CV301 in Non-Small Cell Lung Cancer
The first study to explore the combination of CV301 with checkpoint inhibitors is targeting patients with non-small cell lung cancer (NSCLC). The study initially focused on establishing the safety of the combination of CV301 and KEYTRUDA® (pembrolizumab) and will progress into a Phase 2 proof of concept study during 2018. The study will enroll 176 patients who will receive either pembrolizumab with or without chemotherapy, as standard of care, or a combination of CV301 and standard of care (stratified 2:1 in favor of CV301 and standard of care). While the primary endpoint of the study is overall survival (OS), numerous important short-term secondary endpoints including objective response rate (ORR), progression free survival (PFS) and duration of response (DoR) will be evaluated and offer the potential for an early efficacy signal, prior to an overall survival endpoint. The first data to emerge from this study will be an early look at ORR for the first 60 patients, anticipated in late 2018.