Study on Nivolumab and/or Ipilimumab With or Without Azacitidine for Treating Myelodysplastic Syndrome

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0

ClinicalTrials ID:NCT02530463

Provider View

This clinical trial is exploring the effects of using nivolumab and/or ipilimumab, with or without azacitidine, to treat patients with myelodysplastic syndrome (MDS). The study aims to understand how these treatments work together to stop cancer growth and improve patient outcomes.

Patient Parameters

Program Overview

This phase II study is investigating the safety and effectiveness of combining nivolumab and ipilimumab, which are monoclonal antibodies, with or without the chemotherapy drug azacitidine, in treating myelodysplastic syndrome (MDS). These treatments may help block cancer growth by targeting specific cells and stopping them from growing or spreading. The study aims to see if this combination works better than current treatments for MDS.

Description

The main goal of this study is to determine how safe nivolumab and ipilimumab are, whether used alone or together, and with azacitidine, in patients with myelodysplastic syndrome (MDS). Researchers also want to explore how well these treatments work in controlling the disease and their biological effects on patients.

Patients are divided into six groups based on their treatment history and current condition:

  • Group I: Patients receive nivolumab every two weeks for up to six cycles unless the disease worsens or side effects become unacceptable. If the disease progresses, patients may also receive azacitidine.
  • Group II: Patients receive ipilimumab every three weeks unless the disease worsens or side effects become unacceptable. If the disease progresses, patients may also receive azacitidine.
  • Group III: Patients receive both nivolumab and ipilimumab every four weeks for up to four cycles. Afterward, they continue with nivolumab every two or four weeks, depending on whether they also receive azacitidine, unless the disease worsens or side effects become unacceptable.
  • Group IV: Patients receive azacitidine for five days and nivolumab on days six and twenty, repeating every four weeks unless the disease worsens or side effects become unacceptable.
  • Group V: Patients receive azacitidine for five days and ipilimumab on day six, repeating every four weeks unless the disease worsens or side effects become unacceptable.
  • Group VI: Patients receive azacitidine for five days, nivolumab, and ipilimumab on day six, with ipilimumab repeating every four weeks for four cycles. Nivolumab and azacitidine cycles repeat every four weeks unless the disease worsens or side effects become unacceptable.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with myelodysplastic syndrome (MDS) with up to 20% blasts, either untreated or previously treated with hypomethylating agents.
  • Normal kidney and liver function as indicated by specific blood tests.
  • Good overall health with an ECOG performance status of 0 to 2.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective contraception during and after the study.
  • Men with partners of childbearing potential must agree to use effective contraception during and after the study.
  • Must provide written informed consent to participate.

Exclusion Criteria

  • Currently undergoing treatment for another cancer, except stable breast or prostate cancer on hormone therapy.
  • Recent major surgery, radiation, or chemotherapy within two weeks before starting the study.
  • Severe or uncontrolled medical conditions that could interfere with the study.
  • History of lung inflammation (pneumonitis) or autoimmune diseases like rheumatoid arthritis or lupus.
  • Positive for hepatitis B, hepatitis C, or HIV.
  • Currently pregnant or breastfeeding.
  • Previous treatment with stem cell transplantation.

Locations

FACILITYZIPCITYSTATE
M D Anderson Cancer Center77030HoustonTexas

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