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

To join this study, you would generally need to be at least 18 years old and have been diagnosed with uveal melanoma that has spread and can't be removed by surgery. You would also need to have at least one tumour that can be measured and injected with the study drug, and you should be happy to provide tumour samples for testing. Your overall health, including your blood tests and how well your body systems are working, would need to be within certain normal ranges.

There are also reasons why you might not be able to join. For example, if you've already had immune checkpoint inhibitor treatments for your uveal melanoma, or if you have certain other serious health conditions like uncontrolled infections (including Hepatitis B or C, or HIV), or an active autoimmune disease. If the melanoma has spread to your brain, or if you've recently had major surgery or specific other treatments, you would also likely not be eligible. They also check for specific blood clotting issues.

The study also looks at your general fitness level, often called 'ECOG performance status', which means you should be able to carry out most daily activities without too much difficulty. The research team will carefully check all these points with you.

If you decide to take part in this study, you will receive one of the two treatment combinations: either RP2 combined with nivolumab, or nivolumab combined with ipilimumab. These drugs are given via injections or drips into your vein over a period of time. You will have regular appointments at the hospital or clinic for these treatments and for check-ups.

During your participation, you will have various tests, including blood tests, urine tests, and scans (like CT or MRI scans) to monitor your health and how the treatment is affecting the cancer. You will also be asked to provide tumour biopsy samples at certain points. The medical team will closely watch for any side effects you might experience and manage them appropriately.

After the main treatment period, there will be a follow-up phase where doctors continue to monitor your health and the progress of your cancer, even if you stop getting the study drugs. The total length of your participation, including follow-up, could be ongoing for some time, as it depends on how you respond to the treatment and the study's monitoring plan. You will always have the right to withdraw from the study at any time.