NCT03633110 - Safety, Tolerability, Immunogenicity, and Antitumor Activity of GEN-009 Adjuvanted Vaccine | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

August 29, 2018

Primary Completion Date

December 8, 2021

Study Completion Date

February 28, 2022

Conditions

Cutaneous MelanomaNon-small Cell Lung CancerSquamous Cell Carcinoma of the Head and NeckUrothelial CarcinomaRenal Cell Carcinoma

Interventions

BIOLOGICAL

GEN-009 Adjuvanted Vaccine

GEN-009 Adjuvanted Vaccine consists of GEN-009 Drug Product mixed with Hiltonol (poly-ICLC, adjuvant) and is administered by subcutaneous injection.

DRUG

Nivolumab

Nivolumab is a PD-1 checkpoint inhibitor approved by the FDA to treat the tumor types in this study.

DRUG

Pembrolizumab

Pembrolizumab is a PD-1 checkpoint inhibitor approved by the FDA to treat the tumor types in this study.

Trial Locations (11)

Columbia University Medical Center - Herbert Irving Pavilion, New York

Hospital of the University of Pennsylvania, Philadelphia

The Sarah Cannon Research Institute, Nashville

Karmanos Cancer Institute, Detroit

University of Wisconsin Carbone Cancer Center, Madison

University of Nebraska Medical Center, Omaha

The University of Texas MD Anderson Cancer Center, Houston

University of Colorado, Anschutz Cancer Pavilion, Aurora

John Wayne Cancer Institute - Providence Saint John's Health Center, Santa Monica

UC San Diego Moores Cancer Center, La Jolla

Dana-Farber Cancer Institute, Boston