corticosteroids
(>10 mg daily prednisone or equivalent) or other immunosuppressive medications within
14 days of enrollment. Inhaled or topical steroids and adrenal replacement steroid
doses >10 mg daily prednisone or equivalents are permitted in the absence of active
immune disease.

- Prior use of any anti-TIGIT mAb

Administration of antineoplastic agent, Drug therapy, Drug, Biologic/Vaccine
Cancer, Diffuse large b-cell lymphoma, Hodgkin lymphoma, Lung cancer, Lymphoma, Non-Hodgkin's lymphoma, Non-small cell lung cancer, Stomach cancer
Cancer treatment, Classical Hodgkin lymphoma, Diffuse non-Hodgkin's lymphoma, large cell (clinical), Digestive system, Hematopoietic system, Local recurrence of malignant tumor of lung, Local recurrence of malignant tumor of stomach, Medical Oncology, Metastatic non-small cell lung cancer, Peripheral T-cell lymphoma (clinical), Respiratory system, Secondary malignant neoplasm of stomach, Tumor surgically unresectable
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Accelerated Resolution Therapy for Cancer Related Trauma and Distress: A Pilot Study

A Study to Assess Accelerated Resolution Therapy for Cancer Related Trauma and Distress

Cindy Tofthagen
All
18 years and over
Not Applicable
This study is NOT accepting healthy volunteers
0000-101254-P01-RST
19-006093
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Inclusion Criteria:

  • 18 years of age or older.
  • Able to read, write and understand English.
  • Undergoing chemotherapy, radiation therapy, CAR-T, or bone marrow transplant for a cancer diagnosis within the previous 3 years or have metastatic cancer.
  • A mean score of at least 1.1 on the Cancer and Treatment Distress (CTxD) or at least one item rated at a 3 (often true) or 4 (nearly all the time).
  • A minimum score of 3 on the PC-PTSD-5.
  • Denial of suicidal ideation or intent, with no evidence of psychotic behavior.
  • Participants must be willing and able to travel to Mayo Clinic outside of normally scheduled visits to participate in the study.


Exclusion Criteria:

  • Individuals under 18 years of age.
Other, Cancer emotional and psychosocial support and education, Chemotherapy, Immunotherapy for cancer, Mental health care, Radiation oncology AND/OR radiotherapy, Trauma therapy
Cancer
Anxiety about body function or health, Anxiety about treatment, Biological therapy for cancer, Bone marrow transplant, Bone marrow transplant present, Cancer treatment, Chemotherapy, Distress, Malignant neoplastic disease, Medical Oncology, Psychotherapy, Radiation therapy, Secondary malignant neoplastic disease, Victim of psychological trauma
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Feasibility of Transanal Robot-assisted Resection of Distal Colorectal Lesions Using the Medrobotics Flex® System: A Pilot Study

A Study to Determine the Feasibility of Transanal Robot-assisted Resection of Distal Colorectal Lesions Using the Medrobotics Flex? System

Louis Wong Kee Song
All
22 years to 99 years old
Feasibility
This study is NOT accepting healthy volunteers
0000-101255-P01-RST
19-009663
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Inclusion Criteria:

  • Age > 22 years (minimum age approved for use).
  • Polypoid (0-Is) and non-polypoid (0-IIa, 0-IIb and 0-IIc) lateral spreading lesions according to Paris classification.
  • Colorectal lesions situated between 5 and 15 cm from the dentate line.
  • Colorectal mucosal lesions ranging from 1.5 to 7 cm in maximum diameter.
  • Colorectal subepithelial lesions < 2 cm in size.
  • Absence of uncorrectable bleeding disorder or coagulopathy (platelet count > 50,000 and INR < 1.5).
  • Ability to give informed consent.


Exclusion Criteria:

  • Inability to receive general anesthesia.
  • Presence of medical conditions for which a transanal approach is contraindicated (e.g., anal stricture, radiation proctopathy).
  • Excavated (0-III) colorectal lesions according to Paris classification.
  • Suboptimal colon preparation.
  • Clinical discretion of the provider.

 

Device
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AuTophagy Activation for Cardiomyopathy Due to Anthracycline tReatment (ATACAR) Trial

A Study to Evaluate AuTophagy Activation for Cardiomyopathy Due to Anthracycline tReatment

Joerg Herrmann
All
18 years and over
Phase 2
This study is NOT accepting healthy volunteers
0000-101256-P01-RST
19-007547
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Inclusion criteria:

- ≥ 18 years of age,

- New diagnosis of reduced cardiac function

- Prior anthracycline-based cancer therapy for lymphoma

Exclusion criteria:

- History of HF of any class and type, or diagnosis of cardiomyopathy prior to
anthracycline therapy

- On active therapy with a fibrate, niacin, or eplerenone

- History of myopathy/rhabdomyolysis

- History of statin intolerance

- Active hyperlipidemia

- History of gout

- Active liver disease

- Unexplained persistent elevations of serum transaminases

- Pregnancy

- Breast-feeding

- Hyperkalemia

- Addison disease

- eGFR <30 mL/minute/1.73 m^2

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

Eligibility last updated 12/8/22. Questions regarding updates should be directed to the study team contact.

Drug, Drug therapy
Cancer, Cardiomyopathy, Lymphoma
Cancer treatment, Cardiac complication of procedure, Cardiomyopathy associated with another disorder, Cardiovascular system, Carvedilol, Chemotherapy, Hematopoietic system, Lisinopril, Malignant lymphoma, Malignant lymphoma (clinical), Medical Oncology, Pravastatin [INN:BAN], Spironolactone, carvedilol, lisinopril, pravastatin, spironolactone
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A Prospective Pilot Study Evaluating the Feasibility of Daily, Long-Term Intermittent Fasting for Men on PSA Surveillance Following Radical Prostatectomy for Localized, High-Risk Prostate Cancer

A Study to Evaluate the Feasibility of Daily, Long-Term, Intermittent Fasting for Men on PSA Surveillance Following Radical Prostatectomy

Robert Karnes
Male
18 years and over
Early Phase 1
This study is NOT accepting healthy volunteers
0000-101266-P01-RST
19-006675
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Inclusion Criteria:

  • Biopsy-proven histological diagnosis of localized prostate cancer (pT2 or specimen confined pT3).
  • Having undergone radical prostatectomy (open or laparoscopic) with bilateral pelvic lymph node dissection.
  • Negative surgical margins on final specimen.
  • Men that decline adjuvant therapy.
  • Detectable serum PSA of 0.1 ng/mL or >.
  • 24 months or less since radical prostatectomy at time of study screening.


