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Single Agent and Combined Inhibition After Allogeneic Stem Cell Transplant

NCT02846376 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-11-18

No results posted yet for this study

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.

Conditions

  • Acute Myeloid Leukemia and Myelodysplastic Syndrome

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Andrew Pecora, MD · Hackensack UMC

  • James McCloskey, MD · Hackensack UMC

  • Jamie Koprivnikar, MD · Hackensack UMC

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-08
Primary Completion
2023-12-21
Completion
2023-12-21
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02846376 on ClinicalTrials.gov