Phase 1 Study to Evaluate MEDI4736 in Subjects With Myelodysplastic Syndrome



Status:Recruiting
Conditions:Cancer, Blood Cancer, Blood Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - 99
Updated:3/13/2019
Start Date:May 20, 2014
End Date:March 30, 2020
Contact:AstraZeneca Clinical Study Information Center
Email:information.center@astrazeneca.com
Phone:1-877-240-9479

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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

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

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.

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.
We found this trial at
19
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Detroit, MI
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Greenville, South Carolina 29605
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Houston, TX
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New Haven, CT
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Norfolk, VA
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Paris Cedex 10,
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Rochester, MN
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Springfield, OR
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Tampa, FL
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