A Study of Encorafenib Plus Cetuximab With or Without Chemotherapy in People With Previously Untreated Metastatic Colorectal Cancer
Neoplasms
About this trial
This is an interventional treatment trial for Neoplasms focused on measuring Colorectal cancer, Colon cancer, Rectal cancer, Colorectal Neoplasms, Intestinal cancer, Intestinal Neoplasms, Gastrointestinal cancer, Gastrointestinal Neoplasms, Digestive system cancer, Digestive System Neoplasms, Digestive System Diseases, Gastrointestinal Diseases, Colonic Diseases, Intestinal Diseases, Rectal Diseases, BREAKWATER Study
Eligibility Criteria
Inclusion Criteria:
- Safety Lead-In = Male/female ≥ 18 years old
- Phase 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
- SLI: 0-1 regimens
- Phase 3: None
- Prior adjuvant or neoadjuvant therapy considered metastatic treatment if relapse/metastasis < 6 month from end of adj/neoadjuvant treatment
- Measurable disease (Phase 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
Sites / Locations
- Mayo Clinic - Phoenix Oncology PharmacyRecruiting
- Mayo Clinic HospitalRecruiting
- Mayo Clinic in Arizona - ScottsdaleRecruiting
- Tower Hematology Oncology Medical Group (THO)Recruiting
- Keck Hospital of USCRecruiting
- LAC & USC Medical CenterRecruiting
- USC / Norris Comprehensive Cancer CenterRecruiting
- USC/Norris Comprehensive Cancer Center / Investigational Drug ServicesRecruiting
- USC/Norris Comprehensive Cancer CenterRecruiting
- Cedars- Sinai Medical CenterRecruiting
- Cedars-Sinai Medical Center, Samuel Oschin Comprehensive Cancer InstituteRecruiting
- Cedars-Sinai Medical CenterRecruiting
- Keck Hospital of USC PasadenaRecruiting
- Torrance Memorial Medical Center (TMMC)Recruiting
- Georgetown University Medical CenterRecruiting
- Medstar Georgetown University HospitalRecruiting
- Mount Sinai Comprehensive Cancer Center, AventuraRecruiting
- Sylvester Comprehensive Cancer Center- The Lennar Foundation Medical CenterRecruiting
- Holy Cross Hospital - Michael and Dianne Bienes Comprehensive Cancer CenterRecruiting
- Mayo Clinic FloridaRecruiting
- Mount Sinai Comprehensive Cancer CenterRecruiting
- Mount Sinai Medical CenterRecruiting
- Sylvester Comprehensive Cancer CenterRecruiting
- Baptist Hospital of MiamiRecruiting
- Miami Cancer InstituteRecruiting
- Orlando Health Cancer InstituteRecruiting
- Orlando Health, Inc.Recruiting
- Orlando Health, IncRecruiting
- BRCR GlobalRecruiting
- BRCR Medical Center Inc.Recruiting
- Lewis Cancer & Research Pavilion at St Joseph's/Candler Health SystemRecruiting
- Lewis Cancer & Research Pavilion PharmacyRecruiting
- St. Joseph's/Candler Health System, Inc.Recruiting
- Summit Cancer Care, P.C.Recruiting
- Summit Cancer CareRecruiting
- St. Joseph's/Candler Health System, Inc.Recruiting
- UChicago Medicine - River EastRecruiting
- The University of Chicago Medical Center, CCD - Investigational Drug Service PharmacyRecruiting
- University of Chicago Medical CenterRecruiting
- UChicago Medicine at Ingalls - FlossmoorRecruiting
- UChicago Medicine Ingalls MemorialRecruiting
- University of Chicago Comprehensive Cancer Center at Silver Cross HospitalRecruiting
- The University of Chicago Medicine Center for Advanced Care Orland ParkRecruiting
- UChicago Medicine at Ingalls - Tinley ParkRecruiting
- Ochsner Clinic Foundation Research PharmacyRecruiting
- Ochsner Clinic FoundationRecruiting
- University of Michigan HospitalsRecruiting
- University of MichiganRecruiting
- Mayo Clinic in Rochester, MinnesotaRecruiting
- Mayo Clinic RochesterRecruiting
- Mayo ClinicRecruiting
- Siteman Cancer Center - West CountyRecruiting
- Siteman Cancer Center - North CountyRecruiting
- Barnes- Jewish HospitalRecruiting
- Washington University School of MedicineRecruiting
- Siteman Cancer Center - South CountyRecruiting
- Siteman Cancer Center - St PetersRecruiting
- St Vincent HealthcareRecruiting
