Study of Encorafenib + Cetuximab Plus or Minus Binimetinib vs. Irinotecan/Cetuximab or Infusional 5-Fluorouracil (5-FU)/Folinic Acid (FA)/Irinotecan (FOLFIRI)/Cetuximab With a Safety Lead-in of Encorafenib + Binimetinib + Cetuximab in Patients With BRAF V600E-mutant Metastatic Colorectal Cancer
NCT ID: NCT02928224
Last Updated: 2023-12-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE3
702 participants
INTERVENTIONAL
2016-10-13
2022-11-10
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Safety Lead-in, Triplet Arm
Encorafenib + binimetinib + cetuximab.
Encorafenib
Orally, once daily.
Binimetinib
Orally, twice daily.
Cetuximab
Standard of care.
Doublet Arm
Encorafenib + cetuximab.
Encorafenib
Orally, once daily.
Cetuximab
Standard of care.
Control Arm
Investigator's choice of either irinotecan/cetuximab or FOLFIRI/cetuximab.
Cetuximab
Standard of care.
Irinotecan
Standard of care.
Folinic Acid
Standard of care.
5-Fluorouracil
Standard of care.
Interventions
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Encorafenib
Orally, once daily.
Binimetinib
Orally, twice daily.
Cetuximab
Standard of care.
Irinotecan
Standard of care.
Folinic Acid
Standard of care.
5-Fluorouracil
Standard of care.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Histologically- or cytologically-confirmed CRC that is metastatic
* Presence of BRAFV600E in tumor tissue as previously determined by a local assay at any time prior to Screening or by the central laboratory
* Progression of disease after 1 or 2 prior regimens in the metastatic setting
* Evidence of measurable or evaluable non-measurable disease per RECIST, v1.1
* Adequate bone marrow, cardiac, kidney and liver function
* Able to take oral medications
* Female patients are either postmenopausal for at least 1 year, are surgically sterile for at least 6 weeks, or must agree to take appropriate precautions to avoid pregnancy from screening through follow-up if of childbearing potential
* Males must agree to take appropriate precautions to avoid fathering a child from screening through follow-up
Exclusion Criteria
* Prior irinotecan hypersensitivity or toxicity that would suggest an inability to tolerate irinotecan 180 mg/m2 every 2 weeks
* Symptomatic brain metastasis or leptomeningeal disease
* History or current evidence of retinal vein occlusion or current risk factors for retinal vein occlusion (e.g., uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes)
* Known history of acute or chronic pancreatitis
* History of chronic inflammatory bowel disease or Crohn's disease requiring medical intervention (immunomodulatory or immunosuppressive medications or surgery) ≤12 months prior to randomization
* Uncontrolled blood pressure despite medical treatment
* Impaired GI function or disease that may significantly alter the absorption of encorafenib or binimetinib (e.g., ulcerative diseases, uncontrolled vomiting, malabsorption syndrome, small bowel resection with decreased intestinal absorption)
* Concurrent or previous other malignancy within 5 years of study entry, except cured basal or squamous cell skin cancer, superficial bladder cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, or other noninvasive or indolent malignancy
* History of thromboembolic or cerebrovascular events ≤ 6 months prior to starting study treatment, including transient ischemic attacks, cerebrovascular accidents, deep vein thrombosis or pulmonary emboli
* Concurrent neuromuscular disorder that is associated with the potential of elevated creatine (phosphor)kinase (CK) (e.g., inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy)
* Residual common terminology criteria for adverse events (CTCAE) ≥ Grade 2 toxicity from any prior anticancer therapy, with the exception of Grade 2 alopecia or Grade 2 neuropathy
* Known history of HIV infection
* Active hepatitis B or hepatitis C infection
* Known history of Gilbert's syndrome
* Known contraindication to receive cetuximab or irinotecan at the planned doses
18 Years
ALL
No
Sponsors
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Merck KGaA, Darmstadt, Germany
INDUSTRY
Pierre Fabre Medicament
INDUSTRY
Ono Pharmaceutical Co. Ltd
INDUSTRY
Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Mayo Clinic Hospital
Phoenix, Arizona, United States
Mayo Clinic
Phoenix, Arizona, United States
Mayo Clinic
Scottsdale, Arizona, United States
City of Hope (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States
Compassionate Care Research Group, Inc. at Compassionate Cancer Care Medical Group, Inc.
