RecruitingPhase 2Phase 3NCT06581406

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

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

Sponsor

Replimune, Inc.

Enrollment

280 participants

Start Date

Dec 17, 2024

Study Type

INTERVENTIONAL

Conditions

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.

Eligibility

Plain Language Summary

Simplified for easier understanding

This phase 2/3 trial tests the combination of RP2 (an oncolytic herpes virus that attacks cancer cells and activates the immune system) and nivolumab (an immunotherapy drug) in people with metastatic uveal melanoma — a rare and aggressive eye cancer that has spread to other parts of the body and has few effective treatments. **You may be eligible if...** - You are 18 or older - You have been diagnosed with metastatic uveal melanoma that cannot be surgically removed - You have at least one tumor that can be injected directly and is large enough (at least 1 cm) - You have not previously received immune checkpoint inhibitor therapy **You may NOT be eligible if...** - You have received prior immunotherapy for this cancer - You have active autoimmune disease requiring systemic treatment - You have cancer that has spread to the brain in an active way Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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

Locations(33)

HonorHealth Research Insisute

Scottsdale, Arizona, United States

UC San Diego Moores Cancer Center

La Jolla, California, United States

The Angeles Clinic and Research Institute

Los Angeles, California, United States

University of California Los Angeles

Los Angeles, California, United States

Stanford Cancer Institute

Palo Alto, California, United States

University of Colorado Hospital - Anschutz Cancer Pavilion(ACP)

Aurora, Colorado, United States

The Melanoma & Skin Cancer Institute

Englewood, Colorado, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Mayo Clinic - Jacksonville FL

Jacksonville, Florida, United States

Sylvester Comprehensive Cancer Center

Miami, Florida, United States

Emory Winship Cancer Institute

Atlanta, Georgia, United States

Northwestern Memorial Hospital

Chicago, Illinois, United States

University of Chicago Medical Center

Chicago, Illinois, United States

University of Iowa

Iowa City, Iowa, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Mayo Clinic Rochester

Rochester, Minnesota, United States

Memorial Sloan Kettering Cancer Center

New York, New York, United States

Duke University Medical Center

Durham, North Carolina, United States

The Ohio State University

Columbus, Ohio, United States

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania, United States

The West Clinic, PLLC dba West Cancer Center

Germantown, Tennessee, United States

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Vanderbilt Ingram Cancer Center (Henry-Joyce Cancer Clinic)

Nashville, Tennessee, United States

UT Southwestern Medical Center

Dallas, Texas, United States

The University Of Texas Md Anderson Cancer Center

Houston, Texas, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

University Of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin, United States

Melanoma Institute Australia

Wollstonecraft, New South Wales, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, Merseyside, United Kingdom

The Royal Marsden NHS Foundation Trust

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT06581406

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