A RANDOMIZED, MULTICENTER, OPEN-LABEL, PHASE 2 STUDY EVALUATING THE EFFICACY AND SAFETY OF AZACITIDINE SUBCUTANEOUS IN COMBINATION WITH DURVALUMAB (MEDI4736) IN PREVIOUSLY UNTREATED SUBJECTS WITH HIGHER-RISK MYELODYSPLASTIC SYNDROMES (MDS) OR IN ELDERLY (>/= 65 YEARS) ACUTE MYELOID LEUKEMIA (AML) SUBJECTS NOT ELIGIBLE OR HEMATOPOIETIC STEM CELL TRANSPLANTATION (HSCT)
The goal of this clinical research study is to learn if adding durvalumab to azacitidine can help to control AML and/or MDS. The safety of this drug combination will also be studied.
Treatment Location: N/A
Primary Objectives The primary objective of the study is to evaluate the efficacy of subcutaneous azacitidine in combination with durvalumab as compared with subcutaneous azacitidine alone in the defined study population. Secondary Objectives The secondary objectives are to: Assess the safety and tolerability of subcutaneous azacitidine in combination with durvalumab as compared with subcutaneous azacitidine alone in the defined study population Assess the pharmacokinetics (PK) of durvalumab when given in combination with subcutaneous azacitidine in the defined study population. Exploratory Objectives The exploratory objectives are: Evaluate the effect of subcutaneous azacitidine in combination with durvalumab on health-related quality-of-life (HRQoL) and healthcare resource utilization (HRU) as compared to subcutaneous azacitidine alone, Describe the immunogenicity of durvalumab in combination with subcutaneous azacitidine in the defined study population, Establish PK/pharmacodynamic (PD) relationship, explore pharmacodynamic, mechanistic, and predictive biomarkers of durvalumab when given in combination with subcutaneous azacitidine in the defined study population.
IRB Review and Approval Date: 12/14/2016
Recruitment Status: Closed
Projected Accrual: N/A
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