Spots Global Cancer Trial Database for A Trial of CV301 in Combination With Anti-PD-1 Therapy in Subjects With Non-Small Cell Lung Cancer
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Trial Identification
Brief Title: A Trial of CV301 in Combination With Anti-PD-1 Therapy in Subjects With Non-Small Cell Lung Cancer
Official Title: A Phase 1 Trial of CV301 in Combination With Anti- PD-1 Therapy in Subjects With Non-Small Cell Lung Cancer
Study ID: NCT02840994
Conditions
Study Description
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:
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
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
Contact Details
Name: Cesar Pico-Navarro, MD
Affiliation: Bavarian Nordic
Role: STUDY_DIRECTOR
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