Study on RP2 and Nivolumab for Treating Metastatic Uveal Melanoma in Patients New to Immune Checkpoint Inhibitors

Inclusion Criteria

• Must be 18 years or older.
• Have a confirmed diagnosis of metastatic uveal melanoma that cannot be removed by surgery.
• Have at least one tumor that can be measured and injected, at least 1 cm in size.
• Willing to provide tumor samples for biopsy.
• Have normal levels of LDH (lactate dehydrogenase) up to twice the upper limit of normal.
• Have good blood, liver, and kidney function.
• Have normal blood clotting times.
• Be in good overall health with an ECOG performance status of 0 or 1, meaning fully active or restricted in physically strenuous activity but ambulatory.
• Have a life expectancy of more than 6 months.

Exclusion Criteria

• Have received any immune checkpoint inhibitor treatment since being diagnosed with uveal melanoma.
• Have active or chronic hepatitis B or C, HIV, or any other uncontrolled infection.
• Have active significant herpes infections or past complications from HSV-1.
• Have melanoma that has spread to the brain or spinal cord.
• Have had major surgery within 2 weeks before starting the study treatment.
• Have any bleeding or clotting issues that increase the risk of complications from the treatment.
• Have an active autoimmune disease that requires treatment.
• Have been treated with an oncolytic virus before.
• Need to use antiviral medications that treat herpes regularly.
• Have had cancer treatment or radiation therapy within 2 weeks before starting the study treatment.
• Have taken an investigational drug within 4 weeks or 5 half-lives before starting the study treatment.
• Need to take high doses of steroids (more than 10 mg per day of prednisone or equivalent) for reasons other than hormone replacement within 14 days after joining the study.