A Trial of CV301 in Combination With Anti-PD-1 Therapy in Subjects With Non-Small Cell Lung Cancer
- Conditions
- Non-small Cell Lung Cancer (NSCLC)
- Registration Number
- NCT02840994
- Lead Sponsor
- Bavarian Nordic
- Brief Summary
The objective of the proposed clinical trial is to investigate the safety and tolerability of CV301 in combination with Anti-PD1-Therapy in subjects with non-small cell lung cancer (NSCLC).
The clinical trial is designed to evaluate the possible enhanced antitumor activity of CV301 with Anti-PD1-Therapy. The rationale for combining CV301 with Anti-PD1-Therapy is based on the hypothesis that CV301 can induce specific immune response in the tumor, and that in combination, Anti-PD1-Therapy may augment the T cell-mediated immune response generated by CV301 by blocking the inhibitory signal of the PD-1.
The trial will include a Phase 1 portion and a Phase 1b portion with 2 cohorts. The Phase 1 portion is a dose escalation part to assess the safety and tolerability of CV301 alone, prior to moving into the combination with Anti-PD1-Therapy (the Phase 1b component).
The following Phase 1b portion of the trial aims to test the safety and tolerability of the combination treatment using a two cohort approach with cohort 1 receiving CV301 plus Nivolumab and cohort 2 receiving CV301 plus Pembrolizumab.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Safety and tolerability of CV301 alone and in combination determined by incidence of dose-limiting toxicities (DLTs) Through study completion, up to 2 years Safety and tolerability following administration of CV301 alone (Phase 1) and in combination with Nivolumab or Pembrolizumab (Phase 1b), respectively, as determined by the incidence of dose-limiting toxicities (DLTs).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
H. Lee Moffitt Cancer Center & Research Institute, Inc.
🇺🇸Tampa, Florida, United States
Investigative Clinical Research of Indiana
🇺🇸Indianapolis, Indiana, United States
Metairie Oncologist, LLC
🇺🇸Metairie, Louisiana, United States
NCI
🇺🇸Bethesda, Maryland, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Novant Health Oncology Specialists
🇺🇸Winston-Salem, North Carolina, United States
Millennium Oncology
🇺🇸Houston, Texas, United States
H. Lee Moffitt Cancer Center & Research Institute, Inc.🇺🇸Tampa, Florida, United States