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Long-term Safety Study of Vusolimogene Oderparepvec, RP2, and RP3 in Patients with Melanoma, Liver Cancer, or Advanced Solid Tumors

Verified siteInvestigationalNo 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 the long-term safety of patients who have been treated with experimental medicines called RP1, RP2, or RP3. These medicines are being tested in people with different types of cancer, including melanoma (a type of skin cancer), metastatic melanoma (melanoma that has spread to other parts of the body), hepatocellular carcinoma (a type of liver cancer), and other advanced solid tumors (which are cancers that form solid masses in the body). The medicines are given as injections directly into the tumor. The purpose of this study is to check for any health problems that might appear a long time after treatment with these experimental medicines.

People who join this study must have already received at least one dose of RP1, RP2, or RP3 in a previous study and have either finished that study or stopped participating in it. During this study, doctors will watch for specific types of delayed health problems that might be related to the treatment. These include new cancers, new or worsening problems with the nervous system (which controls things like movement and sensation), new or worsening problems with the immune system (which protects the body from disease) or conditions where the immune system attacks the body itself, new blood disorders, new infections related to the treatment, and new infections caused by the herpes virus.

The study will follow patients for several years to collect information about their health and any new medical problems that develop. This helps researchers understand if there are any long-term effects from treatment with these experimental medicines. Patients will be asked to report any new health issues to their doctors, who will record this information as part of the study.

The research process

The trial runs in 2 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Enrollment in the long-term safety study

    This study begins after completion or discontinuation of participation in the previous study where treatment with RP1, RP2, or RP3 was received.

    The study focuses on monitoring long-term safety outcomes following treatment with these experimental therapies.

    Prior to enrollment, informed consent must be provided, which includes agreement to comply with study requirements and restrictions.

  2. Step 2

    Long-term safety monitoring

    The study will monitor for specific delayed health events that may be related to the previous treatment.

    The following conditions will be evaluated: development of new cancers, new or worsening neurologic disorders (conditions affecting the nervous system), new or worsening autoimmune disorders (conditions where the immune system attacks the body's own tissues), new blood disorders, and new infections related to the previous treatment.

    Special attention will be given to herpetic infections (infections caused by herpes viruses). If such infections occur, samples may be collected from the affected areas to check for the presence of the study product.

    The study will continue until March 31, 2031, allowing for extended observation of any delayed effects.

Who can join the trial?

2 criteria

  • You must have received at least one dose of an RPx product, which is the treatment being studied in the original research study, and you must have either completed or stopped taking part in that original study.
  • You or your legal guardian, which is a person legally responsible for making decisions on your behalf if you cannot do so yourself, must have signed an informed consent form. This form shows that you understand and agree to follow all the rules and requirements described in the consent document and in the study plan.

Who cannot join the trial?

3 criteria

  • The study does not list specific reasons why patients cannot participate
  • Please note that your doctor will review all requirements to determine if this study is appropriate for you
  • General safety considerations will be evaluated by the medical team before enrollment
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Investigated drugs

Replimune oncolytic immunotherapy products are experimental cancer treatments that use modified viruses to fight cancer. These products work by infecting and destroying cancer cells while also helping the body's immune system recognize and attack the tumor. The virus is designed to multiply inside cancer cells, causing them to break apart, and at the same time, it releases signals that alert the immune system to join the fight against the cancer.

What is already known about the treatment

Replimune Oncolytic Immunotherapy – This is an experimental cancer treatment currently being studied in clinical trials for its long-term safety in patients with metastatic melanoma, advanced solid tumors, and hepatocellular carcinoma. The medication belongs to a class of drugs called oncolytic immunotherapies, which work by using modified viruses that selectively infect and destroy cancer cells while also stimulating the body's immune system to recognize and attack the tumor. The treatment is administered directly into the tumor, where the virus multiplies within cancer cells, causing them to break apart and release substances that help activate the immune response against remaining cancer cells. This study specifically focuses on monitoring patients over an extended period to identify any delayed side effects that may occur after treatment with this investigational therapy.

Investigated diseases

  • Metastatic Melanoma

    Metastatic melanoma is an advanced stage of skin cancer that has spread from its original location to other parts of the body. It develops when melanoma cells break away from the primary tumor and travel through the bloodstream or lymphatic system to distant organs. Common sites of spread include the lungs, liver, brain, and bones. The disease represents the most serious form of melanoma because the cancer cells have gained the ability to invade other tissues. As the condition progresses, tumors may develop in multiple organs throughout the body. The spreading nature of this disease makes it significantly more challenging to manage than melanoma confined to the skin.

  • Hepatocellular Carcinoma

    Hepatocellular carcinoma is the most common type of primary liver cancer that originates in the main cells of the liver called hepatocytes. This disease typically develops in people with chronic liver conditions such as cirrhosis or long-term hepatitis infections. The cancer begins as abnormal cell growth within the liver tissue and can form single or multiple tumors. As it progresses, the tumors may grow larger and spread to other parts of the liver. The disease can also extend beyond the liver to nearby blood vessels and lymph nodes. In advanced stages, cancer cells may travel to distant organs including the lungs and bones.

  • Melanoma

    Melanoma is a type of skin cancer that develops in melanocytes, the cells responsible for producing skin pigment. It usually appears as an unusual mole or dark spot on the skin that changes in size, shape, or color over time. The disease can occur anywhere on the body but is most common in areas exposed to sunlight. If detected early while still confined to the outer layer of skin, the abnormal cells remain localized. Without intervention, melanoma cells can grow deeper into the skin layers and potentially spread to lymph nodes. In more advanced cases, the cancer may reach distant parts of the body through the bloodstream.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2025-521621-33-00Protocol codeRPL-123-01Estimated enrolment76 patientsSponsorReplimune Group Inc.

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