A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer

May 15, 2026 updated by: Pfizer

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:

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.

Study Overview

Status

Active, not recruiting

Conditions

Neoplasms

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

841

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, 1426
    - Instituto Médico Especializado Alexander Fleming
  - Córdoba, Argentina, X5004FHP
    - Clinica Universitaria Reina Fabiola
  - Córdoba, Argentina, X5016KEH
    - Hospital Privado Centro Médico de Córdoba
- Tucumán Province
  - San Miguel de Tucumán, Tucumán Province, Argentina, 4000
    - Centro Medico San Roque
Australia
- New South Wales
  - Camperdown, New South Wales, Australia, 2050
    - Chris O'Brien Lifehouse
  - Liverpool, New South Wales, Australia, 2170
    - Liverpool Hospital
  - St Leonards, New South Wales, Australia, 2065
    - GenesisCare North Shore
  - St Leonards, New South Wales, Australia, 2065
    - GenesisCare - North Shore
- Queensland
  - Herston, Queensland, Australia, 4029
    - Royal Brisbane and Women's Hospital
  - Woolloongabba, Queensland, Australia, 4102
    - Princess Alexandra Hospital
- South Australia
  - Adelaide, South Australia, Australia, 5011
    - The Queen Elizabeth Hospital
  - Adelaide, South Australia, Australia, 5000
    - Central Adelaide Local Health Network Incorporated
- Victoria
  - Clayton, Victoria, Australia, 3168
    - Monash Health
  - Heidelberg, Victoria, Australia, 3084
    - Austin Health
  - Melbourne, Victoria, Australia, 3000
    - Peter MacCallum Cancer Centre
  - Melbourne, Victoria, Australia, 3004
    - Alfred Health
Belgium
- - Antwerp, Belgium, 2020
    - ZNA Middelheim
  - Leuven, Belgium, 3000
    - UZ Leuven
  - Liège, Belgium, 4000
    - Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
  - Wilrijk, Belgium, 2610
    - ZAS Augustinus
- Bruxelles-capitale, Région de
  - Brussels, Bruxelles-capitale, Région de, Belgium, 1070
    - Université Libre de Bruxelles - Hôpital Erasme
  - Brussels, Bruxelles-capitale, Région de, Belgium, 1200
    - Cliniques Universitaires Saint-Luc
- Hainaut
  - Charleroi, Hainaut, Belgium, 6060
    - Grand Hôpital de Charleroi
- West-vlaanderen
  - Kortrijk, West-vlaanderen, Belgium, 8500
    - AZ Groeninge Campus Kennedylaan
Brazil
- Rio Grande do Sul
  - Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
    - Hospital de Clinicas de Porto Alegre
- Rio de Janeiro
  - Rio de Janeiro, Rio de Janeiro, Brazil, 20230-130
    - Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA
- Santa Catarina
  - Blumenau, Santa Catarina, Brazil, 89010-340
    - Reichow - Centro de Ensino e Pesquisa
  - Itajaí, Santa Catarina, Brazil, 88301-220
    - Clínica de Neoplasias Litoral
- São Paulo
  - Barretos, São Paulo, Brazil, 14784400
    - Fundação Pio XII - Hospital de Câncer de Barretos
  - Barretos, São Paulo, Brazil, 14.780-070
    - Fundação Pio XII - Hospital de Câncer de Barretos
  - Santo André, São Paulo, Brazil, 09060-650
    - CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC
  - Santo André, São Paulo, Brazil, 09060-870
    - FUNDAÇÃO DO ABC - Faculdade de Medicina do ABC - Centro de Estudos e Pesquisas de Hematologia e Onco
  - São José do Rio Preto, São Paulo, Brazil, 15090000
    - Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
Bulgaria
- - Gabrovo, Bulgaria, 5300
    - MHAT "Dr. Tota Venkova" AD
  - Plovdiv, Bulgaria, 4000
    - MHAT Central Onco Hospital OOD
  - Plovdiv, Bulgaria, 4004
    - Complex Oncology Center - Plovdiv EOOD
  - Sofia, Bulgaria, 1303
    - Medical Center Nadezhda Clinical EOOD
  - Sofia, Bulgaria, 1407
    - Acibadem City Clinic MHAT Tokuda
  - Sofia, Bulgaria, 1750
    - University Multiprofile Hospital for Active Treatment Sofiamed
- Pazardzhik
  - Panagyurishte, Pazardzhik, Bulgaria, 4500
    - MHAT Uni Hospital OOD
Canada
- Alberta
  - Calgary, Alberta, Canada, T2N 4N2
    - Alberta Health Services - Cancer Care, Tom Baker Cancer Centre
  - Calgary, Alberta, Canada, T3N 4N1
    - Arthur J.E. Child Comprehensive Cancer Centre
  - Edmonton, Alberta, Canada, T6G 1Z2
    - Cross Cancer Institute
  - Edmonton, Alberta, Canada, T6G 2C8
