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A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
Sponsor: Pfizer
Summary
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: * has spread to other parts of the body (metastatic); * has a certain type of abnormal gene called "BRAF"; and * has not received prior treatment. Participants in this study will receive one of the following study treatments: * Encorafenib plus cetuximab: These participants will receive encorafenib by mouth at home every day and cetuximab once every two weeks by intravenous (IV) infusion (an injection into the vein) at the study clinic. * Encorafenib plus cetuximab with chemotherapy: These participants will receive encorafenib and cetuximab in the way described in the bullet above. Additionally, they will receive standard chemotherapy by IV infusion and oral treatment at home. * Chemotherapy alone: These participants will receive chemotherapy, the standard treatment for this condition, by IV infusion at the study clinics and oral treatment at home. 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.
Official title: 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
Key Details
Gender
All
Age Range
16 Years - Any
Study Type
INTERVENTIONAL
Enrollment
831
Start Date
2020-12-21
Completion Date
2027-12-28
Last Updated
2025-08-14
Healthy Volunteers
No
Conditions
Interventions
Encorafenib
75 mg capsules
Cetuximab
Injection for intravenous use 100 mg/vial, 200 mg/vial, or 500 mg/vial
Oxaliplatin
Powder for solution for intravenous use 50 mg/vial, 100 mg/vial, or 200 mg/vial
Irinotecan
Solution for intravenous infusion 40 mg/vial, 100 mg/vial, or 300 mg/vial
Leucovorin
Injection 50 mg/vial, 100 mg/vial, 200 mg/vial, or 350 mg/vial
5-FU
Injection for intravenous use 250 mg/vial, 500 mg/vial, or 1000 mg/vial
Capecitabine
150 mg or 500 mg Tablet
Bevacizumab
Optional Injection for intravenous use 100 mg/vial or 400 mg/vial
Locations (268)
Mayo Clinic Hospital
Phoenix, Arizona, United States
Mayo Clinic in Arizona - Scottsdale
Scottsdale, Arizona, United States
Keck Hospital of USC
Los Angeles, California, United States
LAC & USC Medical Center
Los Angeles, California, United States
USC / Norris Comprehensive Cancer Center
Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center/Investigational Drug Services
Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Keck Hospital of USC Pasadena
Pasadena, California, United States
Mount Sinai Comprehensive Cancer Center, Aventura
Aventura, Florida, United States
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
BRCR Global
Plantation, Florida, United States
BRCR Medical Center Inc.
Plantation, Florida, United States
UChicago Medicine - River East
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
UChicago Medicine at Ingalls - Flossmoor
Flossmoor, Illinois, United States
UChicago Medicine Ingalls Memorial
Harvey, Illinois, United States
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois, United States
The University of Chicago Medicine Center for Advanced Care Orland Park
Orland Park, Illinois, United States
UChicago Medicine at Ingalls - Tinley Park
Tinley Park, Illinois, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Siteman Cancer Center - St Peters
City of Saint Peters, Missouri, United States
Siteman Cancer Center - West County
Creve Coeur, Missouri, United States
Siteman Cancer Center - North County
Florissant, Missouri, United States
Barnes- Jewish Hospital
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Siteman Cancer Center - South County
St Louis, Missouri, United States
Oncology Hematology West PC dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Oncology Hematology West PC dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Oncology Hematology West PC dba Nebraska Cancer Specialists
Omaha, Nebraska, United States
Oncology Hematology West PC dba Nebraska Cancer Specialists
Papillion, Nebraska, United States
Memorial Sloan Kettering Cancer Center - Basking Ridge
Basking Ridge, New Jersey, United States
Summit Medical Group
Berkeley Heights, New Jersey, United States
Summit Medical Group
Florham Park, New Jersey, United States
Memorial Sloan Kettering Cancer Center- Monmouth
Middletown, New Jersey, United States
Memorial Sloan Kettering Cancer Center- Bergen
Montvale, New Jersey, United States
Memorial Sloan Kettering Cancer Center Commack