- St. Vincent Frontier Cancer CenterRecruiting
- Oncology Hematology West PC dba Nebraska Cancer SpecialistsRecruiting
- Oncology Hematology West PC dba Nebraska Cancer SpecialistsRecruiting
- Oncology Hematology West PC dba Nebraska Cancer SpecialistsRecruiting
- Oncology Hematology West, PC dba Nebraska Cancer Specialists - IP StorageRecruiting
- Oncology Hematology West PC dba Nebraska Cancer SpecialistsRecruiting
- Memorial Sloan Kettering Cancer Center - Basking RidgeRecruiting
- Summit Medical GroupRecruiting
- Summit Medical GroupRecruiting
- Memorial Sloan Kettering Cancer Center- MonmouthRecruiting
- Memorial Sloan Kettering Cancer Center- BergenRecruiting
- North Shore Hematology Oncology Assoc. P.C. DBA NY Cancer and Blood SpecialistsRecruiting
- North Shore Hematology Oncology Assoc. P.C. DBA NY Cancer and Blood SpecialistsRecruiting
- Memorial Sloan Kettering Cancer Center CommackRecruiting
- Memorial Sloan Kettering Cancer Center - WestchesterRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- North Shore Hematology Oncology Assoc. P.C. DBA NY Cancer and Blood SpecialistsRecruiting
- Memorial Sloan Kettering Cancer Center - Main CampusRecruiting
- North Shore Hematology Oncology Assoc. P.C. DBA NY Cancer and Blood SpecialistsRecruiting
- North Shore Hematology Oncology Assoc. P.C. DBA NY Cancer and Blood SpecialistsRecruiting
- North Shore Hematology Oncology Assoc. P.C. DBA NY Cancer and Blood SpecialistsRecruiting
- Memorial Sloan Kettering Cancer Center- NassauRecruiting
- Carolinas Medical CenterRecruiting
- Carolinas Medical Center Investigational Drug ServicesRecruiting
- Levine Cancer InstituteRecruiting
- Atrium Health MercyRecruiting
- Atrium Health PinevilleRecruiting
- Levine Cancer Institute - SouthparkRecruiting
- Atrium Health University CityRecruiting
- Levine Cancer Institute University CityRecruiting
- Atrium Health CabarrusRecruiting
- Levine Cancer Institute - ConcordRecruiting
- Atrium Health UnionRecruiting
- Cleveland Clinic Taussig Cancer Center Investigational PharmacyRecruiting
- Cleveland ClinicRecruiting
- Investigational Drug Service, The Ohio State University Wexner Medical CenterRecruiting
- The Ohio State University James Cancer Hospital and Solove Research InstituteRecruiting
- Stefanie Spielman Comprehensive Breast CancerRecruiting
- Martha Morehouse Medical PlazaRecruiting
- The James Outpatient Care West CampusRecruiting
- University of Oklahoma Health Sciences Center, OU Health Stephenson Cancer CenterRecruiting
- Providence Cancer Institute Franz ClinicRecruiting
- Providence Portland Medical CenterRecruiting
- Providence Onc and Heme Care Clinic - WestsideRecruiting
- Providence Oncology and Hematology Care Clinic - WestsideRecruiting
- Providence St Vincent Medical CenterRecruiting
- Providence St. Vincent Medical CenterRecruiting
- AHN Cancer Institute at Jefferson HospitalRecruiting
- AHN Cancer Institute Forbes HospitalRecruiting
- AHN Cancer Institute - Allegheny General HospitalRecruiting
- AHN Cancer Institute PharmacyRecruiting
- AHN Cancer Institute West Penn HospitalRecruiting
- UPMC Hillman Cancer Center Investigational Drug ServiceRecruiting
- UPMC Hillman Cancer CenterRecruiting
- Wexford Health and Wellness PavilionRecruiting
- Vanderbilt Health Clinic at Walgreens ClarksvilleRecruiting
- Vanderbilt Health Clinic at Walgreens Cool SpringsRecruiting
- Vanderbilt Health Clinic at Walgreens GallatinRecruiting
- The West Clinic. PLLC. dba West Cancer CenterRecruiting
- Vanderbilt Health Clinic at Walgreens HendersonvilleRecruiting
- Vanderbilt Health Clinic at Walgreens HermitageRecruiting
- Vanderbilt Health Clinic at Walgreens La VergneRecruiting
- Vanderbilt Health Clinic at Walgreens LebanonRecruiting
- The West Clinic PLLC dba West Cancer CenterRecruiting
- Vanderbilt Health Clinic at Walgreens MurfreesboroRecruiting
