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

Program Status

Recruiting

Phase

Phase 3

Immunotherapy-centered Trial

No

Prior Immunotherapy Allowed

No

CRC-directed Trial

Yes

Drugs

5-FU, Bevacizumab, capecitabine, cetuximab, encorafenib, Irinotecan, Leucovorin, oxaliplatin

Tags

MSS/ MMRp

Comments

Phase III BREAKWATER trial. Only for patients with BRAF V600E–mutated, stage IV (metastatic) CRC, who are about to the receive their FIRST LINE of treatment, in the metastatic setting. Trial compares:
1. encorafenib (Braftovi) plus cetuximab (Erbitux) vs.
2. encorafenib (Braftovi) plus cetuximab (Erbitux) plus standard-of-care (SOC) chemotherapy vs.
3. chemotherapy alone

Location Location Status
United States
Mayo Clinic - Phoenix Oncology Pharmacy
Phoenix, Arizona 85054
Recruiting
Mayo Clinic Hospital
Phoenix, Arizona 85054
Recruiting
Mayo Clinic in Arizona - Scottsdale
Scottsdale, Arizona 85259
Recruiting
Tower Hematology Oncology Medical Group (THO)
Beverly Hills, California 90211
Recruiting
Keck Hospital of USC
Los Angeles, California 90033
Recruiting
LAC & USC Medical Center
Los Angeles, California 90033
Recruiting
USC / Norris Comprehensive Cancer Center
Los Angeles, California 90033
Recruiting
USC/Norris Comprehensive Cancer Center / Investigational Drug Services
Los Angeles, California 90033
Recruiting
USC/Norris Comprehensive Cancer Center
Los Angeles, California 90033
Recruiting
Cedars- Sinai Medical Center
Los Angeles, California 90048
Recruiting
Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer Institute
Los Angeles, California 90048
Recruiting
Cedars-Sinai Medical Center
Los Angeles, California 90048
Recruiting
Keck Hospital of USC Pasadena
Pasadena, California 91105
Recruiting
Torrance Memorial Medical Center (TMMC)
Torrance, California 90505
Recruiting
Georgetown University Medical Center
Washington, District of Columbia 20007
Recruiting
Medstar Georgetown University Hospital
Washington, District of Columbia 20007
Recruiting
Mount Sinai Comprehensive Cancer Center, Aventura
Aventura, Florida 33180
Recruiting
Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical Center
Coral Gables, Florida 33146
Recruiting
Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer Center
Fort Lauderdale, Florida 33308
Recruiting
Mayo Clinic Florida
Jacksonville, Florida 32224
Recruiting
Mount Sinai Comprehensive Cancer Center
Miami Beach, Florida 33140
Recruiting
Mount Sinai Medical Center
Miami Beach, Florida 33140
Recruiting
Sylvester Comprehensive Cancer Center
Miami, Florida 33136
Recruiting
Baptist Hospital of Miami
Miami, Florida 33176
Recruiting
Miami Cancer Institute
Miami, Florida 33176
Recruiting
Orlando Health Cancer Institute
Orlando, Florida 32806
Recruiting
Orlando Health, Inc.
Orlando, Florida 32806
Recruiting
Orlando Health, Inc
Orlando, Florida 32806
Recruiting
BRCR Global
Plantation, Florida 33322
Recruiting
BRCR Medical Center Inc.
Plantation, Florida 33322
Recruiting
Lewis Cancer & Research Pavilion at St Joseph's/Candler Health System
Savannah, Georgia 31405
Recruiting
Lewis Cancer & Research Pavilion Pharmacy
Savannah, Georgia 31405
Recruiting
St. Joseph's/Candler Health System, Inc.
Savannah, Georgia 31405
Recruiting
Summit Cancer Care, P.C.
Savannah, Georgia 31405
Recruiting
Summit Cancer Care
Savannah, Georgia 31405
Recruiting
St. Joseph's/Candler Health System, Inc.
Savannah, Georgia 31419
Recruiting
UChicago Medicine - River East
Chicago, Illinois 60611
Recruiting
The University of Chicago Medical Center, CCD - Investigational Drug Service Pharmacy
Chicago, Illinois 60637
Recruiting
University of Chicago Medical Center
Chicago, Illinois 60637
Recruiting
UChicago Medicine at Ingalls - Flossmoor
Flossmoor, Illinois 60422
Recruiting
UChicago Medicine Ingalls Memorial
Harvey, Illinois 60426
Recruiting
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois 60451
Recruiting
The University of Chicago Medicine Center for Advanced Care Orland Park
Orland Park, Illinois 60462
Recruiting
UChicago Medicine at Ingalls - Tinley Park
Tinley Park, Illinois 60477
