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

Part of paid clinical trials in Scottsdale, Arizona.

Sponsor
Replimune, Inc.
Study ID
NCT06581406
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Uveal Melanoma

Eligibility Criteria

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

Interventions

  • RP2 — BIOLOGICAL
    Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation.
  • Ipilimumab — BIOLOGICAL
    Ipilimumab: human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody
  • Nivolumab — BIOLOGICAL
    Nivolumab: Anti-PD-1 Monoclonal antibody

Study Details

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.

Key Dates

Start date
Dec 17, 2024
Status verified
Mar 2026
Primary completion
Jan 31, 2030
Completion
Oct 31, 2031

Study Design

Enrollment
280 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Test Arm: RP2 + nivolumab
    RP2 (Oncolytic virus) and Nivolumab (programmed death receptor-1 (PD-1) inhibitor)
  • Experimental: Control Arm (Active Comparator): ipilimumab + nivolumab
    Immune Checkpoint inhibitor combination

Primary Outcome Measure

Overall Survival (OS) [ Time Frame: From Day 1 up to 3 years after last dose. ]

Central Contacts

Locations (29)

FacilityCityStateZIPSite coordinators
HonorHealth Research InsisuteScottsdaleArizona85258
Justin Moser, MD
UC San Diego Moores Cancer CenterLa JollaCalifornia92037
Gregory Daniels, MD
The Angeles Clinic and Research InstituteLos AngelesCalifornia90025
Inderjit Mehmi, MD
University of California Los AngelesLos AngelesCalifornia90095
Bartosz Chmielowski, MD
Stanford Cancer InstitutePalo AltoCalifornia94304
Allison Betof Warner, MD
University of Colorado Hospital - Anschutz Cancer Pavilion(ACP)AuroraColorado80045
Sapna Pradyuman Patel, MD
The Melanoma & Skin Cancer InstituteEnglewoodColorado80113
Ryan Weight, DO, MS
Georgetown University Medical CenterWashington D.C.District of Columbia20007
Suthee Rapisuwon, MD
Mayo Clinic - Jacksonville FLJacksonvilleFlorida32224
Roxana S. Dronca, MD
Sylvester Comprehensive Cancer CenterMiamiFlorida33136
Leonel Fernando Hernandez Aya, MD
Emory Winship Cancer InstituteAtlantaGeorgia30322
Michael Lowe, MD
Northwestern Memorial HospitalChicagoIllinois60611
Sunandana Chandra, MD, MS
University of Chicago Medical CenterChicagoIllinois60637
Daniel Olson, MD
University of IowaIowa CityIowa52242
Asad Javed, MD
Massachusetts General HospitalBostonMassachusetts02114
Kamaneh Montazeri, MD
Mayo Clinic RochesterRochesterMinnesota55905
Arkadiusz Z. Dudek, MD
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Alexander Shoushtari, MD
Duke University Medical CenterDurhamNorth Carolina27710
April Salama, MD
The Ohio State UniversityColumbusOhio43210
Richard Wu, MD, PhD
Thomas Jefferson UniversityPhiladelphiaPennsylvania19107
Marlana Orloff, MD
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Diwakar Davar, MD
The West Clinic, PLLC dba West Cancer CenterGermantownTennessee38138
Arnel M. Pallera, MD
University of Tennessee Medical CenterKnoxvilleTennessee37920
Timothy Panella, MD
Sarah Cannon Research InstituteNashvilleTennessee37203
Meredith Ann McKean, MD, MPH
Vanderbilt Ingram Cancer Center (Henry-Joyce Cancer Clinic)NashvilleTennessee37232
Douglas B. Johnson, MD
UT Southwestern Medical CenterDallasTexas75390
Sanjay Chandrasekaran, MD
The University Of Texas Md Anderson Cancer CenterHoustonTexas77030
Alexandra Ikeguchi, MD
Fred Hutchinson Cancer CenterSeattleWashington98109
Natalie Miller, MD, PhD
University Of Wisconsin Carbone Cancer Center - University HospitalMadisonWisconsin53792
Vincent Ma, MD

Find similar trials in Scottsdale, AZ

By research site
HonorHealth Research Insisute· Scottsdale, AZUC San Diego Moores Cancer Center· La Jolla, CAThe Angeles Clinic and Research Institute· Los Angeles, CAUniversity of California Los Angeles· Los Angeles, CAStanford Cancer Institute· Palo Alto, CAUniversity of Colorado Hospital - Anschutz Cancer Pavilion(ACP)· Aurora, CO

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