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Your journey
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More info
You can access this
clinical trial
if you have
Leukemia
and you are
over 18
years old
2
This is a second phase trial assessing
efficacy and side effects of the new treatment.
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The purpose

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 ipilimumab 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. This is an investigational study. Azacitidine is FDA approved and commercially available for the treatment of myelodysplastic syndrome (MDS) and it is approved as frontline therapy for AML in elderly participants. Nivolumab is commercially available and approved for the treatment of certain types of melanoma and lung cancers. Their use in this study is considered investigational. The study doctor can explain how the study drugs are designed to work. Up to 182 participants will take part in this study. All will be enrolled at MD Anderson.

Provided treatments

  • Drug: 5-azacytidine
  • Drug: Nivolumab
  • Behavioral: Phone Call
  • Drug: Ipilimumab
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Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT02397720. The sponsor of the trial is M.D. Anderson Cancer Center and it is looking for 182 volunteers for the current phase.
Official trial title:
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