For Healthcare Professionals

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


About the study

The purpose of this study is to evaluate the efficacy and safety of the combination of study drugs encorafenib, binimetinib and cetuximab in patients who have BRAF V600 mutant metastatic colorectal cancer and have not received any prior treatment for their metastatic disease.

Who can take part

You may be eligible to participate in the study if you meet the following criteria:


Inclusion Criteria:

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


Exclusion Criteria:

  1. Prior systemic therapy for metastatic disease
  2. Prior treatment with any RAF inhibitor, MEK inhibitor, cetuximab or other anti-EGFR inhibitors
  3. Symptomatic brain metastasis or Leptomeningeal disease
  4. History or current evidence of Retinal Vein Occlusion (RVO) or current risk factors for RVO
  5. 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.
  6. 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
  7. History of thromboembolic or cerebrovascular events within 6 months prior to start of study treatment
  8. Concurrent neuromuscular disorder that is associated with potential elevation of Creatine Kinase
  9. Known contraindication to cetuximab administration as per SPC/approved label

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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply

Contact the study center to learn if this study is a good match for you.

Study’s details


BRAF V600E-mutant Metastatic Colorectal Cancer

Age (in years)



Phase 2

Participants needed


Est. Completion Date

Apr 29, 2023

Treatment type



Pierre Fabre Medicament identifier


Study number

W00090 GE 2 01

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