Last updated on November 2019

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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: BRAF V600E-mutant Metastatic Colorectal Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male or Female

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 and confirmed by central laboratory
  • Evidence of measurable disease as per RECIST, v1.1
  • Subject able to receive cetuximab as per approved label with regards to RAS status
  • ECOG Status 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

Recruitment Status: Open

Brief Description Eligibility Contact Research Team

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