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

Phase 1

Completed

• Conditions: Non-small Cell Lung Cancer (NSCLC)
• Interventions: Biological: CV301; Biological: Pembrolizumab; Biological: Nivolumab

• Registration Number: NCT02840994
• Lead Sponsor: Bavarian Nordic

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-18
• Study First Submitted QC: 2016-07-20
• Study First Posted: 2016-07-21
• Study Start: 2016-12
• Primary Completion: 2020-01
• Study Completion: 2020-01
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-26
• Last Update Posted: 2020-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CV301 + Pembrolizumab	CV301	CV301 + Pembrolizumab (Phase 1b portion of the trial)
CV301 + Pembrolizumab	Pembrolizumab	CV301 + Pembrolizumab (Phase 1b portion of the trial)
CV301 + Nivolumab	Nivolumab	CV301 + Nivolumab (Phase 1b portion of the trial)
CV301 + Nivolumab	CV301	CV301 + Nivolumab (Phase 1b portion of the trial)

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of CV301 alone and in combination determined by incidence of dose-limiting toxicities (DLTs)	Through study completion, up to 2 years	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).

Trial Locations

Locations (7)

Metairie Oncologist, LLC; 🇺🇸 Metairie, Louisiana, United States

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States

Novant Health Oncology Specialists; 🇺🇸 Winston-Salem, North Carolina, United States

Millennium Oncology; 🇺🇸 Houston, Texas, United States

NCI; 🇺🇸 Bethesda, Maryland, United States

Investigative Clinical Research of Indiana; 🇺🇸 Indianapolis, Indiana, United States

H. Lee Moffitt Cancer Center & Research Institute, Inc.; 🇺🇸 Tampa, Florida, United States