Exclusion Criteria:

  • Unable or unwilling to provide informed consent.
  • Treated prior to surgery with any form of hormone, antiandrogen, or androgen deprivation therapy.
  • Treated prior to surgery with any form of chemotherapy or radiotherapy.
  • Medical conditions/history that precludes subjects from following a fasting regimen including, but not limited to:
    • Diabetes Mellitus.
  • On hormone therapy (Casodex, GnRH agonist/antagonist).

 

 

Behavioral, Active surveillance of prostate cancer, Dietary regime, Modification of schedule of oral intake, Pelvic lymphadenectomy, Radical prostatectomy
Cancer, Prostate cancer
Active surveillance for prostate cancer, Cancer treatment, Local recurrence of malignant tumor of prostate, Lymphadenectomy, Malignant tumor of prostate, Medical Oncology, PSA test, Prostatectomy, Reproductive system
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“Prescribing” Exercise to Cancer Patients at Risk for Falls

A Study to Evaluate Exercise for Cancer Patients at Risk of Falling

Aminah Jatoi
All
18 years to 99 years old
ERROR
This study is NOT accepting healthy volunteers
0000-101267-P01-RST
19-007775
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Inclusion Criteria:

  • 18 years of age or older at registration.
  • Any cancer type, as documented in the clinical record, other than non-melanoma skin cancer.
  • No issues (such as ongoing unstable angina or loss of a limb) that would preclude exercise.


Exclusion Criteria:

  • Younger than 18 years of age at registration.
Other, Exercise therapy, Fall prevention
Acute lymphocytic leukemia, Acute myelogenous leukemia, Aplastic anemia, Bladder cancer, Bone cancer, Brain tumor, Breast cancer, Cancer, Carcinoid tumor, Cervical cancer, Cholangiocarcinoma, Chronic lymphocytic leukemia, Chronic myelogenous leukemia, Chronic myelomonocytic leukemia, Colon cancer, Dysproteinemia, Endometrial cancer, Esophageal cancer, Essential thrombocythemia, Gallbladder cancer, Germ cell tumor, Hairy cell leukemia, Head and neck cancer, Hodgkin lymphoma, Hypereosinophilic syndrome, Immune thrombocytopenia, Kidney cancer, Large cell lung cancer, Large granular lymphocyte disorders, Leukemia, Liver cancer, Lung cancer, Lymphoma, Melanoma, Mesothelioma, Monoclonal gammopathy of undetermined significance, Multiple myeloma, Myelodysplastic syndromes, Myelofibrosis, Non-Hodgkin's lymphoma, Non-small cell lung cancer, Ovarian cancer, Pancreatic cancer, Pancreatic neuroendocrine tumor, Paroxysmal nocturnal hemoglobinuria, Polycythemia vera, Prostate cancer, Rectal cancer, Sarcoma, Skin cancer, Small bowel cancer, Small cell lung cancer, Soft tissue sarcoma, Squamous cell lung cancer, Stomach cancer, Systemic mastocytosis, Testicular cancer, Vaginal cancer, Vulvar cancer, Waldenstrom macroglobulinemia, Metastatic melanoma, Stage 4 melanoma
Nervous system, Acute lymphoid leukemia, Acute myeloid leukemia, disease, Aplastic anemia, At risk for falls, Cancer rehabilitation, Cancer treatment, Chronic myeloid leukemia, Chronic myelomonocytic leukemia, Digestive system, Essential thrombocythemia, Hairy cell leukemia (clinical), Hematopoietic system, Hemolytic anemia, Hodgkin's disease (clinical), Hypereosinophilic syndrome, Idiopathic thrombocytopenic purpura, Integumentary system, Large cell carcinoma of lung, Large granular lymphocytic leukemia, Malignant carcinoid tumor, Malignant melanoma, Malignant mesothelioma of pleura, Malignant neoplasm of brain, Malignant neoplasm of central nervous system, Malignant neoplasm of colon and/or rectum, Malignant neoplasm of endometrium of corpus uteri, Malignant neoplasm of liver, Malignant neoplasm of thorax, Malignant tumor of Islets of Langerhans, Malignant tumor of biliary tract, Malignant tumor of breast, Malignant tumor of cervix, Malignant tumor of esophagus, Malignant tumor of gallbladder, Malignant tumor of head and neck, Malignant tumor of kidney, Malignant tumor of lung, Malignant tumor of pancreas, Malignant tumor of prostate, Malignant tumor of rectum, Malignant tumor of small intestine, Malignant tumor of stomach, Malignant tumor of testis, Malignant tumor of urinary bladder, Malignant tumor of vagina, Malignant tumor of vulva, Medical Oncology, Monoclonal gammopathy of uncertain significance, Multiple myeloma, Musculoskeletal system, Myelodysplastic syndrome, Myelosclerosis with myeloid metaplasia, Non-Hodgkin's lymphoma (clinical), Non-small cell lung cancer, Paroxysmal nocturnal hemoglobinuria, Polycythemia vera (clinical), Primary malignant germ cell neoplasm, Pure red cell aplasia, Reproductive system, Respiratory system, Sarcoma of bone, Sarcoma of soft tissue, Secondary malignant neoplasm of female breast, Small cell carcinoma of lung, Squamous cell carcinoma of lung, Systemic mast cell disease, Urinary system, Waldenström macroglobulinemia, Exercise training
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Wound Infiltration with Liposomal Bupivacaine with or without Intrathecal Analgesia in Laparotomy for Gynecological Malignancy: A Randomized Controlled Trial

A Study to Evaluate Wound Infiltration with Liposomal Bupivacaine in Laparotomy for Gynecological Malignancy

Sean Dowdy
Female
18 years to 80 years old
Not Applicable
This study is NOT accepting healthy volunteers
0000-101270-P01-RST
19-010500
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Inclusion Criteria:

  • Age > 18 and ≤ 80 years old.
  • Elective surgery for suspected (based on consulting surgeon’s opinion
    •imaging, lab, path) gynecological malignancy, ERAS protocol.