Recruiting
Ochsner Clinic Foundation Research Pharmacy
New Orleans, Louisiana 70121
Recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana 70121
Recruiting
University of Michigan Hospitals
Ann Arbor, Michigan 48109
Recruiting
University of Michigan
Ann Arbor, Michigan 48109
Recruiting
Mayo Clinic in Rochester, Minnesota
Rochester, Minnesota 55905
Recruiting
Mayo Clinic Rochester
Rochester, Minnesota 55905
Recruiting
Mayo Clinic
Rochester, Minnesota 55905
Recruiting
Siteman Cancer Center - West County
Creve Coeur, Missouri 63141
Active, not recruiting
Siteman Cancer Center - North County
Florissant, Missouri 63031
Active, not recruiting
Barnes- Jewish Hospital
Saint Louis, Missouri 63110
Active, not recruiting
Washington University School of Medicine
Saint Louis, Missouri 63110
Active, not recruiting
Siteman Cancer Center - South County
Saint Louis, Missouri 63129
Active, not recruiting
Siteman Cancer Center - St Peters
Saint Peters, Missouri 63376
Active, not recruiting
St Vincent Healthcare
Billings, Montana 59101
Recruiting
St. Vincent Frontier Cancer Center
Billings, Montana 59102
Recruiting
Oncology Hematology West PC dba Nebraska Cancer Specialists
Omaha, Nebraska 68114
Recruiting
Oncology Hematology West PC dba Nebraska Cancer Specialists
Omaha, Nebraska 68124
Recruiting
Oncology Hematology West PC dba Nebraska Cancer Specialists
Omaha, Nebraska 68130
Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists - IP Storage
Omaha, Nebraska 68130
Recruiting
Oncology Hematology West PC dba Nebraska Cancer Specialists
Papillion, Nebraska 68046
Recruiting
Memorial Sloan Kettering Cancer Center - Basking Ridge
Basking Ridge, New Jersey 07920
Active, not recruiting
Summit Medical Group
Berkeley Heights, New Jersey 07922
Recruiting
Summit Medical Group
Florham Park, New Jersey 07932
Recruiting
Memorial Sloan Kettering Cancer Center- Monmouth
Middletown, New Jersey 07748
Active, not recruiting
Memorial Sloan Kettering Cancer Center- Bergen
Montvale, New Jersey 07645
Active, not recruiting
North Shore Hematology Oncology Assoc. P.C. DBA NY Cancer and Blood Specialists
Babylon, New York 11702
Recruiting
North Shore Hematology Oncology Assoc. P.C. DBA NY Cancer and Blood Specialists
Bronx, New York 10469
Recruiting
Memorial Sloan Kettering Cancer Center Commack
Commack, New York 11725
Active, not recruiting
Memorial Sloan Kettering Cancer Center - Westchester
Harrison, New York 10604
Active, not recruiting
Memorial Sloan Kettering Cancer Center
New York, New York 10022
Active, not recruiting
North Shore Hematology Oncology Assoc. P.C. DBA NY Cancer and Blood Specialists
New York, New York 10028
Recruiting
Memorial Sloan Kettering Cancer Center - Main Campus
New York, New York 10065
Active, not recruiting
North Shore Hematology Oncology Assoc. P.C. DBA NY Cancer and Blood Specialists
Patchogue, New York 11772
Recruiting
North Shore Hematology Oncology Assoc. P.C. DBA NY Cancer and Blood Specialists
Port Jefferson Station, New York 11776
Recruiting
North Shore Hematology Oncology Assoc. P.C. DBA NY Cancer and Blood Specialists
Riverhead, New York 11901
Recruiting
Memorial Sloan Kettering Cancer Center- Nassau
Uniondale, New York 11553
Active, not recruiting
Carolinas Medical Center
Charlotte, North Carolina 28203
Recruiting
Carolinas Medical Center Investigational Drug Services
Charlotte, North Carolina 28204
Recruiting
Levine Cancer Institute
Charlotte, North Carolina 28204
Recruiting
Atrium Health Mercy
Charlotte, North Carolina 28207
Recruiting
Atrium Health Pineville
Charlotte, North Carolina 28210
Recruiting
Levine Cancer Institute - Southpark
Charlotte, North Carolina 28211
Recruiting
Atrium Health University City
Charlotte, North Carolina 28262
Recruiting
Levine Cancer Institute University City
Charlotte, North Carolina 28262
Recruiting
Atrium Health Cabarrus
Concord, North Carolina 28025
Recruiting
Levine Cancer Institute - Concord
Concord, North Carolina 28025
Recruiting
Atrium Health Union
Monroe, North Carolina 28112
Recruiting
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
Cleveland, Ohio 44195
