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Phase 2/3 Study of RP2 with Nivolumab for Metastatic Uveal Melanoma

This study is testing two different treatment combinations for adults with metastatic uveal melanoma (a type of eye cancer that has spread) who have not yet received immune checkpoint inhibitor therapy. Researchers want to see if combining RP2 (a modified virus that attacks cancer cells and boosts the immune system) with nivolumab (an anti-PD-1 antibody) is more effective than combining nivolumab with ipilimumab (another immune-boosting antibody). To join, you must be 18 or older, have metastatic uveal melanoma that can't be surgically removed, and have at least one measurable tumor that can be injected. The study will measure overall survival and how long you live without the cancer getting worse, for up to 3 years after your last dose. The current recruitment status is unclear.

Study design
This is a randomized study, meaning participants are assigned to one of the two treatment groups by chance. It plans to enroll 280 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 3 years after their last dose to measure overall survival and progression-free survival.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06581406

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

Recruiting
PHASE2All AgesInterventionalTreatment
Replimune, Inc.
~280 participants
Updated 2026-04-02 on ClinicalTrials.gov
What's tested:RP2IpilimumabNivolumab

At a glance

Recruiting sites
33 of 33 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Overall Survival (OS)
Measured over From Day 1 up to 3 years after last dose.
+1 more outcome measured

Conditions

Metastatic Uveal Melanoma

Explore related trials

Uveal Melanoma

Where it's being run

33 sites across 22 states
California4
Tennessee4
Colorado2
Florida2
Illinois2
Pennsylvania2
Texas2
Arizona1

Study leadership

  • Rahul Marpadga, MD MPH · STUDY_DIRECTOR · Replimune, Inc.

Who to contact

Clinical Trials at Replimune
[email protected]
1-781-222-9570
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 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.