NCT06581406 · Replimune Inc.
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
(RP2-202)
What this study is about
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.
View original scientific 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.
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
Primary outcome measures
Overall Survival (OS)
Time frame: From Day 1 up to 3 years after last dose.
OS is the time from the date of randomization to death from any cause.
Progression Free Survival (PFS)
Time frame: From Day 1 up to 3 years after last dose.
PFS is the time from randomization to first evidence of confirmed disease progression as assessed by BICR per RECIST 1.1 or death from any cause.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
- 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. Key
Exclusion criteria
- Any exposure to immune checkpoint inhibitor (ICIs) since the time of first being diagnosed with uveal mela
Where
- Scottsdale, Arizona
- La Jolla, California
- Los Angeles, California
- Palo Alto, California
- Aurora, Colorado
- Englewood, Colorado
- Washington D.C., District of Columbia
- Jacksonville, Florida
- Miami, Florida
- Atlanta, Georgia
- Chicago, Illinois
- Iowa City, Iowa
And 14 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 2, 2026 · Source of record for eligibility and locations