Recruiting
Cleveland Clinic
Cleveland, Ohio 44195
Recruiting
Investigational Drug Service, The Ohio State University Wexner Medical Center
Columbus, Ohio 43210
Recruiting
The Ohio State University James Cancer Hospital and Solove Research Institute
Columbus, Ohio 43210
Recruiting
Stefanie Spielman Comprehensive Breast Cancer
Columbus, Ohio 43212
Recruiting
Martha Morehouse Medical Plaza
Columbus, Ohio 43221
Recruiting
The James Outpatient Care West Campus
Columbus, Ohio 43221
Recruiting
University of Oklahoma Health Sciences Center, OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma 73104
Recruiting
Providence Cancer Institute Franz Clinic
Portland, Oregon 97213
Recruiting
Providence Portland Medical Center
Portland, Oregon 97213
Recruiting
Providence Onc and Heme Care Clinic - Westside
Portland, Oregon 97225
Recruiting
Providence Oncology and Hematology Care Clinic - Westside
Portland, Oregon 97225
Recruiting
Providence St Vincent Medical Center
Portland, Oregon 97225
Recruiting
Providence St. Vincent Medical Center
Portland, Oregon 97225
Recruiting
AHN Cancer Institute at Jefferson Hospital
Jefferson Hills, Pennsylvania 15025
Recruiting
AHN Cancer Institute Forbes Hospital
Monroeville, Pennsylvania 15146
Recruiting
AHN Cancer Institute - Allegheny General Hospital
Pittsburgh, Pennsylvania 15212
Recruiting
AHN Cancer Institute Pharmacy
Pittsburgh, Pennsylvania 15212
Recruiting
AHN Cancer Institute West Penn Hospital
Pittsburgh, Pennsylvania 15224
Recruiting
UPMC Hillman Cancer Center Investigational Drug Service
Pittsburgh, Pennsylvania 15232
Recruiting
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania 15232
Recruiting
Wexford Health and Wellness Pavilion
Wexford, Pennsylvania 15090
Recruiting
Vanderbilt Health Clinic at Walgreens Clarksville
Clarksville, Tennessee 37043
Recruiting
Vanderbilt Health Clinic at Walgreens Cool Springs
Franklin, Tennessee 37067
Recruiting
Vanderbilt Health Clinic at Walgreens Gallatin
Gallatin, Tennessee 37066
Recruiting
The West Clinic. PLLC. dba West Cancer Center
Germantown, Tennessee 38138
Recruiting
Vanderbilt Health Clinic at Walgreens Hendersonville
Hendersonville, Tennessee 37075
Recruiting
Vanderbilt Health Clinic at Walgreens Hermitage
Hermitage, Tennessee 37076
Recruiting
Vanderbilt Health Clinic at Walgreens La Vergne
La Vergne, Tennessee 37086
Recruiting
Vanderbilt Health Clinic at Walgreens Lebanon
Lebanon, Tennessee 37087
Recruiting
The West Clinic PLLC dba West Cancer Center
Memphis, Tennessee 38104
Recruiting
Vanderbilt Health Clinic at Walgreens Murfreesboro
Murfreesboro, Tennessee 37128
Recruiting
Vanderbilt Health Clinic at Walgreens Belle Meade
Nashville, Tennessee 37205
Recruiting
Vanderbilt Health Clinic at Walgreens Nippers Corner
Nashville, Tennessee 37211
Recruiting
Vanderbilt Health Clinic at Walgreens Donelson
Nashville, Tennessee 37214
Recruiting
Vanderbilt Health Clinic at Walgreens Hart Lane
Nashville, Tennessee 37216
Recruiting
Vanderbilt Health Clinic at Walgreens Bellevue
Nashville, Tennessee 37221
Recruiting
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee 37232-6307
Recruiting
Henry-Joyce Cancer Center
Nashville, Tennessee 37232
Recruiting
Vanderbilt Oncology IDS Pharmacy
Nashville, Tennessee 37232
Recruiting
Vanderbilt Health Clinic at Walgreens Smyrna
Smyrna, Tennessee 37167
Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030-4009
Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texas 77030
Recruiting
VCU Health - Adult Outpatient Pavilion (AOP) Investigational Drug Services
Richmond, Virginia 23219
Recruiting
Virginia Commonwealth University
Richmond, Virginia 23219
Recruiting
VCU Health System, Investigational Drug Service Pharmacy
Richmond, Virginia 23298
Recruiting
Virginia Commonwealth University Massey Cancer Center
Richmond, Virginia 23298
Recruiting
Seattle Cancer Care Alliance
Seattle, Washington 98109
Recruiting
University of Washington Medical Center
Seattle, Washington 98195
Recruiting
University of Wisconsin Clinical Science Center
Madison, Wisconsin 53792
Recruiting
