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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

Active, not recruiting

Phase

Phase 3

Prior Immunotherapy Allowed

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 Hospital Phoenix, Arizona 85054	Active, not recruiting
Mayo Clinic in Arizona - Scottsdale Scottsdale, Arizona 85259	Active, not recruiting
Keck Hospital of USC Los Angeles, California 90033	Active, not recruiting
LAC & USC Medical Center Los Angeles, California 90033	Active, not recruiting
USC / Norris Comprehensive Cancer Center Los Angeles, California 90033	Active, not recruiting
USC/Norris Comprehensive Cancer Center Los Angeles, California 90033	Active, not recruiting
Keck Hospital of USC Pasadena Pasadena, California 91105	Active, not recruiting
Mount Sinai Comprehensive Cancer Center, Aventura Aventura, Florida 33180	Active, not recruiting
Mount Sinai Comprehensive Cancer Center Miami Beach, Florida 33140	Active, not recruiting
Mount Sinai Medical Center Miami Beach, Florida 33140	Active, not recruiting
BRCR Global Plantation, Florida 33322	Active, not recruiting
BRCR Medical Center Inc. Plantation, Florida 33322	Active, not recruiting
UChicago Medicine - River East Chicago, Illinois 60611	Active, not recruiting
University of Chicago Medical Center Chicago, Illinois 60637	Active, not recruiting
UChicago Medicine at Ingalls - Flossmoor Flossmoor, Illinois 60422	Active, not recruiting
UChicago Medicine Ingalls Memorial Harvey, Illinois 60426	Active, not recruiting
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital New Lenox, Illinois 60451	Active, not recruiting
The University of Chicago Medicine Center for Advanced Care Orland Park Orland Park, Illinois 60462	Active, not recruiting
UChicago Medicine at Ingalls - Tinley Park Tinley Park, Illinois 60477	Active, not recruiting
Ochsner Clinic Foundation Research Pharmacy New Orleans, Louisiana 70121	Active, not recruiting
Ochsner Clinic Foundation New Orleans, Louisiana 70121	Active, not recruiting
Mayo Clinic Rochester Rochester, Minnesota 55905	Active, not 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
Oncology Hematology West PC dba Nebraska Cancer Specialists Omaha, Nebraska 68114	Active, not recruiting
Oncology Hematology West PC dba Nebraska Cancer Specialists Omaha, Nebraska 68124	Active, not recruiting
Oncology Hematology West PC dba Nebraska Cancer Specialists Omaha, Nebraska 68130	Active, not recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists - IP Storage Omaha, Nebraska 68130	Active, not recruiting
Oncology Hematology West PC dba Nebraska Cancer Specialists Papillion, Nebraska 68046	Active, not recruiting
Memorial Sloan Kettering Cancer Center - Basking Ridge Basking Ridge, New Jersey 07920	Active, not recruiting
Summit Medical Group Florham Park, New Jersey 07932	Active, not 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
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
Memorial Sloan Kettering Cancer Center - Main Campus New York, New York 10065	Active, not recruiting
Memorial Sloan Kettering Cancer Center- Nassau Uniondale, New York 11553	Active, not recruiting
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy Cleveland, Ohio 44195	Active, not recruiting
Cleveland Clinic Cleveland, Ohio 44195	Active, not recruiting
The Ohio State University James Cancer Hospital and Solove Research Institute Columbus, Ohio 43210	Active, not recruiting
Stefanie Spielman Comprehensive Breast Cancer Columbus, Ohio 43212	Active, not recruiting
Martha Morehouse Medical Plaza Columbus, Ohio 43221	Active, not recruiting
The James Outpatient Care West Campus Columbus, Ohio 43221	Active, not recruiting
