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Recruiting Phase 2/3

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

NCT06581406 · tracked via the Priya Life Science UK tracker
Phase
Phase 2/3
Started
2024-12-17
Last updated
2026-04-02

Condition(s) studied

Metastatic Uveal Melanoma

Investigational drug(s) / intervention(s)

RP2 →Ipilimumab →Nivolumab →

RP2: Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation.

Ipilimumab: Ipilimumab: human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody

Nivolumab: Nivolumab: Anti-PD-1 Monoclonal antibody

Study 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

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Overall Survival (OS) — From Day 1 up to 3 years after last dose.
    OS is the time from the date of randomization to death from any cause.
  • Progression Free Survival (PFS) — From Day 1 up to 3 years after last dose.
    PFS is the time from randomization to first evidence of confirmed disease progression as assessed by BICR per RECIST 1.1 or death from any cause.

Trial sites (33)

FacilityCityRegionStatus
HonorHealth Research Insisute Scottsdale Arizona Recruiting
UC San Diego Moores Cancer Center La Jolla California Recruiting
The Angeles Clinic and Research Institute Los Angeles California Recruiting
University of California Los Angeles Los Angeles California Recruiting
Stanford Cancer Institute Palo Alto California Recruiting
University of Colorado Hospital - Anschutz Cancer Pavilion(ACP) Aurora Colorado Recruiting
The Melanoma & Skin Cancer Institute Englewood Colorado Recruiting
Georgetown University Medical Center Washington D.C. District of Columbia Recruiting
Mayo Clinic - Jacksonville FL Jacksonville Florida Recruiting
Sylvester Comprehensive Cancer Center Miami Florida Recruiting
Emory Winship Cancer Institute Atlanta Georgia Recruiting
Northwestern Memorial Hospital Chicago Illinois Recruiting
University of Chicago Medical Center Chicago Illinois Recruiting
University of Iowa Iowa City Iowa Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Mayo Clinic Rochester Rochester Minnesota Recruiting
Memorial Sloan Kettering Cancer Center New York New York Recruiting
Duke University Medical Center Durham North Carolina Recruiting
The Ohio State University Columbus Ohio Recruiting
Thomas Jefferson University Philadelphia Pennsylvania Recruiting
UPMC Hillman Cancer Center Pittsburgh Pennsylvania Recruiting
The West Clinic, PLLC dba West Cancer Center Germantown Tennessee Recruiting
University of Tennessee Medical Center Knoxville Tennessee Recruiting
Sarah Cannon Research Institute Nashville Tennessee Recruiting
Vanderbilt Ingram Cancer Center (Henry-Joyce Cancer Clinic) Nashville Tennessee Recruiting
UT Southwestern Medical Center Dallas Texas Recruiting
The University Of Texas Md Anderson Cancer Center Houston Texas Recruiting
Fred Hutchinson Cancer Center Seattle Washington Recruiting
University Of Wisconsin Carbone Cancer Center - University Hospital Madison Wisconsin Recruiting
Melanoma Institute Australia Wollstonecraft New South Wales Recruiting
Peter MacCallum Cancer Centre Melbourne Victoria Recruiting
The Clatterbridge Cancer Centre NHS Foundation Trust Liverpool Merseyside Recruiting
The Royal Marsden NHS Foundation Trust London United Kingdom Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06581406 on ClinicalTrials.gov ↗ ← All trials in the UK