    - Alberta Health Services and The Governors of The University of Alberta
- Ontario
  - London, Ontario, Canada, N6A 5W9
    - London Regional Cancer Program, London Health Sciences Centre
  - Toronto, Ontario, Canada, M4N 3M5
    - Sunnybrook Health Sciences Centre
- Quebec
  - Montreal, Quebec, Canada, H3T 1E2
    - Jewish General Hospital
China
- - Shanghai, China, 201321
    - Fudan University Shanghai Cancer Center
  - Tianjin, China, 300000
    - Tianjin Union Medical Center
- Beijing Municipality
  - Beijing, Beijing Municipality, China, 100142
    - Beijing Cancer Hospital
  - Beijing, Beijing Municipality, China, 100034
    - Peking University First Hospital
  - Beijing, Beijing Municipality, China, 100730
    - Beijing Hospital
  - Beijing, Beijing Municipality, China, 100021
    - Cancer Hospital Chinese Academy of Medical Science
- Chongqing Municipality
  - Chongqing, Chongqing Municipality, China, 400030
    - Chongqing University Cancer Hospital
- Fujian
  - Fuzhou, Fujian, China, 350001
    - Fujian Medical University Union Hospital
- Guangdong
  - Guangzhou, Guangdong, China, 510655
    - The Sixth Affiliated Hospital of Sun Yat-sen University
- Guangxi
  - Nanning, Guangxi, China, 530200
    - Affiliated Tumor Hospital of Guangxi Medical University
- Hubei
  - Wuhan, Hubei, China, 430030
    - Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
- Hunan
  - Changsha, Hunan, China, 410013
    - The Third Xiangya Hospital of Central South University
  - Changsha, Hunan, China, 410011
    - The Second Xiangya Hospital of Central South University
- Jiangsu
  - Nanjing, Jiangsu, China, 210008
    - Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
- Liaoning
  - Shenyang, Liaoning, China, 110022
    - Shengjing Hospital of China Medical University
- Shandong
  - Jinan, Shandong, China, 250117
    - Shandong province cancer hospital
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, China, 200080
    - Shanghai General Hospital
  - Shanghai, Shanghai Municipality, China, 201800
    - Ruijin Hospital Shanghai Jiaotong University School of Medicine
- Sichuan
  - Chengdu, Sichuan, China, 610041
    - Sichuan Province Cancer Hospital
- Yunnan
  - Kunming, Yunnan, China, 650118
    - Yunnan Cancer Hospital(The Third Affiliated Hospital of Kunming Medical University)
- Zhejiang
  - Hangzhou, Zhejiang, China, 310000
    - The second Affiliated Hospital of College of Medicine, Zhejiang University
Czechia
- - Olomouc, Czechia, 779 00
    - Fakultni nemocnice Olomouc
  - Prague, Czechia, 180 81
    - Fakultni nemocnice Bulovka
- Brno-město
  - Brno, Brno-město, Czechia, 625 00
    - Fakultní nemocnice Brno Bohunice
- Hradec Králové
  - Hradec Králové, Hradec Králové, Czechia, 500 05
    - Fakultni nemocnice Hradec Kralove
- Praha 4
  - Prague, Praha 4, Czechia, 14059
    - Fakultni Thomayerova nemocnice
Denmark
- - Copenhagen, Denmark, 2100
    - Rigshospitalet
  - Herlev, Denmark, 2730
    - Herlev and Gentofte Hospital
  - Odense C, Denmark, 5000
    - Odense University Hospital
- North Denmark
  - Aalborg, North Denmark, Denmark, 9000
    - Aalborg Universitetshospital, Syd
- Region Syddanmark
  - Vejle, Region Syddanmark, Denmark, 7100
    - Vejle Sygehus
  - Vejle, Region Syddanmark, Denmark, 7100
    - Vejle Hospital-Sygehus Lillebaelt
Finland
- - Oulu, Finland, 90220
    - Oulu University Hospital
  - Pori, Finland, 28500
    - Satakunnan Keskussairaala
  - Tampere, Finland, 33521
    - Tampereen yliopistollinen sairaala
  - Tampere, Finland, 33520
    - Tampereen yliopistollinen sairaala
  - Turku, Finland, 20520
    - Turku University Hospital
- Southwest Finland
  - Turku, Southwest Finland, Finland, 20520
    - Turku University Hospital
- Uusimaa
  - Helsinki, Uusimaa, Finland, 00290
    - Helsinki University Central Hospital
  - Helsinki, Uusimaa, Finland, 00180
    - Docrates Syöpäsairaala
Germany
- - Berlin, Germany, 10707
    - Onkologische Schwerpunktpraxis Kurfuerstendamm
  - Berlin, Germany, 13125
    - HELIOS Klinikum Berlin Buch GmbH
  - Charlottenburg, Germany, 10719
    - Radiologie Berlin
  - Dresden, Germany, 01307
    - Universitätsklinikum Carl Gustav Carus Dresden
  - Dresden, Germany, 01307
    - Technische Universität Dresden, Medizinische Fakultät Carl Gustav Carus
