Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With

• Status: Active, not recruiting
• Trial end date: 2022-05-31

Summary

This is a multicenter, randomized, open-label, 3-arm Phase 3 study to evaluate encorafenib + cetuximab plus or minus binimetinib versus Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab, as controls, in patients with BRAFV600E mCRC whose disease has progressed after 1 or 2 prior regimens in the metastatic setting. The study contains a Safety Lead-in Phase in which the safety and tolerability of encorafenib + binimetinib + cetuximab will be assessed prior to the Phase 3 portion of the study.

• Phase: Phase 3

Details

• Lead Sponsor: Array BioPharma; Pfizer
• Collaborators: Merck KGaA; Merck KGaA, Darmstadt, Germany; Ono Pharmaceutical Co. Ltd; Pierre Fabre Medicament
• Treatments: Camptothecin; Cetuximab; Fluorouracil; Folic Acid; Irinotecan; Leucovorin; Levoleucovorin