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin 53226
Recruiting
Argentina
Centro Medico San Roque
San Miguel De Tucumán, Tucumán 4000
Recruiting
Centro Medico San Roque
Tucuman, Tucumán 4000
Recruiting
Instituto Médico Especializado Alexander Fleming
Ciudad Autónoma de Buenos Aires 1426
Recruiting
Clinica Universitaria Reina Fabiola
Cordoba X5004FHP
Recruiting
Hospital Privado Centro Médico de Córdoba
Cordoba X5016KEH
Recruiting
Hospital Privado Centro Médico de Córdoba
Córdoba X5016KEH
Recruiting
Australia
Chris O'Brien Lifehouse
Camperdown, New South Wales 2050
Recruiting
Liverpool Hospital
Liverpool, New South Wales 2170
Recruiting
Slade Pharmacy
Mount Kuring-Gai, New South Wales 2080
Recruiting
GenesisCare - North Shore
St Leonards, New South Wales 2065
Recruiting
GenesisCare North Shore
St Leonards, New South Wales 2065
Recruiting
Royal Brisbane & Women's Hospital
Herston, Queensland 4029
Recruiting
Princess Alexandra Hospital
Woolloongabba, Queensland 4102
Recruiting
The Queen Elizabeth Hospital
Adelaide, South Australia 5011
Recruiting
Monash Health
Clayton, Victoria 3168
Recruiting
Austin Health
Heidelberg, Victoria 3084
Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria 3000
Recruiting
Alfred Health
Melbourne, Victoria 3004
Recruiting
Belgium
Université Libre de Bruxelles - Hôpital Erasme
Brussels, Bruxelles-capitale, Région DE 1070
Recruiting
Cliniques universitaires Saint-Luc
Brussels, Bruxelles-capitale, Région DE 1200
Recruiting
Grand Hôpital de Charleroi
Charleroi, Hainaut 6000
Recruiting
CHR Verviers East Belgium
Verviers, Liège 4800
Recruiting
AZ Groeninge Campus Kennedylaan
Kortrijk, West-vlaanderen 8500
Recruiting
ZNA Middelheim
Antwerpen 2020
Recruiting
UZ Leuven
Leuven 3000
Recruiting
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège 4000
Recruiting
Brazil
Hospital Bruno Born
Lajeado, RIO Grande DO SUL 95900-000
Recruiting
Hospital Bruno Born
Lajeado, RIO Grande DO SUL 95900-010
Recruiting
Hospital Bruno Born
Lajeado, RIO Grande DO SUL 95900-022
Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, RIO Grande DO SUL 90035-903
Recruiting
INCA
Rio de Janeiro, RJ 20230-130
Recruiting
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA
Rio de Janeiro, RJ 20230-130
Recruiting
Reichow - Centro de Ensino e Pesquisa
Blumenau, Santa Catarina 89010-340
Recruiting
Clínica de Neoplasias Litoral
Itajaí, Santa Catarina 88301-220
Recruiting
Hospital do Cancer de Barretos - Fundacao Pio XII
Barretos, SP 14784-400
Recruiting
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC
Santo Andre, SP 09060-650
Recruiting
Fundacao do ABC-Faculdade de Medicina do ABC
Santo Andre, SP 09060-870
Recruiting
FUNDAÇÃO DO ABC - Faculdade de Medicina do ABC - Centro de Estudos e Pesquisas de Hematologia e Onc
Santo Andre, SP 09060-870
Recruiting
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC
Santo André, SP 09060-650
Recruiting
Instituto do Cancer do Estado de Sao Paulo, ICESP
Sao Paulo, SP 01246-000
Recruiting
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, SÃO Paulo 14784400
Recruiting
Medical School Famerp-HB-FUNFARME_Do not use - Duplicate facility
Sao jose do Rio Preto, SÃO Paulo 15090-000
Recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto, SÃO Paulo 15090000
Recruiting
Bulgaria
MHAT Uni Hospital OOD
Panagyurishte, Pazardzhik 4500
Recruiting
MHAT "Dr. Tota Venkova" AD
Gabrovo 5300
Recruiting
Complex Oncology Center - Plovdiv EOOD
Plovdiv 4000
Recruiting
MHAT Central Onco Hospital OOD
Plovdiv 4000
Recruiting
Complex Oncology Center - Plovdiv EOOD
Plovdiv 4004
Recruiting
Medical Center Nadezhda Clinical EOOD
Sofia 1303
Recruiting
Acibadem City Clinic MHAT Tokuda
Sofia 1407
Recruiting
University Multiprofile Hospital for Active Treatment Sofiamed
Sofia 1750
Recruiting
Canada
Tom Baker Cancer Centre
Calgary, Alberta T2N 4N2
Recruiting
Cross Cancer Institute
Edmonton, Alberta T6G 1Z2
Recruiting
Kingston Health Sciences Centre-Kingston General Hospital Site
Kingston, Ontario K7L 2V7
Recruiting
London Regional Cancer Program, London Health Sciences Centre
London, Ontario N6A 5W9
Recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario M4N 3M5
Recruiting
Centre Intégré de Santé et de Services Sociaux (CISSS) de Laval / Hôpital de la Cité-de-la-Sant
Laval, Quebec H7M 3L9
Recruiting
Jewish General Hospital
Montreal, Quebec H3T 1E2
Recruiting
China
Anhui Provincial Cancer Hospital
Hefei, Anhui 230031
Not yet recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui 230088
Recruiting
Cancer Hospital Chinese Academy of Medical Science
Beijing, Beijing 100021
Recruiting
Beijing Cancer hospital
Beijing, Beijing 100142
Recruiting
Beijing Hospital
Beijing, Beijing 100730
Recruiting
Chongqing University Cancer Hospital
Chongqing, Chongqing 400030
Recruiting
Fujian Medical University Union Hospital-1 Bingfanglou
Fuzhou, Fujian 350001
Recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong 510080
Not yet recruiting
Guangdong Provincial People's Hospital
Guangzhou, Guangdong 510080
Recruiting
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong 510655
Recruiting
Affiliated Tumor Hospital of Guangxi Medical University
Nanning, Guangxi 530021
Recruiting
Henan provincial people's hospital
Zhengzhou, Henan 450003
Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei 430030
Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan 410011
Recruiting
The Third Xiangya Hospital of Central South University
Changsha, Hunan 410013
Recruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu 210008
Recruiting
Shengjing Hospital Of China Medical University
Shenyang, Liaoning 110022
Recruiting
Jinan Central Hospital
Jinan, Shandong 250013
Recruiting
Shandong province cancer hospital
Jinan, Shandong 250117
Recruiting
The Affiliated Hospital of Qingdao University
Qingdao, Shandong 266031
Recruiting
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Shanghai, Shanghai 200025
Recruiting
Shanghai General Hospital
Shanghai, Shanghai 200080
Recruiting
Sichuan Province Cancer Hospital
Chengdu, Sichuan 610041
Recruiting
Yunnan Cancer Hospital(The Third Affiliated Hospital of Kunming Medical University)
Kunming, Yunnan 650118
Recruiting
The second Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou, Zhejiang 310000
Recruiting
Peking University First Hospital
Beijing 100034
Recruiting
Fudan University Shanghai Cancer Center
Shanghai 201321
Recruiting
Tianjin Union Medical Center
Tianjin 300000
Recruiting
Czechia
Fakultní nemocnice Brno Bohunice
Brno, Brno-město 625 00
Recruiting
Fakultni nemocnice Hradec Kralove
Hradec Kralove, Hradec Králové 500 05
Recruiting
Fakultni Thomayerova nemocnice
Prague, Praha 4 14059
Recruiting
Fakultni nemocnice Olomouc
Olomouc 779 00
Recruiting
Fakultni nemocnice v Motole
Praha 5 150 06
Recruiting
Fakultni nemocnice Bulovka
Praha 8 180 81
Active, not recruiting
Denmark
Aalborg Universitetshospital, Syd
Aalborg, Nordjylland 9000
Recruiting
Vejle Hospital-Sygehus Lillebaelt
Vejle, Syddanmark 7100
Recruiting
Vejle Sygehus
Vejle, Syddanmark 7100
Recruiting
Aalborg Universitetshospital
Aalborg 9000
Recruiting
Rigshospitalet
Copenhagen 2100
Recruiting
Herlev and Gentofte Hospital
Herlev 2730
Recruiting
Odense University Hospital
Odense C 5000
Recruiting
Finland
Docrates Syöpäsairaala
Helsinki, Nyland 00180
Recruiting
Tampereen yliopistollinen sairaala
Tampere, Pirkanmaa 33520
Recruiting
Helsinki University Central Hospital
Helsinki 00029
Recruiting
Oulu University Hospital
Oulu 90220
Recruiting
Satakunnan Keskussairaala
Pori 28500
Recruiting
Tampereen yliopistollinen sairaala
Tampere 33520
Recruiting
Turku University Hospital
Turku 20520
Recruiting
Germany
Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie
Muenchen, Bayern 81737
Recruiting
Institut für Klinisch Onkologische Forschung
Frankfurt, Hessen 60488
Recruiting
Medizinische Hochschule Hannover
Hannover, Lower Saxony 30625
Recruiting
Medizinische Hochschule Hannover
Hannover, Niedersachsen 30625
Recruiting
Universitätsklinikum Leipzig
Leipzig, Sachsen 04103
Recruiting
Radiologie Berlin
Berlin - Charlottenburg 10719
Recruiting
Onkologische Schwerpunktpraxis Kurfuerstendamm
Berlin 10707
Recruiting
Waage Apotheke
