Clinical Trials Search
Clinical Trial 18772
Cancer Type: Malignant Hematology
Interventions:AMP-514 (Durvalumab); Durvalumab; MEDI4736 (Durvalumab); azacitidine (5-azacitidine)
Study Type: Treatment
Phase of Study: Phase II
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 for Hematopoietic Stem Cell Transplantation (HSCT)
The purpose of this study is to look at the safety and effectiveness of the addition of a study drug (durvalumab, also referenced as MEDI4736), to the standard of care treatment azacitidine.
Primary Objective: Efficacy: - Evaluate the efficacy of subcutaneous (sc) azacitidine in combination with durvalumab as compared with subcutaneous azacitidine alone in the defined study population. Secondary Objectives: Safety: - Assess the safety and tolerability of subcutaneous (sc) azacitidine in combination with durvalumab compared with subcutaneous azacitidine alone in the defined study population. Pharmacokinetics: - To assess the pharmacokinetics (PK) of durvalumab when given in combination with subcutaneous azacitidine in the defined study population.