  - Hamburg, Germany, 20249
    - Facharztzentrum Eppendorf
  - Hamburg, Germany, 22045
    - ZytoService Deutschland GmbH, Standort-Hamburg-Jenfeld
  - Hamburg, Germany, 22297
    - Radiologie im Israelitischen Krankenhaus
- Bavaria
  - Munich, Bavaria, Germany, 81737
    - Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie
- Hesse
  - Frankfurt am Main, Hesse, Germany, 60488
    - Institut für Klinisch Onkologische Forschung
- Lower Saxony
  - Hanover, Lower Saxony, Germany, 30625
    - Medizinische Hochschule Hannover
- Saxony
  - Leipzig, Saxony, Germany, 04103
    - Universitatsklinikum Leipzig
India
- Maharashtra
  - Mumbai, Maharashtra, India, 400012
    - Tata Memorial Hospital
  - Pune, Maharashtra, India, 411 004
    - Deenanath Mangeshkar Hospital & Research Centre
  - Pune, Maharashtra, India, 411 004
    - Sahyadri Speciality Hospital
  - Thane, Maharashtra, India, 401107
    - Bhakti Vedanta Hospital and Research Institute
- National Capital Territory of Delhi
  - New Delhi, National Capital Territory of Delhi, India, 110085
    - Rajiv Gandhi Cancer Institute And Research Centre
- Rajasthan
  - Jaipur, Rajasthan, India, 302004
    - Sawai Man Singh Medical College Hospital (SMS Hospital)
Italy
- - Brescia, Italy, 25124
    - Fondazione Poliambulanza Istituto Ospedaliero
  - Milan, Italy, 20141
    - Istituto Europeo di Oncologia IRCCS
  - Naples, Italy, 80131
    - Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli" di Napoli
  - Padova, Italy, 35128
    - IRCCS Istituto Oncologico Veneto (IOV)
  - Reggio Emilia, Italy, 42123
    - Azienda USL - IRCCS di Reggio Emilia - Arcispedale Santa Maria Nuova
- Cagliari
  - Monserrato (CA), Cagliari, Italy, 09042
    - Azienda Ospedaliera Universitaria di Cagliari - Presidio Policlinico Universitario "D.Casula"
- Foggia
  - San Giovanni Rotondo, Foggia, Italy, 71013
    - IRCCS Casa Sollievo della Sofferenza
- Milano
  - Milan, Milano, Italy, 20162
    - ASST Grande Ospedale Metropolitano Niguarda
- Torino
  - Candiolo, Torino, Italy, 10060
    - Fondazione del Piemonte per l'Oncologia - Istituto di Candiolo IRCCS
  - Orbassano, Torino, Italy, 10043
    - Azienda Ospedaliero Universitaria San Luigi Gonzaga
Japan
- - Fukuoka, Japan, 811-1395
    - National Hospital Organization Kyushu Cancer Center
  - Osaka, Japan, 540-0006
    - National Hospital Organization - Osaka National Hospital - Institute For Clinical Research
- Chiba
  - Chiba, Chiba, Japan, 260-8717
    - Chiba cancer center
  - Kashiwa, Chiba, Japan, 277-8577
    - National Cancer Center Hospital East
- Hokkaido
  - Sapporo, Hokkaido, Japan, 060-8648
    - Hokkaido University Hospital
- Ishikawa-ken
  - Kanazawa, Ishikawa-ken, Japan, 920-8641
    - Kanazawa University Hospital
- Kanagawa
  - Kawasaki, Kanagawa, Japan, 216-8511
    - St. Marianna University Hospital
  - Yokohama, Kanagawa, Japan, 2418515
    - Kanagawa Cancer Center
- Nagoya, Aichi
  - Nagoya, Nagoya, Aichi, Japan, 464-8681
    - Aichi Cancer Center Hospital
- Osaka
  - Osaka, Osaka, Japan, 5418567
    - Osaka Prefectural Hospital Organization Osaka International Cancer Institute
  - Sayama, Osaka, Japan, 589-8511
    - Kindai University Hospital
  - Suita, Osaka, Japan, 565-0871
    - Osaka University Hospital
  - Takatsuki, Osaka, Japan, 569-8686
    - Osaka Medical and Pharmaceutical University Hospital
- Saitama
  - Hidaka, Saitama, Japan, 350-1298
    - Saitama Medical University International Medical Center
  - Ina-machi, Saitama, Japan, 362-0806
    - Saitama Prefectural Cancer Center
- Shizuoka
  - Nakatogari, Shizuoka, Japan, 411-8777
    - Shizuoka Cancer Center
- Tokyo
  - Chuo-ku, Tokyo, Japan, 104-0045
    - National Cancer Center Hospital
  - Koto-ku, Tokyo, Japan, 135-8550
    - The Cancer Institute Hospital of JFCR
  - Shinjuku-ku, Tokyo, Japan, 160-8582
    - Keio University Hospital
Mexico
- - Oaxaca City, Mexico, 68020
    - Centro de Investigacion Clinica de Oaxaca
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64000
    - Accelerium, S. de R.L. de C.V.
Netherlands
- - Utrecht, Netherlands, 3584 CX
    - Universitair Medisch Centrum Utrecht
- North Brabant
  - Eindhoven, North Brabant, Netherlands, 5623 EJ
    - Catharina Ziekenhuis
