An official website of the United States government
Phase 1 Study to Evaluate MEDI4736 in Subjects With Myelodysplastic Syndrome
Trial Status: complete
This is a multicenter, open-label, Phase 1 study to assess the safety and antitumor
activity of MEDI4736 as Monotherapy or in Combination with Tremelimumab with or without
Azacitidine in Subjects with myelodysplastic syndrome after treatment with
hypomethylating agents
Inclusion 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.
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT02117219.