Exclusion Criteria:

  • Inability to read or understand English.
  • Prehospitalization narcotic use if weekly average daily oral morphine equivalent of > 20 mg.
  • Chronic pain syndromes such as fibromyalgia.
  • Extensive surgery planned (surrogate for postop pain):
    • Planned ICU admission, abdominoperineal resection, exenteration, use of IORT, HIPEC.
  • Contraindication to neuraxial analgesia:
    • Coagulopathy:
      • INR >1.2 Current or predicted after surgery (e.g., planned right hepatic resection);
      • Thrombocytopenia (plts < 100);
      • Hemophiliac disease states (hemophilia, von Willebrand disease, etc.);
      • Patients receiving antithrombotic or thrombolytic therapy are excluded according to the ASRA guidelines (Reference: https://rapm.bmj.com/content/rapm/43/3/263.full.pdf).
    • Localized infection at the potential site of injection.
    • Significant developmental or structural spinal abnormalities that would preclude a safe spinal technique. These include spina bifida, tethered spinal cord, lumbar spinal fusion, and active lumbar radiculopathy.
  • Patients with stage 4 or 5 kidney disease (GFR less than 30 ml/min per 1.73 m^2).
  • Intolerance or allergy to opioids, acetaminophen, or amide-type local anesthetics.
  • Current pregnancy.
Drug
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Moderately Hypofractionated Photon and Proton Chemoradiotherapy as Definitive or Neoadjuvant Therapy in Non-metastatic Pancreatic Cancer with Assessment of Treatment Response Utilizing Molecular Biomarkers (ROR1741)

A Study of Photon and Proton Chemoradiotherapy as Definitive or Neoadjuvant Therapy in Non-Metastatic Pancreatic Cancer

Kenneth Merrell
All
18 years and over
This study is NOT accepting healthy volunteers
0000-101273-P01-RST
17-011198
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Inclusion Criteria:

  • Age ≥ 18 years.
  • Histological confirmation of adenocarcinoma of the pancreas (head, body, or tail of pancreas).
  • Imaging consistent with T1-4, N0-2,  M0 pancreas cancer, including potentially resectable, borderline resectable, or unresectable disease as per NCCN classification. When CT of the chest, abdomen, and pelvis are performed, this must be with contast per pancreas protocol. Imaging with a PET/MRI alone is acceptable on study. If a PET/CT is performed, a separate pancreas protocol CT is required for inclusion.
    • *Note: Imaging must be done prior to initiation of radiotherapy and does not need to be completed at time of enrollment.
  • Must have received neoadjuvant chemotherapy at the discretion of medical oncology.
  • Medical oncology consultation to confirm that patient is an appropriate candidate for concurrent chemotherapy, and surgical oncology consultation for confirmation of resection status.
    • Note: Consultation must be completed prior to initiation of radiotherapy and does not need to be completed at time of enrollment.
  • Patients who have received previous chemotherapy for pancreatic cancer are allowed to participate in this study, unless they experienced a previous allergic reaction to the drugs used in this study.
  • Planned to receive CRT, consisting of PBT or IMRT (45 Gy/15 fractions) with concurrent chemotherapy with 5 FU or Capecitabine.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1 or Karnofsky Performance Status 70-100. 
  • Willing to sign consent onto the Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking study, IRB 15-000136*.
    • *Patients do not need to agree to Biobank blood draw. 
  • Able to complete standard of care clinical questionnaire(s) by themselves or with assistance.


Exclusion Criteria:

  • Presence of non-regional nodal involvement or distant metastatic disease (M1).
  • Prior radiotherapy resulting in overlap of radiation treatment fields.
  • History of prior malignancy < 2 years of enrollment, except non-melanotic skin cancer or carcinoma-in-situ of the cervix.
  • Immunocompromised patients and patients known to be HIV positive and not currently receiving antiretroviral therapy. 
    • Note: Patients known to be HIV positive, but without clinical evidence of an immunocompromised state, are eligible for this trial.
  • Receiving any investigational agent concurrent with CRT which would be considered as a treatment for the primary neoplasm.
  • 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 or psychiatric 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.        
  • 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.

 

Cancer, Pancreatic cancer
Adenocarcinoma of pancreas, Cancer treatment, Chemotherapy, Digestive system, IMRT, Medical Oncology, Proton therapy, Radiation therapy
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A Study of MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue

An Extension Study MRI/US Fusion Imaging and Biopsy in Combination With Nanoparticle Directed Focal Therapy for Ablation of Prostate Tissue

Lance Mynderse
Male
45 years and over
Feasibility
This study is NOT accepting healthy volunteers
0000-101275-P01-RST
19-011495
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Inclusion Criteria:
-Patients must have documented histological or cytological evidence of tumor(s) of the prostate. -Patients must be ≥ 45 years of age -Patients or their legal representative must be able to read, understand and sign an informed consent -Organ confined clinical T1C or clinical T2a prostate cancer that is visualized on MR imaging -Prostate cancer is diagnosed by MR image guided biopsies -Gleason Score ≤ 7; and 2 or less positive lesions on prior MR US fusion guided prostate biopsy. -A non MRI visible cancer detected via systematic standard biopsy will not be considered an exclusion condition provided the non-MRI visible cancer is singularly located in the contralateral hemisphere of the prostate; is Gleason 6 cancer; and comprises no more than 6mm linear extent of cancer in a single core on standard biopsy. -If any standard biopsy cores are positive on the same hemisphere of the prostate gland, they must be confirmed as likely to form a contiguous lesion with the target lesion detected on MRI and therefore be from the same location in the prostate as MR lesion was biopsied and proven to be cancerous. (e.g., Left/Right, Base, Mid Gland, Apex). -Prior mpMRI results dated within 120 days prior to ablation. -No metastatic disease as per NCCN guidelines (www.nccn.org)
•Bone scan indicated to r/o metastatic disease if clinical T1 and PSA > 20 or T2 and PSA > 10 -PSA < 15 ng/ml or PSA density < 0.15 ng/ml2 in patients with a PSA > 15 ng/ml -The patient has given written informed consent after the nature of the study and alternative treatment options have been explained.
Exclusion Criteria:
-Patients with known hypersensitivity to any of the components of the PEGylated AuroShell suspension (polyethylene glycol, gold). -Patients who are receiving concurrent investigational therapy or who have received investigational therapy within a period of 5 half-lives of the investigational therapy in questions prior to the day of dosing with PEGylated AuroShell particles (investigational therapy is defined as treatment for which there is currently no regulatory authority approved indication) -Patients with evidence of an active bacterial infection or with a fever ≥ 38.5 ºC (101.3 ºF) within 3 days of the first scheduled day of dosing -Any other medical condition, including mental illness or substance abuse, deemed by the Investigator to be likely to interfere with a patient's ability to sign informed consent, cooperate and participate in the study, or interfere with the interpretation of the results. -The presence of 3 or more MR Visible lesions positive on biopsy. -The presence of extra capsular, seminal vesicle invasion or metastatic disease. -Patient is unable to tolerate MRI (foreign body; i.e. pacemaker or other implanted device; claustrophobia; inability to tolerate rectal coil, etc.…) -Patient with inability to follow up. -History of prior treatment for prostate cancer. -Acute urinary tract infection. -Lower urinary tract symptoms defined by International Prostate symptom score (IPSS) > 20 -Patients with renal insufficiency with an estimated glomerular filtration (EGF) <= 30 are excluded, as they will not be able to undergo gadolinium enhance MRI. -Patients with acute or chronic hepatic dysfunction as evidenced by clinically important (> grade 1) changes in AST, ALT, bilirubin, or albumin, or either ALP or GGT values. -Patients with uncontrolled coagulopathies who are at increased risk of bleeding, or with abnormal PT (INR) or PTT. -Altered mental status preventing consent or answering questions during conduct of the trial will be excluded for safety purposes. -Other medical or surgical conditions, especially involving the cardiac, respiratory, renal or hepatic organ systems that would either be unsafe for the patient, would limit study participation, or that would impede the determination of causality of any adverse events experienced during the conduct of this study.
Laser ablation of prostate, MRI guided high intensity focused ultrasound ablation of thalamus, Device
Cancer, Prostate cancer
Ablation, Cancer treatment, Malignant tumor of prostate, Medical Oncology, Prostate biopsy, Reproductive system
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AALL1731, A Phase 3 Trial Investigating Blinatumomab (IND# 117467, NSC# 765986) in Combination with Chemotherapy in Patients with Newly Diagnosed Standard Risk or Down Syndrome B Lymphoblastic Leukemia (B-ALL) and the Treatment of Patients with Localized B-Lymphoblastic Lymphoma (B-LLy) (AALL1731)