University of Oklahoma Health Sciences Center, OU Health Stephenson Cancer Center Oklahoma City, Oklahoma 73104	Active, not recruiting
Providence Cancer Institute Franz Clinic Portland, Oregon 97213	Active, not recruiting
Providence Portland Medical Center Portland, Oregon 97213	Active, not recruiting
Providence Onc and Heme Care Clinic - Westside Portland, Oregon 97225	Active, not recruiting
Providence St Vincent Medical Center Portland, Oregon 97225	Active, not recruiting
UPMC Hillman Cancer Center Investigational Drug Service Pittsburgh, Pennsylvania 15232	Active, not recruiting
UPMC Hillman Cancer Center Pittsburgh, Pennsylvania 15232	Active, not recruiting
The West Clinic. PLLC. dba West Cancer Center Germantown, Tennessee 38138	Active, not recruiting
Henry-Joyce Cancer Center Nashville, Tennessee 37232	Active, not recruiting
Vanderbilt Oncology IDS Pharmacy Nashville, Tennessee 37232	Active, not recruiting
Vanderbilt-Ingram Cancer Center Nashville, Tennessee 37232	Active, not recruiting
The University of Texas MD Anderson Cancer Center Houston, Texas 77030	Active, not recruiting
VCU Health - Adult Outpatient Pavilion (AOP) Investigational Drug Services Richmond, Virginia 23219	Active, not recruiting
Virginia Commonwealth University Richmond, Virginia 23219	Active, not recruiting
Seattle Cancer Care Alliance Seattle, Washington 98109	Active, not recruiting
University of Washington Medical Center Seattle, Washington 98195	Active, not recruiting
University of Wisconsin Clinical Science Center Madison, Wisconsin 53792	Active, not recruiting
Argentina
Centro Medico San Roque San Miguel De Tucumán, Tucumán 4000	Active, not recruiting
Instituto Médico Especializado Alexander Fleming Ciudad Autónoma de Buenos Aires 1426	Active, not recruiting
Clinica Universitaria Reina Fabiola Cordoba X5004FHP	Active, not recruiting
Hospital Privado Centro Médico de Córdoba Cordoba X5016KEH	Active, not recruiting
Australia
Chris O'Brien Lifehouse Camperdown, New South Wales 2050	Active, not recruiting
Liverpool Hospital Liverpool, New South Wales 2170	Active, not recruiting
GenesisCare - North Shore St Leonards, New South Wales 2065	Active, not recruiting
GenesisCare North Shore St Leonards, New South Wales 2065	Active, not recruiting
Royal Brisbane & Women's Hospital Herston, Queensland 4029	Active, not recruiting
Princess Alexandra Hospital Woolloongabba, Queensland 4102	Active, not recruiting
The Queen Elizabeth Hospital Adelaide, South Australia 5011	Active, not recruiting
Monash Health Clayton, Victoria 3168	Active, not recruiting
Austin Health Heidelberg, Victoria 3084	Active, not recruiting
Peter MacCallum Cancer Centre Melbourne, Victoria 3000	Active, not recruiting
Alfred Health Melbourne, Victoria 3004	Active, not recruiting
Belgium
Université Libre de Bruxelles - Hôpital Erasme Brussels, Bruxelles-capitale, Région DE 1070	Active, not recruiting
Cliniques universitaires Saint-Luc Brussels, Bruxelles-capitale, Région DE 1200	Active, not recruiting
Grand Hôpital de Charleroi Charleroi, Hainaut 6060	Active, not recruiting
AZ Groeninge Campus Kennedylaan Kortrijk, West-vlaanderen 8500	Active, not recruiting
ZNA Middelheim Antwerpen 2020	Active, not recruiting
UZ Leuven Leuven 3000	Active, not recruiting
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman Liège 4000	Active, not recruiting
GZA Hospitals Campus Sint Augustinus Wilrijk 2610	Active, not recruiting
Brazil
Hospital de Clinicas de Porto Alegre Porto Alegre, RIO Grande DO SUL 90035-903	Active, not recruiting
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA Rio de Janeiro, RJ 20230-130	Active, not recruiting
