Nivolumab + Ipilimumab + Azacitidine for Myelodysplastic Syndrome
What You Need to Know Before You Apply
What is the purpose of this trial?
This phase II trial studies the side effects of nivolumab and/or ipilimumab with or without azacitidine and to see how well they work in treating patients with myelodysplastic syndrome. Monoclonal antibodies, such as nivolumab and ipilimumab, may block cancer growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as azacitidine, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab and/or ipilimumab with or without azacitidine may work better in treating myelodysplastic syndrome.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on high-dose steroids or immune suppression medications, you may not be eligible to participate.
Is the combination of Nivolumab, Ipilimumab, and Azacitidine safe for humans?
Azacitidine has been studied for safety in patients with myelodysplastic syndrome and other blood disorders, showing some common side effects like pneumonia, joint pain, and constipation. In combination with other drugs, it has been generally safe with manageable side effects, but specific safety data for the combination with Nivolumab and Ipilimumab is not provided in the available research.12345
How is the drug combination of Nivolumab, Ipilimumab, and Azacitidine unique for treating Myelodysplastic Syndrome?
This drug combination is unique because it combines immune checkpoint inhibitors (Nivolumab and Ipilimumab) with Azacitidine, a drug that affects DNA methylation, potentially offering a novel approach by enhancing the immune system's ability to fight cancer cells in Myelodysplastic Syndrome, a condition with limited standard treatment options.678910
What data supports the effectiveness of the drug azacitidine for myelodysplastic syndrome?
Who Is on the Research Team?
Guillermo Garcia-Manero
Principal Investigator
M.D. Anderson Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with Myelodysplastic Syndrome (MDS) who have previously been treated with hypomethylating agents but didn't respond well or the disease came back. They should not have had a stem cell transplant, any other cancer treatments, or major surgery within 2 weeks before starting the study. Participants need to be relatively healthy otherwise and can't be pregnant, breastfeeding, or have certain autoimmune diseases.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive nivolumab, ipilimumab, and/or azacitidine based on cohort assignment. Treatment cycles repeat every 3-4 weeks depending on the cohort.
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Azacitidine
- Ipilimumab
- Nivolumab
Azacitidine is already approved in European Union, United States, Canada, Japan for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
M.D. Anderson Cancer Center
Lead Sponsor
National Cancer Institute (NCI)
Collaborator