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NCT02840994 · ClinicalTrials.gov registry record · Phase 1
A Trial of CV301 in Combination With Anti-PD-1 Therapy in Subjects With Non-Small Cell Lung Cancer
A Phase 1 study of Non-small Cell Lung Cancer (NSCLC), sponsored by Bavarian Nordic.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 7
- Study locations
NCT02840994: Completed Phase 1 study of Non-small Cell Lung Cancer (NSCLC), sponsored by Bavarian Nordic.
NCT02840994 is a Phase 1 study of Non-small Cell Lung Cancer (NSCLC) that has completed, run by Bavarian Nordic. The registered enrollment target is 24 participants, below the 285-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (92% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02840994, a Phase 1 study of Non-small Cell Lung Cancer (NSCLC), has completed, sponsored by Bavarian Nordic.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 7
- Study locations
Study 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.
Primary Outcome
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).
Conditions Studied
Interventions
- BIOLOGICAL Pembrolizumab
- BIOLOGICAL Nivolumab
- BIOLOGICAL CV301
Study Locations (7)
Florida
- H. Lee Moffitt Cancer Center & Research Institute, Inc. - Tampa
Indiana
- Investigative Clinical Research of Indiana - Indianapolis
Louisiana
- Metairie Oncologist, LLC - Metairie
Maryland
- NCI - Bethesda
Missouri
- Washington University School of Medicine - St Louis
North Carolina
- Novant Health Oncology Specialists - Winston-Salem
Texas
- Millennium Oncology - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2016-12 |
| Est. Completion | 2020-01 |
| Phase | Phase 1 |
What the finished NCT02840994 record still lists
NCT02840994 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 285-participant average among 59 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Non-small Cell Lung Cancer (NSCLC) appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT02840994 lists 7 locations in 7 states (Florida, Indiana, Louisiana).
Frequently Asked Questions
What is clinical trial NCT02840994 about?
NCT02840994 is a clinical study titled "A Trial of CV301 in Combination With Anti-PD-1 Therapy in Subjects With Non-Small Cell Lung Cancer". 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-Th...
What is the current status of trial NCT02840994?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2016-12. Estimated completion is 2020-01.
What conditions does trial NCT02840994 study?
This clinical trial studies the following conditions: Non-small Cell Lung Cancer (NSCLC).
What interventions are being tested in trial NCT02840994?
The interventions under investigation include: Pembrolizumab (BIOLOGICAL), Nivolumab (BIOLOGICAL), CV301 (BIOLOGICAL).
Who is sponsoring clinical trial NCT02840994?
This trial is sponsored by Bavarian Nordic, which has 41 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02840994 being conducted?
This trial has 7 study locations across Florida, Indiana, Louisiana, Maryland, Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02840994's enrollment target sits among peer trials
24 54th of 59 higher than 6 of 59 other Non-small Cell Lung Cancer (NSCLC) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Non-small Cell Lung Cancer (NSCLC) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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