Actively Recruiting
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-Naive Adult Patients With Metastatic Uveal Melanoma
Led by Replimune, Inc. · Updated on 2026-04-02
280
Participants Needed
33
Research Sites
91 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the clinical benefits of combining RP2, a genetically modified herpes simplex virus, with nivolumab, an immune checkpoint inhibitor, in adults with metastatic uveal melanoma who have not previously received immune checkpoint inhibitor therapy. This phase 2/3 randomized trial compares this combination against the combination of nivolumab and ipilimumab, another immune checkpoint inhibitor, to evaluate their effects on survival and disease progression. Participants will be randomly assigned to receive either RP2 plus nivolumab or ipilimumab plus nivolumab. RP2 is designed to stimulate the immune system and directly attack tumors, while nivolumab and ipilimumab work by blocking proteins that limit immune response against cancer cells. The study treatment is administered over time, with careful monitoring of safety and effectiveness. There are no placebo groups, and the trial is open-label, meaning both participants and researchers know which treatment is given. Throughout the study, participants will undergo regular assessments to evaluate overall survival and progression-free survival for up to three years after the last treatment dose. Additional evaluations include tracking response rates and disease control every 12 weeks and monitoring for any treatment-related adverse events for up to 100 days post-treatment. Blood tests, tumor biopsies, and imaging will be part of the ongoing evaluations. Participants are expected to remain engaged with the study procedures for the duration of the follow-up period to help researchers understand the treatments' impact.
CONDITIONS
Brief Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients 18 years of age or older at the time of signed informed consent.
- Confirmed diagnosis of metastatic uveal melanoma not suitable for surgical removal.
- At least one measurable and injectable tumor 1 cm or larger in longest diameter (1.5 cm minimum in shortest axis for lymph nodes) suitable for repeated RP2 injections.
- Willingness to provide tumor biopsy samples.
- Lactate dehydrogenase (LDH) at or below 2 times the upper limit of normal.
- Adequate blood, liver, and kidney function.
- Prothrombin time (PT) at or below 1.5 times the upper limit of normal or INR at or below 1.3 and partial thromboplastin time (PTT or aPTT) at or below 1.5 times the upper limit of normal.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Estimated life expectancy greater than 6 months as assessed by the investigator.
You will not qualify if you...
- Prior exposure to immune checkpoint inhibitors since first diagnosis of uveal melanoma.
- Known acute or chronic hepatitis B or C infection, HIV infection, or any uncontrolled infection.
- Current active or significant past herpes simplex virus type 1 (HSV-1) infections or complications.
- Melanoma involvement in the central nervous system, including carcinomatous meningitis.
- Major surgery within 2 weeks before first dose of study treatment.
- Any bleeding, clotting, or other conditions that increase risk with intratumoral therapy.
- Active, known, or suspected autoimmune disease requiring systemic treatment.
- Prior treatment with an oncolytic virus.
- Need for intermittent or chronic systemic antiviral treatment with known antiherpetic drugs.
- Systemic anticancer therapy or radiotherapy within 2 weeks before first dose.
- Receipt of investigational agents within 4 weeks or 5 half-lives before first dose.
- Use of immunosuppressive doses over 10 mg prednisone (or equivalent) within 14 days after enrollment, except for corticosteroid replacement therapy.
- Other criteria as detailed in the study protocol.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From first dose until discontinuation as per protocol
Participants receive treatment with RP2 plus nivolumab or ipilimumab plus nivolumab to investigate efficacy and safety for metastatic uveal melanoma.
Regular visits during treatment as per protocol
Duration - Up to 3 years after last dose
Participants are monitored for up to 3 years after last dose to assess overall survival, progression-free survival, and safety.
Visits every 12 weeks up to 3 years after last dose
Trial Site Locations
Total: 33 locations
1
HonorHealth Research Insisute
Scottsdale, Arizona, United States, 85258
Actively Recruiting
2
UC San Diego Moores Cancer Center
La Jolla, California, United States, 92037
Actively Recruiting
3
The Angeles Clinic and Research Institute
Los Angeles, California, United States, 90025
Actively Recruiting
4
University of California Los Angeles
Los Angeles, California, United States, 90095
Actively Recruiting
5
Stanford Cancer Institute
Palo Alto, California, United States, 94304
Actively Recruiting
6
University of Colorado Hospital - Anschutz Cancer Pavilion(ACP)
Aurora, Colorado, United States, 80045
Actively Recruiting
7
The Melanoma & Skin Cancer Institute
Englewood, Colorado, United States, 80113
Actively Recruiting
8
Georgetown University Medical Center
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
9
Mayo Clinic - Jacksonville FL
Jacksonville, Florida, United States, 32224
Actively Recruiting
10
Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Actively Recruiting
11
Emory Winship Cancer Institute
Atlanta, Georgia, United States, 30322
Actively Recruiting
12
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Actively Recruiting
13
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Actively Recruiting
14
University of Iowa
Iowa City, Iowa, United States, 52242
Actively Recruiting
15
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Actively Recruiting
16
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
Actively Recruiting
17
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Actively Recruiting
18
Duke University Medical Center
Durham, North Carolina, United States, 27710
Actively Recruiting
19
The Ohio State University
Columbus, Ohio, United States, 43210
Actively Recruiting
20
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
Actively Recruiting
21
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
Actively Recruiting
22
The West Clinic, PLLC dba West Cancer Center
Germantown, Tennessee, United States, 38138
Actively Recruiting
23
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Actively Recruiting
24
Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37203
Actively Recruiting
25
Vanderbilt Ingram Cancer Center (Henry-Joyce Cancer Clinic)
Nashville, Tennessee, United States, 37232
Actively Recruiting
26
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
27
The University Of Texas Md Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
28
Fred Hutchinson Cancer Center
Seattle, Washington, United States, 98109
Actively Recruiting
29
University Of Wisconsin Carbone Cancer Center - University Hospital
Madison, Wisconsin, United States, 53792
Actively Recruiting
30
Melanoma Institute Australia
Wollstonecraft, New South Wales, Australia, 2065
Actively Recruiting
31
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Actively Recruiting
32
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, Merseyside, United Kingdom, L7 8YA
Actively Recruiting
33
The Royal Marsden NHS Foundation Trust
London, United Kingdom, SW3 6JJ
Actively Recruiting
Research Team
C
Clinical Trials at Replimune
G
Giuseppe Gullo, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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