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
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
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 Inclusion Criteria:
Key Exclusion Criteria:
Duarte, California 91010, United States
Fountain Valley, California 92708, United States
Aurora, Colorado 80045, United States
Aurora, Colorado 80045, United States
New Lenox, Illinois 60451, United States
Orland Park, Illinois 60462, United States
Indianapolis, Indiana 46202, United States
Westwood, Kansas 66205, United States
Baltimore, Maryland 21287, United States
Baltimore, Maryland 21287, United States
Spokane Valley, Washington 99216, United States
Pergamino, Buenos Aires 2700, Argentina
San Miguel de TucumĂĄn, TucumĂĄn Province T4000GTB, Argentina
Adelaide, South Australia 5000, Australia
Woodville South, South Australia 5011, Australia
Wels, Upper Austria 4600, Austria
Wels, Upper Austria 4600, Austria
Libramont-Chevigny, Luxembourg 6800, Belgium
Roeselaere, 8800, Belgium
Cachoeiro de Itapemirim, EspĂrito Santo 29300-045, Brazil
Cachoeiro de Itapemirim, EspĂrito Santo 29308-014, Brazil
Cachoeiro de Itapemirim, EspĂrito Santo 29308-055, Brazil
Lajeado, Rio Grande do Sul 95900-000, Brazil
Lajeado, Rio Grande do Sul 95900-010, Brazil
Passo Fundo, Rio Grande do Sul 99010-080, Brazil
Passo Fundo, Rio Grande do Sul 99010-080, Brazil
Porto Alegre, Rio Grande do Sul 90020-090, Brazil
Porto Alegre, Rio Grande do Sul 90020-090, Brazil
Porto Alegre, Rio Grande do Sul 90110-270, Brazil
ItajaĂ, Santa Catarina 88301-220, Brazil
São José do Rio Preto, São Paulo 15090-000, Brazil
Montreal, Quebec H3T 1M5, Canada
Saint Jeand de Vedas, 34430, France
Falkensee, Brandenburg 14612, Germany
Bochum, North Rhine Westfalia 44789, Germany
Essen, North Rhine-Westphalia 45131, Germany
Essen, North Rhine-Westphalia 45147, Germany
Essen, North Rhine-Westphalia 45147, Germany
Essen, North Rhine-Westphalia 45239, Germany
Mönchengladbach, North Rhine-Westphalia 41063, Germany
Mönchengladbach, North Rhine-Westphalia 41063, Germany
Worms, Rhineland-Palatinate 67547, Germany
Hamburg, 20251, Germany
Jerusalem, 9112001, Israel
Jerusalem, 9112001, Israel
Torrette Di Ancona, Ancona 60020, Italy
Monserrato, Cagliari 09042, Italy
Milan, MI 20133, Italy
Florence, 50134, Italy
Modena, 41124, Italy
Modena, 41124, Italy
Naples, 80131, Italy
Pisa, 56126, Italy
Roma, 00133, Italy
Kashiwa-shi, Chiba 277-8577, Japan
Chuo-ku, Tokyo 104-0045, Japan
Fukuoka, 815-8588, Japan
Mexico City, Cuauhtemoc 06760, Mexico
Delegacion Cuauhtemoc, Mexico City 06760, Mexico
BrzozĂłw, 36-200, Poland
Moscow, 115478, Russia
Moscow, 115478, Russia
Saint Petersburg, 197022, Russia
Hwasun-gun, Jeollanam-do 58128, South Korea
Istanbul, Kadikoy 34722, Turkey (TĂŒrkiye)
Dnipropetrovsk, Dnipropetrovsk Oblast 49102, Ukraine
Dnipropetrovsk, Dnipropetrovsk Oblast 49102, Ukraine
Kyiv, Kyivska Oblast' 02096, Ukraine
Kyiv, Kyivska Oblast' 02096, Ukraine
Kyiv, Kyivska Oblast 01601, Ukraine
Vinnytsia, Vinnytsia Oblast 21029, Ukraine
Uzhhorod, Zakarpattia Oblast 88000, Ukraine
Glasglow, Glasglow City, Scotland G12 0YH, United Kingdom
Birmingham, WEST Midlands B15 2TH, United Kingdom