A Phase 1 interventional study of Ipilimumab and Laboratory Biomarker Analysis in Allogeneic Hematopoietic Stem Cell Transplant Recipient, Myeloproliferative Neoplasm and Recurrent Acute Lymphoblastic Leukemia, sponsored by National Cancer Institute (NCI). Completed at 13 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-24.
Sponsored by National Cancer Institute (NCI) · Phase 1, Interventional, and Treatment
This phase I/Ib trial studies the side effects and best dose of ipilimumab or nivolumab in treating patients with cancers of the blood and blood-forming tissues (hematologic cancers) that have returned after a period of improvement (relapsed) after donor stem cell transplant. Immunotherapy with monoclonal antibodies, such as ipilimumab and nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.
PRIMARY OBJECTIVES:
I. To determine the maximum-tolerated dose (MTD) of ipilimumab or nivolumab administered to patients with relapsed hematologic malignancies following allogeneic stem cell transplantation. (Phase I) II. To characterize the toxicity of ipilimumab or nivolumab administered at the MTD in this patient population. (Phase Ib)
SECONDARY OBJECTIVES:
I. To assess response rate. II. To assess progression free and overall survival.
EXPLORATORY OBJECTIVE:
I. To assess the phenotypic and functional effects of ipilimumab or nivolumab on immune cells.
OUTLINE: This is a dose-escalation study.
INDUCTION PHASE: Patients receive ipilimumab intravenously (IV) over 90 minutes on day 1. Treatment repeats every 21 days for 4 cycles in the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab IV over 30 minutes on day 1. Treatment repeats every 14 days for 8 cycles in the absence of disease progression or unacceptable toxicity.
MAINTENANCE PHASE: Patients receive ipilimumab IV over 90 minutes. Treatment repeats every 12 weeks beginning at cycle 5 (24 weeks after the first dose of ipilimumab) for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients achieving clinical benefit will have the option to continue with ongoing maintenance dosing every 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also receive nivolumab IV over 30 minutes every 2 weeks in the absence of disease progression or unacceptable toxicity. Treatment repeats every 14 days for up to a total of 60 weeks (including Induction) in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up for 1 year.
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The following malignancies will be considered eligible if progressive or persistent:
Exclusion Criteria:
See Detailed Description.
Biological: Ipilimumab · Other: Laboratory Biomarker Analysis · Biological: Nivolumab
Given IV
Also known as: Anti-Cytotoxic T-Lymphocyte-Associated Antigen-4 Monoclonal Antibody, BMS-734016, Ipilimumab Biosimilar CS1002, MDX-010, MDX-CTLA4, Yervoy
Correlative studies
Given IV
Also known as: BMS-936558, CMAB819, MDX-1106, NIVO, Nivolumab Biosimilar CMAB819, ONO-4538, Opdivo
Maximum tolerated dose (MTD) of ipilimumab according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Phase I)
Dose-limiting toxic (DLT) effects were defined as grade III or IV acute graft versus host disease (GVHD), grade 4 hematologic toxic effects unrelated to the underlying disease, or grade 3 nonhematologic toxic effects that did not improve to grade 1 with a 3-week dose delay. Immune-related adverse events that resolved to grade 1 or lower with the use of glucocorticoids were not considered to be dose-limiting toxic effects. We designated the observation period for toxic effects to be 12 weeks to capture delayed immunologic toxic effects.
Time frame: At 12 weeks
Maximum tolerated dose (MTD) of nivolumab according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Phase I)
Dose-limiting toxic (DLT) effects are defined as grade III or IV acute GVHD, grade 4 hematologic toxic effects unrelated to the underlying disease, or grade 3 nonhematologic toxic effects that did not improve to grade 1 with a 3-week dose delay. Immune-related adverse events that resolved to grade 1 or lower with the use of glucocorticoids were not considered to be dose-limiting toxic effects. We designated the observation period for toxic effects to be 12 weeks to capture delayed immunologic toxic effects.
Time frame: At 12 weeks
Incidence of adverse events as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Phase Ib)
A serious adverse event (SAE) is any adverse event, occurring at any dose and regardless of causality that 1) Results in death, 2) Is life-threatening, 3) Requires or prolongs inpatient hospitalization, 4) Results in persistent or significant disability/incapacity, 5) Is an important medical event when, based upon appropriate medical judgment, it may jeopardize the participant and require medical or surgical intervention to prevent one of the outcomes listed above.
Time frame: Up to 1 year after completion of study treatment
Clinical response
Summarized by simple descriptive summary statistics delineating complete, partial, and best overall response, stable and progressive disease.
Time frame: Up to 1 year
Progression-free survival (PFS)
Using the Kaplan-Meier method. Will be analyzed and reported both for the entire cohort and within each disease group if feasible.
Time frame: From start of treatment to time of objective disease progression, assessed up to 1 year
Overall survival (OS)
Using the Kaplan-Meier method. Will be analyzed and reported both for the entire cohort and within each disease group if feasible.
Time frame: From the start of treatment to time of death, assessed up to 1 year
Change in immune cell numbers
Laboratory studies will be performed to characterize the effects of ipilimumab and nivolumab in the post allogeneic stem cell transplantation (alloSCT) setting on B cells, NK, cells, or dendritic cells, both in terms of pre and post alloSCT changes in cell numbers.
Time frame: Baseline to up to 1 year
Change in cytokine production
Laboratory studies will be performed to characterize the effects of ipilimumab and nivolumab in the post alloSCT setting on B cells, NK, cells, or dendritic cells, both in terms of pre and post alloSCT changes in cell numbers.
Time frame: Baseline to up to 1 year
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)