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

• Status: Active, not recruiting
• Trial end date: 2021-12-29
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pierre Fabre Medicament
• Collaborators: Array BioPharma; Merck KGaA, Darmstadt, Germany; Ono Pharmaceutical Co. Ltd; Pfizer
• Treatments: Cetuximab

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 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