Commack, New York, United States
Memorial Sloan Kettering Cancer Center - Westchester
Harrison, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York, United States
Memorial Sloan Kettering Cancer Center- Nassau
Uniondale, New York, United States
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
Cleveland, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
The Ohio State University James Cancer Hospital and Solove Research Institute
Columbus, Ohio, United States
Stefanie Spielman Comprehensive Breast Cancer
Columbus, Ohio, United States
Martha Morehouse Medical Plaza
Columbus, Ohio, United States
The James Outpatient Care West Campus
Columbus, Ohio, United States
University of Oklahoma Health Sciences Center, OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Providence Cancer Institute Franz Clinic
Portland, Oregon, United States
Providence Portland Medical Center
Portland, Oregon, United States
Providence Onc and Heme Care Clinic - Westside
Portland, Oregon, United States
Providence St Vincent Medical Center
Portland, Oregon, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
The West Clinic. PLLC. dba West Cancer Center
Germantown, Tennessee, United States
Henry-Joyce Cancer Center
Nashville, Tennessee, United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Seattle Cancer Care Alliance
Seattle, Washington, United States
University of Washington Medical Center
Seattle, Washington, United States
University of Wisconsin Clinical Science Center
Madison, Wisconsin, United States
Centro Medico San Roque
San Miguel de Tucumán, Tucumán Province, Argentina
Instituto Médico Especializado Alexander Fleming
Buenos Aires, Argentina
Clinica Universitaria Reina Fabiola
Córdoba, Argentina
Hospital Privado Centro Médico de Córdoba
Córdoba, Argentina
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Liverpool Hospital
Liverpool, New South Wales, Australia
GenesisCare - North Shore
St Leonards, New South Wales, Australia
GenesisCare North Shore
St Leonards, New South Wales, Australia
Royal Brisbane & Women's Hospital
Herston, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
The Queen Elizabeth Hospital
Adelaide, South Australia, Australia
Monash Health
Clayton, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Alfred Health
Melbourne, Victoria, Australia
Université Libre de Bruxelles - Hôpital Erasme
Brussels, Bruxelles-capitale, Région de, Belgium
Cliniques universitaires Saint-Luc
Brussels, Bruxelles-capitale, Région de, Belgium
Grand Hôpital de Charleroi
Charleroi, Hainaut, Belgium
AZ Groeninge Campus Kennedylaan
Kortrijk, West-vlaanderen, Belgium
ZNA Middelheim
Antwerp, Belgium
UZ Leuven
Leuven, Belgium
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège, Belgium
GZA Hospitals Campus Sint Augustinus
Wilrijk, Belgium
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Reichow - Centro de Ensino e Pesquisa
Blumenau, Santa Catarina, Brazil
Clínica de Neoplasias Litoral
Itajaí, Santa Catarina, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, Brazil
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil
FUNDAÇÃO DO ABC - Faculdade de Medicina do ABC - Centro de Estudos e Pesquisas de Hematologia e Onco
Santo André, São Paulo, Brazil
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, São Paulo, Brazil
MHAT Uni Hospital OOD
Panagyurishte, Pazardzhik, Bulgaria
MHAT "Dr. Tota Venkova" AD
Gabrovo, Bulgaria
MHAT Central Onco Hospital OOD
Plovdiv, Bulgaria
Complex Oncology Center - Plovdiv EOOD
Plovdiv, Bulgaria
Medical Center Nadezhda Clinical EOOD
Sofia, Bulgaria
Acibadem City Clinic MHAT Tokuda
Sofia, Bulgaria
University Multiprofile Hospital for Active Treatment Sofiamed
Sofia, Bulgaria
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta, Canada
Cross Cancer Institute
Edmonton, Alberta, Canada
London Regional Cancer Program, London Health Sciences Centre
London, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Jewish General Hospital
Montreal, Quebec, Canada
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing Municipality, China
Beijing Cancer hospital
Beijing, Beijing Municipality, China
Beijing Hospital
Beijing, Beijing Municipality, China
Chongqing University Cancer Hospital
Chongqing, Chongqing Municipality, China
Fujian Medical University Union Hospital
Fuzhou, Fujian, China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, China
Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi, China