Reichow - Centro de Ensino e Pesquisa Blumenau, Santa Catarina 89010-340	Active, not recruiting
Clínica de Neoplasias Litoral Itajaí, Santa Catarina 88301-220	Active, not recruiting
FUNDAÇÃO DO ABC - Faculdade de Medicina do ABC - Centro de Estudos e Pesquisas de Hematologia e Onco Santo Andre, SP 09060-870	Active, not recruiting
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC Santo André, SP 09060-650	Active, not recruiting
Fundação Pio XII - Hospital de Câncer de Barretos Barretos, SÃO Paulo 14784400	Active, not recruiting
Fundação Faculdade Regional de Medicina de São José do Rio Preto São José do Rio Preto, SÃO Paulo 15090000	Active, not recruiting
Bulgaria
MHAT Uni Hospital OOD Panagyurishte, Pazardzhik 4500	Active, not recruiting
MHAT "Dr. Tota Venkova" AD Gabrovo 5300	Active, not recruiting
MHAT Central Onco Hospital OOD Plovdiv 4000	Active, not recruiting
Complex Oncology Center - Plovdiv EOOD Plovdiv 4004	Active, not recruiting
Medical Center Nadezhda Clinical EOOD Sofia 1303	Active, not recruiting
Acibadem City Clinic MHAT Tokuda Sofia 1407	Active, not recruiting
University Multiprofile Hospital for Active Treatment Sofiamed Sofia 1750	Active, not recruiting
Canada
Arthur J.E. Child Comprehensive Cancer Centre Calgary, Alberta T3N 4N1	Active, not recruiting
Cross Cancer Institute Edmonton, Alberta T6G 1Z2	Active, not recruiting
London Regional Cancer Program, London Health Sciences Centre London, Ontario N6A 5W9	Active, not recruiting
Sunnybrook Health Sciences Centre Toronto, Ontario M4N 3M5	Active, not recruiting
Jewish General Hospital Montreal, Quebec H3T 1E2	Active, not recruiting
China
Cancer Hospital Chinese Academy of Medical Science Beijing, Beijing 100021	Active, not recruiting
Beijing Cancer hospital Beijing, Beijing 100142	Active, not recruiting
Beijing Hospital Beijing, Beijing 100730	Active, not recruiting
Chongqing University Cancer Hospital Chongqing, Chongqing 400030	Active, not recruiting
Fujian Medical University Union Hospital Fuzhou, Fujian 350001	Active, not recruiting
The Sixth Affiliated Hospital of Sun Yat-sen University Guangzhou, Guangdong 510655	Active, not recruiting
Affiliated Tumor Hospital of Guangxi Medical University Nanning, Guangxi 530021	Active, not recruiting
Affiliated Tumor Hospital of Guangxi Medical University Nanning, Guangxi 530200	Active, not recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology Wuhan, Hubei 430030	Active, not recruiting
The Second Xiangya Hospital of Central South University Changsha, Hunan 410011	Active, not recruiting
The Third Xiangya Hospital of Central South University Changsha, Hunan 410013	Active, not recruiting
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School Nanjing, Jiangsu 210008	Active, not recruiting
Shengjing Hospital Of China Medical University Shenyang, Liaoning 110022	Active, not recruiting
Shandong province cancer hospital Jinan, Shandong 250117	Active, not recruiting
Shanghai Jiaotong University School of Medicine Ruijin Hospital Shanghai, Shanghai 200025	Active, not recruiting
Shanghai General Hospital Shanghai, Shanghai 200080	Active, not recruiting
Sichuan Province Cancer Hospital Chengdu, Sichuan 610041	Active, not recruiting
Yunnan Cancer Hospital(The Third Affiliated Hospital of Kunming Medical University) Kunming, Yunnan 650118	Active, not recruiting
The second Affiliated Hospital of College of Medicine, Zhejiang University Hangzhou, Zhejiang 310000	Active, not recruiting
Peking University First Hospital Beijing 100034	Active, not recruiting
Fudan University Shanghai Cancer Center Shanghai 201321	Active, not recruiting
Tianjin Union Medical Center Tianjin 300000	Active, not recruiting
Czechia