A Study to Determine the Outcomes of Patients With Localized B Cell Lymphoblastic Lymphoma (B-LLy) When Treated With Standard Risk B-ALL Therapy

Asmaa Ferdjallah
All
365 days to 31 years old
Phase 3
This study is NOT accepting healthy volunteers
0000-101280-P01-RST
19-009277
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Inclusion Criteria:


- All B-ALL patients must be enrolled on APEC14B1 and consented to Eligibility Screening
(Part A) prior to treatment and enrollment on AALL1731. APEC 14B1 is not a requirement
for B-LLy patients. B-LLy patients may directly enroll on AALL1731.

- Age at diagnosis:

- Patients must be >= 365 days and < 10 years of age (B-ALL patients without DS).

- Patients must be >= 365 days and =< 31 years of age (B-ALL patients with DS).

- Patients must be >= 365 days and =< 31 years of age (B-LLy patients with or
without DS).

- B-ALL patients without DS must have an initial white blood cell count < 50,000/uL
(performed within 7 days prior to enrollment).

- B-ALL patients with DS are eligible regardless of the presenting white blood cell
count (WBC) (performed within 7 days prior to enrollment).

- Patient has newly diagnosed B-cell ALL, with or without Down syndrome: > 25% blasts on
a bone marrow (BM) aspirate;

- OR if a BM aspirate is not obtained or is not diagnostic of B-ALL, the diagnosis
can be established by a pathologic diagnosis of B-ALL on a BM biopsy;

- OR a complete blood count (CBC) documenting the presence of at least 1,000/uL
circulating leukemic cells;

- OR patient has newly diagnosed B-cell LLy Murphy stages I or II, with or without
Down syndrome.

- Note: For B-LLy patients with tissue available for flow cytometry, the criterion
for diagnosis should be analogous to B-ALL. For tissue processed by other means
(i.e., paraffin blocks), the methodology and criteria for immunophenotypic
analysis to establish the diagnosis of B-LLy defined by the submitting
institution will be accepted (diagnostic biopsy for B-LLy must be performed
within 14 days prior to enrollment).

- All institutional, Food and Drug Administration (FDA), and National Cancer Institute
(NCI) requirements for human studies must be met.

- All patients and/or their parents or legal guardians must sign a written informed
consent.


Exclusion Criteria:


- Patient must not have secondary ALL that developed after treatment of a prior
malignancy with cytotoxic chemotherapy. Note: patients with Down syndrome with a prior
history of transient myeloproliferative disease (TMD) are not considered to have had a
prior malignancy. They would therefore be eligible whether or not the TMD was treated
with cytarabine.

- With the exception of steroid pretreatment or the administration of intrathecal
cytarabine, patients must not have received any prior cytotoxic chemotherapy for
either the current diagnosis of B ALL or B LLy or for any cancer diagnosed prior to
initiation of protocol therapy on AALL1731.

- For patients receiving steroid pretreatment, the following additional exclusion
criteria apply:

- Non-DS B-ALL patients must not have received steroids for more than 24 hours in
the 2 weeks prior to diagnosis without a CBC obtained within 3 days prior to
initiation of the steroids.

- DS and non-DS B-LLy patients must not have received > 48 hours of oral or IV
steroids within 4 weeks of diagnosis.

- Patients who have received > 72 hours of hydroxyurea within 1 week (7 days) prior to
the start of systemic protocol therapy.

- B-ALL patients who do not have sufficient diagnostic bone marrow submitted for
APEC14B1 diagnostic testing and who do not have a peripheral blood sample submitted
containing > 1,000/uL circulating leukemia cells.

- Patient must not have acute undifferentiated leukemia (AUL).

- Non-DS B-ALL patients with central nervous system [CNS]3 leukemia (CNS status must be
known prior to enrollment).

- Note: DS patients with CNS3 disease are eligible but will be assigned to the
DS-High B-ALL arm. CNS status must be determined based on a sample obtained prior
to administration of any systemic or intrathecal chemotherapy, except for steroid
pretreatment.

- Non-DS B-ALL patients with testicular leukemia. (Note: DS patients with testicular
disease are eligible but will be assigned to the DS-High B-ALL arm).

- For LLy patients, the following additional exclusion criteria apply:

- T-Lymphoblastic Lymphoma.

- Morphologically unclassifiable lymphoma.

- Absence of both B-cell and T-cell phenotype markers in a case submitted as
lymphoblastic lymphoma.

- CNS positive disease or testicular involvement.

- M2 (5%
•25% blasts) or M3 (> 25% blasts) marrow.

- Patients with known Charcot-Marie-Tooth disease.

- Patients with known MYC translocation associated with mature (Burkitt) B-cell ALL,
regardless of blast immunophenotype.

- Patients requiring radiation at diagnosis.

- Female patients who are pregnant since fetal toxicities and teratogenic effects have
been noted for several of the study drugs. A pregnancy test is required for female
patients of childbearing potential.

- Lactating females who plan to breastfeed their infants.

- Sexually active patients of reproductive potential who have not agreed to use an
effective contraceptive method for the duration of their study participation.

