Replimune Group ((REPL)) announced an update on their ongoing clinical study.
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Study Overview: Replimune Group is conducting a randomized, Phase 2/3 study titled 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. The study aims to evaluate the clinical benefits of combining RP2 with nivolumab compared to the combination of nivolumab and ipilimumab in patients with metastatic uveal melanoma who have not yet received immune checkpoint inhibitor therapy.
Intervention/Treatment: The interventions being tested include RP2, a genetically modified herpes simplex virus designed for tumor lysis and immune stimulation, and nivolumab, a PD-1 inhibitor. These are compared against a combination of ipilimumab, a CTLA-4-blocking antibody, and nivolumab.
Study Design: This interventional study uses a randomized, parallel assignment model with no masking. It includes three periods: a 28-day screening period, a treatment period with tumor assessments every 12 weeks, and follow-up periods for safety and efficacy. The primary purpose is treatment.
Study Timeline: The study began on August 29, 2024, with the latest update submitted on October 10, 2025. These dates are crucial for tracking the study’s progress and ensuring timely updates for stakeholders.
Market Implications: This study update could influence Replimune’s stock performance and investor sentiment, particularly if the results show significant clinical benefits. The study’s outcome may also impact the competitive landscape in the treatment of metastatic uveal melanoma, potentially affecting other companies in the oncology sector.
The study is currently recruiting, with further details available on the ClinicalTrials portal.
