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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

NCT06581406 · Status: RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 280

Last updated 2026-04-02

No results posted yet for this study

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

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

Sponsors & Collaborators

  • Replimune Inc.

    lead INDUSTRY

Principal Investigators

  • Rahul Marpadga, MD MPH · Replimune Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-17
Primary Completion
2030-01-31
Completion
2031-10-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06581406 on ClinicalTrials.gov