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Chemotherapy
Nivolumab + Ipilimumab + Azacitidine for Myelodysplastic Syndrome
Phase 2
Waitlist Available
Led By Guillermo Garcia-Manero
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Previously untreated
Eastern Cooperative Oncology Group (ECOG) performance status =< 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30 weeks
Awards & highlights
Study Summary
This trial studies the side effects of nivolumab and/or ipilimumab with or without azacitidine for patients with myelodysplastic syndrome.
Who is the study for?
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.Check my eligibility
What is being tested?
The trial is testing how effective and safe it is to use Nivolumab and/or Ipilimumab with or without Azacitidine in treating MDS. These drugs include monoclonal antibodies that may block cancer growth by targeting specific cells and chemotherapy that stops cancer cells from growing.See study design
What are the potential side effects?
Possible side effects include immune-related reactions like inflammation of organs, skin rash, hormone gland problems (like thyroid), liver issues; infusion reactions; tiredness; nausea; blood count changes increasing infection risk; potential harm to an unborn baby.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have not received any treatment for my condition.
Select...
I can take care of myself and am up and about more than half of my waking hours.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Overall Response Rate (ORR) in MDS Participants Who Have Not Received Hypomethylating Agents
Muscular Dystrophy
Trial Design
6Treatment groups
Experimental Treatment
Group I: Cohort VI (azacitidine, nivolumab, ipilimumab)Experimental Treatment4 Interventions
Patients receive azacitidine IV over 10-40 minutes on days 1-5 and nivolumab IV over 30 minutes and ipilimumab IV over 30 minutes on day 6. Treatment with ipilimumab repeats every 4 weeks for 4 cycles in the absence of disease progression or unacceptable toxicity. Cycles with nivolumab and azacitidine repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Group II: Cohort V (azacitidine, ipilimumab)Experimental Treatment3 Interventions
Patients receive azacitidine IV over 10-40 minutes on days 1-5 and ipilimumab IV over 30 minutes on day 6. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Group III: Cohort IV (azacitidine, nivolumab)Experimental Treatment3 Interventions
Patients receive azacitidine IV over 10-40 minutes on days 1-5 and nivolumab IV over 30 minutes on days 6 and 20. Cycles repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Group IV: Cohort III (nivolumab, ipilimumab)Experimental Treatment3 Interventions
Patients receive nivolumab IV over 30 minutes on days 1 and 15 and ipilimumab IV over 30 minutes on day 1. Treatment repeats every 4 weeks for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients then receive nivolumab IV over 30 minutes every 2 weeks (or every 4 weeks if patients receive azacitidine) in the absence of disease progression or unacceptable toxicity. Patients with disease progression may receive ipilimumab, nivolumab, and azacitidine at the discretion of the treating physician.
Group V: Cohort II (ipilimumab)Experimental Treatment2 Interventions
Patients receive ipilimumab IV over 30 minutes on day 1. Cycles repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients with disease progression may receive ipilimumab and azacitidine at the discretion of the treating physician.
Group VI: Cohort I (nivolumab)Experimental Treatment2 Interventions
Patients receive nivolumab IV over 30 minutes on days 1 and 15. Treatment repeats every 4 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients with disease progression may receive nivolumab and azacitidine at the discretion of the treating physician.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Azacitidine
FDA approved
Ipilimumab
FDA approved
Nivolumab
FDA approved
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,967 Previous Clinical Trials
1,804,703 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,933,568 Total Patients Enrolled
Guillermo Garcia-ManeroPrincipal InvestigatorM.D. Anderson Cancer Center
9 Previous Clinical Trials
1,459 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not pregnant or breastfeeding.I will use effective birth control during and for 31 weeks after the study.I haven't had major surgery or cancer treatment in the last 2 weeks.I have an autoimmune disease like rheumatoid arthritis or lupus.I have not received any treatment for my condition.I have had treatment with an HMA and my condition either got worse or didn't improve.I am willing and able to follow the study's requirements.I have had pneumonitis before.I am taking high doses of steroids or medications that suppress my immune system.I am not pregnant, can take a pregnancy test, and will use birth control during and after treatment.I do not have active hepatitis B, hepatitis C, or HIV.I am not undergoing active treatment for a second cancer, except if it's breast or prostate cancer being managed with hormone therapy.My condition is MDS with up to 20% blasts.I have a history of inflammatory bowel disease like Crohn's or ulcerative colitis.I have had a stem cell transplant from a donor.I can take care of myself and am up and about more than half of my waking hours.I am not currently on any cancer treatment drugs or in any cancer drug trials.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort V (azacitidine, ipilimumab)
- Group 2: Cohort IV (azacitidine, nivolumab)
- Group 3: Cohort I (nivolumab)
- Group 4: Cohort III (nivolumab, ipilimumab)
- Group 5: Cohort VI (azacitidine, nivolumab, ipilimumab)
- Group 6: Cohort II (ipilimumab)
Awards:
This trial has 3 awards, including:- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 5 Other Conditions - This treatment demonstrated efficacy for 5 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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