NCT02928224

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 BRAF V600E-mutant Metastatic Colorectal Cancer

A Multicenter, Randomized, Open-label, 3-Arm Phase 3 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 BRAF V600E-mutant Metastatic Colorectal Cancer

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 702 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• BRAF V600E-mutant Metastatic Colorectal Cancer

Interventions

Type	Name	Description
DRUG	Encorafenib	Orally, once daily.
DRUG	Binimetinib	Orally, twice daily.
DRUG	Cetuximab	Standard of care.
DRUG	Irinotecan	Standard of care.
DRUG	Folinic Acid	Standard of care.
DRUG	5-Fluorouracil	Standard of care.

Timeline

• Start date: 2016-10-13
• Primary completion: 2019-02-11
• Completion: 2022-11-10
• First posted: 2016-10-10
• Last updated: 2023-12-21
• Results posted: 2020-07-14

Locations

418 sites across 27 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, Denmark, France, Germany, Hungary, Israel, Italy, Japan, Mexico, Netherlands, Norway, Poland, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom

Regulatory

• FDA-regulated drug study