NCT02846376

Single Agent and Combined Inhibition After Allogeneic Stem Cell Transplant

Phase I Study of Single-agent and Combined Checkpoint Inhibition After Allogeneic Hematopoietic Stem Cell Transplantation in Patients at High Risk for Post-transplant Recurrence

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Hackensack Meridian Health · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the safety and benefit of nivolumab, ipilimumab or the combination of nivolumab with ipilimumab given after bone marrow transplant for patients with acute myelogenous leukemia and myelodysplastic syndrome.

Detailed description

The primary objectives of this study are: * To assess the safety of single-agent and combined checkpoint inhibition with nivolumab and ipilimumab in patients with acute myelogenous leukemia and myelodysplastic syndrome who have undergone hematopoietic stem cell transplantation and are at high risk for post-transplant recurrence. * Safety endpoint: The composite endpoint consisting of the occurrence of at least one treatment-related limiting toxicity (after checkpoint inhibitor treatment is initiated) defined as a ≥ grade 4 non-hematologic toxicity as specified by the CTCAE. Exceptions listed in section 5.9 apply to this endpoint as well. If 3 of 7 patients in a single cohort experience a treatment-related limiting toxicity, that single cohort will be terminated.

Conditions

• Acute Myeloid Leukemia and Myelodysplastic Syndrome

Interventions

Type	Name	Description
DRUG	Nivolumab	Nivolumab is a fully humanized immunoglobulin 4 (IgG4) monoclonal antibody (mAb) which binds to PD-1 (CD279) with nanomolar affinity and shows a high degree of specificity for PD-1; blocking binding of PD-1 to PD-L1 and PD-L2. Nivolumab binds selectively to human PD-1 and does not bind to other members of the cluster of differentiation protein 28 (CD28) family.
DRUG	Ipilimumab	Ipilimumab is a recombinant, human mAb that binds to the cytotoxic T-lymphocyte-associated antigen 4 (CTLA-4). Ipilimumab is an immunoglobulin 1 (IgG1) kappa immunoglobulin with an approximate molecular weight of 148 kilo-Daltons (kDa). Ipilimumab is produced in mammalian (Chinese hamster ovary) cell culture.

Timeline

• Start date: 2019-03-08
• Primary completion: 2023-12-21
• Completion: 2023-12-21
• First posted: 2016-07-27
• Last updated: 2024-11-18

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study