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A Phase I/II Study of Pembrolizumab and Vorinostat in Patients with Immune Therapy Naïve and Immune Therapy Pretreated Stage IV NSCLC
The main purpose of this study is to see whether the combination of two drugs called pembrolizumab and vorinostat can help people with advanced lung cancer. Researchers also want to find out if the combination of pembrolizumab and vorinostat is safe and tolerable. This study will compare the effects of the combination of two drugs called pembrolizumab and vorinostat with the effects of pembrolizumab alone. The U.S. Food and Drug Administration (FDA) has approved pembrolizumab for use to treat a deadly skin cancer called melanoma and lung cancer and vorinostat to treat some forms of blood and lymph node cancers.
PRIMARY OBJECTIVES Phase 1 Escalation: Primary Objective: To determine the safety, tolerability and feasibility of concurrent administration of vorinostat and Pembrolizumab. Phase 1b Expansion (Single Arm, Pre-treated Cohort): Primary Objective: To determine whether concurrent administration of vorinostat and Pembrolizumab will be effective in NSCLC patients who have been previously exposed to anti-PD-1 or anti-PD-L1 therapy. Phase II (Randomized, Treatment Naïve Cohort): Primary Objective: To determine whether concurrent administration of vorinostat and Pembrolizumab is more effective than Pembrolizumab alone. SECONDARY OBJECTIVES Secondary Objectives (Phase 1 expansion and phase II Arms A and B): 1.To determine immunogenicity molecular profiles that correlate with outcome measures. 2.To determine immunogenicity profiles that correlate with resistance to therapy.