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
Completed · Phase 3
Conditions studied: BRAF V600E-mutant Metastatic Colorectal Cancer
In brief
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.
Key facts
- Study ID
- NCT02928224
- Run by
- Pfizer
- People needed
- 702
- Starts
- 2016-10-13
- Expected to finish
- 2022-11-10
- Last updated by the study team
- 2023-12-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Mayo Clinic — Phoenix, Arizona, United States
- Mayo Clinic — Scottsdale, Arizona, United States
- City of Hope (City of Hope National Medical Center, City of Hope Medical Center) — Duarte, California, United States
- Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc. — Fountain Valley, California, United States
- Keck Hospital of USC - Norris Healthcare Center (HC3) — Los Angeles, California, United States
- Keck Hospital of USC — Los Angeles, California, United States
- LAC+USC Medical Center — Los Angeles, California, United States
- Norris Healthcare Center 3 (HC3) — Los Angeles, California, United States
- USC Eye Institute — Los Angeles, California, United States
- USC/Norris Comprehensive Cancer Center — Los Angeles, California, United States
- Hoag Memorial Hospital Presbyterian — Newport Beach, California, United States
- Harvard Eye Associates — Orange, California, United States
- Rocky Mountain Lions Eye Institute — Aurora, Colorado, United States
- University of Colorado Cancer Center - Anschutz Cancer Pavilion — Aurora, Colorado, United States
- University of Colorado Denver CTO (CTRC) — Aurora, Colorado, United States
- University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP) — Aurora, Colorado, United States
- University of Colorado Hospital Inpatient Pavillion' — Aurora, Colorado, United States
- Smilow Cancer Hospital at Yale - New Haven — New Haven, Connecticut, United States
- Temple Medical Center — New Haven, Connecticut, United States
- Yale University, Yale Cancer Center — New Haven, Connecticut, United States
- Smilow Cancer Hospital Care Center at North Haven — North Haven, Connecticut, United States
- The Lennar Foundation Medical Center — Coral Gables, Florida, United States
- Broward Health Medical Center — Fort Lauderdale, Florida, United States
- Dr. Clayton Berger (opthalmology) — Fort Lauderdale, Florida, United States
- Mayo Clinic Hospital — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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