Phase 1 Study to Evaluate MEDI4736

Status: Recruiting
Phase:
Diagnosis: Leukemia/MDS
NCT ID: NCT02117219 (View complete trial on ClinicalTrials.gov)
DFCI Protocol ID: 14-115

 

This is a multicenter, open-label, Phase 1 study to assess the safety and antitumor activity of MEDI4736 in subjects with myelodysplastic syndrome.

 

Conducting Institutions:
Dana-Farber Cancer Institute, Brigham and Women's Hospital

Overall PI:
Robert Coleman Lindsley, MD, PhD, Dana Farber Cancer Institute

Site-responsible Investigators:

Contacts:
Dana-Farber Cancer Institute: Ilene Galinsky, 617-632-3902, igalinsky@partners.org

Eligibility Criteria

Inclusion Criteria: Adult male or female subjects with pathologically confirmed MDS who failed to respond, relapsed after an initial response, or were unable to tolerate hypomethylating agents, ECOG performance status of 0 - 2, and adequate organ and marrow function. Exclusion Criteria: Concurrent chemotherapy, immunotherapy, biologic, or hormonal therapy for cancer treatment, prior MAb against CTLA-4, PD-1, or PD-L1, alllogenic or haploidentical transplant, current immunosuppressive medication or autoimmune or inflammatory disease.
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