CV301 in Non-Small Cell Lung Cancer
CV301 is subject of a randomized Phase 2 proof of concept study in non-small cell lung cancer patients. The study will enroll 176 patients who will receive either KEYTRUDA® (pembrolizumab) monotherapy, as standard of care, or a combination of CV301 and standard of care.
A small Phase 1b study will investigate the safety of combining CV301 and KEYTRUDA before initiation of the Phase 2. Additionally safety data will emerge from the original Phase 1 study that investigated the combination of CV301 and OPDIVO® (nivolumab). 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 Phase 2 part of the study is anticipated to initiate in the fourth quarter of 2017.