The purpose of this study is to measure the clinical benefits of the combination of RP2 and nivolumab as compared with the combination of nivolumab and ipilimumab in patients with metastatic uveal melanoma who have not been treated with immune checkpoint inhibitor therapy.
Patients who are 18 years of age or older at the time of signed informed consent.
Patients with confirmed diagnosis of metastatic Uveal melanoma not amenable to surgical resection.
Has at least 1 measurable and injectable tumor of ≥ 1 cm in longest diameter (≥ 1.5 cm in the shortest axis for a lymph node [LN]) that is amenable to serial RP2 injections.
Must be willing to provide tumor biopsy samples.
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.