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Investigating RP2 and Nivolumab for 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

Phase2; Phase3 Interventional Replimune, Inc. · NCT06581406

This study is testing whether a new treatment combining RP2 with nivolumab can help adults with metastatic uveal melanoma feel better compared to the standard treatment of nivolumab and ipilimumab.

Quick facts

PhasePhase2; Phase3
Study typeInterventional
Enrollment280 (estimated)
SexAll
SponsorReplimune, Inc. Industry-sponsored
Drugs / interventionsprednisone, nivolumab, ipilimumab
Locations33 sites (Scottsdale, Arizona and 32 other locations)
Trial IDNCT06581406 on ClinicalTrials.gov

What this trial studies

This study aims to evaluate the efficacy and safety of RP2 in combination with nivolumab compared to the combination of nivolumab and ipilimumab in adult patients with metastatic uveal melanoma who have not previously received immune checkpoint inhibitor therapy. Participants must have measurable tumors suitable for treatment and be willing to provide tumor biopsy samples. The study is designed to assess clinical benefits and improve treatment options for this specific cancer population.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed metastatic uveal melanoma that cannot be surgically removed.

Not a fit: Patients who have previously received immune checkpoint inhibitor therapy will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with metastatic uveal melanoma.

How similar studies have performed: Other studies have shown promise with similar combinations of immune checkpoint inhibitors, suggesting potential for success in this approach.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Scottsdale, Arizona and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Metastatic Uveal MelanomaMetastaticUvealMelanomaNivolumabIpilimumabRandomizedImmune checkpoint inhibitor-naïve
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.