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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

Must not have

Females who are pregnant or lactating

Patients with autoimmune diseases (e.g., rheumatoid arthritis, systemic progressive sclerosis [scleroderma], systemic lupus erythematosus, autoimmune vasculitis [e.g., Wegener's granulomatosis])

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 weeks

Awards & highlights

All Individual Drugs Already Approved

Approved for 5 Other Conditions

No Placebo-Only Group

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.

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.

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 below

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I have not received any treatment for my condition.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or breastfeeding.

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I have an autoimmune disease like rheumatoid arthritis or lupus.

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I have had pneumonitis before.

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I am taking high doses of steroids or medications that suppress my immune system.

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I do not have active hepatitis B, hepatitis C, or HIV.

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I am not undergoing active treatment for a second cancer, except if it's breast or prostate cancer being managed with hormone therapy.

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I have a history of inflammatory bowel disease like Crohn's or ulcerative colitis.

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I have had a stem cell transplant from a donor.

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I am not currently on any cancer treatment drugs or in any cancer drug trials.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Overall Response Rate (ORR) in MDS Participants Who Have Not Received Hypomethylating Agents

Muscular Dystrophy

Awards & Highlights

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.

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

0 / 11Eligibility criteria met