- North Holland
  - Amsterdam, North Holland, Netherlands, 1066 CX
    - Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)
New Zealand
- - Auckland, New Zealand, 1023
    - Auckland City Hospital
Norway
- - Oslo, Norway, 0379
    - Oslo universitetssykehus, Radiumhospitalet
  - Oslo, Norway, 0450
    - Oslo Universitetssykehus Ullevål
- Sør-trøndelag
  - Trondheim, Sør-trøndelag, Norway, 7030
    - St. Olavs hospital
- Vest-agder
  - Kristiansand, Vest-agder, Norway, N-4615
    - Sørlandet Sykehus Kristiansand
Poland
- - Brzozów, Poland, 36-200
    - Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
  - Bytom, Poland, 41-902
    - Wojewodzki Szpital Specjalistyczny Nr 4 w Bytomiu Oddzial Onkologii
  - Gdansk, Poland, 80-219
    - COPERNICUS Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii
  - Gdansk, Poland, 80-219
    - COPERNICUS PL sp. z. o. o. Wojewodzkie Centrum Onkologii w Gdansku Ambulatoryjna
- Greater Poland Voivodeship
  - Konin, Greater Poland Voivodeship, Poland, 62-500
    - Przychodnia Lekarska KOMED
Russia
- - Chelyabinsk, Russia, 454087
    - GBUZ
  - Kaluga, Russia, 248007
    - Kaluga Regional Clinical Oncology Center
  - Moscow, Russia, 119991
    - FSAEI HE I.M Sechenov First MSMU MoH Russia (Sechenovskiy University),
  - Omsk, Russia, 644013
    - BHI of Omsk Region "Clinical Oncology Dispensary"
  - Omsk, Russia, 644046
    - BHI of Omsk Region "Clinical Oncology Dispensary"
  - Saint Petersburg, Russia, 191025
    - LLC "Medicina Severnoy Stolitsy"
  - Saint Petersburg, Russia, 192007
    - LLC "Severo-Zapadny Medical Center"
  - Saint Petersburg, Russia, 195271
    - Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of St. Petersburg
  - Saint Petersburg, Russia, 197022
    - LLC "EuroCityClinic"
  - Saint Petersburg, Russia, 197758
    - FSBI "Russian Scientific Center For Radiology and Surgical Technologies n.a. Academician A.M. Granov
  - Yaroslavl, Russia, 150054
    - SHI YR Regional Clinical Oncology Hospital
- Sankt-Peterburg
  - Pushkin, Sankt-Peterburg, Russia, 196603
    - Private Medical Institution "Euromedservice"
Slovakia
- - Bratislava, Slovakia, 833 10
    - Narodny Onkologicky Ustav
  - Košice, Slovakia, 04191
    - Vychodoslovensky onkologicky ustav, a.s.
South Africa
- - Johannesburg, South Africa, 2193
    - Wits Health Consortium (Pty) Ltd
- CAPE TOWN
  - Rondebosch, CAPE TOWN, South Africa, 7700
    - Cancercare Rondebosch Oncology
- Eastern Cape
  - Port Elizabeth, Eastern Cape, South Africa, 6045
    - Cancercare Langenhoven Drive Oncology Centre
South Korea
- - Busan, South Korea, 49201
    - Dong-A University Hospital
  - Daegu, South Korea, 41404
    - Kyungpook National University Chilgok Hospital
  - Incheon, South Korea, 21565
    - Gachon University Gil Medical Center
  - Seoul, South Korea, 03080
    - Seoul National University Hospital
  - Seoul, South Korea, 05505
    - Asan Medical Center
  - Seoul, South Korea, 06351
    - Samsung Medical Center
  - Seoul, South Korea, 03722
    - Severance Hospital, Yonsei University Health System
  - Seoul, South Korea, 02841
    - Korea University Anam Hospital
- Gyeonggi-do
  - Goyang-si, Gyeonggi-do, South Korea, 10408
    - National Cancer Center
Spain
- - Barcelona, Spain, 08035
    - Hospital Universitario Vall d'Hebron
  - Barcelona, Spain, 08036
    - Hospital Clinic Barcelona
  - Madrid, Spain, 28034
    - Hospital Universitario Ramón y Cajal
  - Madrid, Spain, 28041
    - Hospital Universitario 12 de Octubre
  - Madrid, Spain, 28007
    - Hospital General Universitario Gregorio Marañón
  - Seville, Spain, 41013
    - Hospital Universitario Virgen del Rocio
  - Valencia, Spain, 46010
    - Hospital Clinico Universitario de Valencia
  - Valencia, Spain, 46014
    - Hospital General Universitario de Valencia
  - Zaragoza, Spain, 50009
    - Hospital Universitario Miguel Servet
- A Coruña
  - Santiago de Compostela, A Coruña, Spain, 15706
    - Complejo Hospitalario Universitario Santiago de Compostela
- Alicante
  - Elche, Alicante, Spain, 03203
    - Hospital General Universitario de Elche
- Barcelona
  - L'Hospitalet de Llobregat, Barcelona, Spain, 08908
    - ICO L'Hospitalet (Hospital Duran i Reynals)
Sweden
- - Stockholm, Sweden, 171 76
