Tests RP2 with nivolumab against ipilimumab with nivolumab in uveal melanoma
Compares RP2 plus nivolumab with ipilimumab plus nivolumab in adults with metastatic uveal melanoma.
Plain-language title generated from the registry record
Registry title: 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
Key facts
- Where
- Berlin, Hamburg, and Heidelberg, GermanySee the 3 sites
- Phase
- Phase 2/3
Where in Germany
- Charite Universitaetsmedizin Berlin KöRBerlin, GermanyNot yet recruiting
- University Medical Center Hamburg-EppendorfHamburg, GermanyNot yet recruiting
- Universitaetsklinikum Heidelberg AöRHeidelberg, GermanyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Replimune, Inc.
- Trial code
- NCT06581406EU 2023-508784-68-00
- Record updated
- 2 April 2026
- Original description
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.Read full original descriptionShow less
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 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.
Inclusion: 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; LDH ≤ 2 × upper limit of normal (ULN); Has adequate hematologic, hepatic and renal function; Prothrombin time (PT) ≤ 1.5 × ULN (or international normalization ratio [INR] ≤ 1.3) and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) ≤ 1.5 × ULN; Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1; Life expectancy of > 6 months as estimated by the Investigator.
Exclusion: Any exposure to immune checkpoint inhibitor (ICIs) since the time of first being diagnosed with uveal melanoma; Current active significant herpetic infections or prior complications of HSV-1 infection; Major surgery ≤ 2 weeks prior to the first dose of study intervention; Prior treatment with an oncolytic virus; Systemic anticancer therapy or prior radiotherapy within 2 weeks of the first dose; Has received Investigation agent within 4 weeks or 5 half-lives (whichever longer) prior to the first dose; Conditions requiring treatment with immunosuppressive doses (> 10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement therapy within 14 days after enrollment; Additional inclusion/ exclusion criteria are outlined in the study protocol; Known acute or chronic Hepatitis B or C infection or human immunodeficiency virus (HIV) infection or any other uncontrolled infection; Any bleeding, thrombotic and/or other event that places the patient at an unacceptable risk of complications of intratumoral therapy; Active, known, or suspected autoimmune disease requiring systemic treatment; Any central nervous system (CNS) involvement of melanoma, including carcinomatous meningitis; Requires intermittent or chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (eg, acyclovir).