Fakultní nemocnice Brno Bohunice Brno, Brno-město 625 00	Active, not recruiting
Fakultni nemocnice Hradec Kralove Hradec Kralove, Hradec Králové 500 05	Active, not recruiting
Fakultni Thomayerova nemocnice Prague, Praha 4 14059	Active, not recruiting
Fakultni nemocnice Olomouc Olomouc 779 00	Active, not recruiting
Fakultni nemocnice Bulovka Praha 8 180 81	Active, not recruiting
Denmark
Aalborg Universitetshospital, Syd Aalborg, Nordjylland 9000	Active, not recruiting
Vejle Hospital-Sygehus Lillebaelt Vejle, Syddanmark 7100	Active, not recruiting
Vejle Sygehus Vejle, Syddanmark 7100	Active, not recruiting
Rigshospitalet Copenhagen 2100	Active, not recruiting
Herlev and Gentofte Hospital Herlev 2730	Active, not recruiting
Odense University Hospital Odense C 5000	Active, not recruiting
Finland
Docrates Syöpäsairaala Helsinki, Nyland 00180	Active, not recruiting
Helsinki University Central Hospital Helsinki 00029	Active, not recruiting
Oulu University Hospital Oulu 90220	Active, not recruiting
Satakunnan Keskussairaala Pori 28500	Active, not recruiting
Tampereen yliopistollinen sairaala Tampere 33520	Active, not recruiting
Turku University Hospital Turku 20520	Active, not recruiting
Germany
Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie Muenchen, Bayern 81737	Active, not recruiting
Institut für Klinisch Onkologische Forschung Frankfurt, Hessen 60488	Active, not recruiting
Medizinische Hochschule Hannover Hannover, Lower Saxony 30625	Active, not recruiting
Medizinische Hochschule Hannover Hannover, Niedersachsen 30625	Active, not recruiting
Universitätsklinikum Leipzig Leipzig, Sachsen 04103	Active, not recruiting
Radiologie Berlin Berlin - Charlottenburg 10719	Active, not recruiting
Onkologische Schwerpunktpraxis Kurfuerstendamm Berlin 10707	Active, not recruiting
Waage Apotheke Berlin 10709	Active, not recruiting
HELIOS Klinikum Berlin Buch GmbH Berlin 13125	Active, not recruiting
Technische Universität Dresden, Medizinische Fakultät Carl Gustav Carus Dresden 01307	Active, not recruiting
Universitätsklinikum Carl Gustav Carus Dresden Dresden 01307	Active, not recruiting
Facharztzentrum Eppendorf Hamburg 20249	Active, not recruiting
ZytoService Deutschland GmbH, Standort-Hamburg-Jenfeld Hamburg 22045	Active, not recruiting
Radiologie im Israelitischen Krankenhaus Hamburg 22297	Active, not recruiting
India
Rajiv Gandhi Cancer Institute And Research Centre New Delhi, Delhi 110085	Active, not recruiting
Tata Memorial Hospital Mumbai, Maharashtra 400012	Active, not recruiting
Deenanath Mangeshkar Hospital & Research Centre Pune, Maharashtra 411 004	Active, not recruiting
Sahyadri Speciality Hospital Pune, Maharashtra 411 004	Active, not recruiting
Bhakti Vedanta Hospital and Research Institute Thane, Maharashtra 401107	Active, not recruiting
R K Birla Cancer Center, SMS Hospital Jaipur, Rajasthan 302004	Active, not recruiting
Sawai Man Singh Medical College Hospital (SMS Hospital) Jaipur, Rajasthan 302004	Active, not recruiting
Italy
Azienda Ospedaliera Universitaria di Cagliari - Presidio Policlinico Universitario "D.Casula" Monserrato (CA), Cagliari 09042	Active, not recruiting
IRCCS Casa Sollievo della Sofferenza San Giovanni Rotondo, Foggia 71013	Active, not recruiting
ASST Grande Ospedale Metropolitano Niguarda Milan, Milano 20162	Active, not recruiting
Fondazione del Piemonte per l'Oncologia - Istituto di Candiolo IRCCS Candiolo, Torino 10060	Active, not recruiting
Azienda Ospedaliero Universitaria San Luigi Gonzaga Orbassano, Torino 10043	Active, not recruiting
Fondazione Poliambulanza Istituto Ospedaliero Brescia 25124	Active, not recruiting
Istituto Europeo di Oncologia IRCCS Milano 20141	Active, not recruiting
Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli" di Napoli Napoli 80131	Active, not recruiting
IRCCS Istituto Oncologico Veneto (IOV) Padova 35128	Active, not recruiting
Azienda USL - IRCCS di Reggio Emilia - Arcispedale Santa Maria Nuova Reggio Emilia 42123	Active, not recruiting
Japan
Chiba cancer center Chiba-shi, Chiba 260-8717	Active, not recruiting
National Cancer Center Hospital East Kashiwa, Chiba 277-8577	Active, not recruiting
Hokkaido University Hospital Sapporo, Hokkaido 060-8648	Active, not recruiting
Kanazawa University Hospital Kanazawa, Ishikawa 920-8641	Active, not recruiting
St. Marianna University Hospital Kawasaki, Kanagawa 216-8511	Active, not recruiting
Kanagawa cancer center Yokohama, Kanagawa 2418515	Active, not recruiting
Aichi Cancer Center Hospital Nagoya, Nagoya, Aichi 464-8681	Active, not recruiting
Osaka Prefectural Hospital Organization Osaka International Cancer Institute Osaka-shi, Osaka 5418567	Active, not recruiting
Kindai University Hospital Osakasayama, Osaka 589-8511	Active, not recruiting
Osaka University Hospital Suita, Osaka 565-0871	Active, not recruiting
Osaka Medical and Pharmaceutical University Hospital Takatsuki, Osaka 569-8686	Active, not recruiting
Saitama Medical University International Medical Center Hidaka-city, Saitama 350-1298	Active, not recruiting
Saitama Prefectural Cancer Center Ina-machi, Saitama 362-0806	Active, not recruiting
Shizuoka Cancer Center Nagaizumi, Shizuoka 411-8777	Active, not recruiting
National Cancer Center Hospital Chuo-ku, Tokyo 104-0045	Active, not recruiting
Japanese Foundation for Cancer Research Koto-ku, Tokyo 135-8550	Active, not recruiting
National Hospital Organization Kyushu Cancer Center Fukuoka 811-1395	Active, not recruiting
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research Osaka 540-0006	Active, not recruiting
Keio university hospital Tokyo 1600035	Active, not recruiting
Korea, Republic of
National Cancer Center Goyang-si, Gyeonggi-do 10408	Active, not recruiting
Kyungpook National University Hospital Daegu, Taegu-kwangyǒkshi 41404	Active, not recruiting
Dong-A University Hospital Busan 49201	Active, not recruiting
Kyungpook National University Chilgok Hospital Daegu 41404	Active, not recruiting
Gachon University Gil Medical Center Incheon 21565	Active, not recruiting
Korea University Anam Hospital Seoul 02841	Active, not recruiting
Seoul National University Hospital Seoul 03080	Active, not recruiting
Severance Hospital, Yonsei University Health System Seoul 03722	Active, not recruiting
Asan Medical Center Seoul 05505	Active, not recruiting
Samsung Medical Center Seoul 06351	Active, not recruiting
Mexico
Accelerium, S. de R.L. de C.V. Monterrey, Nuevo LEON 64000	Active, not recruiting
Centro de Investigacion Clinica de Oaxaca Oaxaca 68020	Active, not recruiting
Netherlands
Catharina Ziekenhuis Eindhoven, Noord-brabant 5623 EJ	Active, not recruiting
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL) Amsterdam, Noord-holland 1066 CX	Active, not recruiting
Universitair Medisch Centrum Utrecht Utrecht 3584 CX	Active, not recruiting
New Zealand
Auckland City Hospital Auckland 1023	Active, not recruiting
Norway
St. Olavs hospital Trondheim, Sør-trøndelag 7030	Active, not recruiting
Sørlandet Sykehus Kristiansand Kristiansand, Vest-agder N-4615	Active, not recruiting
Oslo universitetssykehus, Radiumhospitalet Oslo 0379	Active, not recruiting
Oslo Universitetssykehus Ullevål Oslo 0450	Active, not recruiting
Poland
Przychodnia Lekarska KOMED Konin, Wielkopolskie 62-500	Active, not recruiting
Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza Brzozow 36-200	Active, not recruiting