    - Department of Pelvic cancer, colorecta section, Karolinska University Hospital
- Stockholms LÄN [se-01]
  - Solna, Stockholms LÄN [se-01], Sweden, 171 64
    - Karolinska Universitetssjukhuset Solna
- Uppsala LÄN [se-03]
  - Uppsala, Uppsala LÄN [se-03], Sweden, 751 85
    - Akademiska sjukhuset
- Västerbottens LÄN [se-24]
  - Umeå, Västerbottens LÄN [se-24], Sweden, 90185
    - Norrlands universitetssjukhus
- Västra Götalands LÄN [se14]
  - Gothenburg, Västra Götalands LÄN [se14], Sweden, 413 45
    - Sahlgrenska Universitetssjukhuset
Taiwan
- - Kaohsiung City, Taiwan, 807
    - Kaohsiung Medical University Chung-Ho Memorial Hospital
  - Taichung, Taiwan, 404
    - China Medical University Hospital
  - Tainan, Taiwan, 704
    - National Cheng-Kung University Hospital
  - Tainan, Taiwan, 73657
    - Chi Mei Hospital, Liouying
  - Taipei, Taiwan, 100
    - National Taiwan University Hospital
  - Taipei, Taiwan, 11031
    - Taipei Medical University Hospital
  - Taipei, Taiwan, 112
    - Taipei Veterans General Hospital
  - Taoyuan, Taiwan, 333
    - Chang Gung Medical Foundation-Linkou Branch
Ukraine
- - Dnipro, Ukraine, 49102
    - Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council
  - Ivano-Frankivsk, Ukraine, 76018
    - Ivano-Frankivsk National Medical University
  - Ivano-Frankivsk, Ukraine, 76018
    - MNPE "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Regional Council"
  - Kryvyi Rih, Ukraine, 50048
    - Communal enterprise "Kryvyi Rih Oncology Dispensary" of Dnipropetrovsk Regional Council
United Kingdom
- - Birmingham, United Kingdom, B9 5SS
    - Heartlands Hospital
  - London, United Kingdom, W12 0HS
    - Hammersmith Hospital, Imperial College Healthcare NHS Trust
  - London, United Kingdom, W6 8RF
    - Hammersmith Hospital
  - Oxford, United Kingdom, OX3 7LE
    - Churchill Hospital - Oncology
- HIGH Heaton
  - Newcastle upon Tyne, HIGH Heaton, United Kingdom, NE7 7DN
    - Freeman Hospital
- Surrey
  - Sutton, Surrey, United Kingdom, SM2 5PT
    - Royal Marsden NHS Foundation Trust
United States
- Arizona
  - Phoenix, Arizona, United States, 85054
    - Mayo Clinic Hospital
  - Scottsdale, Arizona, United States, 85259
    - Mayo Clinic in Arizona - Scottsdale
- California
  - Los Angeles, California, United States, 90033
    - USC / Norris Comprehensive Cancer Center
  - Los Angeles, California, United States, 90033
    - USC/Norris Comprehensive Cancer Center
  - Los Angeles, California, United States, 90033
    - Keck Hospital of USC
  - Los Angeles, California, United States, 90033
    - LAC & USC Medical Center
  - Los Angeles, California, United States, 90033
    - USC/Norris Comprehensive Cancer Center/Investigational Drug Services
  - Pasadena, California, United States, 91105
    - Keck Hospital of USC Pasadena
- Florida
  - Aventura, Florida, United States, 33180
    - Mount Sinai Comprehensive Cancer Center, Aventura
  - Miami Beach, Florida, United States, 33140
    - Mount Sinai Medical Center
  - Miami Beach, Florida, United States, 33140
    - Mount Sinai Comprehensive Cancer Center
  - Plantation, Florida, United States, 33322
    - BRCR Medical Center Inc.
  - Plantation, Florida, United States, 33322
    - BRCR Global
- Illinois
  - Chicago, Illinois, United States, 60637
    - University of Chicago Medical Center
  - Chicago, Illinois, United States, 60611
    - UChicago Medicine - River East
  - Flossmoor, Illinois, United States, 60422
    - UChicago Medicine at Ingalls - Flossmoor
  - Harvey, Illinois, United States, 60426
    - UChicago Medicine Ingalls Memorial
  - New Lenox, Illinois, United States, 60451
    - University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
  - Orland Park, Illinois, United States, 60462
    - The University of Chicago Medicine Center for Advanced Care Orland Park
  - Tinley Park, Illinois, United States, 60477
    - UChicago Medicine at Ingalls - Tinley Park
- Louisiana
  - New Orleans, Louisiana, United States, 70121
    - Ochsner Clinic Foundation
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic Rochester
- Missouri
  - City of Saint Peters, Missouri, United States, 63376
    - Siteman Cancer Center - St Peters
  - Creve Coeur, Missouri, United States, 63141
    - Siteman Cancer Center - West County
