Clinical Trials Search
Clinical Trial 19344
Interventions:FPV-CV301; MVA-BN-CV301; Pembrolizumab (Keytruda)
Study Type: Treatment
Phase of Study: Phase I
- Jhanelle Gray
A Phase 1/2 Trial of CV301 in Combination with Anti-PD-1 Therapy versus Anti-PD-1 Therapy alone in Subjects with Non-Small Cell Lung Cancer
The purpose of this clinical trial is to investigate the combination of CV301 (an experimental cancer vaccine) with Anti-PD-1 Therapy (Pembrolizumab) for treatment of non-small cell lung cancer. In Phase 1b Pembrolizumab will be used. In Phase 2 Pembrolizumab will be used. Pembrolizumab is an Anti-PD-1 Therapy which was approved as of June 2017 for first-line treatment of NSCLC.
Phase 1: To assess the safety and identify the recommended dose of CV301 for the next development phases. Phase 1b: Cohort 1: To assess the safety, tolerability, and dose of CV301 in combination with Nivolumab. Cohort 2: To assess the safety, tolerability, and dose of CV301 in combination with Pembrolizumab. Phase 2: To assess the safety and preliminary efficacy of CV301 in combination with Pembrolizumab maintenance compared to Pembrolizumab maintenance alone in subjects with NSCLC as measured by overall survival (OS).