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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE2/PHASE3

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

NCT06581406•Replimune Inc.

View on ClinicalTrials.gov

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

Age

All ages

Sex

ALL

Healthy Volunteers

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.

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.
+2 more criteria

Locations (31)

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

Key Dates

Start Date

December 17, 2024

Primary Completion Date

January 1, 2030

Completion Date

October 1, 2031

Last Updated

February 18, 2026

Enrollment

280

ESTIMATED participants

Conditions

Metastatic Uveal Melanoma

Interventions

RP2

BIOLOGICAL

Ipilimumab

BIOLOGICAL

Nivolumab

BIOLOGICAL

Contacts

Clinical Trials at Replimune

CONTACT

1-781-222-9570 Clinicaltrials@replimune.com

Giuseppe Gullo, MD

CONTACT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

A Study of LN-144 or LN-145 in People With Advanced Uveal Melanoma, Undifferentiated Pleomorphic Sarcoma, or Dedifferentiated Liposarcoma

Evaluation of the Safety, Efficacy, and Pharmacokinetics of NBM-BMX in Patients With Metastatic Uveal Melanoma

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Intrahepatic Delivery of SD-101 by Pressure-Enabled Regional Immuno-oncology (PERIO), With Checkpoint Blockade in Adults With Metastatic Uveal Melanoma

Hepatic Arterial Infusion of Autologous Tumor Infiltrating Lymphocytes in Patients With Melanoma and Liver Metastases