Trials / Completed

CompletedNCT02397720

Nivolumab and Azacitidine With or Without Ipilimumab in Treating Patients With Refractory/Relapsed or Newly Diagnosed Acute Myeloid Leukemia

An Open-Label Phase II Study of Nivolumab (BMS-936558) in Combination With 5-Azacytidine (Vidaza) or Nivolumab With Ipilimumab in Combination With 5-Azacytidine for the Treatment of Patients With Refractory/ Relapsed Acute Myeloid Leukemia and Newly Diagnosed Older AML (> 65 Years) Patients

Status: Completed
Phase: Phase 2
Study type: Interventional
Enrollment: 150 (actual)

Sponsor: M.D. Anderson Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

This will be a phase II, open-label, non-randomized study with a safety lead-in phase. There are 3 Arms in this study each with 2 parts. If you are eligible, you will be assigned to an Arm and a part when you join the study. In each arm, you will receive a different combination of study drugs: Arm 1: nivolumab and azacitidine, Ih Arm 2: nivolumab, azacitidine, and ipilimumab, Arm 3: nivolumab, azacitidine, and venetoclax. There are 2 parts in each arm: Part A (dose escalation) and Part B (dose expansion). The goal of Part A of this clinical research study is to find the highest tolerable dose of the study drugs (nivolumab, azacitidine, ipilimumab, and/or venetoclax) that can be given to patients with AML. The goal of Part B of this study is to learn if the dose found in Part A can help to control AML.

Detailed description

Arm 1 Up to 5 groups of up to 6 participants will be enrolled in Part A of the study, and up to 110 participants will be enrolled in Part B of the study. If you are enrolled in Part A of the study, the dose of nivolumab and azacitidine you receive will depend on when you joined this study. The first group of participants will receive the starting dose levels of nivolumab and azacitidine. If intolerable side effects are seen, the next group may receive a lower dose level of nivolumab and/or azacitidine. This will continue until the highest tolerable combination dose is found. If you are enrolled in Part B, you will receive nivolumab and azacitidine at the highest dose that was tolerated in Part A. Arm 2 Up to 4 groups of up to 6 participants will be enrolled in Part A of the study, and up to 84 participants will be enrolled in Part B of the study. If you are enrolled in Part A of the study, the dose of nivolumab, azacitidine, and ipilimumab you receive will depend on when you joined this study. The first group of participants will receive the starting dose levels of nivolumab, azacitidine and ipilimumab. If intolerable side effects are seen, the next group may receive a lower dose level of nivolumab, azacitidine and/or ipilimumab. This will continue until the highest tolerable combination dose is found. If you are enrolled in Part B, you will receive nivolumab, azacitidine, and ipilimumab at the highest dose that was tolerated in Part A. Arm 3 About 6-18 participants will be enrolled in Part A and up to 60 participants will be enrolled in Part B. If you are enrolled in Part A of the study, the dose of nivolumab, azacitidine, and venetoclax you receive will depend on when you joined this study. The first group of participants will receive the starting dose levels of nivolumab, azacitidine and venetoclax. If intolerable side effects are seen, the next group may receive a lower dose level of nivolumab, azacitidine and/or venetoclax. This will continue until the highest tolerable combination dose is found. If you are enrolled in Part B, you will receive nivolumab, azacitidine, and venetoclax at the highest dose that was tolerated in Part A.

Conditions

Interventions

Type	Name	Description
DRUG	Azacitidine	Given SC or IV
DRUG	Ipilimumab
DRUG	Venetoclax	Given Orally
DRUG	Nivolumab	Given IV

Timeline

Start date: 2015-04-07
Primary completion: 2023-10-09
Completion: 2023-10-09
First posted: 2015-03-25
Last updated: 2025-06-08
Results posted: 2024-11-04

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT02397720. Inclusion in this directory is not an endorsement.