A Phase 1b/2, Open-label, Dose Escalation Study of Entinostat in Combination with Pembrolizumab in Patients with Non-small Cell Lung Cancer, with Expansion Cohorts in Patients with Non-small Cell Lung Cancer and Melanoma
Description: 
Study SNDX-275-0601 is an open-label, Phase 1b/2 study evaluating the combination of entinostat plus pembrolizumab in patients with advanced metastatic or recurrent NSCLC or melanoma. The study has 2 phases, a Dose Escalation/Confirmation Phase (Phase 1b) and an Expansion Phase (Phase 2), with the Expansion Phase utilizing a Simon 2-stage design (Simon 1989) for each cohort. An additional cohort (Entinostat Monotherapy Immune Correlate [EMIC] Cohort) evaluating single agent entinostat followed by the combination will also be evaluated in patients with NSCLC in the Phase 2 expansion phase.
Study Number: 

PH 269015

Phase: 
Early Phase
Principal Investigator: 
ClinicalTrials.Gov ID: 
NCT02437136

To inquire about participating in these studies, call 1-877-ASK-RPCI (1-877-275-7724) or e-mail askrpci@roswellpark.org.