A Randomized, Phase 2/3, Open-Label Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab Versus Ipilimumab in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma
Summary
The purpose of this study is to measure the clinical benefits of the combination of RP2 and nivolumab as compared with the combination of nivolumab and ipilimumab in patients with metastatic uveal melanoma who have not been treated with immune checkpoint inhibitor therapy.
Arms & interventions
- BiologicalRP2
Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation.
- BiologicalIpilimumab
Ipilimumab: human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody
- BiologicalNivolumab
Nivolumab: Anti-PD-1 Monoclonal antibody
Outcome measures
Primary
Overall Survival (OS)
OS is the time from the date of randomization to death from any cause.
Time frame: From Day 1 up to 3 years after last dose.
Progression Free Survival (PFS)
PFS is the time from randomization to first evidence of confirmed disease progression as assessed by BICR per RECIST 1.1 or death from any cause.
Time frame: From Day 1 up to 3 years after last dose.
Secondary
Number of patients with treatment-emergent adverse events (TEAEs)
Time frame: From first dose up to 100 days after last dose.
Overall Response Rate (ORR)
Time frame: Every 12 weeks from Day 1 up to 3 years after last dose.
Disease Control Rate (DCR)
Time frame: Every 12 weeks from Day 1 up to 3 years after last dose.
Eligibility criteria
Study locations (29)
HonorHealth Research Insisute
Scottsdale, Arizona, 85258
UC San Diego Moores Cancer Center
La Jolla, California, 92037
The Angeles Clinic and Research Institute
Los Angeles, California, 90025
University of California Los Angeles
Los Angeles, California, 90095
Stanford Cancer Institute
Palo Alto, California, 94304
University of Colorado Hospital - Anschutz Cancer Pavilion(ACP)
Aurora, Colorado, 80045
The Melanoma & Skin Cancer Institute
Englewood, Colorado, 80113
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
Mayo Clinic - Jacksonville FL
Jacksonville, Florida, 32224
Sylvester Comprehensive Cancer Center
Miami, Florida, 33136
Emory Winship Cancer Institute
Atlanta, Georgia, 30322
Northwestern Memorial Hospital
Chicago, Illinois, 60611
University of Chicago Medical Center
Chicago, Illinois, 60637
University of Iowa
Iowa City, Iowa, 52242
Massachusetts General Hospital
Boston, Massachusetts, 02114
Mayo Clinic Rochester
Rochester, Minnesota, 55905
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Duke University Medical Center
Durham, North Carolina, 27710
The Ohio State University
Columbus, Ohio, 43210
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee, 38138
University of Tennessee Medical Center
Knoxville, Tennessee, 37920
Sarah Cannon Research Institute
Nashville, Tennessee, 37203
Vanderbilt Ingram Cancer Center (Henry-Joyce Cancer Clinic)
Nashville, Tennessee, 37232
UT Southwestern Medical Center
Dallas, Texas, 75390
The University Of Texas Md Anderson Cancer Center
Houston, Texas, 77030
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
University Of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, 53792