This is a multicenter, randomized, open-label, Phase 3 study
Before study entry, written informed consent must be obtained from the patient prior to performing any study-related procedures.
Male or female patients with 18 to 70 years of age at time of informed consent;
Histological or cytologically confirmed metastatic CRC
Presence of BRAFV600E in tumor tissue as previously determined by a local assay at any time prior to Screening or by the central laboratory (BRAFV600 is permitted)
Prior treatment with any BRAF and MEK inhibitor;
Known contraindication to receive the treatment of control arm (according to latest PI).
Symptomatic brain metastasis or leptomeningeal disease
History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to randomization