A Randomized, Phase 2/3 Study to Investigate the Efficacy and Safety of RP2 in Combination With Nivolumab in Immune Checkpoint Inhibitor-Naïve Adult Patients With Metastatic Uveal Melanoma

Exclusion Criteria

• •Any exposure to immune checkpoint inhibitor (ICIs) since the time of first being diagnosed with uveal melanoma.
• •Known acute or chronic Hepatitis B or C infection or human immunodeficiency virus (HIV) infection or any other uncontrolled infection.
• •Current active significant herpetic infections or prior complications of HSV-1 infection.
• •Any central nervous system (CNS) involvement of melanoma, including carcinomatous meningitis.
• •Major surgery ≤ 2 weeks prior to the first dose of study intervention.
• •Any bleeding, thrombotic and/or other event that places the patient at an unacceptable risk of complications of intratumoral therapy.
• •Active, known, or suspected autoimmune disease requiring systemic treatment.
• •Prior treatment with an oncolytic virus.
• •Requires intermittent or chronic use of systemic (oral or IV) antivirals with known antiherpetic activity (eg, acyclovir).
• •Systemic anticancer therapy or prior radiotherapy within 2 weeks of the first dose.
• •Has received Investigation agent within 4 weeks or 5 half-lives (whichever longer) prior to the first dose.
• •Conditions requiring treatment with immunosuppressive doses (\> 10 mg per day of prednisone or equivalent) of systemic corticosteroids other than for corticosteroid replacement therapy within 14 days after enrollment.