A Trial of CV301 in Combination With Anti-PD-1 Therapy in Subjects With Non-Small Cell Lung Cancer
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|ClinicalTrials.gov Identifier: NCT02840994|
Recruitment Status : Completed
First Posted : July 21, 2016
Last Update Posted : February 27, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer (NSCLC)||Biological: CV301 Biological: Pembrolizumab Biological: Nivolumab||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||24 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Trial of CV301 in Combination With Anti- PD-1 Therapy in Subjects With Non-Small Cell Lung Cancer|
|Actual Study Start Date :||December 2016|
|Actual Primary Completion Date :||January 2020|
|Actual Study Completion Date :||January 2020|
Experimental: CV301 + Pembrolizumab
CV301 + Pembrolizumab (Phase 1b portion of the trial)
Other Name: KEYTRUDA
Experimental: CV301 + Nivolumab
CV301 + Nivolumab (Phase 1b portion of the trial)
Other Name: OPDIVO
- Safety and tolerability of CV301 alone and in combination determined by incidence of dose-limiting toxicities (DLTs) [ Time Frame: 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).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840994
|United States, Florida|
|H. Lee Moffitt Cancer Center & Research Institute, Inc.|
|Tampa, Florida, United States, 33612|
|United States, Indiana|
|Investigative Clinical Research of Indiana|
|Indianapolis, Indiana, United States, 46260|
|United States, Louisiana|
|Metairie Oncologist, LLC|
|Metairie, Louisiana, United States, 70006|
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63110|
|United States, North Carolina|
|Novant Health Oncology Specialists|
|Winston-Salem, North Carolina, United States, 27103|
|United States, Texas|
|Houston, Texas, United States, 77090|
|Study Director:||Cesar Pico-Navarro, MD||Bavarian Nordic|