Biologic/Vaccine, Drug, Administration of antineoplastic agent, Chemotherapy, Drug therapy, Immunotherapy for cancer
Acute lymphocytic leukemia, Cancer, Leukemia, Lymphoma, Non-Hodgkin's lymphoma
B-cell acute lymphoblastic leukemia, Biological therapy for cancer, Cancer treatment, Chemotherapy, Hematopoietic system, Medical Oncology
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ACNS1723, A Phase 2 Study of Dabrafenib (NSC# 763760) with Trametinib (NSC# 763093) after Local Irradiation in Newly-Diagnosed BRAFV600-Mutant High-Grade Glioma (HGG) (IND# 145355) (ACNS1723)

Dabrafenib Combined With Trametinib After Radiation Therapy in Treating Patients With Newly-Diagnosed High-Grade Glioma

Jonathan Schwartz
All
3 years to 21 years old
Phase 2
This study is NOT accepting healthy volunteers
0000-101282-P01-RST
19-010786
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Inclusion Criteria:

  • All clinical and laboratory studies to determine eligibility must be performed within 7 days prior to enrollment unless otherwise indicated.
  • Laboratory values used to assess eligibility must be no older than 7 days at the start of therapy.
  • Laboratory tests need not be repeated if therapy starts within 7 days of obtaining labs to assess eligibility.
  • If a post-enrollment lab value is outside the limits of eligibility, or laboratory values are > 7 days old, then laboratory evaluations must be re-checked within 48 hours prior to initiating therapy. If the recheck is outside the limits of eligibility, the patient may not receive protocol therapy and will be considered off protocol therapy.
  • A pre- and post-operative brain MRI with and without contrast, and a baseline spine MRI with contrast, must be obtained prior to enrollment. The requirement for post-operative MRI is waived for patients who undergo biopsy only.
  • Patients must be ≥ 3 years and ≤ 21 years of age at the time of enrollment.
  • Patients must have eligibility confirmed by Rapid Central Pathology and Molecular Screening Reviews performed on APEC14B1:
    • Newly diagnosed high-grade glioma with BRAFV600-mutation;
    • Positive or negative results for H3 K27M by immunohistochemistry (IHC)
    • Histologically confirmed high-grade glioma (WHO Grade III or IV) including but not limited to: anaplastic astrocytoma (AA), anaplastic pleomorphic xanthoastrocytoma (aPXA), anaplastic gangliogliomas (aGG), glioblastoma (GB), and high-grade astrocytoma, NOS.
  • Patients must have had histologic verification of a high-grade glioma diagnosis. CSF cytology by lumbar puncture must be done if clinically indicated and determined to be safe prior to study enrollment. If cytology proves positive, the patient would be considered to have metastatic disease and would, therefore, be ineligible.
  • A pre- and post-operative brain MRI with and without contrast and a baseline spine MRI with contrast must be obtained prior to enrollment. The requirement for a post-operative MRI is waived for patients who undergo biopsy only. If the spine MRI is positive, the patient would be considered to have metastatic disease and would be ineligible.
  • Patients must have a performance status corresponding to ECOG scores of 0, 1, or 2. Use Karnofsky for patients > 16 years of age and Lansky for patients ≤ 16 years of age. See https://www.cogmembers.org/site/pages/default.aspx?page=Prot_reference_materials under Standard Sections for Protocols.
  • Adequate Bone Marrow Function defined as:
    • Peripheral absolute neutrophil count (ANC) ≥ 1000/µL;
    • Platelet count ≥ 100,000/µL (transfusion independent);
    • Hemoglobin ≥ 8.0 g/dL (may receive RBC transfusions).
  • Adequate Renal Function defined as:
    • Creatinine clearance or radioisotope GFR ≥ 70 mL/min/1.73 m^2; or
    • A serum creatinine based on age/gender as follows:
    • 3 to < 6 years | Male 0.8 | Female 0.8;
    • 6 to < 10 years | Male 1.0 | Female 1.0;
    • 10 to < 13 years | Male 1.2 | Female 1.2;
    • 13 to < 16 years | Male 1.5 | Female 1.4;
    • ≥ 16 years | Male 1.7 | Female 1.4.
    • The threshold creatinine values in this Table were derived from the Schwartz formula for estimating GFR32 utilizing child length and stature data published by the CDC.
    • Adequate Liver Function defined as:
      • Total bilirubin ≤ 1.5 x upper limit of normal (ULN) for age; and
      • SGPT (ALT) ≤ 135 U/L. For the purpose of this study, the ULN for SGPT is 45 U/L.
  • Central Nervous System Function defined as:
    • Patients with a seizure disorder may be enrolled if their seizures are well controlled while on non-enzyme inducing anticonvulsants permitted on this study.
  • Patients must be enrolled and protocol therapy must be projected to begin no later than 31 days after definitive surgery (Day 0). If a biopsy only was performed, the biopsy date will be considered the date of definitive surgery. For patients who have a biopsy or incomplete resection at diagnosis followed by additional surgery, the date of the last resection will be considered the date of definitive surgery.


Exclusion Criteria:

  • Patients with intrinsic brainstem or primary spinal cord tumors will be excluded.
  • Patients with metastatic disease (defined as neuraxis dissemination either by imaging or by cytology) will be excluded.
  • Patients must not have received any prior tumor-directed therapy including chemotherapy, radiation therapy, immunotherapy, or bone marrow transplant for the treatment of HGG other than surgical intervention and/or corticosteroids.
  • Previous treatment with dabrafenib or another RAF inhibitor, trametinib or another MEK inhibitor, or an ERK inhibitor.
  • Patients with a history of a malignancy with confirmed activating RAS mutation.
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to dabrafenib, trametinib, and their excipients.
  • Uncontrolled medical conditions (e.g., diabetes mellitus, hypertension, liver disease, or uncontrolled infection), psychological, familial, sociological, or geographical conditions that do not permit compliance with the protocol; or unwillingness or inability to follow the procedures required in the protocol.
  • Presence of active gastrointestinal (GI) disease or other condition (e.g., small bowel or large bowel resection) that will interfere significantly with the absorption of drugs.
  • History of Hepatitis B Virus, or Hepatitis C Virus infection (patients with laboratory evidence of cleared Hepatitis B Virus and/or Hepatitis C Virus may be enrolled).
  • History or current diagnosis of cardiac disease indicating significant risk of safety for patients participating in the study such as uncontrolled or significant cardiac disease, including any of the following:
    • Recent myocardial infarction (within the last 6 months);
    • Uncontrolled congestive heart failure;
    • Unstable angina (within last 6 months);
    • Clinically significant (symptomatic) or known, uncontrolled cardiac arrhythmias (e.g., sustained ventricular tachycardia, and clinically significant second or third degree AV block without a pacemaker) except sinus arrhythmia within the past 24 weeks prior to the first dose of study treatment;
    • Coronary angioplasty or stenting (within last 6 months);
    • Intra-cardiac defibrillators;
    • Abnormal cardiac valve morphology (≥ Grade 2) documented by echocardiogram.
  • Patients with a history or current evidence of retinal vein occlusion (RVO) or central serous retinopathy (CSR), or predisposing factors to RVO or CSR (e.g., uncontrolled glaucoma or ocular hypertension).
  • Patients with presence of interstitial lung disease or pneumonitis.
  • Female patients who are pregnant are ineligible since there is yet no available information regarding human fetal or teratogenic toxicities.
  • Lactating females are not eligible unless they have agreed not to breastfeed their infants for the duration of the study and for 4 months following discontinuation of study therapy.
  • Female patients of childbearing potential are not eligible unless a negative pregnancy test result has been obtained.
  • Sexually active patients of reproductive potential (male or female) are not eligible unless they have agreed to use an effective contraceptive method for the duration of their study participation and for 4 months following discontinuation of study therapy. Male patients (including those who have had a vasectomy) taking dabrafenib and trametinib combination therapy must use a condom during intercourse while on study and for 16 weeks after stopping treatment, and should not father a child during these periods. Women of childbearing potential should use. effective non-hormonal contraception during therapy and for 4 weeks following discontinuation of dabrafenib and at least 4 months following the last dose of trametinib in patients taking combination therapy.  Women should be advised that dabrafenib may decrease the efficacy of hormonal contraceptives and an alternate method of contraception, such as barrier methods, should be used.
  • 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.