  - Florissant, Missouri, United States, 63031
    - Siteman Cancer Center - North County
  - St Louis, Missouri, United States, 63110
    - Washington University School of Medicine
  - St Louis, Missouri, United States, 63129
    - Siteman Cancer Center - South County
  - St Louis, Missouri, United States, 63110
    - Barnes- Jewish Hospital
- Nebraska
  - Omaha, Nebraska, United States, 68130
    - Oncology Hematology West PC dba Nebraska Cancer Specialists
  - Omaha, Nebraska, United States, 68124
    - Oncology Hematology West PC dba Nebraska Cancer Specialists
  - Omaha, Nebraska, United States, 68114
    - Oncology Hematology West PC dba Nebraska Cancer Specialists
  - Papillion, Nebraska, United States, 68046
    - Oncology Hematology West PC dba Nebraska Cancer Specialists
- New Jersey
  - Basking Ridge, New Jersey, United States, 07920
    - Memorial Sloan Kettering Cancer Center - Basking Ridge
  - Berkeley Heights, New Jersey, United States, 07922
    - Summit Medical Group
  - Florham Park, New Jersey, United States, 07932
    - Summit Medical Group
  - Middletown, New Jersey, United States, 07748
    - Memorial Sloan Kettering Cancer Center- Monmouth
  - Montvale, New Jersey, United States, 07645
    - Memorial Sloan Kettering Cancer Center- Bergen
- New York
  - Commack, New York, United States, 11725
    - Memorial Sloan Kettering Cancer Center Commack
  - Harrison, New York, United States, 10604
    - Memorial Sloan Kettering Cancer Center - Westchester
  - New York, New York, United States, 10022
    - Memorial Sloan Kettering Cancer Center
  - New York, New York, United States, 10065
    - Memorial Sloan Kettering Cancer Center - Main Campus
  - Uniondale, New York, United States, 11553
    - Memorial Sloan Kettering Cancer Center- Nassau
- Ohio
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
  - Columbus, Ohio, United States, 43221
    - Martha Morehouse Medical Plaza
  - Columbus, Ohio, United States, 43210
    - The Ohio State University James Cancer Hospital and Solove Research Institute
  - Columbus, Ohio, United States, 43212
    - Stefanie Spielman Comprehensive Breast Cancer
  - Columbus, Ohio, United States, 43210
    - The Ohio State University Wexner Medical Center Investigational Drug Services
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center, OU Health Stephenson Cancer Center
- Oregon
  - Portland, Oregon, United States, 97213
    - Providence Cancer Institute Franz Clinic
  - Portland, Oregon, United States, 97213
    - Providence Portland Medical Center
  - Portland, Oregon, United States, 97225
    - Providence St Vincent Medical Center
  - Portland, Oregon, United States, 97225
    - Providence Onc and Heme Care Clinic - Westside
- Pennsylvania
  - Pittsburgh, Pennsylvania, United States, 15232
    - UPMC Hillman Cancer Center
- Tennessee
  - Germantown, Tennessee, United States, 38138
    - The West Clinic. PLLC. dba West Cancer Center
  - Nashville, Tennessee, United States, 37232
    - Vanderbilt-Ingram Cancer Center
  - Nashville, Tennessee, United States, 37232
    - Henry-Joyce Cancer Clinic
- Texas
  - Houston, Texas, United States, 77030
    - The University of Texas MD Anderson Cancer Center
- Virginia
  - Richmond, Virginia, United States, 23219
    - Virginia Commonwealth University
- Washington
  - Seattle, Washington, United States, 98109
    - Seattle Cancer Care Alliance
  - Seattle, Washington, United States, 98195
    - University of Washington Medical Center
- Wisconsin
  - Madison, Wisconsin, United States, 53792
    - University of Wisconsin Clinical Science Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Safety Lead-In = Male/female ≥ 18 years old
Phase 3 and Cohort 3: Male/female ≥ 16 years old (where permitted locally)
Histologically or cytologically confirmed Stage IV CRC that contains BRAF V600E mutation
Prior systemic treatment in metastatic setting: 0-1 regimens for Safety Lead In; none for Phase 3 and Cohort 3. (Note: Prior adjuvant or neoadjuvant therapy considered metastatic treatment if relapse/metastasis < 6 month from end of adj/neoadjuvant treatment )
Measurable disease (Phase 3 and Cohort 3)/ Measurable or evaluable disease (Safety Lead-in)
ECOG PS 0-1
Adequate organ function