Berlin 10709
Recruiting
HELIOS Klinikum Berlin Buch GmbH
Berlin 13125
Recruiting
Helios Klinikum Berlin-Buch
Berlin 13125
Recruiting
Technische Universität Dresden, Medizinische Fakultät Carl Gustav Carus
Dresden 01307
Recruiting
Universitätsklinikum Carl Gustav Carus Dresden
Dresden 01307
Recruiting
Facharztzentrum Eppendorf
Hamburg 20249
Recruiting
ZytoService Deutschland GmbH, Standort-Hamburg-Jenfeld
Hamburg 22045
Recruiting
Radiologie im Israelitischen Krankenhaus
Hamburg 22297
Recruiting
Klinikum Oldenburg AöR
Oldenburg 26133
Recruiting
Klinikum Oldenburg AöR
Oldenburg 26135
Recruiting
India
Rajiv Gandhi Cancer Institute And Research Centre
New Delhi, Delhi 110 085
Recruiting
Rajiv Gandhi Cancer Institute And Research Centre
New Delhi, Delhi 110085
Recruiting
Tata Memorial Hospital
Mumbai, Maharashtra 400012
Recruiting
Deenanath Mangeshkar Hospital & Research Centre
Pune, Maharashtra 411 004
Recruiting
Sahyadri Speciality Hospital
Pune, Maharashtra 411 004
Recruiting
Bhakti Vedanta Hospital and Research Institute
Thane, Maharashtra 401107
Recruiting
R K Birla Cancer Center, SMS Hospital
Jaipur, Rajasthan 302004
Recruiting
Sawai Man Singh Medical College Hospital (SMS Hospital)
Jaipur, Rajasthan 302004
Recruiting
Italy
Azienda Ospedaliera Universitaria di Cagliari - Presidio Policlinico Universitario "D.Casula"
Monserrato (CA), Cagliari 09042
Recruiting
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, Foggia 71013
Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, Milano 20162
Recruiting
Fondazione del Piemonte per l'Oncologia - Istituto di Candiolo IRCCS
Candiolo, Torino 10060
Recruiting
Azienda Ospedaliero Universitaria San Luigi Gonzaga
Orbassano, Torino 10043
Recruiting
Fondazione Poliambulanza Istituto Ospedaliero
Brescia 25124
Recruiting
Istituto Europeo di Oncologia IRCCS
Milano 20141
Recruiting
Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli" di Napoli
Napoli 80131
Recruiting
IRCCS Istituto Oncologico Veneto (IOV)
Padova 35128
Recruiting
Azienda USL - IRCCS di Reggio Emilia - Arcispedale Santa Maria Nuova
Reggio Emilia 42123
Recruiting
Japan
Chiba cancer center
Chiba-shi, Chiba 260-8717
Recruiting
National Cancer Center Hospital East
Kashiwa, Chiba 277-8577
Recruiting
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime 791-0280
Recruiting
Hokkaido University Hospital
Sapporo, Hokkaido 060-8648
Recruiting
Kanazawa University Hospital
Kanazawa, Ishikawa 920-8641
Recruiting
St. Marianna University Hospital
Kawasaki, Kanagawa 216-8511
Recruiting
Kanagawa cancer center
Yokohama, Kanagawa 2418515
Recruiting
Aichi Cancer Center Hospital
Nagoya, Nagoya, Aichi 464-8681
Recruiting
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Osaka-shi, Osaka 5418567
Recruiting
Kindai University Hospital
Osakasayama, Osaka 589-8511
Recruiting
Osaka University Hospital
Suita, Osaka 565-0871
Recruiting
Osaka Medical and Pharmaceutical University Hospital
Takatsuki, Osaka 569-8686
Recruiting
Saitama Medical University International Medical Center
Hidaka-city, Saitama 350-1298
Recruiting
Saitama Prefectural Cancer Center
Ina-machi, Saitama 362-0806
Recruiting
Shizuoka Cancer Center
Nagaizumi, Shizuoka 411-8777
Recruiting
National Cancer Center Hospital
Chuo-ku, Tokyo 104-0045
Recruiting
Japanese Foundation for Cancer Research
Koto-ku, Tokyo 135-8550
Recruiting
National Hospital Organization Kyushu Cancer Center
Fukuoka 811-1395
Recruiting
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research
Osaka 540-0006
Recruiting
Keio university hospital
Tokyo 1600035
Recruiting
Korea, Republic of
National Cancer Center
Goyang-si, Gyeonggi-do 10408
Terminated
Kyungpook National University Hospital
Daegu, Taegu-kwangyǒkshi 41404
Recruiting
Dong-A University Hospital
Busan 49201
Recruiting
Kyungpook National University Chilgok Hospital
Daegu 41404
Recruiting
Gachon University Gil Medical Center
Incheon 21565
Recruiting
Chonnam National University Hwasun Hospital Pharmacy
Jeonnam 58128
Recruiting
Chonnam National University Hwasun Hospital
Jeonnam 58128
Recruiting
Korea University Anam Hospital
