At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- RP2 (biological), Ipilimumab (biological), Nivolumab (biological)
- How long the study runs
- Study runs about 82 months (dates as stated)
- About the drug or intervention
- RP2 — biological: Genetically modified herpes simplex type 1 virus for tumor lysis and immune stimulation. · Ipilimumab — biological: Ipilimumab: human cytotoxic T-lymphocyte antigen 4 (CTLA-4)-blocking antibody · Nivolumab — biological: Nivolumab: Anti-PD-1 Monoclonal antibody
- Patient visit burden
- Not specified by the sponsor
In plain English
This study is looking at how well and how safely a treatment called RP2 works when given with nivolumab. It is for adults whose uveal melanoma (a rare eye cancer) has spread to other parts of the body. RP2 is injected directly into tumours, and nivolumab is given through a vein.
Who can take part
- Adults aged 18 or over
- Confirmed metastatic uveal melanoma (eye cancer that has spread) that cannot be removed by surgery
- At least one tumour measuring 1 cm or more (1.5 cm or more if a lymph node) that can be injected with RP2 repeatedly
- Willing to provide tumour biopsy samples
- Blood test (LDH) no more than twice the normal limit
- Healthy enough blood, liver and kidney function
- Blood clotting tests within the limit set by the study
- Able to carry out day-to-day activities (performance status 0 or 1)
- Expected to live more than 6 months
Who may not be able to
- Have ever had an immune checkpoint inhibitor (a type of immunotherapy) since being diagnosed with uveal melanoma
- Hepatitis B or C, HIV, or any other uncontrolled infection
- Active herpetic infections or past serious complications from HSV-1 (the cold sore virus)
- Melanoma that has spread to the brain or spinal cord, including carcinomatous meningitis
- Major surgery in the 2 weeks before the first dose
- Bleeding, clotting or other problems that make injecting into a tumour too risky
- Active autoimmune disease needing treatment for the whole body
- Previous treatment with an oncolytic virus (a virus used to fight cancer)
- Regular use of antiviral medicines such as acyclovir
- Cancer treatment or radiotherapy in the 2 weeks before the first dose
- Received an experimental drug within 4 weeks or 5 half-lives (whichever is longer) before the first dose
- Need steroid doses above 10 mg prednisone a day (except as replacement therapy) within 14 days of joining
What taking part involves
- • RP2 injected directly into a tumour that can be injected
- • RP2 given together with nivolumab, an immunotherapy drug
- • Providing tumour biopsy samples
- • Whether RP2 or other treatment is given first, and how long treatment lasts — not stated — ask the trial team
Time commitment: The data does not state how many visits or how long the trial lasts — ask the trial team; taking part involves repeated injections of RP2 into a tumour, nivolumab treatment, and giving tumour biopsy samples.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- Not specified
- Who
- All
- Number of participants
- 280
- Started
- 2024-12-17
- Last checked
- 2026-03
Plain English Summary
What is this study?
- • Testing a new treatment for metastatic uveal melanoma
- • Phase2/Phase3 - 280 participants
- • 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 take part?
- • Adults
- • Diagnosed with metastatic uveal melanoma
Where?
- • Liverpool - The Clatterbridge Cancer Centre NHS Foundation Trust
- • London - The Royal Marsden NHS Foundation Trust
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: Not specified
- Who can join: All genders
What the study is looking for
- ✓Patients who are 18 years of age or older at the time of signed agreement to take part.
- ✓Patients with confirmed diagnosis of that has spread 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...
- ✓Must be willing to provide tumor biopsy samples.
- ✓LDH ≤ 2 × upper limit of normal (ULN).
Who cannot take part
- ✗Any exposure to immune checkpoint inhibitor (ICIs) since the time of first being diagnosed with uveal melanoma.
- ✗Known acute or chronic Hepatitis B or C infection or human immunodeficiency virus (HIV) infection or any other...
- ✗Current active significant herpetic infections or prior complications of HSV-1 infection.
- ✗Any central nervous system (CNS) involvement of melanoma, including carcinomatous meningitis.
- ✗Major surgery ≤ 2 weeks prior to the first dose of study intervention.
See the full criteria
Where Is This Study? (2 UK sites)
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool L7 8YA, United Kingdom
The Royal Marsden NHS Foundation Trust
London SW3 6JJ, United Kingdom
How to Get in Touch
Clinical Trials at Replimune
Sponsor contactCONTACT
Giuseppe Gullo, MD
Sponsor contactCONTACT
