A Randomized, Phase 2/3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma
Condition(s) studied
Investigational drug(s) / intervention(s)
RP2: Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation.
Ipilimumab: Ipilimumab: human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody
Nivolumab: Nivolumab: Anti-PD-1 Monoclonal antibody
Study 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.
Eligibility
Primary outcome measure(s)
- Overall Survival (OS) — From Day 1 up to 3 years after last dose.
OS is the time from the date of randomization to death from any cause. - Progression Free Survival (PFS) — From Day 1 up to 3 years after last dose.
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.
Trial sites (33)
| Facility | City | Region | Status |
|---|---|---|---|
| HonorHealth Research Insisute | Scottsdale | Arizona | Recruiting |
| UC San Diego Moores Cancer Center | La Jolla | California | Recruiting |
| The Angeles Clinic and Research Institute | Los Angeles | California | Recruiting |
| University of California Los Angeles | Los Angeles | California | Recruiting |
| Stanford Cancer Institute | Palo Alto | California | Recruiting |
| University of Colorado Hospital - Anschutz Cancer Pavilion(ACP) | Aurora | Colorado | Recruiting |
| The Melanoma & Skin Cancer Institute | Englewood | Colorado | Recruiting |
| Georgetown University Medical Center | Washington D.C. | District of Columbia | Recruiting |
| Mayo Clinic - Jacksonville FL | Jacksonville | Florida | Recruiting |
| Sylvester Comprehensive Cancer Center | Miami | Florida | Recruiting |
| Emory Winship Cancer Institute | Atlanta | Georgia | Recruiting |
| Northwestern Memorial Hospital | Chicago | Illinois | Recruiting |
| University of Chicago Medical Center | Chicago | Illinois | Recruiting |
| University of Iowa | Iowa City | Iowa | Recruiting |
| Massachusetts General Hospital | Boston | Massachusetts | Recruiting |
| Mayo Clinic Rochester | Rochester | Minnesota | Recruiting |
| Memorial Sloan Kettering Cancer Center | New York | New York | Recruiting |
| Duke University Medical Center | Durham | North Carolina | Recruiting |
| The Ohio State University | Columbus | Ohio | Recruiting |
| Thomas Jefferson University | Philadelphia | Pennsylvania | Recruiting |
| UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania | Recruiting |
| The West Clinic, PLLC dba West Cancer Center | Germantown | Tennessee | Recruiting |
| University of Tennessee Medical Center | Knoxville | Tennessee | Recruiting |
| Sarah Cannon Research Institute | Nashville | Tennessee | Recruiting |
| Vanderbilt Ingram Cancer Center (Henry-Joyce Cancer Clinic) | Nashville | Tennessee | Recruiting |
| UT Southwestern Medical Center | Dallas | Texas | Recruiting |
| The University Of Texas Md Anderson Cancer Center | Houston | Texas | Recruiting |
| Fred Hutchinson Cancer Center | Seattle | Washington | Recruiting |
| University Of Wisconsin Carbone Cancer Center - University Hospital | Madison | Wisconsin | Recruiting |
| Melanoma Institute Australia | Wollstonecraft | New South Wales | Recruiting |
| Peter MacCallum Cancer Centre | Melbourne | Victoria | Recruiting |
| The Clatterbridge Cancer Centre NHS Foundation Trust | Liverpool | Merseyside | Recruiting |
| The Royal Marsden NHS Foundation Trust | London | United Kingdom | Recruiting |
On this site
📄 Opdivo (nivolumab) drug profile →More Replimune, Inc. trials in the UK
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06581406 on ClinicalTrials.gov ↗ ← All trials in the UK