Houston, Texas 77030


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: 1. Patients with MDS (up to 20% blasts) of any risk as defined as: a. Previously untreated; b. Previously treated with HMA agent. Patients need to have relapsed or progressed after any number of cycles of HMA therapy. Patients that do not respond to HMA therapy will also be allowed in the study. Relapse or progression will be measured by IWG 2006 criteria. No response will be lack of clinical benefit after at least 6 cycles of HMA therapy. 2. Age 18 years or older. 3. Adequate organ function: creatinine </=2.5 x ULN; serum bilirubin </=2.5 x ULN; AST and ALT </=2.5 x ULN. 4. ECOG performance status </=2 5. Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotrophin (beta-hCG) pregnancy test result within 24 hours prior to the first dose of treatment and must agree to use an effective contraception method to avoid pregnancy for 23 weeks (30 days plus the time required for nivolumab to undergo five half-lives) after the last dose of investigational drugs. Females of non- childbearing potential are those who are postmenopausal greater than 1 year or who have had a bilateral tubal ligation or hysterectomy. 6. Males who have partners of childbearing potential must agree to use an effective contraceptive method during the study and a period of 31 weeks after the last dose of investigational drug. 7. Patients or their legally authorized representative must provide written informed consent. Exclusion Criteria: 1. History of another primary invasive malignancy that has not been definitively treated or in remission for at least 2 years. Patients with non-melanoma skin cancers or with carcinomas in situ are eligible regardless of the time from diagnosis (including concomitant diagnoses). 2. Any major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy, experimental therapy within 2 weeks prior to the first dose of the study drugs. 3. Patients with any other known concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure NYHA Class III or IV, myocardial infarction within 6 months, and poorly controlled hypertension; chronic renal failure; or active uncontrolled infection) which, in the opinion of the investigator could compromise participation in the study. 4. Patients unwilling or unable to comply with the protocol. 5. History of pneumonitis. 6. Patients who are on high dose steroid (equivalent of prednisone more than 10 mg a day) or immune suppression medications. 7. Patients with autoimmune diseases (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], Systemic Lupus Erythematosus, autoimmune vasculitis [e.g., Wegener's Granulomatosis]). 8. Patients with a history of Inflammatory Bowel Disease such as Crohn's disease and ulcerative colitis. 9. Patients known to be positive for hepatitis B surface antigen expression or with active hepatitis C infection (positive by polymerase chain reaction or on antiviral therapy for hepatitis C within the last 6 months). Patients with history of HIV disease are also excluded from the study. 10. Current therapy with other systemic anti-neoplastic or anti-neoplastic investigational agents. 11. Females who are pregnant or lactating. 12. Treatment for MDS with any other drug not being an HMA. Prior treatment with growth factors, lenalidomide, and any HMA is allowed. 13. More than 4 months since last cycle of HMA (in previously treated patients). 14. Prior treatment with allogeneic stem cell transplantation.


NCT ID:

NCT02530463


Primary Contact:

Principal Investigator
Guillermo Garcia-Manero, MD
M.D. Anderson Cancer Center

Guillermo Garcia-Manero, MD
Phone: 713-745-3428


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 24, 2017

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