- Vanderbilt Health Clinic at Walgreens Belle MeadeRecruiting
- Vanderbilt Health Clinic at Walgreens Nippers CornerRecruiting
- Vanderbilt Health Clinic at Walgreens DonelsonRecruiting
- Vanderbilt Health Clinic at Walgreens Hart LaneRecruiting
- Vanderbilt Health Clinic at Walgreens BellevueRecruiting
- Vanderbilt-Ingram Cancer CenterRecruiting
- Henry-Joyce Cancer CenterRecruiting
- Vanderbilt Oncology IDS PharmacyRecruiting
- Vanderbilt Health Clinic at Walgreens SmyrnaRecruiting
- The University of Texas MD Anderson Cancer CenterRecruiting
- The University of Texas MD Anderson Cancer CenterRecruiting
- VCU Health System, Investigational Drug Service PharmacyRecruiting
- Virginia Commonwealth University Massey Cancer CenterRecruiting
- Seattle Cancer Care AllianceRecruiting
- University of Washington Medical CenterRecruiting
- University of Wisconsin Clinical Science CenterRecruiting
- Froedtert Hospital and the Medical College of WisconsinRecruiting
- Centro Medico San RoqueRecruiting
- Centro Medico San RoqueRecruiting
- Instituto Médico Especializado Alexander FlemingRecruiting
- Clinica Universitaria Reina FabiolaRecruiting
- Hospital Privado Centro Médico de CórdobaRecruiting
- Hospital Privado Centro Médico de CórdobaRecruiting
- Chris O'Brien LifehouseRecruiting
- Liverpool HospitalRecruiting
- Slade PharmacyRecruiting
- GenesisCare - North ShoreRecruiting
- GenesisCare North ShoreRecruiting
- Royal Brisbane & Women's HospitalRecruiting
- Princess Alexandra HospitalRecruiting
- The Queen Elizabeth HospitalRecruiting
- Monash HealthRecruiting
- Austin HealthRecruiting
- Peter MacCallum Cancer CentreRecruiting
- Alfred HealthRecruiting
- Université Libre de Bruxelles - Hôpital ErasmeRecruiting
- Cliniques universitaires Saint-LucRecruiting
- Grand Hôpital de CharleroiRecruiting
- CHR Verviers East BelgiumRecruiting
- AZ Groeninge Campus KennedylaanRecruiting
- ZNA MiddelheimRecruiting
- UZ LeuvenRecruiting
- Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart TilmanRecruiting
- Hospital Bruno BornRecruiting
- Hospital Bruno BornRecruiting
- Hospital Bruno BornRecruiting
- Hospital de Clinicas de Porto AlegreRecruiting
- INCARecruiting
- Instituto Nacional de Câncer José Alencar Gomes da Silva - INCARecruiting
- Reichow - Centro de Ensino e PesquisaRecruiting
- Clínica de Neoplasias LitoralRecruiting
- Hospital do Cancer de Barretos - Fundacao Pio XIIRecruiting
- CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABCRecruiting
- Fundacao do ABC-Faculdade de Medicina do ABCRecruiting
- FUNDAÇÃO DO ABC - Faculdade de Medicina do ABC - Centro de Estudos e Pesquisas de Hematologia e OnRecruiting
- CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABCRecruiting
- Instituto do Cancer do Estado de Sao Paulo, ICESPRecruiting
- Fundação Pio XII - Hospital de Câncer de BarretosRecruiting
- Medical School Famerp-HB-FUNFARME_Do not use - Duplicate facilityRecruiting
- Fundação Faculdade Regional de Medicina de São José do Rio PretoRecruiting
- MHAT Uni Hospital OODRecruiting
- MHAT "Dr. Tota Venkova" ADRecruiting
- Complex Oncology Center - Plovdiv EOODRecruiting
- MHAT Central Onco Hospital OODRecruiting
- Complex Oncology Center - Plovdiv EOODRecruiting
- Medical Center Nadezhda Clinical EOODRecruiting
- Acibadem City Clinic MHAT TokudaRecruiting
- University Multiprofile Hospital for Active Treatment SofiamedRecruiting
- Tom Baker Cancer CentreRecruiting
- Cross Cancer InstituteRecruiting
- Kingston Health Sciences Centre-Kingston General Hospital SiteRecruiting
- London Regional Cancer Program, London Health Sciences CentreRecruiting
- Sunnybrook Health Sciences CentreRecruiting
- Centre Intégré de Santé et de Services Sociaux (CISSS) de Laval / Hôpital de la Cité-de-la-SantRecruiting
- Jewish General HospitalRecruiting
- Anhui Provincial Cancer Hospital
- The First Affiliated Hospital of Anhui Medical UniversityRecruiting