Exclusion Criteria:

Tumors that are locally confirmed or unknown MSI-H or dMMR unless participant is ineligible to receive immune checkpoint inhibitors due to a pre-existing medical condition
Active bacterial or viral infections in 2 weeks prior to starting dosing
Symptomatic brain metastases

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Safety Lead-in Cohort 1 Encorafenib 300 mg orally once daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks Irinotecan 180 mg/m2 (90-minute IV infusion) every two weeks Leucovorin 400 mg/m2 (120-minute IV infusion) every two weeks 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours every two weeks	Drug: Encorafenib 75 mg capsules Other Names: Braftovi, PF-07263896, LGX818, ONO-7702 Drug: Cetuximab Injection for intravenous use 100 mg/vial, 200 mg/vial, or 500 mg/vial Other Names: Erbitux Drug: Irinotecan Solution for intravenous infusion 40 mg/vial, 100 mg/vial, or 300 mg/vial Other Names: Campostar Drug: Leucovorin Injection 50 mg/vial, 100 mg/vial, 200 mg/vial, or 350 mg/vial Other Names: Wellcovorin, Fusilev, Khapzory Drug: 5-FU Injection for intravenous use 250 mg/vial, 500 mg/vial, or 1000 mg/vial Other Names: Fluorouracil
Experimental: Safety Lead-in Cohort 2 Encorafenib 300 mg orally once daily Cetuximab 500 mg/m2 (120 minute IV infusion) every two weeks Oxaliplatin 85 mg/m2 (120-minute IV infusion) every two weeks Leucovorin 400 mg/m2 (120-minute IV infusion) every two weeks 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours every two weeks	Drug: Encorafenib 75 mg capsules Other Names: Braftovi, PF-07263896, LGX818, ONO-7702 Drug: Cetuximab Injection for intravenous use 100 mg/vial, 200 mg/vial, or 500 mg/vial Other Names: Erbitux Drug: Leucovorin Injection 50 mg/vial, 100 mg/vial, 200 mg/vial, or 350 mg/vial Other Names: Wellcovorin, Fusilev, Khapzory Drug: 5-FU Injection for intravenous use 250 mg/vial, 500 mg/vial, or 1000 mg/vial Other Names: Fluorouracil Drug: Oxaliplatin Powder for solution for intravenous use 50 mg/vial, 100 mg/vial, or 200 mg/vial Other Names: Eloxatin
Experimental: Phase 3 Arm A Encorafenib 300 mg orally once daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks	Drug: Encorafenib 75 mg capsules Other Names: Braftovi, PF-07263896, LGX818, ONO-7702 Drug: Cetuximab Injection for intravenous use 100 mg/vial, 200 mg/vial, or 500 mg/vial Other Names: Erbitux
Experimental: Phase 3 Arm B Encorafenib 300 mg orally once daily Cetuximab 500 mg/m2 (120 minute IV infusion) every two weeks Oxaliplatin 85 mg/m2 (120-minute IV infusion) every two weeks Leucovorin 400 mg/m2 (120-minute IV infusion) every two weeks 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours every two weeks	Drug: Encorafenib 75 mg capsules Other Names: Braftovi, PF-07263896, LGX818, ONO-7702 Drug: Cetuximab Injection for intravenous use 100 mg/vial, 200 mg/vial, or 500 mg/vial Other Names: Erbitux Drug: Leucovorin Injection 50 mg/vial, 100 mg/vial, 200 mg/vial, or 350 mg/vial Other Names: Wellcovorin, Fusilev, Khapzory Drug: 5-FU Injection for intravenous use 250 mg/vial, 500 mg/vial, or 1000 mg/vial Other Names: Fluorouracil Drug: Oxaliplatin Powder for solution for intravenous use 50 mg/vial, 100 mg/vial, or 200 mg/vial Other Names: Eloxatin
Active Comparator: Phase 3 Arm C Every two weeks: Oxaliplatin 85 mg/m2 (120-minute IV infusion) Leucovorin 400 mg/m2 (120-minute IV infusion) 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours Bevacizumab (optional; given per prescribing instructions) -OR- Every two weeks: Irinotecan 165 mg/m2 (90-minute IV infusion) Oxaliplatin 85 mg/m2 (120-minute IV infusion) Leucovorin 400 mg/m2 (120-minute IV infusion) 5-FU 2400 or 3200 mg/m2 continuous IV infusion over 46 48 hours Bevacizumab (optional; given per prescribing instructions) -OR- Oxaliplatin 130 mg/m2 (120-minute IV infusion) every 3 weeks Capecitabine 1000 mg/m2 oral tablet twice daily on Days 1-14 Bevacizumab (optional; given per prescribing instructions)	Drug: Irinotecan Solution for intravenous infusion 40 mg/vial, 100 mg/vial, or 300 mg/vial Other Names: Campostar Drug: Leucovorin Injection 50 mg/vial, 100 mg/vial, 200 mg/vial, or 350 mg/vial Other Names: Wellcovorin, Fusilev, Khapzory Drug: 5-FU Injection for intravenous use 250 mg/vial, 500 mg/vial, or 1000 mg/vial Other Names: Fluorouracil Drug: Oxaliplatin Powder for solution for intravenous use 50 mg/vial, 100 mg/vial, or 200 mg/vial Other Names: Eloxatin Drug: Capecitabine 150 mg or 500 mg Tablet Other Names: Xeloda Drug: Bevacizumab Optional Injection for intravenous use 100 mg/vial or 400 mg/vial Other Names: Zirabev
Experimental: Cohort 3 Arm D Encorafenib 300 mg orally once daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks Irinotecan 180 mg/m2 (90-minute IV infusion) every two weeks Leucovorin 400 mg/m2 (120-minute IV infusion) every two weeks 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours every two weeks	Drug: Encorafenib 75 mg capsules Other Names: Braftovi, PF-07263896, LGX818, ONO-7702 Drug: Cetuximab Injection for intravenous use 100 mg/vial, 200 mg/vial, or 500 mg/vial Other Names: Erbitux Drug: Irinotecan Solution for intravenous infusion 40 mg/vial, 100 mg/vial, or 300 mg/vial Other Names: Campostar Drug: Leucovorin Injection 50 mg/vial, 100 mg/vial, 200 mg/vial, or 350 mg/vial Other Names: Wellcovorin, Fusilev, Khapzory Drug: 5-FU Injection for intravenous use 250 mg/vial, 500 mg/vial, or 1000 mg/vial Other Names: Fluorouracil
Active Comparator: Cohort 3 Arm E Irinotecan 180 mg/m2 (90-minute IV infusion) every 2 weeks, Leucovorin 400 mg/m2 (120-minute IV infusion) every 2 weeks, 5-FU 400 mg/m2 IV bolus, then 5-FU 2400 mg/m2 continuous IV infusion over 46-48 hours every two weeks, Bevacizumab (optional; given per prescribing instructions)	Drug: Irinotecan Solution for intravenous infusion 40 mg/vial, 100 mg/vial, or 300 mg/vial Other Names: Campostar Drug: Leucovorin Injection 50 mg/vial, 100 mg/vial, 200 mg/vial, or 350 mg/vial Other Names: Wellcovorin, Fusilev, Khapzory Drug: 5-FU Injection for intravenous use 250 mg/vial, 500 mg/vial, or 1000 mg/vial Other Names: Fluorouracil Drug: Bevacizumab Optional Injection for intravenous use 100 mg/vial or 400 mg/vial Other Names: Zirabev

