Testing the Safety and Efficacy of the Combination of the Antibody Pembrolizumab and Entinostat in Patients With Myelodysplastic Syndrome Who Are Not Responding to Hypomethylating Agents

Summary

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Description

PRIMARY OBJECTIVE: I. To assess safety, tolerability, and identify the maximum tolerated dose (MTD) of entinostat given in combination with MK-3475 (pembrolizumab). SECONDARY OBJECTIVE: I. To obtain a preliminary estimate of efficacy of entinostat in combination with MK-3475 (pembrolizumab). EXPLORA...

PRIMARY OBJECTIVE: I. To assess safety, tolerability, and identify the maximum tolerated dose (MTD) of entinostat given in combination with MK-3475 (pembrolizumab). SECONDARY OBJECTIVE: I. To obtain a preliminary estimate of efficacy of entinostat in combination with MK-3475 (pembrolizumab). EXPLORATORY OBJECTIVE: I. To assess the dynamic quantitative change in measurable immunological biomarkers (proportions of myeloid-derived suppressor cells [MDSCs], and programmed death protein-1 [PD-1] expression in bone marrow) with the combined epigenetic-immunotherapy and correlation with any observed clinical responses. OUTLINE: This is a dose-escalation study of entinostat. Patients receive lower dose entinostat orally (PO) on days 1 and 8 or higher dose entinostat PO on days 1, 8, and 15, and pembrolizumab intravenously (IV) over 30 minutes on day 1 of cycle 2 and cycles thereafter. Treatment repeats every 21 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients who achieve an objective response or maintain a stable disease (SD) status after the first 4 cycles may continue to receive entinostat and pembrolizumab for up to 1 year. After completion of study treatment, patients are followed up monthly for 6 months.

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