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
To compare the effect of RP2 + nivolumab relative to ipilimumab + nivolumab on overall survival (OS)
Why this Research Matters
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.
Who can Participate
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. Key Exclusion Criteria: Any exposure to immune checkpoint inhibitor (ICIs) since the time of first being diagnosed with uveal melanoma. Detailed eligibility criteria is available on clinicaltrials.gov. These requirements will be discussed with your doctor and/or study representative. Click the NCT number link below to learn more about this study on ClinicalTrials.gov
Study ID
Protocol Number: 25-0004
More information available at ClinicalTrials.gov: NCT06581406
Meet the Team
Principal Investigator