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

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

• Status: Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 280 (estimated)
• Sponsor: Replimune, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Uveal Melanoma

Interventions

Type	Name	Description
BIOLOGICAL	RP2	Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation.
BIOLOGICAL	Ipilimumab	Ipilimumab: human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody
BIOLOGICAL	Nivolumab	Nivolumab: Anti-PD-1 Monoclonal antibody

Timeline

• Start date: 2024-12-17
• Primary completion: 2030-01-01
• Completion: 2031-10-01
• First posted: 2024-09-03
• Last updated: 2026-04-02

Locations

33 sites across 3 countries: United States, Australia, United Kingdom

Regulatory

• FDA-regulated drug study