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Brief Title: Phase 1 Study to Evaluate MEDI4736 in Subjects With Myelodysplastic Syndrome
Official Title: A Phase 1 Study to Evaluate the Safety and Tolerability of MEDI4736 as Monotherapy or in Combination With Tremelimumab With or Without Azacitidine in Subjects With Myelodysplastic Syndrome After Treatment With Hypomethylating Agents
Study ID: NCT02117219
Brief Summary: 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
Detailed Description: A dose-escalation and dose-expansion study of MEDI4736 (a monoclonal antibody that targets programmed cell death-1 ligand 1 \[PD-L1\]) to evaluate the safety, tolerability, PK, IM, and antitumor activity of MEDI4736 as monotherapy or in combination with Tremelimumab with or without Azacitidine in adult patients with myelodysplastic syndrome.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Research Site, Scottsdale, Arizona, United States
Research Site, Los Angeles, California, United States
Research Site, New Haven, Connecticut, United States
Research Site, Tampa, Florida, United States
Research Site, Atlanta, Georgia, United States
Research Site, Chicago, Illinois, United States
Research Site, Baltimore, Maryland, United States
Research Site, Boston, Massachusetts, United States
Research Site, Detroit, Michigan, United States
Research Site, Rochester, Minnesota, United States
Research Site, New York, New York, United States
Research Site, New York, New York, United States
Research Site, Greenville, South Carolina, United States
Research Site, Houston, Texas, United States
Research Site, San Antonio, Texas, United States
Research Site, Milwaukee, Wisconsin, United States
Research Site, Paris Cedex 10, , France
Research Site, Dresden, , Germany
Research Site, Brighton, , United Kingdom
Research Site, London, , United Kingdom
Research Site, Manchester, , United Kingdom
Name: MedImmune LLC
Affiliation: MedImmune LLC
Role: STUDY_DIRECTOR