A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma

To join this study, you need to be at least 18 years old and have been diagnosed with advanced melanoma that has spread or cannot be removed by surgery. Critically, your melanoma must have a specific gene change called 'BRAF V600E' or 'V600K', which will be checked with a special test.

You also need to be generally well enough to take part, meaning you can look after yourself and handle daily activities, as measured by a simple score called 'ECOG performance status 0 or 1'. It's also important that you haven't received any treatment for your advanced melanoma before.

There are also some reasons why you might not be able to join. For example, if you have other serious medical conditions that could make taking part risky, or if you have certain types of melanoma like mucosal or eye melanoma. The study team will review all your medical information carefully to see if this study is suitable for you.

If you join the study, you'll be assigned to one of two groups by chance – like flipping a coin. Everyone in the study will receive pembrolizumab, which is given into a vein (an 'IV drip') at the clinic every three weeks. Half of the participants will also receive encorafenib and binimetinib, which are tablets you take by mouth every day at home.

You'll be monitored closely with regular visits to the clinic. These visits will involve blood tests, scans, and discussions with the study team to check how you're responding to the treatment and for any side effects. You might receive pembrolizumab for up to two years, and if you're taking the tablets, you can continue them as long as your melanoma is responding well to the treatment. The study team will guide you through all the steps.