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

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What is this study about?

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.

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 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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Universitaetsklinikum Heidelberg AöR Heidelberg Germany

Other Sites

Site Name City Country Status
Hospital Universitario 12 De Octubre Madrid Spain
Institut Des Neurosciences De La Timone Marseille France
Hippokration Hospital Athens Greece
Hospital Clinic De Barcelona Barcelona Spain
Andreas Syngros Hospital Of Venereal And Dermatological Diseases Athens Greece
Ctxtmc Ltpt Bcndpz Lyon France
Lktzn Gdylrnc Hejyrkww Og Atksnf Athens Greece
Nstmdwjk Iydxvdgs Oxzwctfup Igr Mvxpd Saerlfpjzbsasyxayjqjrlzyofmo Iumoofcr Bvrscdzx Cracow Poland
Khnmeepc duj Uqhpybcbsnkc Mfwjlusz Atw Munich Germany
Uheigvureydbtv Cithtkp Kkrndmntk Gdansk Poland
Hlqbdslx Vnbi dhewguch Barcelona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
01.11.2025
Germany Germany
Recruiting
01.11.2025
Greece Greece
Recruiting
01.11.2025
Poland Poland
Recruiting
01.11.2025
Spain Spain
Recruiting
01.11.2025

Trial locations

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.

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 ID:
2025-521621-33-00
Protocol code:
RPL-123-01
NCT ID:
NCT06887348
Trial Phase:
Therapeutic confirmatory (Phase III)

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