Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer

Inclusion Criteria

• Male or female ≥ 18 years of age
• Histologically or cytologically confirmed CRC that is metastatic
• Presence of BRAF V600E in tumor tissue determined by local assay at any time prior to screening
• Evidence of measurable disease as per RECIST, v1.1
• Subject able to receive cetuximab as per approved label with regards to RAS status
• Eastern Cooperative Oncology Group Status (ECOG) 0 or 1
• Adequate renal, hepatic, cardiac and bone marrow functions and adequate electrolytes as per protocol
• Subject able to take oral medications

Exclusion Criteria

• Prior systemic therapy for metastatic disease
• Prior treatment with any RAF inhibitor, MEK inhibitor, cetuximab or other anti-EGFR inhibitors
• Symptomatic brain metastasis or Leptomeningeal disease
• History or current evidence of Retinal Vein Occlusion (RVO) or current risk factors for RVO
• History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤ 12 months prior to first dose.
• Impaired cardiovascular function or clinically significant cardiovascular diseases: history of myocardial infarction or coronary disorders within 6 months prior to start of study treatment, symptomatic congestive heart failure (grade 2 or higher), past or current clinically significant arrhythmia and/or conduction disorder within 6 months prior to study treatment start
• History of thromboembolic or cerebrovascular events within 6 months prior to start of study treatment
• Concurrent neuromuscular disorder that is associated with potential elevation of Creatine Kinase
• Known contraindication to cetuximab administration as per SPC/approved label