Study Comparing RP2 Plus Nivolumab Versus Ipilimumab Plus Nivolumab in Adults With Untreated Metastatic Uveal Melanoma

What this Trial Is About

Researchers are investigating the clinical benefits of combining RP2, a genetically modified herpes simplex virus, with nivolumab, an immune checkpoint inhibitor, in adults with metastatic uveal melanoma who have not previously received immune checkpoint inhibitor therapy. This phase 23 randomized trial compares this combination against the combination of nivolumab and ipilimumab, another immune checkpoint inhibitor, to evaluate their effects on survival and disease progression. Participants will be randomly assigned to receive either RP2 plus nivolumab or ipilimumab plus nivolumab. RP2 is designed to stimulate the immune system and directly attack tumors, while nivolumab and ipilimumab work by blocking proteins that limit immune response against cancer cells. The study treatment is administered over time, with careful monitoring of safety and effectiveness. There are no placebo groups, and the trial is open-label, meaning both participants and researchers know which treatment is given. Throughout the study, participants will undergo regular assessments to evaluate overall survival and progression-free survival for up to three years after the last treatment dose. Additional evaluations include tracking response rates and disease control every 12 weeks and monitoring for any treatment-related adverse events for up to 100 days post-treatment. Blood tests, tumor biopsies, and imaging will be part of the ongoing evaluations. Participants are expected to remain engaged with the study procedures for the duration of the follow-up period to help researchers understand the treatments impact.

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