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

There are 2 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. Arm 1: There are 2 parts : 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 nivolumab and azacitidine 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. The safety of this drug combination will also be studied. Arm 2: There are 2 parts: 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 nivolumab, azacitidine, and ipilimumb 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. The safety of this drug combination will also be studied.

Disease Group: Leukemia

Treatment Agent: 5-Azacytidine, Nivolumab

Treatment Location: Only at MD Anderson

Sponsor: BMS Pharmaceuticals

IRB Review and Approval Date: 04/07/2015

Recruitment Status: Open

Projected Accrual: N/A

Phone Number: 1-877-MDA-6789

clinicaltrials.gov NCT No: NCT02397720

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