Immunotherapy With Ipilimumab and Nivolumab Preceded or Not by a Targeted Therapy With Encorafenib and Binimetinib

To be considered for this study, you would need to have advanced melanoma (stage III or IV) that cannot be surgically removed or has spread to other parts of your body. Importantly, your melanoma must have a specific genetic change called a BRAF V600 mutation. This mutation will be checked in a sample of your tumour tissue.

You must be 18 years or older and generally well enough to participate in a clinical study, meaning you can perform most of your daily activities without much difficulty. You should also be able to swallow tablets. The study will also check that your major organs, like your heart and kidneys, are working properly. If you have conditions like an overactive or underactive thyroid that are well-controlled with medication, you might still be able to join.

However, there are reasons you might not be able to take part. For example, if your melanoma affects your eyes (uveal melanoma), or if you have active or symptomatic brain tumours. Also, if you have received previous treatments for your advanced melanoma, including certain types of immunotherapy or targeted therapies, you would not be eligible. The study also cannot include individuals who are allergic to any of the study medications.

If you decide to take part in this study, you will first undergo a series of health checks, including scans (like CT or MRI) and blood tests, to make sure you fit the study criteria. Once enrolled, you will be randomly assigned to one of two groups. Depending on your group, you'll either start treatment with a combination of two immunotherapy drugs given by drip, or you'll first take two targeted therapy drugs as tablets for 12 weeks, followed by the immunotherapy drugs.

Throughout the study, you will have regular clinic visits, blood tests, and scans to monitor your health, how you are responding to treatment, and any side effects you might experience. The frequency of these visits will vary but will be explained in detail. The total duration of your participation will depend on how your cancer responds to the treatment and for how long you tolerate it. After treatment ends, there will be a follow-up period to continue monitoring your health.