A Trial of CV301 in Combination With Anti-PD-1 Therapy in Subjects With Non-Small Cell Lung Cancer
Completed · Phase 1
Conditions studied: Non-small Cell Lung Cancer (NSCLC)
In brief
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.
Key facts
- Study ID
- NCT02840994
- Run by
- Bavarian Nordic
- People needed
- 24
- Starts
- 2016-12-01
- Expected to finish
- 2020-01-01
- Last updated by the study team
- 2020-02-27
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- 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 — St Louis, Missouri, United States
- Novant Health Oncology Specialists — Winston-Salem, North Carolina, United States
- Millennium Oncology — Houston, Texas, United States
Full record on ClinicalTrials.gov
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