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, China
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Shengjing Hospital Of China Medical University
Shenyang, Liaoning, China
Shandong province cancer hospital
Jinan, Shandong, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
Shanghai General Hospital
Shanghai, Shanghai Municipality, China
Sichuan Province Cancer Hospital
Chengdu, Sichuan, China
Yunnan Cancer Hospital(The Third Affiliated Hospital of Kunming Medical University)
Kunming, Yunnan, China
The second Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Peking University First Hospital
Beijing, China
Fudan University Shanghai Cancer Center
Shanghai, China
Tianjin Union Medical Center
Tianjin, China
Fakultní nemocnice Brno Bohunice
Brno, Brno-město, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, Hradec Králové, Czechia
Fakultni Thomayerova nemocnice
Prague, Praha 4, Czechia
Fakultni nemocnice Olomouc
Olomouc, Czechia
Fakultni nemocnice Bulovka
Prague, Czechia
Aalborg Universitetshospital, Syd
Aalborg, North Denmark, Denmark
Vejle Hospital-Sygehus Lillebaelt
Vejle, Region Syddanmark, Denmark
Vejle Sygehus
Vejle, Region Syddanmark, Denmark
Rigshospitalet
Copenhagen, Denmark
Herlev and Gentofte Hospital
Herlev, Denmark
Odense University Hospital
Odense C, Denmark
Docrates Syöpäsairaala
Helsinki, Uusimaa, Finland
Helsinki University Central Hospital
Helsinki, Finland
Oulu University Hospital
Oulu, Finland
Satakunnan Keskussairaala
Pori, Finland
Tampereen yliopistollinen sairaala
Tampere, Finland
Turku University Hospital
Turku, Finland
Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie
Munich, Bavaria, Germany
Institut für Klinisch Onkologische Forschung
Frankfurt am Main, Hesse, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany
Onkologische Schwerpunktpraxis Kurfuerstendamm
Berlin, Germany
HELIOS Klinikum Berlin Buch GmbH
Berlin, Germany
Radiologie Berlin
Charlottenburg, Germany
Technische Universität Dresden, Medizinische Fakultät Carl Gustav Carus
Dresden, Germany
Universitätsklinikum Carl Gustav Carus Dresden
Dresden, Germany
Facharztzentrum Eppendorf
Hamburg, Germany
ZytoService Deutschland GmbH, Standort-Hamburg-Jenfeld
Hamburg, Germany
Radiologie im Israelitischen Krankenhaus
Hamburg, Germany
Tata Memorial Hospital
Mumbai, Maharashtra, India
Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra, India
Sahyadri Speciality Hospital
Pune, Maharashtra, India
Bhakti Vedanta Hospital and Research Institute
Thane, Maharashtra, India
Rajiv Gandhi Cancer Institute And Research Centre
New Delhi, National Capital Territory of Delhi, India
R K Birla Cancer Center, SMS Hospital
Jaipur, Rajasthan, India
Sawai Man Singh Medical College Hospital (SMS Hospital)
Jaipur, Rajasthan, India
Azienda Ospedaliera Universitaria di Cagliari - Presidio Policlinico Universitario "D.Casula"
Monserrato (CA), Cagliari, Italy
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Milano, Italy
Fondazione del Piemonte per l'Oncologia - Istituto di Candiolo IRCCS
Candiolo, Torino, Italy
Azienda Ospedaliero Universitaria San Luigi Gonzaga
Orbassano, Torino, Italy
Fondazione Poliambulanza Istituto Ospedaliero
Brescia, Italy
Istituto Europeo di Oncologia IRCCS
Milan, Italy
Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli" di Napoli
Naples, Italy
IRCCS Istituto Oncologico Veneto (IOV)
Padova, Italy
Azienda USL - IRCCS di Reggio Emilia - Arcispedale Santa Maria Nuova
Reggio Emilia, Italy
Chiba cancer center
Chiba, Chiba, Japan
National Cancer Center Hospital East
Kashiwa, Chiba, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
St. Marianna University Hospital
Kawasaki, Kanagawa, Japan
Kanagawa cancer center
Yokohama, Kanagawa, Japan
Aichi Cancer Center Hospital
Nagoya, Nagoya, Aichi, Japan
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Osaka, Osaka, Japan
Kindai University Hospital
Sayama, Osaka, Japan
Osaka University Hospital
Suita, Osaka, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka, Japan
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan
Saitama Prefectural Cancer Center
Ina-machi, Saitama, Japan
Shizuoka Cancer Center
Nakatogari, Shizuoka, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, Japan
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research
Osaka, Japan
Keio university hospital
Tokyo, Japan
Accelerium, S. de R.L. de C.V.
