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NCT06581406PHASE2, PHASE3Recruiting

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

Replimune, Inc.

Start Date

12/17/2024

Completion Date

10/1/2031

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 Criteria

Age Range: No minimum to No maximum

Key Inclusion Criteria: * 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 ≥ 1 cm in longest diameter (≥ 1.5 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 ≤ 2 × upper limit of normal (ULN). * Has adequate hematologic, hepatic and renal function * Prothrombin time (PT) ≤ 1.5 × ULN (or international normalization ratio \[INR\] ≤ 1.3) and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN. * Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1. * Life expectancy of \> 6 months as estimated by the Investigator. Key Exclusion Criteria: * 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 ≤ 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. Additional inclusion/ exclusion criteria are outlined in the study protocol

Interventions

BIOLOGICAL

RP2

BIOLOGICAL

Ipilimumab

BIOLOGICAL

Nivolumab

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Conditions

Metastatic Uveal Melanoma

Locations

HonorHealth Research Insisute

Scottsdale, Arizona 85258

United States

UC San Diego Moores Cancer Center

La Jolla, California 92037

United States

The Angeles Clinic and Research Institute

Los Angeles, California 90025

United States

University of California Los Angeles

Los Angeles, California 90095

United States

Stanford Cancer Institute

Palo Alto, California 94304

United States

University of Colorado Hospital - Anschutz Cancer Pavilion(ACP)

Aurora, Colorado 80045

United States

The Melanoma & Skin Cancer Institute

Englewood, Colorado 80113

United States

Georgetown University Medical Center

Washington D.C., District of Columbia 20007

United States

Mayo Clinic - Jacksonville FL

Jacksonville, Florida 32224

United States

Sylvester Comprehensive Cancer Center

Miami, Florida 33136

United States

Emory Winship Cancer Institute

Atlanta, Georgia 30322

United States

Northwestern Memorial Hospital

Chicago, Illinois 60611

United States

University of Chicago Medical Center

Chicago, Illinois 60637

United States

University of Iowa

Iowa City, Iowa 52242

United States

Massachusetts General Hospital

Boston, Massachusetts 02114

United States

Mayo Clinic Rochester

Rochester, Minnesota 55905

United States

Memorial Sloan Kettering Cancer Center

New York, New York 10065

United States

Duke University Medical Center

Durham, North Carolina 27710

United States

The Ohio State University

Columbus, Ohio 43210

United States

Thomas Jefferson University

Philadelphia, Pennsylvania 19107

United States

UPMC Hillman Cancer Center

Pittsburgh, Pennsylvania 15232

United States

The West Clinic, PLLC dba West Cancer Center

Germantown, Tennessee 38138

United States

University of Tennessee Medical Center

Knoxville, Tennessee 37920

United States

Sarah Cannon Research Institute

Nashville, Tennessee 37203

United States

Vanderbilt Ingram Cancer Center (Henry-Joyce Cancer Clinic)

Nashville, Tennessee 37232

United States

UT Southwestern Medical Center

Dallas, Texas 75390

United States

The University Of Texas Md Anderson Cancer Center

Houston, Texas 77030

United States

Fred Hutchinson Cancer Center

Seattle, Washington 98109

United States

University Of Wisconsin Carbone Cancer Center - University Hospital

Madison, Wisconsin 53792

United States

Melanoma Institute Australia

Wollstonecraft, New South Wales 2065

Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria 3000

Australia

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, Merseyside L7 8YA

United Kingdom

The Royal Marsden NHS Foundation Trust

London, SW3 6JJ

United Kingdom