Seoul 02841
Recruiting
Seoul National University Hospital
Seoul 03080
Recruiting
Severance Hospital, Yonsei University Health System
Seoul 03722
Recruiting
Asan Medical Center
Seoul 05505
Recruiting
Samsung Medical Center
Seoul 06351
Recruiting
Mexico
Accelerium, S. de R.L. de C.V.
Monterrey, Nuevo LEON 64000
Recruiting
Centro de Investigacion Clinica de Oaxaca
Oaxaca 68020
Recruiting
Netherlands
Maastricht UMC+
Maastricht, Limburg 6229 HX
Recruiting
Catharina Ziekenhuis
Eindhoven, Noord-brabant 5623 EJ
Recruiting
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)
Amsterdam, Noord-holland 1066 CX
Recruiting
Haaglanden Medisch Centrum
Leidschendam, Zuid-holland 2262 BA
Recruiting
Amsterdam UMC, location VUMc
Amsterdam 1081 HV
Recruiting
Maastricht University Medical Center
Maastricht 6229 HX
Recruiting
Universitair Medisch Centrum Utrecht
Utrecht 3584 CX
Recruiting
New Zealand
Tauranga Hospital
Tauranga, BAY OF Plenty 3112
Recruiting
Auckland City Hospital
Auckland 1023
Recruiting
Auckland District Health Board Charitable Trust
Auckland 1023
Recruiting
Norway
Haukeland University Hospital
Bergen, Hordaland 5021
Recruiting
Stavanger Universitetssykehus
Stavanger, Rogaland 4011
Recruiting
St. Olavs hospital
Trondheim, Sør-trøndelag 7030
Recruiting
Sørlandet Sykehus Kristiansand
Kristiansand, Vest-agder N-4615
Recruiting
Oslo universitetssykehus, Radiumhospitalet
Oslo 0379
Recruiting
Oslo Universitetssykehus Ullevål
Oslo 0450
Recruiting
Poland
Przychodnia Lekarska KOMED
Konin, Wielkopolskie 62-500
Recruiting
Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Brzozow 36-200
Recruiting
Wojewodzki Szpital Specjalistyczny Nr 4 w Bytomiu Oddzial Onkologii
Bytom 41-902
Recruiting
COPERNICUS PL sp. z. o. o. Wojewodzkie Centrum Onkologii w Gdansku Ambulatoryjna
Gdansk 80-219
Recruiting
COPERNICUS Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii
Gdansk 80-219
Recruiting
Przychodnia Lekarska KOMED
Konin 62-500
Recruiting
Russian Federation
Private Medical Institution "Euromedservice"
Pushkin, Saint-petersburg 196603
Active, not recruiting
Private Medical Institution "Euromedservice"
Pushkin, Sankt-peterburg 196603
Active, not recruiting
GBUZ
Chelyabinsk 454087
Active, not recruiting
Kaluga Regional Clinical Oncology Center
Kaluga 248007
Active, not recruiting
FSAEI HE I.M Sechenov First MSMU MoH Russia (Sechenovskiy University),
Moscow 119991
Active, not recruiting
BHI of Omsk Region "Clinical Oncology Dispensary"
Omsk 644013
Active, not recruiting
BHI of Omsk Region "Clinical Oncology Dispensary"
Omsk 644046
Active, not recruiting
LLC "EuroCityClinic"
Saint Petersburg 197022
Active, not recruiting
LLC "Medicina Severnoy Stolitsy"
Saint-Petersburg 191025
Active, not recruiting
LLC "Severo-Zapadny Medical Center"
Saint-Petersburg 192007
Active, not recruiting
Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of St. Petersburg
Saint-Petersburg 195271
Active, not recruiting
FSBI "Russian Scientific Center For Radiology and Surgical Technologies n.a. Academician A.M. Granov
St. Petersburg 197758
Active, not recruiting
SHI YR Regional Clinical Oncology Hospital
Yaroslavl 150040
Active, not recruiting
SHI YR Regional Clinical Oncology Hospital
Yaroslavl 150054
Active, not recruiting
SHI YR Regional Clinical Oncology Hospital
Yaroslav 150054
Active, not recruiting
Slovakia
Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica
Banska Bystrica 974 01
Recruiting
Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska Bystrica
Banska Bystrica 975 17
Recruiting
Onkologicky ustav sv. Alzbety s.r.o.
Bratislava 812 50
Recruiting
Narodny Onkologicky Ustav
Bratislava 833 10
Recruiting
Vychodoslovensky onkologicky ustav, a.s.
Kosice 04191
Recruiting
POKO Poprad s.r.o.
Poprad 058 01
Recruiting
South Africa
Cancercare Rondebosch Oncology
Rondebosch, Cape Town 7700
Recruiting
Cancercare Langenhoven Drive Oncology Centre
Port Elizabeth, Eastern CAPE 6045
Recruiting
Charlotte Maxeke Johannesburg Academic Hospital
Johannesburg, Gauteng 2193
Recruiting
Wits Clinical Research
Parktown, Johannesburg, Gauteng 2193