Eligibility last updated 9/28/21. Questions regarding updates should be directed to the study team contact.

Drug, Radiation
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A Phase 1/2 Multiple Expansion Cohort Trial of MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation

A Study to Evaluate MRTX849 in Patients with Advanced Solid Tumors with KRAS G12C Mutation

Konstantinos Leventakos
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
0000-101283-P01-RST
20-001187
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Inclusion Criteria:

  • Histologically confirmed diagnosis of a solid tumor malignancy with KRAS G12C mutation.
  • Unresectable or metastatic disease.
  • Standard treatment is not available or patient declines.
  • Adequate organ function.


Exclusion Criteria:

  • Active brain metastases.
  • History of intestinal disease or major gastric surgery or inability to swallow oral medications.
  • Other active cancer.
Drug, Administration of antineoplastic agent, Drug therapy
Cancer
Cancer treatment, Genetic mutation, MRTX-849, Malignant neoplastic disease, Medical Oncology, Secondary malignant neoplastic disease, Solid tumor configuration, Targeted drug therapy, Tumor surgically unresectable
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A Multi-Center, Open Label Phase 1/2 Study of CYT-0851 in Patients With Relapsed/Refractory B-Cell Malignancies and Advanced Solid Tumors

A Phase 1/2 Study of CYT-0851 in B-Cell Malignancies and Advanced Solid Tumors

Grzegorz Nowakowski
All
18 years and over
Phase 1/2
This study is NOT accepting healthy volunteers
0000-101291-P01-RST
20-000712
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Key Phase 1 Inclusion Criteria

1. Male or female ≥18 years of age at time of informed consent.

1. Female subjects of childbearing potential must be non-lactating, not pregnant as
confirmed by a negative serum pregnancy test at most 30 days before enrollment
and within 72 hours before the first administration of CYT-0851

2. Female subjects of childbearing potential must not donate ova during the study
and for at least 90 days after the last dose of study drug and must agree to
continue using an effective method of contraception during the screening period
to first study drug administration until 90 days after the last dose of study
drug

3. Male subjects who have not had a vasectomy must agree to use an effective method
of contraception during the study and until 90 days after the last dose of the
study drug, and to not donate sperm during the study and for at least 90 days
after the last dose of study drug

2. ECOG Performance Status of 0-1

3. Measurable disease defined by disease-specific response criteria

4. Histologically-proven B cell malignancies, meeting the following criteria:

1. Relapsed, refractory B-cell non-Hodgkin lymphoma requiring therapy, after at
least two prior therapies, and if transplanted, then at least 3-month post
autologous stem cell transplant and if CART-treated, then evidence of progression
no sooner than 3 months post CART treatment, or

2. Relapsed, refractory chronic lymphocytic leukemia requiring therapy after at
least two prior therapies, including BTK and BCL-2 inhibitor therapy (unless
ineligible for such therapy), or

3. For multiple myeloma, relapsed or progressive on or after treatment with at least
three prior therapies that included a proteasome inhibitor, an imide,
daratumumab, and if transplant eligible, a bone marrow transplant (unless unfit
for transplant), or

5. Histologically-proven solid tumor meeting the following criteria:

1. Patients must have failed, refused, or not be eligible for further standard
therapies (including chemotherapy, hormonal therapies, Her-2 directed therapies,
as appropriate) expected to provide clinical benefit, and meeting the following
criteria

2. Metastatic breast cancer (including ER/PR positive or negative, Her-2 positive
and negative, triple negative), treated with at least 1 prior therapy for
metastatic disease, or

3. Recurrent squamous cell carcinoma of the head and neck (HNSCC) (dose escalation)
or human papilloma virus positive (HPV+) HNSCC (dose-escalation and backfill),
treated with at least 1 prior therapy, or

4. Ovarian cancer, progressive after treatment with at least prior platinum-based
chemotherapy, and therapy with a PARP inhibitor or

5. Soft tissue sarcoma, treated with at least one line of prior systemic therapy, or

6. Recurrent metastatic or locally advanced pancreatic cancer after first line
chemotherapy (backfill or combination patients only) or

7. Histologically-proven advanced small-cell lung cancer (SCLC) (monotherapy
backfill patients only).

1. Patients with mixed histology are not allowed

2. Prior treatment with platinum containing chemotherapy regimen with no
evidence of progression within 90 days of last dose of platinum agent and
anti-PD-(L)1 unless contraindicated

3. At least 1 prior line of chemotherapy, but no more than 3 prior lines of
therapy

6. Understands the procedures and requirements of the study and provides written informed
consent and authorization for protected health information disclosure

7. Willing and able to comply with the requirements of the study protocol

8. Site of disease amenable to a biopsy and willing to undergo biopsy required for
backfill, or for dose-escalation if considered unsafe (approval to participate in the
study required by the Medical Monitor) provide an archival sample ≤ 12 months old

Key Phase 2 Inclusion Criteria

1. Male or female ≥18 years of age at time of informed consent.

1. Female subjects of childbearing potential must be non-lactating, not pregnant as
confirmed by a negative serum pregnancy test at most 30 days before enrollment
and within 72 hours before the first administration of CYT-0851

2. Female subjects of childbearing potential must not donate ova during the study
and for at least 90 days after the last dose of study drug and must agree to
continue using, an effective method of contraception during the screening period
to first study drug administration until 90 days after the last dose of study
drug

3. Male subjects who have not had a vasectomy must agree to use an effective method
of contraception during the study and until 90 days after the last dose of the
study drug, and to not donate sperm during the study and for at least 90 days
after the last dose of study drug

2. ECOG Performance Status of 0-1

3. Measurable disease defined by disease-specific response criteria

4. Site of disease amenable to a biopsy and willing to undergo a biopsy for the
determination of biomarker status, or, if considered unsafe (approval to participate
in the study required by the Medical Monitor), archival sample ≤ 12 months old for
determination of biomarker status.

