A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer

To join this study, people generally need to be at least 16 years old. Your doctor will need to confirm that you have bowel cancer that has spread (Stage IV), and that your cancer has the specific 'BRAF V600E' gene change. You cannot have received any previous treatment for your bowel cancer that has spread to other parts of the body. Your general health and organ function will also be checked to make sure you are well enough to take part.

There are also reasons why someone might not be able to join. For example, if you have certain active infections or if your doctor finds that your cancer has features that make it unsuitable for this specific trial. If your cancer has spread to your brain and is causing symptoms, you would also not be able to participate. Your study doctor will go through all these details with you carefully.

If you join this study, you will be assigned to one of three treatment groups. Two groups will receive the new medicines, encorafenib (a tablet taken daily at home) and cetuximab (given as an injection into a vein at the clinic every two weeks). One of these groups will also receive standard chemotherapy, given both into a vein at the clinic and as tablets at home. The third group will receive standard chemotherapy only, also given into a vein at the clinic and as tablets at home.

The study team will regularly monitor your health and how you are responding to the treatment. This will involve regular visits to the clinic for treatments, check-ups, and tests. They will follow your progress for up to about three years. You will have a dedicated study team to support you throughout your participation.