A Trial of CV301 in Combination With Anti-PD-1 Therapy in Subjects With Non-Small Cell Lung Cancer

Part of paid clinical trials in Tampa, Florida.

Sponsor
Bavarian Nordic
Study ID
NCT02840994
Phase
PHASE1
Status
Completed

Conditions

  • Non-small Cell Lung Cancer (NSCLC)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CV301 — BIOLOGICAL
  • Pembrolizumab — BIOLOGICAL
  • Nivolumab — BIOLOGICAL

Study Details

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.

Key Dates

Start date
Dec 31, 2016
Status verified
Feb 2020
Primary completion
Jan 31, 2020
Completion
Jan 31, 2020

Study Design

Enrollment
24 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: CV301 + Pembrolizumab
    CV301 + Pembrolizumab (Phase 1b portion of the trial)
  • Experimental: CV301 + Nivolumab
    CV301 + Nivolumab (Phase 1b portion of the trial)

Primary Outcome Measure

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 ]

Locations (7)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center & Research Institute, Inc.TampaFlorida33612-
Investigative Clinical Research of IndianaIndianapolisIndiana46260-
Metairie Oncologist, LLCMetairieLouisiana70006-
NCIBethesdaMaryland20892-
Washington University School of MedicineSt LouisMissouri63110-
Novant Health Oncology SpecialistsWinston-SalemNorth Carolina27103-
Millennium OncologyHoustonTexas77090-

Find similar trials in Tampa, FL

By research site
H. Lee Moffitt Cancer Center & Research Institute, Inc.· Tampa, FLInvestigative Clinical Research of Indiana· Indianapolis, INMetairie Oncologist, LLC· Metairie, LANCI· Bethesda, MDWashington University School of Medicine· St Louis, MONovant Health Oncology Specialists· Winston-Salem, NC

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