A Trial of CV301 in Combination With Anti-PD-1 Therapy in Subjects With Non-Small Cell Lung Cancer
Public ClinicalTrials.gov record NCT02840994. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 1 Trial of CV301 in Combination With Anti- PD-1 Therapy in Subjects With Non-Small Cell Lung Cancer
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT02840994
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 1
- Enrollment
- 24 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2016
- Primary completion
- Dec 31, 2019
- Completion
- Dec 31, 2019
- Last update posted
- Feb 26, 2020
2016 – 2020
United States locations
- U.S. sites
- 7
- U.S. states
- 7
- U.S. cities
- 7
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| H. Lee Moffitt Cancer Center & Research Institute, Inc. | Tampa | Florida | 33612 | — |
| Investigative Clinical Research of Indiana | Indianapolis | Indiana | 46260 | — |
| Metairie Oncologist, LLC | Metairie | Louisiana | 70006 | — |
| NCI | Bethesda | Maryland | 20892 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Novant Health Oncology Specialists | Winston-Salem | North Carolina | 27103 | — |
| Millennium Oncology | Houston | Texas | 77090 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02840994, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Feb 26, 2020 · Synced Sep 29, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT02840994 live on ClinicalTrials.gov.