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SLI: Number of Participants With Dose Limiting Toxicity (DLTs) Time Frame: Cycle 1 (28 days)	DLT: Any AE/lab value during first 28 days (D) of treatment that met at least 1 criteria: AE/lab value unrelated to underlying disease,PD,intercurrent illness,concomitant medications resulting in inability to tolerate atleast 75% of planned dose intensity of study drug,fatigue grade (G)3>14 consecutive D, interstitial lung disease G>=2,rash,hand foot skin reaction G3>14 consecutive D or G4,diarrhea G3 >=48 hours or G4,nausea/vomiting G3>=48 hours or G4,mucositis G>=3,total bilirubin G>=3, aspartate aminotransferase/alanine aminotransferase G>=3 in conjunction with total bilirubin G>=2 or G3 >7 consecutive D or G4,Serum creatinine G>=3,absolute neutrophil count G4 >7 consecutive D, >=G3 febrile neutropenia,G3 platelet count decreased with signs of bleeding,platelet count G4,ECG QTcF prolonged >=G3,G>=3 uveitis >21 consecutive D,G4 confirmed by ophthalmic examination,paresthesia/dysesthesias G>=3,other G>=3 hematologic/nonhematologic toxicity except lymphocyte count decreased G>=3.	Cycle 1 (28 days)
Phase 3: Progression Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) for Arm B vs Arm C - FAS Time Frame: From date of randomization to earliest documentation of PD by BICR or death or censoring date, whichever occurred first (maximum up to 37.25 months)	PFS was defined as the time from date of randomization to earliest documented disease progression (PD) per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 or death due to any cause as assessed by BICR. PD: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, with minimum absolute increase of 5 millimeter (mm) for target disease or unequivocal progression of pre-existing lesions for non-target disease or any new lesion. Censoring details: no adequate baseline assessment, including no disease at baseline: participants were censored to randomization date; no PD, lost to follow-up, withdrawal of consent, PD or death >12 (or 16) weeks after the last adequate tumor assessment, and start of new anticancer treatment: participants were censored to last adequate tumor assessment documenting no PD prior to new anticancer therapy, or missed assessments. Analysis was performed using Kaplan Meier method.	From date of randomization to earliest documentation of PD by BICR or death or censoring date, whichever occurred first (maximum up to 37.25 months)
Phase 3: Objective Response Rate (ORR) as Assessed by BICR for Arm B vs Arm C - FAS ORR Subset Time Frame: From date of randomization to until documented PD by BICR, or start of subsequent anticancer therapy or death, whichever occurred first (maximum up to 24.71 months)	ORR was defined as the percentage of participants who achieved best overall response (BOR) of confirmed complete response (CR) or partial response (PR) according to RECIST v 1.1 as assessed by BICR. CR: complete disappearance of all target lesions (with the exception of nodal disease) and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions. PD: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, with minimum absolute increase of 5 mm for target disease or unequivocal progression of pre-existing lesions for non-target disease or any new lesion.	From date of randomization to until documented PD by BICR, or start of subsequent anticancer therapy or death, whichever occurred first (maximum up to 24.71 months)
Cohort 3: ORR as Assessed by BICR for Arm D vs Arm E - FAS Time Frame: From date of randomization until documented PD by BICR, or start of subsequent anticancer therapy or death, whichever occurred first (maximum up to 14.1 months)	ORR was defined as the percentage of participants who achieved BOR of confirmed CR or PR according to RECIST v 1.1 as assessed by BICR. CR: complete disappearance of all target lesions (with the exception of nodal disease) and non-target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. PR: >=30% decrease under baseline of the sum of diameters of all target measurable lesions. PD: 20% increase in sum of diameters of target measurable lesions above smallest sum observed, with minimum absolute increase of 5 mm for target disease or unequivocal progression of pre-existing lesions for non-target disease or any new lesion.	From date of randomization until documented PD by BICR, or start of subsequent anticancer therapy or death, whichever occurred first (maximum up to 14.1 months)

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

Eli Lilly and Company

Merck KGaA, Darmstadt, Germany

Ono Pharmaceutical Co., Ltd.

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

To obtain contact information for a study center near you, click here.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2020

Primary Completion (Actual)

March 1, 2025

Study Completion (Estimated)

December 28, 2027

Study Registration Dates

First Submitted

October 5, 2020

First Submitted That Met QC Criteria

October 22, 2020

First Posted (Actual)

October 29, 2020

Study Record Updates

Last Update Posted (Actual)

June 11, 2026

Last Update Submitted That Met QC Criteria

May 15, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

C4221015
BREAKWATER (Other Identifier: Pfizer)
2023-509405-77-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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