5. Biomarker positive on recent biopsy or bone marrow sample if required for the specific
cohort.

6. Histologically-proven B cell malignancies, meeting the following criteria:

1. DLBCL Cohort

1. Histologically-documented DLBCL or double hit lymphoma (B-cell lymphoma,
unclassifiable, with features intermediate between diffuse large B-cell
lymphoma and Burkitt lymphoma with BCL2 and MYC translocations (WHO
Classification)

2. Progressing on or after treatment with at least two prior lines of therapy,
including R-CHOP or equivalent first line therapy

3. If transplanted, then at least 3-month post autologous stem cell transplant

4. If CART-treated, then evidence of progression no sooner than 3 months post
CART treatment

2. MCL Cohort

1. Histologically-documented MCL

2. Any stage at diagnosis

3. Progressing on or after treatment with at least 2 prior lines of therapy,
including a Bruton tyrosine kinase (BTK) inhibitor, after a 14-day washout
period

3. Multiple Myeloma Cohort

1. Relapsed or progressing after treatment with at least 3 prior therapies that
include a proteasome inhibitor, an Immunomodulatory imide drug (IMiD),
daratumumab, and, if transplant eligible, a bone marrow transplant (unless
unfit for transplant)

7. Or Histologically-proven solid tumors meeting the following criterial

1. Patients must have failed, refused, or not be eligible for further standard
therapies (including chemotherapy, hormonal therapies, Her-2 directed therapies,
as appropriate) expected to provide clinical benefit, and meeting the following
criteria

2. Triple Negative Breast Cancer Cohort

1. Histologically-documented triple negative breast cancer, ER/PR negative
(defined as <10% of cells expressing hormonal receptors via
immunohistochemistry (IHC) analysis), and HER2-negative, defined as either
of the following by local laboratory assessment:

- In situ hybridization (ISH) non-amplified (ratio of HER2 to CEP17 < 2.0
or single probe average HER2 gene copy number < 4 signals/cell), or

- IHC 0 or IHC 1+

2. At least 1 prior line of chemotherapy, but no more than 5 prior lines of
chemotherapy

3. Ovarian Cancer Cohort

1. Histologically-proven metastatic epithelial ovarian cancer

2. Prior treatment with a platinum containing chemotherapy regimen

3. At least 1 prior line of therapy, but no more than 5 prior lines of
chemotherapy

4. Pancreatic Cancer Cohort

1. Histologically-proven metastatic or locally advanced pancreatic cancer

2. At least 1 prior line of chemotherapy but no more than 4 prior lines of
systemic therapy

5. Soft Tissue Sarcoma Cohort 1) Histologically-proven advanced soft-tissue sarcoma
excluding all types of adipocytic sarcoma and GIST 2) At least 1 prior line of
systemic therapy (unless no standard of care exists), but no more than 5 prior
lines of systemic therapy

8. Follicular Lymphoma Cohort

1. Histologically-documented follicular lymphoma

2. Relapsed, refractory follicular lymphoma requiring therapy, after at least two
prior therapies, and if CART-treated, then evidence of progression no sooner than
3 months post CART treatment

9. Understands the procedures and requirements of the study and provides written informed
consent and authorization for protected health information disclosure

10. Willing and able to comply with the requirements of the study protocol

Key Exclusion Criteria

1. Medical Conditions

1. Known history of HIV

2. Known history of viral hepatitis B unless HBV viral load is below the limit of
quantification and off viral suppressive therapy

3. Know history of hepatitis C unless antiviral treatment with curative intent
completed and HCV viral load is below the limit of quantification.

4. Myocardial infarction or stroke within 6 months

5. Uncontrolled hypertension (systolic blood pressure (SBP) > 160 or diastolic blood
pressure (DBP) >100 on maximal medical therapy)

6. History of interstitial pulmonary disease

7. Unresolved pneumonitis

8. Grade ≥ 3 neuropathy

9. Known active central nervous system (CNS) metastases. Subjects with previously
treated CNS metastases may participate as long as clinically and radiologically
stable for at least 4 weeks after treatment, have no evidence of new or enlarging
lesions and are off steroids and asymptomatic for 28 days prior to dosing with
study medication

10. Known history of meningeal involvement or meningeal carcinomatosis

11. Spinal cord compression not definitively treated with surgery and/or radiation,
or previously diagnosed and treated spinal cord compression without evidence that
disease has been clinically stable for > 2 weeks prior to screening visit

12. Presence of clinically significant cataracts

13. Second malignancy, except treated basal cell or localized squamous skin
carcinomas, localized prostate cancer, or other malignancy that is in remission
or stable and for which patients have not been on active anti-cancer therapy for
2 years

14. Pregnant or lactating. If ?-HCG is elevated, eligible if ultrasound confirms
absence of a pregnancy.

15. Dementia or significantly altered metal status

16. Bowel obstruction requiring medical management less than 4 weeks prior to
screening

17. Inability to tolerate oral intake that includes 2 full meals per day (or
equivalent) or swallow pills.

18. Recurrent ascites requiring paracentesis more frequently than every 4 weeks or
within 14 days of screening.

19. Weight loss of more than 10% over the preceding 3 months prior to screening

2. Prior/Concomitant Therapy

1. Prior allogeneic stem cell transplant

2. On systemic antibiotic, antifungal or anti-viral therapy

3. White blood cell (WBC) growth factors administered within 14 days of screening
visit

4. Cancer therapy within 14 days prior to treatment with study drug

5. On narrow therapeutic index medications that are sensitive substrates of CYP3A,
P-gp or BCRP (or caution is warranted with approval by the Sponsor).

