Clinical Trials Search
Clinical Trial 18599
Cancer Type: Malignant Hematology
Interventions:AMP-514 (Durvalumab); Azacitidine (Oral); CC-486 (Azacitidine (Oral)); Durvalumab; MEDI4736 (Durvalumab)
Study Type: Treatment
Phase of Study: Phase II
- Rami Komrokji
A Phase 2, International, Multicenter,Randomized, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of CC-486 (Oral Azacitidine) Alone and in Combination with Durvalumab (Medi4736) in Subjects with Myelodysplastic Syndromes who Fail to Achieve an Objective Response to Treatment with Azacitidine for Injection or Decitabine
The purpose of this study is to evaluate the safety and efficacy of CC-486 and Durvalumab in participants with Myelodysplastic Syndromes who failed to achieve an objective response post iHMA treatment.
Primary Objective: The primary objective of this study is to investigate the efficacy of CC-486 as monotherapy and in combination with anti-PD-L1 monoclonal antibody, durvalumab (MEDI4736), in subjects with MDS that did not respond to prior treatment with an injectable hypomethylating agent (HMA azacitidine for injection or decitabine), or were unable to tolerate treatment with an injectable HMA. Secondary Objectives: The secondary objectives of the study are to: - Assess the safety and tolerability of CC-486 alone and in combination with durvalumab, as treatment for MDS. - Describe the clinical relevance of objective hematologic and/or biologic responses associated with treatment with CC-486 alone and in combination with durvalumab. - Evaluate the impact (if any) of durvalumab on the pharmacokinetics of CC-486 and CC-486 on durvalumab in subjects with MDS. Exploratory Objectives: - Determine the immunogenicity of durvalumab when given in combination with CC-486 in subjects with MDS. - Evaluate molecular and cellular markers in bone marrow and/or peripheral blood that may impact azacitidine efficacy (resistance to azacitidine for injection and/or CC-486 resistance or sensitivity). - Establish PK/pharmacodynamic relationship, explore pharmacodynamic mechanistic, and predictive biomarkers of CC-486 as a single agent and when given in combination with durvalumab in subjects with MDS. - Evaluate additional measures of efficacy of monotherapy and combination therapy in subjects with MDS.