Ipilimumab or Nivolumab in Treating Patients With Relapsed Hematologic Malignancies After Donor Stem Cell Transplant

• Incidence of adverse events as assessed by National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase Ib) [ Time Frame: Up to 1 year after completion of study treatment ]
  Incidence of adverse events will be evaluated.
  
  
• Maximum tolerated dose (MTD) of ipilimumab according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I) [ Time Frame: At 12 weeks ]
  MTD of ipilimumab will be assessed.
  
  
• Maximum tolerated dose (MTD) of nivolumab according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 (Phase I) [ Time Frame: At 12 weeks ]
  MTD of nivolumab will be assessed.
  
  

• Clinical response [ Time Frame: Up to 1 year ]
  Summarized by simple descriptive summary statistics delineating complete, partial, and best overall response, stable and progressive disease.
  
  
• Overall survival (OS) [ Time Frame: From the start of treatment to time of death, assessed up to 1 year ]
  Using the Kaplan-Meier method. Will be analyzed and reported both for the entire cohort and within each disease group if feasible.
  
  
• Progression-free survival (PFS) [ Time Frame: From start of treatment to time of objective disease progression, assessed up to 1 year ]
  Using the Kaplan-Meier method. Will be analyzed and reported both for the entire cohort and within each disease group if feasible.
  
  

• Change in cytokine production [ Time Frame: Baseline to up to 1 year ]
  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.
  
  
• Change in immune cell numbers [ Time Frame: Baseline to up to 1 year ]
  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.
  
  

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.

TERTIARY OBJECTIVES:

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 courses 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 courses 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 course 5 (24 weeks after the first dose of ipilimumab) for up to 4 courses 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.