Recruiting
Cape Town Oncology Trials
Cape Town, Western CAPE 7570
Not yet recruiting
Mary Potter Oncology Centre
Pretoria 0181
Recruiting
Spain
Complejo Hospitalario Universitario Santiago de Compostela
Santiago de Compostela, A Coruña 15706
Recruiting
Hospital General Universitario de Elche
Elche, Alicante 03203
Recruiting
ICO L'Hospitalet (Hospital Duran i Reynals)
Hospitalet de Llobregat, Barcelona 08908
Recruiting
Hospital Universitario Vall d'Hebron
Barcelona 08035
Recruiting
Hospital Clinic Barcelona
Barcelona 08036
Recruiting
Hospital General Universitario Gregorio Marañon
Madrid 28007
Recruiting
Hospital Universitario Ramon Y Cajal
Madrid 28034
Recruiting
Hospital Universitario 12 de octubre
Madrid 28041
Recruiting
Hospital Universitario Virgen Del Rocio
Sevilla 41013
Recruiting
Hospital Clinico Universitario de Valencia
Valencia 46010
Recruiting
Hospital General Universitario de Valencia
Valencia 46014
Recruiting
Hospital Universitario Miguel Servet
Zaragoza 50009
Recruiting
Sweden
Karolinska Universitetssjukhuset Solna
Solna, Stockholms LÄN [se-01] 171 64
Recruiting
Akademiska sjukhuset
Uppsala, Uppsala LÄN [se-03] 751 85
Recruiting
Norrlands universitetssjukhus
Umeå, Västerbottens LÄN [se-24] 90185
Recruiting
Sahlgrenska Universitetssjukhuset
Göteborg, Västra Götalands LÄN [se14] 413 45
Recruiting
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung 807
Recruiting
China Medical University Hospital
Taichung 40447
Recruiting
China Medical University Hospital
Taichung 404
Recruiting
National Cheng-Kung University Hospital
Tainan 704
Recruiting
Chi Mei Hospital, Liouying
Tainan 73657
Recruiting
National Taiwan University Hospital
Taipei 10002
Recruiting
National Taiwan University Hospital
Taipei 100
Recruiting
Taipei Medical University Hospital
Taipei 11031
Recruiting
Taipei Veterans General Hospital
Taipei 11217
Recruiting
Taipei Veterans General Hospital
Taipei 112
Recruiting
Chang Gung Medical Foundation-Linkou Branch
Taoyuan 333
Recruiting
Ukraine
Medical and diagnostic center of MediX-Ray International Group LLC Israeli Oncology Hospital "LISOD"
Pliuty Village, KYIV Region, Obuhovskiy District 08720
Not yet recruiting
Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council
Dnipro 49102
Active, not recruiting
PRECARPATHIAN NUCLEAR MEDICINE CENTER, Limited Liability Company
Ivano-Frankivsk 76011
Active, not recruiting
Ivano-Frankivsk National Medical University
Ivano-Frankivsk 76018
Active, not recruiting
MNPE "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Regional Council"
Ivano-Frankivsk 76018
Active, not recruiting
Municipal non-profit enterprise "City clinical hospital #2 named after O.O.Shalimov"
Kharkiv 61037
Not yet recruiting
Communal Non-Profit Enterprise "Regional Center of Oncology"
Kharkiv 61070
Not yet recruiting
Communal enterprise "Kryvyi Rih Oncology Dispensary" of Dnipropetrovsk Regional Council
Kryvyi Rih 50048
Active, not recruiting
SI "Insitute of Neurosurgery n.a.acad. A.P.
Kyiv 04050
Active, not recruiting
SI "Insitute of Neurosurgery n.a.acad. A.P.
Kyiv 04050
Not yet recruiting
Municipal non-profit enterprise of Kyiv regional council "Kyiv regional clinical hospital"
Kyiv 04107
Not yet recruiting
Municipal non-profit enterprise "Zaporizhzhia Regional Antitumor Center" Zaporizhzhia Regional
Zaporizhzhia 69040
Recruiting
United Kingdom
Freeman Hospital
Newcastle upon Tyne, HIGH Heaton NE7 7DN
Recruiting
Royal Marsden NHS Foundation Trust
Sutton, Surrey SM2 5PT
Recruiting
Heartlands Hospital
Birmingham B9 5SS
Recruiting
Royal Marsden NHS Foundation Trust
London SW3 6JJ
Recruiting
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London W12 0HS
Recruiting
Hammersmith Hospital
London W6 8RF
Recruiting
Churchill Hospital - Oncology
Oxford OX3 7LE
Recruiting

Contacts

Pfizer CT.gov Call Center
Contact
1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Inclusion Criteria

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

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

NCT ID

NCT04607421

Date Trial Added

2020-10-29

Updated Date

2024-03-19