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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 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 288-participant average among 58 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (92% lower). The trial reports 7 study locations across 7 states.

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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.

Conditions Studied

Non-small Cell Lung Cancer (NSCLC)

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

FieldValue
Enrollment Target 24 participants
Start Date 2016-12
Est. Completion 2020-01
Phase Phase 1

Sponsor

Bavarian Nordic

41 total trials

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What the Registry Record Tells You About NCT02840994

The ClinicalTrials.gov registry entry for NCT02840994 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 288-participant average among 58 other Non-small Cell Lung Cancer (NSCLC) trials with a reported enrollment target (92% lower). The listed sponsor is Bavarian Nordic, which has 41 total studies on file at ClinicalTrials.gov.

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 reports 7 study locations spanning 7 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.