NCT02530463Active, not recruitingPhase 2
Nivolumab and/or Ipilimumab With or Without Azacitidine in Treating Patients With Myelodysplastic Syndrome
Combination of Nivolumab and Ipilimumab With 5-Azacitidine in Patients With Myelodysplastic Syndromes (MDS)
Source: ClinicalTrials.gov · Last updated 14 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 99 (actual)
- First submitted
- 19 Aug 2015
- Start date
- 8 Sept 2015
- Primary completion date
- 30 Sept 2027
- Lead sponsor
- M.D. Anderson Cancer Center
- Diseases
- Myelodysplastic syndromes
- NCT number
- NCT02530463
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 99
- From 8 Sept 2015 to the primary completion date, 30 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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 who are on high dose steroid (equivalent of prednisone more than 10 mg a day) or immune suppression medications
- Current therapy with other systemic anti-neoplastic or anti-neoplastic investigational agents
- Prior treatment with allogeneic stem cell transplantation
Other illness
- Second malignancy currently requiring active therapy, except breast or prostate cancer stable on or responding to endocrine therapy
- History of pneumonitis
- 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
Other
- Patients unwilling or unable to comply with the protocol
- Females who are pregnant or lactating
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| M D Anderson Cancer Center Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.