A Phase 1/2 Study of Azacitidine in Combination With Pembrolizumab and Epacadostat Advanced Solid Tumors including Lung and Colorectal Cancer

Primary objectives: • Part 1: To evaluate the safety and tolerability and to determine the maximum tolerated dose (MTD; or the maximum tested dose) of the combination in subjects with advanced or metastatic solid tumors.
• Part 2: To evaluate the efficacy of the combination in subjects with previously treated Stage IIIB or Stage IV non–small cell lung cancer (NSCLC), Stage IV microsatellite stable (MSS) colorectal cancer (CRC), and other select solid tumors by assessing the objective response rate (ORR) per RECIST v1.1 at the MTD or maximum tested dose.
Primary endpoints: • Part 1: Safety and tolerability will be assessed by monitoring the frequency, duration, and severity of adverse events (AEs); through physical examinations; by evaluating changes in vital signs and electrocardiograms (ECGs); and through clinical laboratory blood and urine sample evaluations.
• Part 2: Objective response rate, defined as the percentage of subjects having a complete response (CR) or partial response (PR), will be determined by investigator assessment of radiographic disease as per RECIST v1.1.