6. On any drug known to prolong QTc interval (eg, certain antiarrhythmic,
antimicrobials) that cannot be discontinued or interrupted 72 hours before the
Day 1 dose through Day 2, and 72 hours before the Day 15 dose until Day 16 (BID
dosing) or the Day 22 dose until Day 23 (QD dosing), in Cycle 1 (see Section
7.6.1 for a list of drugs).

7. On systemic corticosteroid treatment for non-tumor indication at a daily dose
equivalent to >10mg of Prednisone

3. Prior/Concurrent Clinical Study Experience a. Participation in another clinical trial
(unless in the observation phase, or an observational study), or exposure to any
investigational agent within 14 days prior to treatment with study drug

4. Laboratory assessments

1. Complete blood count (CBC):

Monotherapy and Chemotherapy Combinations 1 and 2:

1. ANC < 1.0 × 10^9/L

2. PLT < 75 × 10^9/L

3. Hgb < 9.0 g/dL

Chemotherapy Combination Group 3:

1) ANC < 1.5 × 10^9/L 2) PLT < 100 × 10^9/L 3) Hgb < 9.0 g/dL

Monotherapy and Chemotherapy Combination Groups 1 and 2:

2. Calculated Creatinine clearance (Cockcroft-Gault) < 40 mL/min

Chemotherapy Combination Group 3:

b. Calculated Creatinine clearance (Cockcroft-Gault) < 50 mL/min c. Hepatic function

1. AST > 2.0 × ULN

2. ALT > 2.0 × ULN d. Total bilirubin > 1.5 x ULN e. Albumin < 2.8 g/dL 5. ECG Exclusion
a. Screening QTc interval > 450 milliseconds for males and QTc > 470 ms for females
(corrected by Fridericia) 6. Other Exclusions

1. Unwilling or unable to make all planned study visits

2. Unwilling or unable to provide a recent biopsy or bone marrow sample prior to
enrollment and during study; Note: certain exceptions may be permitted allowing
archival specimens prior to treatment or for subjects where a specimen is not
required for biomarker positive testing

3. Significant medical diseases or conditions, as assessed by the Investigators and
Cyteir that would substantially increase the risk-benefit ratio of participating
in the study. This includes but is not limited to acute myocardial infarction,
arterial thrombosis, significant gastrointestinal bleed, or unstable angina
within the last 6 months uncontrolled diabetes mellitus, current active
infections, severely immunocompromised state, and congestive heart failure New
York Heart Association (NYHA) Class III-IV, left ventricular ejection fraction
(LVEF) < 40% d: Chemotherapy Combination Group 3 only: known history of
dhydropyrimidine dehydrogenase deficiency

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

Eligibility last updated 11/9/22. Questions regarding updates should be directed to the study team contact.

Administration of antineoplastic agent, Drug therapy, Drug
Breast cancer, Cancer, Chronic lymphocytic leukemia, Diffuse large b-cell lymphoma, Head and neck cancer, Leukemia, Lymphoma, Multiple myeloma, Non-Hodgkin's lymphoma, Ovarian cancer, Pancreatic cancer, Plasma cell disorders, Recurrent cancer, Sarcoma, Soft tissue sarcoma, Triple-negative breast cancer
B-cell lymphoma (clinical), Cancer treatment, Chronic lymphoid leukemia in relapse, Diffuse non-Hodgkin's lymphoma, large cell (clinical), Digestive system, Hematopoietic system, Immune system, Local recurrence of malignant tumor of pancreas, Malignant tumor of ovary, Mantle cell lymphoma, Medical Oncology, Musculoskeletal system, Relapse multiple myeloma, Reproductive system, Sarcoma of soft tissue, Secondary malignant neoplasm of female breast, Secondary malignant neoplasm of pancreas, Squamous cell carcinoma of head and neck, Targeted drug therapy, Triple-negative breast cancer
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Mayo Clinic — Rochester, MN

A Phase I/Ib Open-label, Multi-center Dose Escalation Study of JBH492 in Patients With Relapsed/Refractory Chronic Lymphocytic Leukemia (CLL) and Non-Hodgkin's Lymphoma (NHL) (CJBH492A12101)

A Study to Evaluate the Safety and Effectiveness of JBH492 in Patients with Chronic Lymphocytic Leukemia and Non-Hodgkin's Lymphoma

Grzegorz Nowakowski
All
18 years and over
Phase 1
This study is NOT accepting healthy volunteers
0000-101292-P01-RST
20-001091
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Inclusion Criteria:

For Patients with CLL

  • Confirmed diagnosis of chronic lymphocytic leukemia (CLL).
  • Must have received at least two (2) prior therapy regimens.
  • Patients with Richter's transformation should have failed standard therapy.

For Patients with NHL

  • Histologically confirmed diagnosis of B- or T-cell non-Hodgkins lymphoma (NHL).
  • Must have a site of disease amenable to biopsy, and be suitable and willing to undergo study required biopsies at screening and during therapy.
  • The histologic subtypes of NHL that are permitted in the dose escalation part were specified.
  • Must have received at least two (2) prior therapy regimens.
  • Patients with indolent lymphoma must have received and failed standard-of-care therapy or be intolerant or ineligibile to approved therapies and must be in need of therapeutic intervention.
  • Patients with prior CART T-cell therapy will be permitted on this trial 30 days after CART infusion and meet protocol defined inclusion/exclusion criteria.

Exclusion Criteria:

Applicable to both CLL and NHL

  • History of anaphylactic or other severe hypersensitivity/infusion reactions to ADCs, monoclonal antibodies (mAbs) and/or their excipients such that the patient in unable to tolerate immunoglobulin/monoclonal antibody administration.
  • Any prior history of treatment with maytansine (DM1 or DM4)-based ADC.
  • Known intolerance to a maytansinoid.
  • Patients with any active or chronic corneal disorders.
  • Patients who have any other condition that precludes monitoring of the retina or fundus.
  • Patients with active CNS involvement are excluded, except if the CNS involvement has been effectively treated and provided that local treatment was > 4 weeks before enrollment. Patients that have been effectively treated for CNS disease and are stable under systemic therapy may be enrolled provided all other inclusion and exclusion criteria are met.
  • Impaired cardiac function or clinically significant cardiac disease.
  • Known history of Human Immunodeficiency Virus (HIV) infection, Active Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection.
Drug, Administration of antineoplastic agent, Drug therapy
Cancer, Chronic lymphocytic leukemia, Leukemia, Lymphoma, Non-Hodgkin's lymphoma
B-cell lymphoma (clinical), Cancer treatment, Chronic lymphoid leukemia in relapse, Hematopoietic system, Medical Oncology, T-cell lymphoma (clinical), Targeted drug therapy
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Location Contacts
Mayo Clinic — Rochester, MN