Actively Recruiting
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
Led by Replimune, Inc. · Updated on 2026-04-02
280
Participants Needed
33
Research Sites
354 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 who are 18 years of age or older at the time of signed informed consent.
- Patients with confirmed diagnosis of metastatic Uveal melanoma not amenable to surgical resection.
- Has at least 1 measurable and injectable tumor of 261 cm in longest diameter (261.5 cm in the shortest axis for a lymph node [LN]) that is amenable to serial RP2 injections.
- Must be willing to provide tumor biopsy samples.
- LDH 2c 2 �d7 upper limit of normal (ULN).
- Has adequate hematologic, hepatic and renal function
- Prothrombin time (PT) 2c 1.5 �d7 ULN (or international normalization ratio [INR] 2c 1.3) and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) 2c 1.5 �d7 ULN.
- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
- Life expectancy of > 6 months as estimated by the Investigator.
You will not qualify if you...
- Any exposure to immune checkpoint inhibitor (ICIs) since the time of first being diagnosed with uveal melanoma.
- Known acute or chronic Hepatitis B or C infection or human immunodeficiency virus (HIV) infection or any other uncontrolled infection.
- Current active significant herpetic infections or prior complications of HSV-1 infection.
- Any central nervous system (CNS) involvement of melanoma, including carcinomatous meningitis.
- Major surgery 2c 2 weeks prior to the first dose of study intervention.
- Any bleeding, thrombotic and/or other event that places the patient at an unacceptable risk of complications of intratumoral therapy.
- Active, known, or suspected autoimmune disease requiring systemic treatment.
- Prior treatment with an oncolytic virus.
- Requires intermittent or chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (eg, acyclovir).
- Systemic anticancer therapy or prior radiotherapy within 2 weeks of the first dose.
- Has received Investigation agent within 4 weeks or 5 half-lives (whichever longer) prior to the first dose.
- Conditions requiring treatment with immunosuppressive doses (> 10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement therapy within 14 days after enrollment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
G
Giuseppe Gullo, MD
CONTACT
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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