We want to find out if using RP2 with nivolumab works better than using ipilimumab with nivolumab to help adults with eye cancer that has spread and cannot be removed by surgery live longer.
RP2 is an experimental drug, which means it has not been approved by the FDA to treat eye cancer. RP2, nivolumab, and ipilimumab are types of immunotherapy, which help the immune system fight cancer. Using both RP2 and nivolumab together is experimental treatment. First, you will have a visit to see if you qualify for the study. At this visit, you will have a physical exam, a tumor biopsy, and a heart test (ECG). Your temperature, pulse, and blood pressure will be checked. You will answer questions about your health, medications, and quality of life. If you qualify and join, you will be randomly placed into one of two groups, like flipping a coin. One group will get RP2 and nivolumab. RP2 will be given for about 16 weeks, and you may get up to 8 extra doses if the study doctor thinks it will help. Nivolumab will be given for up to 2 years. The other group will get ipilimumab and nivolumab. You will get 4 doses each of ipilimumab and nivolumab over 12 weeks. Then, you will get nivolumab for up to 2 years. During the study, you will give blood, urine, and tumor samples, in addition to your regular medical tests. You will not be paid for being in this study. You and your insurance will pay for regular medical care costs like doctor visits, tests, and treatments.
You may be able to join this study if you are 18 or older and have uveal (a type of eye cancer) that has spread (metastasized) and cannot be removed with surgery. You need to have at least one tumor that is large enough (more than 1 cm wide) for repeated RP2 injections. You must also agree to give tumor samples for testing. You cannot join if you have ever received immune checkpoint inhibitor treatment since being diagnosed. More details about who can and cannot join are on ClinicalTrials.gov. Your study doctor or study team member will review these requirements with you.
Protocol Number: 25-0004
More information available at ClinicalTrials.gov: NCT06581406
Principal Investigator