AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE 3 STUDY OF FIRST-LINE ENCORAFENIB PLUS CETUXIMAB WITH OR WITHOUT CHEMOTHERAPY VERSUS STANDARD OF CARE THERAPY WITH A SAFETY LEAD-IN OF ENCORAFENIB AND CETUXIMAB PLUS CHEMOTHERAPY IN PARTICIPANTS WITH METASTATIC BRAF V600E-MUTANT COLORECTAL CANCER
AN OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE 3 STUDY OF FIRST-LINE ENCORAFENIB PLUS CETUXIMAB WITH OR WITHOUT CHEMOTHERAPY VERSUS STANDARD OF CARE THERAPY WITH A SAFETY LEAD-IN OF ENCORAFENIB AND CETUXIMAB PLUS CHEMOTHERAPY IN PARTICIPANTS WITH METASTATIC BRAF V600E-MUTANT COLORECTAL CANCER
The purpose of this study is to evaluate two study medicines (encorafenib plus cetuximab) taken alone or together with standard chemotherapy for the potential treatment of colorectal cancer that:
Participants in this study will receive one of the following study treatments:
This study is currently enrolling participants who will receive either encorafenib plus cetuximab with chemotherapy or chemotherapy alone.
The study team will monitor how each participant responds to the study treatment for up to about 3 years.
The purpose of the study is to evaluate whether encorafenib plus cetuximab (EC), alone or in combination with chemotherapy, can improve clinical outcomes relative to current standard of-care chemotherapy in participants with previously untreated BRAF V600E-mutant mCRC. Since encorafenib has not previously been combined with chemotherapy, the tolerability and PK of EC in combination with mFOLFOX6 and in combination with FOLFIRI will be evaluated in separate cohorts in the safety lead-in portion of the trial in order to identify which chemotherapy combination is to be used in the Phase 3 portion of the study.
Inclusion Criteria:
Exclusion Criteria:
Los Angeles, California 90033, United States
New Lenox, Illinois 60451, United States
Orland Park, Illinois 60462, United States
Basking Ridge, New Jersey 07920, United States
Columbus, Ohio 43210, United States
Columbus, Ohio 43210, United States
Oklahoma City, Oklahoma 73104, United States
Liège, 4000, Belgium
Rio de Janeiro, Rio de Janeiro 20230-130, Brazil
Santo André, São Paulo 09060-650, Brazil
Santo André, São Paulo 09060-870, Brazil
São José do Rio Preto, São Paulo 15090000, Brazil
Edmonton, Alberta T6G 2C8, Canada
Wuhan, Hubei 430030, China
Nanjing, Jiangsu 210008, China
Shanghai, Shanghai Municipality 201800, China
Kunming, Yunnan 650118, China
Hangzhou, Zhejiang 310000, China
New Delhi, National Capital Territory of Delhi 110085, India
Monserrato (CA), Cagliari 09042, Italy
Osaka, Osaka 5418567, Japan
Ina-machi, Saitama 362-0806, Japan
Chuo-ku, Tokyo 104-0045, Japan
Koto-ku, Tokyo 135-8550, Japan
Shinjuku-ku, Tokyo 160-8582, Japan
Osaka, 540-0006, Japan
Amsterdam, North Holland 1066 CX, Netherlands
Brzozów, 36-200, Poland
Gdansk, 80-219, Poland
Saint Petersburg, 195271, Russia
Saint Petersburg, 197758, Russia
Santiago de Compostela, A Coruña 15706, Spain
Stockholm, 171 76, Sweden
Dnipro, 49102, Ukraine
Ivano-Frankivsk, 76018, Ukraine
Kryvyi Rih, 50048, Ukraine