This trial is examining the effectiveness and safety of encorafenib (Braftovi), binimetinib (Mektovi) and cetuximab (Erbitux) in patients with advanced colorectal cancer. The main outcome to be measured will be tumor response to the treatment.
Colorectal cancer is the third most common cancer worldwide. A high number of patients present metastatic disease (spread to other parts of the body) at diagnosis. In these cases, the standard treatment with chemotherapy is only of limited effectiveness. Especially, in tumors with the BRAF mutation (permanent change). This mutation activates tumor growth and is associated with a poorer prognosis.
The addition of encorafenib, binimetinib and cetuximab to the treatment of these patients might improve the chemotherapy treatment. These are targeted therapy drugs that block the activity of molecules that help cancer grow and spread.
This trial is evaluating the combination of encorafenib, binimetinib, and cetuximab in patients with metastatic colorectal cancer that have not been treated for metastatic disease. The main outcome evaluated will be a response to treatment.
Who are they looking for?
This trial is recruiting 90 participants. Patients should have a BRAF mutation and adequate liver, kidney, heart and bone marrow activity.
Patients should not have had prior therapy for metastatic disease. Patients must also not have brain metastasis, eye disease, bowel disease, cardiovascular disease or neuromuscular disease.
How will it work
All patients will have the same treatment. Patients will receive encorafenib once daily, binimetinib twice daily orally and cetuximab every 2 weeks after 28 weeks of standard care. The main outcome will be measured by assessing the tumor response (shrinkage). Patients will be followed up for up to 25 months.