Myelodysplastic Syndrome Clinical Trial
Phase 1 Study to Evaluate MEDI4736 in Subjects With Myelodysplastic Syndrome
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
Full 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.
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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There are 21 Locations for this study
Scottsdale Arizona, 85259, United States
Los Angeles California, 90095, United States
New Haven Connecticut, 06520, United States
Tampa Florida, 33612, United States
Atlanta Georgia, 30322, United States
Chicago Illinois, 60637, United States
Baltimore Maryland, 21201, United States
Boston Massachusetts, 02215, United States
Detroit Michigan, 48201, United States
Rochester Minnesota, 55905, United States
New York New York, 10029, United States
New York New York, 10065, United States
Greenville South Carolina, 29601, United States
Houston Texas, 77030, United States
San Antonio Texas, 78229, United States
Milwaukee Wisconsin, 53226, United States
Paris Cedex 10 , 75475, France
Dresden , 1307, Germany
Brighton , BN2 5, United Kingdom
London , SE5 9, United Kingdom
Manchester , M20 4, United Kingdom
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