Wojewodzki Szpital Specjalistyczny Nr 4 w Bytomiu Oddzial Onkologii Bytom 41-902	Active, not recruiting
COPERNICUS PL sp. z. o. o. Wojewodzkie Centrum Onkologii w Gdansku Ambulatoryjna Gdansk 80-219	Active, not recruiting
COPERNICUS Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii Gdansk 80-219	Active, not recruiting
Russian Federation
Private Medical Institution "Euromedservice" Pushkin, Saint-petersburg 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 150054	Active, not recruiting
Slovakia
Narodny Onkologicky Ustav Bratislava 833 10	Active, not recruiting
Vychodoslovensky onkologicky ustav, a.s. Kosice 04191	Active, not recruiting
South Africa
Cancercare Rondebosch Oncology Rondebosch, Cape Town 7700	Active, not recruiting
Cancercare Langenhoven Drive Oncology Centre Port Elizabeth, Eastern CAPE 6045	Active, not recruiting
Wits Health Consortium (Pty) Ltd Johannesburg 2193	Active, not recruiting
Spain
Complejo Hospitalario Universitario Santiago de Compostela Santiago de Compostela, A Coruña 15706	Active, not recruiting
Hospital General Universitario de Elche Elche, Alicante 03203	Active, not recruiting
ICO L'Hospitalet (Hospital Duran i Reynals) Hospitalet de Llobregat, Barcelona 08908	Active, not recruiting
Hospital Universitario Vall d'Hebron Barcelona 08035	Active, not recruiting
Hospital Clinic Barcelona Barcelona 08036	Active, not recruiting
Hospital General Universitario Gregorio Marañon Madrid 28007	Active, not recruiting
Hospital Universitario Ramon Y Cajal Madrid 28034	Active, not recruiting
Hospital Universitario 12 de octubre Madrid 28041	Active, not recruiting
Hospital Universitario Virgen Del Rocio Sevilla 41013	Active, not recruiting
Hospital Clinico Universitario de Valencia Valencia 46010	Active, not recruiting
Hospital General Universitario de Valencia Valencia 46014	Active, not recruiting
Hospital Universitario Miguel Servet Zaragoza 50009	Active, not recruiting
Sweden
Karolinska Universitetssjukhuset Solna Solna, Stockholms LÄN [se-01] 171 64	Active, not recruiting
Akademiska sjukhuset Uppsala, Uppsala LÄN [se-03] 751 85	Active, not recruiting
Norrlands universitetssjukhus Umeå, Västerbottens LÄN [se-24] 90185	Active, not recruiting
Sahlgrenska Universitetssjukhuset Göteborg, Västra Götalands LÄN [se14] 413 45	Active, not recruiting
Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital Kaohsiung 807	Active, not recruiting
China Medical University Hospital Taichung 404	Active, not recruiting
National Cheng-Kung University Hospital Tainan 704	Active, not recruiting
Chi Mei Hospital, Liouying Tainan 73657	Active, not recruiting
National Taiwan University Hospital Taipei 100	Active, not recruiting
Taipei Medical University Hospital Taipei 11031	Active, not recruiting
Taipei Veterans General Hospital Taipei 112	Active, not recruiting
Chang Gung Medical Foundation-Linkou Branch Taoyuan 333	Active, not recruiting
Ukraine
Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council Dnipro 49102	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
Communal enterprise "Kryvyi Rih Oncology Dispensary" of Dnipropetrovsk Regional Council Kryvyi Rih 50048	Active, not recruiting
United Kingdom
Freeman Hospital Newcastle upon Tyne, HIGH Heaton NE7 7DN	Active, not recruiting
Royal Marsden NHS Foundation Trust Sutton, Surrey SM2 5PT	Active, not recruiting
Heartlands Hospital Birmingham B9 5SS	Active, not recruiting
Hammersmith Hospital, Imperial College Healthcare NHS Trust London W12 0HS	Active, not recruiting
Hammersmith Hospital London W6 8RF	Active, not recruiting
Churchill Hospital - Oncology Oxford OX3 7LE	Active, not recruiting

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

2025-04-15