Last updated on May 2017

Nivolumab and Ipilimumab With 5-azacitidine in Patients With Myelodysplastic Syndromes (MDS)


Brief description of study

The goal of this clinical research study is to learn if nivolumab and/or ipilimumab, with or without azacitidine, are safe to give to patients with MDS. Researchers also want to learn if the study drug combinations can help to control the disease.

Detailed Study Description

Study Groups: If you are found to be eligible to take part in this study, you will be assigned to 1 of 6 study cohorts, based on when you join this study and on what treatments you have already received. Participants who have already received treatments called hypomethylating agents will be in Cohorts 1-3. Participants who have not received treatment will be in Cohorts 4-6: - If you are in Cohort 1, you will receive nivolumab. - If you are in Cohort 2, you will receive ipilimumab. - If you are in Cohort 3, you will receive nivolumab and ipilimumab. - If you are in Cohort 4, you will receive azacitidine and nivolumab. - If you are in Cohort 5, you will receive azacitidine and ipilimumab. - If you are in Cohort 6, you will receive azacitidine, nivolumab, and ipilimumab. Study Drug Administration: Study cycles for Cohorts 1-3 will be 3-4 weeks long. Study cycles for Cohorts 4-6 will be 4 weeks long. If you receive nivolumab, you will receive it by vein over about 1 hour on Days 1 and 15. If you receive ipilimumab, you will receive it by vein over about 90 minutes on Day 1. If you receive azacitidine, you will receive it by vein over about 10-40 minutes for 5 days every 4 weeks, then receive the other drug(s) as described above on Days 6 and/or 20 of each cycle. If you are in Cohorts 1-3 and the doctor thinks it is in your best interest, you may begin to receive azacitidine after Cycle 6. Study Visits: One (1) time each week during Cycle 1, and then one time during every cycle after that: - You will have a physical exam. - Blood (about 2-3 teaspoons) will be drawn for routine tests. These tests may be done more often if your doctor thinks it is needed. If the doctor thinks it is needed, on Day 21 or 28 of Cycles 1 (depending on to which cohort you are assigned) and then every 3 months, you will have a bone marrow aspiration to check the status of the disease and for cytogenetic testing. If you can become pregnant, you will have a urine or blood (about 1 teaspoon) pregnancy test every 6 weeks. Length of Treatment: You may continue taking the study drug(s) for as long as the doctor thinks it is in your best interest. You will no longer be able to take the study drug(s) if the disease gets worse, if intolerable side effects occur, or if you are unable to follow study directions. Your participation on the study will be over after the follow-up visits. Follow-up Visits: If you can become pregnant, you will have a urine or blood (about 1 teaspoon) pregnancy test 30 and 70 days after you have stopped taking the study drugs. There are additional laboratory research studies that you may be eligible for that may help researchers learn more about the disease. You will be given separate consent forms for these studies that explain their goals and risks. This is an investigational study. Nivolumab and ipilimumab are not FDA approved or commercially available for the treatment of MDS. Nivolumab and ipilimumab are each approved for the treatment of melanoma. Their use in MDS is investigational. Azacitidine is approved by the FDA for the treatment of MDS. The use of these drugs in combination is investigational. Up to 120 participants will be enrolled in this study. All will take part at MD Anderson.

Clinical Study Identifier: NCT02530463

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Guillermo Garcia-Manero, MD

University of Texas MD Anderson Cancer Center
Houston, TX United States
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