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A study comparing RP2 with nivolumab versus ipilimumab with nivolumab in adults with metastatic uveal melanoma not previously treated with immune checkpoint inhibitors

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study is looking at a type of skin cancer called metastatic uveal melanoma, which is a cancer that starts in the eye and has spread to other parts of the body. The study will compare two different treatment combinations. One group will receive RP2 (an experimental treatment given by injection directly into the tumor) combined with nivolumab (a medicine given through a vein). The other group will receive ipilimumab combined with nivolumab (both medicines given through a vein). RP2 is a modified virus that has been designed to attack cancer cells and help the body's immune system fight the cancer. It contains substances that cause cancer cells to die and help activate the immune system against the tumor. Nivolumab and ipilimumab are medicines that help the immune system recognize and attack cancer cells.

The purpose of this study is to compare how well RP2 with nivolumab works compared to ipilimumab with nivolumab in terms of how long patients live and how long they live without their cancer getting worse. During the study, patients will receive their assigned treatment combination over a period of time. Those receiving RP2 will have injections directly into their tumor at certain time points, while all patients will receive infusions of nivolumab through a vein. Patients in the comparison group will also receive ipilimumab infusions. Throughout the study, patients will have regular check-ups and scans to monitor how their cancer responds to treatment and to check for any side effects.

The study will also look at other measures of how well the treatments work, such as how many patients see their tumors shrink, how long any improvement lasts, and how many patients have their disease remain stable. Safety information will be collected to understand what side effects patients may experience with each treatment combination. This study is designed for adult patients who have not previously been treated with medicines called immune checkpoint inhibitors for their cancer.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline assessment and treatment assignment

    After enrollment, your medical condition will be assessed and you will be assigned to one of two treatment groups through a random process.

    You will provide a tissue sample from your tumor. This can be either an archived sample collected within 90 days before starting treatment, or a fresh sample taken during this period.

    Blood tests will be performed to check your blood cell counts, liver function, kidney function, and blood clotting ability.

    If you are a woman of childbearing potential, a pregnancy test will be conducted within 72 hours before the first dose and again on the day of the first dose.

  2. Step 2

    Treatment with RP2 and nivolumab or ipilimumab and nivolumab

    You will receive one of two treatment combinations based on your assigned group.

    Group 1 receives RP2 injected directly into the tumor combined with nivolumab given through a vein.

    Group 2 receives ipilimumab given through a vein combined with nivolumab given through a vein.

    The study medication RP2 is injected directly into at least one tumor that measures 1 centimeter or larger. This tumor must be suitable for repeated injections and must not have been previously treated with surgery, radiation, or other local treatments.

    The study medication nivolumab is given as an infusion into a vein at a concentration of 10 milligrams per milliliter.

    The study medication ipilimumab is given as an infusion into a vein at a concentration of 5 milligrams per milliliter.

    The specific dosage amounts, frequency of administration, and duration of treatment will be determined according to the study protocol for your assigned treatment group.

  3. Step 3

    Regular monitoring and assessments

    Throughout the treatment period, you will undergo regular medical examinations and tests to monitor your response to treatment and any side effects.

    Imaging scans will be performed at scheduled intervals to measure the size of your tumors and assess whether the disease is progressing, staying stable, or shrinking.

    Blood samples will be collected regularly to monitor your overall health, including blood cell counts, liver function, kidney function, and other laboratory values.

    Your physical condition will be assessed using the ECOG performance status scale, which measures your ability to carry out daily activities.

    Any side effects or health changes you experience will be documented and evaluated by the medical team.

  4. Step 4

    Contraception requirements during treatment

    If you are a woman of childbearing potential, you must use highly effective birth control methods during treatment and for at least 5 months after your last dose of nivolumab, or 3 months after your last dose of ipilimumab, or 90 days after your last dose of RP2, whichever period is longest.

    If you are a male patient, you must use a condom during sexual intercourse and your partner should also use highly effective birth control during treatment and for at least 90 days after your last dose of RP2.

    Male patients must not donate semen during treatment and for 90 days after the last dose of RP2.

  5. Step 5

    Management of blood-thinning medications

    If you are taking blood-thinning medications, specific adjustments will be required around the time of RP2 injections and tissue sample collections.

    For preventive doses of blood thinners, these medications must be temporarily stopped for an appropriate time before and after each RP2 injection and tissue sample collection.

    For therapeutic doses of blood thinners, your treatment may need to be interrupted or the dose decreased as medically appropriate around the time of RP2 injections and tissue sample collections.

    Your blood clotting ability will be monitored through laboratory tests to ensure it is within safe limits before procedures.

  6. Step 6

    Ongoing treatment and follow-up

    Treatment will continue according to the study schedule until your disease progresses, unacceptable side effects occur, or other reasons for stopping treatment arise.

    The study will monitor your overall survival, which is the time from when you were assigned to a treatment group until death from any cause.

    The study will also monitor your progression-free survival, which is the time from when you were assigned to a treatment group until your disease worsens or death occurs.

