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Looking for participantsPhase2/Phase3

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

Sponsor: Replimune, Inc.

NCT ID: NCT06581406

View on ClinicalTrials.gov ↗

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.

Metastatic Uveal Melanoma

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
Age· Tell us your age for better matching
Gender· Tell us your sex for better matching

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
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. * 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 melanoma. * Known acute or chronic Hepatitis B or C infection or human immunodeficiency virus (HIV) infection or any other uncontrolled infection. * 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. * 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. * Prior treatment with an oncolytic virus. * Requires intermittent or chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (eg, acyclovir). * 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

Where Is This Study? (2 UK sites)

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool L7 8YA, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Maria Maguire

maria.maguire2@nhs.net0151 556 5321

The Royal Marsden NHS Foundation Trust

London SW3 6JJ, United Kingdom

Recruiting
Hospital R&D contact (matched)

Mark Brandon-Grove

research.development@rmh.nhs.uk020 3186 5416

How to Get in Touch

Clinical Trials at Replimune

Sponsor contact

CONTACT

1-781-222-9570 Clinicaltrials@replimune.com

Giuseppe Gullo, MD

Sponsor contact

CONTACT

Data sourced from ClinicalTrials.gov · Last verified: 2026-03