Lirilumab and Nivolumab With 5-Azacitidine in Patients With Myelodysplastic Syndromes (MDS)

Leukemia Clinical Trial

Official title: Phase II Combination of Lirilumab and Nivolumab With 5-Azacitidine in Patients With Myelodysplastic Syndromes (MDS)

Status Terminated

Clinical Trial Summary

The goal of this clinical research study is to learn if lirilumab and Opdivo (nivolumab), alone or in combination with Vidaza (azacitidine), can help to control MDS. The safety of these drug combinations will also be studied.

This is an investigational study. Lirilumab is not FDA approved or commercially available. It is currently being used for research purposes. Nivolumab is FDA approved and commercially available for the treatment of melanoma and non small cell lung cancer (NSCLC). Azacitidine is FDA approved and commercially available for the treatment of MDS. The study doctor can explain how the study drugs are designed to work.

Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.

Clinical Trial Description

Study Groups and Study Drug Administration:

If you are found to be eligible to take part in this study, you will be assigned to 1 of 2 study groups based on the status of the disease and then you will be assigned to a cohort based on when you join this study. Each study group will be made up of 2 cohorts. Group 1 is made up of Cohorts A and B. Group 2 is made up of Cohorts C and D. Each cohort will enroll up to 20 participants each.

Each study cycle is 4 weeks.

If you have low risk (low or intermediate-1) MDS, you will be enrolled in Group 1.

• If you are assigned to Cohort A, you will receive lirilumab by vein over about 1 hour 1 time each cycle.

• If you are assigned to Cohort B, you will receive nivolumab by vein over about 1 hour every 2 weeks during Cycles 1-9 and then 1 time each cycle after that. You will also receive lirilumab by vein over about 1 hour 1 time each cycle.

If you have high risk MDS, you will be enrolled in Group 2.

• If you are assigned to Cohort C, you will receive azacitidine by vein for up to 40 minutes on Days 1-7 of each cycle. You will also receive lirilumab by vein over about 1 hour on Day 7 of each cycle.

• If you are assigned to Cohort D, you will receive azacitidine by vein for up to 40 minutes on Days 1-7 of each cycle. You will receive lirilumab by vein over about 1 hour on Day 7 of each cycle. On Days 7 and 21 of Cycles 1-9 and then on Day 7 of Cycles 10 and beyond, you will also receive nivolumab by vein over about 1 hour.

If you are assigned to Cohorts B or D, you will need to stay in the clinic for up to 1 hour after your dose of nivolumab so the study staff may check your vitals and monitor your health for any side effects.

Both you and the study doctor will know to which group you have been assigned.

Study Visits:

One (1) time each week during Cycle 1 and then 1 time during each 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 28 of Cycle 1 and then every 3 months after that, you will have a bone marrow aspiration to check the status of the disease and for cytogenetic testing.

Every 6 weeks, if you can become pregnant, blood (about 1 teaspoon) or urine will be collected for a pregnancy test.

Length of Study:

You may continue receiving the study drug(s) as long as the study 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.

You participation on this study, if you cannot become pregnant, will end after your last dose of study drug(s). If you can become pregnant, your participation on this study will be over after the follow-up pregnancy tests.

Follow-Up Pregnancy Tests:

If you can become pregnant, at 30 days and 70 days after you have stopped taking the study drug(s), blood (about 1 teaspoon) or urine will be collected for a pregnancy test. ;

Related Conditions & MeSH terms

• Leukemia
• Myelodysplastic Syndromes
• Preleukemia

• NCT number: NCT02599649
• Study type: Interventional
• Source: M.D. Anderson Cancer Center
• Status: Terminated
• Phase: Phase 2
• Start date: March 21, 2016
• Completion date: January 30, 2019