- Cancer Hospital Chinese Academy of Medical ScienceRecruiting
- Beijing Cancer hospitalRecruiting
- Beijing HospitalRecruiting
- Chongqing University Cancer HospitalRecruiting
- Fujian Medical University Union Hospital-1 BingfanglouRecruiting
- Guangdong Provincial People's Hospital
- Guangdong Provincial People's HospitalRecruiting
- The Sixth Affiliated Hospital of Sun Yat-sen University
- Affiliated Tumor Hospital of Guangxi Medical UniversityRecruiting
- Henan provincial people's hospitalRecruiting
- Tongji Hospital, Tongji Medical College, Huazhong University of Science & TechnologyRecruiting
- The Second Xiangya Hospital of Central South UniversityRecruiting
- The Third Xiangya Hospital of Central South UniversityRecruiting
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical SchoolRecruiting
- Shengjing Hospital Of China Medical UniversityRecruiting
- Jinan Central HospitalRecruiting
- Shandong province cancer hospitalRecruiting
- The Affiliated Hospital of Qingdao UniversityRecruiting
- Shanghai Jiaotong University School of Medicine Ruijin HospitalRecruiting
- Shanghai General HospitalRecruiting
- Sichuan Province Cancer HospitalRecruiting
- Yunnan Cancer Hospital(The Third Affiliated Hospital of Kunming Medical University)Recruiting
- The second Affiliated Hospital of College of Medicine, Zhejiang UniversityRecruiting
- Peking University First HospitalRecruiting
- Fudan University Shanghai Cancer CenterRecruiting
- Tianjin Union Medical CenterRecruiting
- Fakultní nemocnice Brno BohuniceRecruiting
- Fakultni nemocnice Hradec KraloveRecruiting
- Fakultni Thomayerova nemocniceRecruiting
- Fakultni nemocnice OlomoucRecruiting
- Fakultni nemocnice v MotoleRecruiting
- Fakultni nemocnice BulovkaRecruiting
- Aalborg Universitetshospital, SydRecruiting
- Vejle Hospital-Sygehus LillebaeltRecruiting
- Vejle SygehusRecruiting
- Aalborg UniversitetshospitalRecruiting
- RigshospitaletRecruiting
- Herlev and Gentofte HospitalRecruiting
- Odense University HospitalRecruiting
- Docrates SyöpäsairaalaRecruiting
- Tampereen yliopistollinen sairaalaRecruiting
- Helsinki University Central HospitalRecruiting
- Oulu University HospitalRecruiting
- Satakunnan KeskussairaalaRecruiting
- Tampereen yliopistollinen sairaalaRecruiting
- Turku University HospitalRecruiting
- Muenchen Klinik Neuperlach, Klinik fuer Haematologie und OnkologieRecruiting
- Institut für Klinisch Onkologische ForschungRecruiting
- Medizinische Hochschule HannoverRecruiting
- Medizinische Hochschule HannoverRecruiting
- Universitätsklinikum LeipzigRecruiting
- Radiologie BerlinRecruiting
- Onkologische Schwerpunktpraxis KurfuerstendammRecruiting
- Waage ApothekeRecruiting
- HELIOS Klinikum Berlin Buch GmbHRecruiting
- Helios Klinikum Berlin-BuchRecruiting
- Technische Universität Dresden, Medizinische Fakultät Carl Gustav CarusRecruiting
- Universitätsklinikum Carl Gustav Carus DresdenRecruiting
- Facharztzentrum EppendorfRecruiting
- ZytoService Deutschland GmbH, Standort-Hamburg-JenfeldRecruiting
- Radiologie im Israelitischen KrankenhausRecruiting
- Klinikum Oldenburg AöRRecruiting
- Klinikum Oldenburg AöRRecruiting
- Rajiv Gandhi Cancer Institute And Research CentreRecruiting
- Rajiv Gandhi Cancer Institute And Research CentreRecruiting
- Tata Memorial HospitalRecruiting
- Deenanath Mangeshkar Hospital & Research CentreRecruiting
- Sahyadri Speciality HospitalRecruiting
- Bhakti Vedanta Hospital and Research InstituteRecruiting
- R K Birla Cancer Center, SMS HospitalRecruiting
- Sawai Man Singh Medical College Hospital (SMS Hospital)Recruiting
- Azienda Ospedaliera Universitaria di Cagliari - Presidio Policlinico Universitario "D.Casula"Recruiting
- IRCCS Casa Sollievo della SofferenzaRecruiting
- ASST Grande Ospedale Metropolitano NiguardaRecruiting
- Fondazione del Piemonte per l'Oncologia - Istituto di Candiolo IRCCSRecruiting
