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

Launched by PIERRE FABRE MEDICAMENT · Oct 1, 2018

Keywords

ClinConnect Summary

The presence of a BRAFV600E mutation is considered a marker of poor prognosis in subjects with mCRC. The preclinical results and preliminary clinical data together justify the evaluation of this triple combination in the first-line setting of this population. The primary objective of the study is to evaluate the antitumor activity of the combination of encorafenib, binimetinib and cetuximab by assessing the overall response rate in adult subjects with previously untreated BRAFV600E-mutant metastatic colorectal cancer. It will also assess the effect of the triple combination on the duration ...

Gender

ALL

Eligibility criteria

• 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