A Trial of CV301 in Combination With Anti-PD-1 Therapy Versus Anti-PD-1 Therapy in Subjects With Non-Small Cell Lung Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02840994|
Recruitment Status : Recruiting
First Posted : July 21, 2016
Last Update Posted : September 25, 2017
The objective of the proposed clinical trial is to investigate the safety and tolerability of CV301 in combination with Anti-PD1-Therapy compared to Anti-PD1-Therapy alone 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 compared to Anti-PD1-Therapy alone. 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, a Phase 1b portion with 2 cohorts and a Phase 2 portion.
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, before expanding the number of patients to be treated in the randomized Phase 2 portion of the trial.
The objective of the Phase 2 portion is to assess the safety and preliminary efficacy of CV301 in combination with Pembrolizumab compared to Pembrolizumab alone in subjects with NSCLC.
|Condition or disease||Intervention/treatment||Phase|
|Non-small Cell Lung Cancer (NSCLC)||Biological: CV301 Biological: Pembrolizumab||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||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|
|Study Start Date :||December 2016|
|Estimated Primary Completion Date :||December 2020|
Experimental: CV301 + Pembrolizumab
CV301 + Pembrolizumab (Phase 2 portion of the trial)
Other Name: KEYTRUDA
Active Comparator: Pembrolizumab
Pembrolizumab (Phase 2 portion of the trial)
Other Name: KEYTRUDA
- Overall survival (OS) [ Time Frame: 5 years post end of 2 year treatment period ]
- Progression free survival (PFS) of both treatment arms [ Time Frame: 5 years post end of 2 year treatment period ]
- Objective response rate (ORR) [ Time Frame: 5 years post end of 2 year treatment period ]
- Landmark analyses of PFS and OS at 12 months, 18 months, and 24 months in both arms. [ Time Frame: 5 years post end of 2 year treatment period ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02840994
|Contact: Eva Wagnerfirstname.lastname@example.org|
|United States, Maryland|
|Bethesda, Maryland, United States, 20892|
|Contact: James L Gulley, MD|
|Principal Investigator: James L Gulley, MD|
|Study Director:||Cesar Pico-Navarro, MD||Bavarian Nordic|