Immunotherapy-Chemo cocktail targets Hard-to-Treat MDS
NCT ID NCT02530463
First seen Jun 27, 2026 · Last updated Sep 15, 2026 · Updated 2 times
Summary
This phase 2 trial tests a combination of two immunotherapy drugs (nivolumab and ipilimumab) plus a chemotherapy drug (azacitidine) in 99 people with myelodysplastic syndromes (MDS), a type of blood cancer. The goal is to see if the combination improves response rates, especially in patients who have not responded to standard treatments. Participants receive the drugs intravenously, and the study tracks side effects and how well the cancer responds.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- nivolumab, ipilimumab, and azacitidine
- What this could lead to
- If it works, this could offer a new treatment option for people with myelodysplastic syndromes, especially those who have not responded to standard therapy.
- What could go wrong
- This is an early phase 2 trial with only 99 participants, so results may not apply to everyone. The combination of drugs can cause serious side effects, and it is not yet known if it works better than existing treatments.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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99 people
The number who actually took part.
- Started
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Sep 2015
- Expected to finish
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Sep 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Patients with MDS (up to 20% blasts) of any risk as defined as: * Previously untreated * Previously treated with hypomethylating agent (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 International Working Group (IWG) 2006 criteria; no response will be lack of clinical benefit after at least 6 cycles of HMA therapy * Creatinine =\< 2.0 x upper limit of normal (ULN) * Serum bilirubin =\< 2.0 x ULN * Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) =\< 2.0 x ULN * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 * Females of childbearing potential must have a negative serum or urine beta human chorionic gonadotropin (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 * 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 * Patients or their legally authorized representative must provide written informed consent Exclusion Criteria: * Second malignancy currently requiring active therapy, except breast or prostate cancer stable on or responding to endocrine therapy * Any major surgery, radiotherapy, chemotherapy, biologic therapy, immunotherapy, experimental therapy within 2 weeks prior to the first dose of the study drugs * Patients with any other known concurrent severe and/or uncontrolled medical condition (e.g. uncontrolled diabetes; cardiovascular disease including congestive heart failure New York Heart Association \[NYHA\] 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 * Patients unwilling or unable to comply with the protocol * History of pneumonitis * Patients who are on high dose steroid (equivalent of prednisone more than 10 mg a day) or immune suppression medications * Patients with autoimmune diseases (e.g., rheumatoid arthritis, systemic progressive sclerosis \[scleroderma\], systemic lupus erythematosus, autoimmune vasculitis \[e.g., Wegener's granulomatosis\]) * Patients with a history of inflammatory bowel disease such as Crohn's disease and ulcerative colitis * 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 human immunodeficiency virus (HIV) disease are also excluded from the study * Current therapy with other systemic anti-neoplastic or anti-neoplastic investigational agents * Females who are pregnant or lactating * Prior treatment with allogeneic stem cell transplantation
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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M D Anderson Cancer Center
Houston, Texas, 77030, United States
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