- Azienda Ospedaliero Universitaria San Luigi GonzagaRecruiting
- Fondazione Poliambulanza Istituto OspedalieroRecruiting
- Istituto Europeo di Oncologia IRCCSRecruiting
- Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli" di NapoliRecruiting
- IRCCS Istituto Oncologico Veneto (IOV)Recruiting
- Azienda USL - IRCCS di Reggio Emilia - Arcispedale Santa Maria NuovaRecruiting
- Chiba cancer centerRecruiting
- National Cancer Center Hospital EastRecruiting
- National Hospital Organization Shikoku Cancer CenterRecruiting
- Hokkaido University HospitalRecruiting
- Kanazawa University HospitalRecruiting
- St. Marianna University HospitalRecruiting
- Kanagawa cancer centerRecruiting
- Aichi Cancer Center HospitalRecruiting
- Osaka Prefectural Hospital Organization Osaka International Cancer InstituteRecruiting
- Kindai University HospitalRecruiting
- Osaka University HospitalRecruiting
- Osaka Medical and Pharmaceutical University HospitalRecruiting
- Saitama Medical University International Medical CenterRecruiting
- Saitama Prefectural Cancer CenterRecruiting
- Shizuoka Cancer CenterRecruiting
- National Cancer Center HospitalRecruiting
- Japanese Foundation for Cancer ResearchRecruiting
- National Hospital Organization Kyushu Cancer CenterRecruiting
- National Hospital Organization - Osaka National Hospital - Institute For Clinical ResearchRecruiting
- Keio University HospitalRecruiting
- National Cancer CenterRecruiting
- Kyungpook National University HospitalRecruiting
- Dong-A University HospitalRecruiting
- Kyungpook National University Chilgok HospitalRecruiting
- Gachon University Gil Medical CenterRecruiting
- Chonnam National University Hwasun Hospital PharmacyRecruiting
- Chonnam National University Hwasun HospitalRecruiting
- Korea University Anam HospitalRecruiting
- Seoul National University HospitalRecruiting
- Severance Hospital, Yonsei University Health SystemRecruiting
- Asan Medical CenterRecruiting
- Samsung Medical CenterRecruiting
- Accelerium, S. de R.L. de C.V.Recruiting
- Centro de Investigacion Clinica de OaxacaRecruiting
- Maastricht UMC+Recruiting
- Catharina ZiekenhuisRecruiting
- Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)Recruiting
- Haaglanden Medisch CentrumRecruiting
- Amsterdam UMC, location VUMcRecruiting
- Maastricht University Medical CenterRecruiting
- Universitair Medisch Centrum UtrechtRecruiting
- Tauranga HospitalRecruiting
- Auckland City HospitalRecruiting
- Auckland District Health Board Charitable TrustRecruiting
- Haukeland University HospitalRecruiting
- Stavanger UniversitetssykehusRecruiting
- St. Olavs hospitalRecruiting
- Sørlandet Sykehus KristiansandRecruiting
- Oslo universitetssykehus, RadiumhospitaletRecruiting
- Oslo Universitetssykehus UllevålRecruiting
- Przychodnia Lekarska KOMEDRecruiting
- Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.MarkiewiczaRecruiting
- Wojewodzki Szpital Specjalistyczny Nr 4 w Bytomiu Oddzial OnkologiiRecruiting
- COPERNICUS PL sp. z. o. o. Wojewodzkie Centrum Onkologii w Gdansku AmbulatoryjnaRecruiting
- COPERNICUS Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum OnkologiiRecruiting
- Przychodnia Lekarska KOMEDRecruiting
- Private Medical Institution "Euromedservice"
- Private Medical Institution "Euromedservice"
- GBUZ
- Kaluga Regional Clinical Oncology Center
- FSAEI HE I.M Sechenov First MSMU MoH Russia (Sechenovskiy University),
- BHI of Omsk Region "Clinical Oncology Dispensary"
- BHI of Omsk Region "Clinical Oncology Dispensary"
- LLC "EuroCityClinic"
- LLC "Medicina Severnoy Stolitsy"
- LLC "Severo-Zapadny Medical Center"
- Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of St. Petersburg
- FSBI "Russian Scientific Center For Radiology and Surgical Technologies n.a. Academician A.M. Granov
- SHI YR Regional Clinical Oncology Hospital
- SHI YR Regional Clinical Oncology Hospital
