PHASE II: All patients enrolled in the Phase II portion of this trial must have a history of biopsy-proven ovarian, fallopian tube or primary peritoneal cancer
PHASE II REGISTRATION - INCLUSION CRITERIA
PHASE II REGISTRATION: EXCLUSION CRITERIA:
PHASE I:
PHASE II:
PHASE I AND II:
PHASE I PATIENTS:
PHASE I (ARMS A, B, C, D, E, F, G, H, I, X, Y, Z)
RANDOMIZED PHASE II (ARMS K AND L): Patients must have pathologically confirmed relapsed or refractory classical Hodgkin lymphoma (cHL); a biopsy at any relapse is acceptable; other histologies including lymphocyte predominant (LP) HL are not permitted
RANDOMIZED PHASE II (ARMS K AND L): ECOG-ACRIN performance status between 0-2
RANDOMIZED PHASE II (ARMS K AND L): ANC >= 1500/mcL (1.5 x 0^9/L), obtained within 2 weeks prior to registration
RANDOMIZED PHASE II (ARMS K AND L): Platelets >= 75,000/mcL (75 x 10^9/L), obtained within 2 weeks prior to registration
RANDOMIZED PHASE II (ARMS K AND L): AST/ALT =< 2.5 x upper limit of normal (ULN), obtained within 2 weeks prior to registration
RANDOMIZED PHASE II (ARMS K AND L): Patient must have no current or prior history of CNS involvement
RANDOMIZED PHASE II (ARMS K AND L): All prior therapy must have been completed at least 21 days prior to enrollment (6 weeks for nitrosoureas or mitomycin C); no concomitant anti lymphoma therapy, including systemic corticosteroids for the purpose of treatment of lymphoma are allowed; topical steroids are allowed
RANDOMIZED PHASE II (ARMS K AND L): No history of Steven�s Johnson�s syndrome, TENs syndrome, or motor neuropathy
RANDOMIZED PHASE II (ARMS K AND L): Patients must not have grade 2 or greater peripheral sensory neuropathy
RANDOMIZED PHASE II (ARMS K AND L): Patients must not have NYHA class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia
RANDOMIZED PHASE II (ARMS K AND L): Patients must not have previously existing hypersensitivity to brentuximab vedotin or ipilimumab
RANDOMIZED PHASE II (ARMS K AND L): Patients must not have a serious medical or psychiatric illness likely to interfere with study participation
RANDOMIZED PHASE II (ARMS K AND L): Patients must not be participating in any other clinical trial or taking any other experimental medications within 21 days prior to registration
RANDOMIZED PHASE II (ARMS K AND L): Routine vaccinations, including seasonal influenza, should be given at least 2 weeks prior to study treatment; vaccines are not prohibited on study, but must be given at least 6 weeks after cycle 1 and not within 7 days of treatment
RANDOMIZED PHASE II (ARMS K AND L): Patients must not currently be smoking tobacco or other agents
PHASE I PORTION ELIGIBILITY CRITERIA
PHASE II PORTION ELIGIBILITY CRITERIA
PHASE I SUBJECTS ONLY: Patients must not have received prior navitoclax, unless the patient received < 7 days of navitoclax lead-in on this or another study and had to stop for reasons other than toxicity or disease progression; in the phase II portion of the study
Disease status: * Phase 1 (Part A):** Patients must have either measurable or evaluable disease * Phase 2 (Part B):** Ewing sarcoma or peripheral PNET: patients must have measurable disease* Phase 2 (Part C):** Acute lymphoblastic leukemias (ALL): patients with ALL must have an M3 marrow with or without extramedullary site of relapse OR an M2 bone marrow with an extramedullary site of relapse; patients with CNS 3 status are not eligible for enrollment
For Part C (Phase 2): recurrent ALL patients with CNS 3 status are not eligible
Feasibility Phase: Patients must be < 21 years of age at the time of enrollment; please note: the feasibility phase is complete, effective with amendment #1
Tumor amenable to biopsy and willingness to undergo tumor biopsies before and after M6620 (VX-970) treatment during the expansion phase of the trial (biopsies optional during the escalation phase)