Long-term Safety Evaluation of RP1, RP2, RP3, and Combination Therapy in Patients with Melanoma or Advanced Solid Tumors

The primary objective is to evaluate the long-term safety of patients previously treated with an RPx product and to identify any delayed adverse events associated with such treatment. The secondary objective is:

• Identification of systemic HSV-1 infection related to treatment with an RPx product.

The study population consists of 35 patients who have been diagnosed with metastatic melanoma, melanoma, hepatocellular carcinoma, or advanced solid tumors. The cohort includes both male and female participants within the specified age ranges of 3 and 4. Inclusion requires that individuals have received at least one dose of an RPx product and have either completed or discontinued participation in the parent study. The primary objectives are:

• To evaluate the long-term safety of patients treated with an RPx product.
• To identify any delayed adverse events related to treatment with an RPx product.

This noninterventional, observational, long-term follow-up study is designed to evaluate the long-term safety of patients previously treated with oncolytic immunotherapy products, specifically RP1, RP2, or RP3. The study focuses on patients with conditions such as metastatic melanoma, melanoma, hepatocellular carcinoma, or advanced solid tumors who have received at least one dose of an RPx product and have completed or discontinued their participation in the parent study. The primary objective is to identify delayed adverse events, including the occurrence of new malignancy, neurologic disorder exacerbation, autoimmune disorder, hematologic disorder, or infection related to the treatment. Particular attention is given to herpetic infection and the presence of the therapeutic agent in lesion samples. The study is estimated to occur between November 2025 and March 2031.

Vusolimogene oderparepvec is administered as a solution for injection. The dosage is 10,000,000 PFU/ml (plaque forming units per millilitre) and the route of administration is intratumoral.

RP2 is administered as a solution for injection. The dosage is 10,000,000 PFU/ml and the route of administration is intratumoral.

RP3 is administered as a solution for injection. The dosage is 10,000,000 PFU/ml and the route of administration is intratumoral.

The efficacy assessment in this clinical trial is focused on the evaluation of delayed adverse events following treatment with an RPx product. The primary endpoints include the occurrence of new malignancy, new incidence or exacerbation of a pre-existing neurologic disorder, and new incidence or exacerbation of a pre-existing rheumatologic or autoimmune disorder. Additionally, the assessment includes the new incidence of a hematologic disorder and new incidence of infection related to the RPx product.

The evaluation also monitors for new herpetic infection and the presence of the RPx product within samples collected from herpetic lesions.