- SHI YR Regional Clinical Oncology Hospital
- Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska BystricaRecruiting
- Fakultna nemocnica s poliklinikou F. D. Roosevelta Banska BystricaRecruiting
- Onkologicky ustav sv. Alzbety s.r.o.Recruiting
- Narodny Onkologicky UstavRecruiting
- Vychodoslovensky onkologicky ustav, a.s.Recruiting
- POKO Poprad s.r.o.Recruiting
- Cancercare Rondebosch OncologyRecruiting
- Cancercare Langenhoven Drive Oncology CentreRecruiting
- Charlotte Maxeke Johannesburg Academic HospitalRecruiting
- Wits Clinical ResearchRecruiting
- Cape Town Oncology Trials
- Mary Potter Oncology CentreRecruiting
- Complejo Hospitalario Universitario Santiago de CompostelaRecruiting
- Hospital General Universitario de ElcheRecruiting
- ICO L'Hospitalet (Hospital Duran i Reynals)Recruiting
- Hospital Universitario Vall d'HebronRecruiting
- Hospital Clinic BarcelonaRecruiting
- Hospital General Universitario Gregorio MarañonRecruiting
- Hospital Universitario Ramon Y CajalRecruiting
- Hospital Universitario 12 de octubreRecruiting
- Hospital Universitario Virgen Del RocioRecruiting
- Hospital Clinico Universitario de ValenciaRecruiting
- Hospital General Universitario de ValenciaRecruiting
- Hospital Universitario Miguel ServetRecruiting
- Karolinska Universitetssjukhuset SolnaRecruiting
- Akademiska sjukhusetRecruiting
- Norrlands universitetssjukhusRecruiting
- Sahlgrenska UniversitetssjukhusetRecruiting
- Kaohsiung Medical University Chung-Ho Memorial HospitalRecruiting
- China Medical University HospitalRecruiting
- China Medical University HospitalRecruiting
- National Cheng-Kung University HospitalRecruiting
- Chi Mei Hospital, LiouyingRecruiting
- National Taiwan University HospitalRecruiting
- National Taiwan University HospitalRecruiting
- Taipei Medical University HospitalRecruiting
- Taipei Veterans General HospitalRecruiting
- Taipei Veterans General HospitalRecruiting
- Chang Gung Medical Foundation-Linkou BranchRecruiting
- Medical and diagnostic center of MediX-Ray International Group LLC Israeli Oncology Hospital "LISOD"
- Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council
- PRECARPATHIAN NUCLEAR MEDICINE CENTER, Limited Liability Company
- Ivano-Frankivsk National Medical University
- MNPE "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Regional Council"
- Municipal non-profit enterprise "City clinical hospital #2 named after O.O.Shalimov"
- Communal Non-Profit Enterprise "Regional Center of Oncology"
- Communal enterprise "Kryvyi Rih Oncology Dispensary" of Dnipropetrovsk Regional Council
- SI "Insitute of Neurosurgery n.a.acad. A.P.
- SI "Insitute of Neurosurgery n.a.acad. A.P.
- Municipal non-profit enterprise of Kyiv regional council "Kyiv regional clinical hospital"
- Municipal non-profit enterprise "Zaporizhzhia Regional Antitumor Center" Zaporizhzhia RegionalRecruiting
- Freeman HospitalRecruiting
- Royal Marsden NHS Foundation TrustRecruiting
- Heartlands HospitalRecruiting
- Royal Marsden NHS Foundation TrustRecruiting
- Hammersmith Hospital, Imperial College Healthcare NHS TrustRecruiting
- Charing Cross Hospital, Imperial College Healthcare NHS TrustRecruiting
- Churchill Hospital - OncologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Experimental
Experimental
Experimental
Experimental
Active Comparator
Experimental
Active Comparator
Safety Lead-in Cohort 1
Safety Lead-in Cohort 2
Phase 3 Arm A
Phase 3 Arm B
Phase 3 Arm C
Cohort 3 Arm D
Cohort 3 Arm E
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
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
Encorafenib 300 mg orally once daily Cetuximab 500 mg/m2 (120-minute IV infusion) every two weeks
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
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)
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
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)