Monterrey, Nuevo León, Mexico
Centro de Investigacion Clinica de Oaxaca
Oaxaca City, Mexico
Catharina Ziekenhuis
Eindhoven, North Brabant, Netherlands
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)
Amsterdam, North Holland, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, Netherlands
Auckland City Hospital
Auckland, New Zealand
St. Olavs hospital
Trondheim, Sør-trøndelag, Norway
Sørlandet Sykehus Kristiansand
Kristiansand, Vest-agder, Norway
Oslo universitetssykehus, Radiumhospitalet
Oslo, Norway
Oslo Universitetssykehus Ullevål
Oslo, Norway
Przychodnia Lekarska KOMED
Konin, Greater Poland Voivodeship, Poland
Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Brzozów, Poland
Wojewodzki Szpital Specjalistyczny Nr 4 w Bytomiu Oddzial Onkologii
Bytom, Poland
COPERNICUS PL sp. z. o. o. Wojewodzkie Centrum Onkologii w Gdansku Ambulatoryjna
Gdansk, Poland
COPERNICUS Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii
Gdansk, Poland
Private Medical Institution "Euromedservice"
Pushkin, Sankt-Peterburg, Russia
GBUZ
Chelyabinsk, Russia
Kaluga Regional Clinical Oncology Center
Kaluga, Russia
FSAEI HE I.M Sechenov First MSMU MoH Russia (Sechenovskiy University),
Moscow, Russia
BHI of Omsk Region "Clinical Oncology Dispensary"
Omsk, Russia
BHI of Omsk Region "Clinical Oncology Dispensary"
Omsk, Russia
LLC "Medicina Severnoy Stolitsy"
Saint Petersburg, Russia
LLC "Severo-Zapadny Medical Center"
Saint Petersburg, Russia
Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of St. Petersburg
Saint Petersburg, Russia
LLC "EuroCityClinic"
Saint Petersburg, Russia
FSBI "Russian Scientific Center For Radiology and Surgical Technologies n.a. Academician A.M. Granov
Saint Petersburg, Russia
SHI YR Regional Clinical Oncology Hospital
Yaroslavl, Russia
Narodny Onkologicky Ustav
Bratislava, Slovakia
Vychodoslovensky onkologicky ustav, a.s.
Košice, Slovakia
Cancercare Rondebosch Oncology
Rondebosch, CAPE TOWN, South Africa
Cancercare Langenhoven Drive Oncology Centre
Port Elizabeth, Eastern Cape, South Africa
Wits Health Consortium (Pty) Ltd
Johannesburg, South Africa
National Cancer Center
Goyang-si, Gyeonggi-do, South Korea
Kyungpook National University Hospital
Daegu, Taegu-kwangyǒkshi, South Korea
Dong-A University Hospital
Busan, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
Korea University Anam Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Complejo Hospitalario Universitario Santiago de Compostela
Santiago de Compostela, A Coruña, Spain
Hospital General Universitario de Elche
Elche, Alicante, Spain
ICO L'Hospitalet (Hospital Duran i Reynals)
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Clinic Barcelona
Barcelona, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain
Hospital Universitario Ramon Y Cajal
Madrid, Spain
Hospital Universitario 12 de octubre
Madrid, Spain
Hospital Universitario Virgen Del Rocio
Seville, Spain
Hospital Clinico Universitario de Valencia
Valencia, Spain
Hospital General Universitario de Valencia
Valencia, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
Karolinska Universitetssjukhuset Solna
Solna, Stockholms LÄN [se-01], Sweden
Akademiska sjukhuset
Uppsala, Uppsala LÄN [se-03], Sweden
Norrlands universitetssjukhus
Umeå, Västerbottens LÄN [se-24], Sweden
Sahlgrenska Universitetssjukhuset
Gothenburg, Västra Götalands LÄN [se14], Sweden
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan
China Medical University Hospital
Taichung, Taiwan
National Cheng-Kung University Hospital
Tainan, Taiwan
Chi Mei Hospital, Liouying
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Medical Foundation-Linkou Branch
Taoyuan District, Taiwan
Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council
Dnipro, Ukraine
Ivano-Frankivsk National Medical University
Ivano-Frankivsk, Ukraine
MNPE "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Regional Council"
Ivano-Frankivsk, Ukraine
Communal enterprise "Kryvyi Rih Oncology Dispensary" of Dnipropetrovsk Regional Council
Kryvyi Rih, Ukraine
Freeman Hospital
Newcastle upon Tyne, HIGH Heaton, United Kingdom
Royal Marsden NHS Foundation Trust
Sutton, Surrey, United Kingdom
Heartlands Hospital
Birmingham, United Kingdom
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London, United Kingdom
Hammersmith Hospital
London, United Kingdom
Churchill Hospital - Oncology
Oxford, United Kingdom