    Other measures being evaluated include the proportion of patients whose tumors shrink, how long any tumor shrinkage lasts, and the proportion of patients whose disease remains stable or improves.

    The study is expected to continue until February 2030.

Who can join the trial?

14 criteria

  • You must be 18 years of age or older at the time you sign the consent form.
  • You must have a confirmed diagnosis of metastatic uveal melanoma, which is a type of cancer that started in the eye and has spread to other parts of the body, and it cannot be removed by surgery.
  • You must have at least one tumor that is 1 centimeter or larger in size that can be safely injected with the study medicine and measured by imaging scans. This tumor should not have been previously treated with surgery, radiation, or other local treatments.
  • You must be willing to provide a tumor tissue sample either from a previous biopsy taken within 90 days before starting the study or agree to have a new biopsy taken.
  • Your performance status must be 0 or 1 on the ECOG scale, which means you are able to carry out normal activities or have only minor symptoms that do not interfere much with daily life.
  • Your life expectancy must be greater than 3 months as determined by your doctor.
  • Your blood clotting tests must show normal or near-normal results. If you are taking blood thinning medications, special arrangements may be made, and these medications may need to be temporarily stopped around the time of injections and biopsies.
  • Your LDH level, which is a substance in the blood that can indicate disease activity, must be no more than 2 times the upper limit of normal.
  • Your blood counts must be adequate, including: white blood cells at least 2.0, neutrophils at least 1.5, platelets at least 100, and hemoglobin at least 8 grams per deciliter without recent blood transfusions.
  • Your liver function tests must be adequate, with bilirubin no more than 1.5 times the upper limit of normal, liver enzymes no more than 3 times the upper limit of normal, and alkaline phosphatase no more than 2.5 times the upper limit of normal.
  • Your kidney function must be adequate, with creatinine no more than 1.5 times the upper limit of normal or creatinine clearance at least 30.
  • Female patients must not be pregnant or breastfeeding. Women who can become pregnant must have a negative pregnancy test before starting the study and agree to use highly effective birth control during treatment and for up to 5 months after the last dose. Women who cannot become pregnant due to surgery or age are also eligible.
  • Male patients must agree to use a condom during sexual activity and ensure their partner uses effective birth control during treatment and for at least 90 days after the last dose. They must also not donate semen during this time.
  • You must be willing and able to sign an informed consent form and follow all study requirements.

Who cannot join the trial?

1 criterion

  • The specific reasons why patients cannot participate in this study have not been provided in the available information.
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Investigated drugs

  • RP2

    is an experimental cancer treatment being tested in this study. It is given together with nivolumab to see if it can help treat uveal melanoma that has spread to other parts of the body.

  • Nivolumab

    is a type of immunotherapy medication that helps your immune system recognize and fight cancer cells. It works by blocking a protein that prevents immune cells from attacking the cancer.

  • Ipilimumab

    is another type of immunotherapy medication that also helps your immune system fight cancer. It works in a different way than nivolumab by activating immune cells to attack cancer cells. In this study, it is given together with nivolumab as a comparison treatment.

What is already known about the treatment

  • RP2

    RP2 is an experimental cancer treatment currently being studied in clinical trials for metastatic uveal melanoma, a rare type of eye cancer that has spread to other parts of the body. It is given in combination with nivolumab, an immunotherapy drug, and is being tested to see if it can help patients live longer and prevent the cancer from getting worse. RP2 works as a modified virus that selectively infects and destroys cancer cells while also stimulating the body's immune system to recognize and attack the tumor.

  • Nivolumab

    Nivolumab is an approved immunotherapy medication given through an intravenous infusion (directly into a vein) that helps treat various types of cancer, including metastatic uveal melanoma. It works by blocking a protein called PD-1 on immune cells, which removes the "brakes" on the immune system and allows the body's natural defenses to better recognize and fight cancer cells. This medication belongs to a class of drugs called immune checkpoint inhibitors and is widely used in oncology to enhance the immune response against tumors.

  • Ipilimumab

    Ipilimumab is an approved immunotherapy drug administered through intravenous infusion that is used to treat several types of cancer, including metastatic uveal melanoma. It works by blocking a protein called CTLA-4 on immune cells, which helps activate the immune system to attack cancer cells more effectively. This medication is classified as an immune checkpoint inhibitor and is often combined with other immunotherapy drugs like nivolumab to improve treatment outcomes for cancer patients.

Investigated diseases

Metastatic Uveal Melanoma – Metastatic uveal melanoma is an advanced form of cancer that originates in the uvea, which is the middle layer of the eye containing the iris, ciliary body, and choroid. This type of melanoma develops from pigment-producing cells called melanocytes located within the eye. Unlike skin melanoma, uveal melanoma arises specifically within the structures of the eye. When the disease becomes metastatic, cancer cells spread from the original tumor in the eye to other parts of the body, most commonly to the liver. The disease progresses as these cancer cells multiply and form new tumors in distant organs. As the condition advances, the metastatic tumors can affect the function of the organs where they have spread.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-508784-68-00Protocol codeRP2-202Estimated enrolment328 patientsSponsorReplimune Group Inc.

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