Fountain Valley, California, United States
Keck Hospital of USC - Norris Healthcare Center (HC3)
Los Angeles, California, United States
Keck Hospital of USC
Los Angeles, California, United States
LAC+USC Medical Center
Los Angeles, California, United States
Norris Healthcare Center 3 (HC3)
Los Angeles, California, United States
USC Eye Institute
Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Hoag Memorial Hospital Presbyterian
Newport Beach, California, United States
Harvard Eye Associates
Orange, California, United States
Rocky Mountain Lions Eye Institute
Aurora, Colorado, United States
University of Colorado Cancer Center - Anschutz Cancer Pavilion
Aurora, Colorado, United States
University of Colorado Denver CTO (CTRC)
Aurora, Colorado, United States
University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
Aurora, Colorado, United States
University of Colorado Hospital Inpatient Pavillion'
Aurora, Colorado, United States
Smilow Cancer Hospital at Yale - New Haven
New Haven, Connecticut, United States
Temple Medical Center
New Haven, Connecticut, United States
Yale University, Yale Cancer Center
New Haven, Connecticut, United States
Smilow Cancer Hospital Care Center at North Haven
North Haven, Connecticut, United States
The Lennar Foundation Medical Center
Coral Gables, Florida, United States
Broward Health Medical Center
Fort Lauderdale, Florida, United States
Dr. Clayton Berger (opthalmology)
Fort Lauderdale, Florida, United States
Mehmet F. Hepgur, MD - Broward Health Medical Center
Fort Lauderdale, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
Sylvester Comprehensive Cancer Center/UMHC
Miami, Florida, United States
Sylvester at Kendall
Miami, Florida, United States
Illinois CancerCare- Bloomington
Bloomington, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Illinois CancerCare- Galesburg
Galesburg, Illinois, United States
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox, Illinois, United States
The University of Chicago Medicine Center for Advanced Care Orland Park
Orland Park, Illinois, United States
Illinois CancerCare- Ottawa
Ottawa, Illinois, United States
Illinois Cancer Care, PC
Peoria, Illinois, United States
Illinois Eye Center
Peoria, Illinois, United States
Carle Cancer Center
Urbana, Illinois, United States
Indiana University Health Hospital
Indianapolis, Indiana, United States
Indiana University Health Melvin and Bren Simon Cancer Center
Indianapolis, Indiana, United States
Investigational Drug Services IUHSCC
Indianapolis, Indiana, United States
Sidney &Lois Eskenazi Hospital
Indianapolis, Indiana, United States
IU Health Springmill
Indianapolis, Indiana, United States
Baptist Health Floyd Cancer Center
New Albany, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
The University of Kansas Clinical Research Center
Fairway, Kansas, United States
The University of Kansas Hospital
Kansas City, Kansas, United States
KU Eye
Prairie Village, Kansas, United States
The University of Kansas Cancer Center and Medical Pavilion
Westwood, Kansas, United States
The University of Kansas Cancer Center, Investigational Drug Services
Westwood, Kansas, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
The Investigational Drug Pharmacy (IDS) in the Sidney Kimmel Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
The Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Ophthalmic Consultants of Boston Inc
Boston, Massachusetts, United States
Brigham & Women's Hospital
Boston, Massachusetts, United States
Dana-Farber Cancer Institute (DFCI)
Boston, Massachusetts, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, United States
Mayo Clinic
Rochester, Minnesota, United States
Siteman Cancer Center - St Peters
City of Saint Peters, Missouri, United States
Siteman Cancer Center - West County
Creve Coeur, Missouri, United States
SSM Health Saint Louis University Hospital
St Louis, Missouri, United States
Barnes Jewish Hospital
St Louis, Missouri, United States
Saint Louis University
St Louis, Missouri, United States
SSM Health Saint Louis University Hospital
St Louis, Missouri, United States
Washington University Infusion Center Pharmacy
St Louis, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Siteman Cancer Center - South County
St Louis, Missouri, United States
Memorial Sloan Kettering: Basking Ridge
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering: Commack
Commack, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Memorial Sloan Kettering: Rockefeller Outpatient Pavilion
New York, New York, United States
Gabrail Cancer Center Research
Canton, Ohio, United States
Cleveland Clinic Taussig Cancer Institute
Cleveland, Ohio, United States
Casey Eye Institute-South Waterfront
Portland, Oregon, United States
OHSU Center for Health and Healing
Portland, Oregon, United States
OHSU Research Pharmacy Services
Portland, Oregon, United States
Oregon Health and Science University
Portland, Oregon, United States
Henry-Joyce Cancer Clinic
Nashville, Tennessee, United States
Vanderbilt Eye Institute
Nashville, Tennessee, United States
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Scott & White Clinic - Temple Pavilion
Temple, Texas, United States
Scott & White Medical Center - Temple
Temple, Texas, United States
Spokane Eye Clinic
Spokane, Washington, United States
Inland Imaging, LLC Holy Family Hospital
Spokane, Washington, United States
Medical Oncology Associates, PS DBA Summit Cancer Centers
Spokane, Washington, United States
Providence Holy Family Nuclear Medicine
Spokane, Washington, United States
Medical Oncology Associates, PS DBA Summit Cancer Centers
Spokane Valley, Washington, United States
University of Wisconsin Clinical Science Center
Madison, Wisconsin, United States
CLINICA PERGAMINO S.A. (Centro de Investigacion Pergamino S.A.)
Pergamino, Buenos Aires, Argentina
Centro Medico INFINITO
Santa Rosa, La Pampa Province, Argentina
Centro Medico CAIPO (Centro para la Atención del paciente Oncológico)
San Miguel de Tucumán, Tucumán Province, Argentina
Clinica Universitaria Reina Fabiola
Córdoba, , Argentina
Centro Oncologico Riojano Integral - CORI
La Rioja, , Argentina
St Vincent's Clinic
Darlinghurst, NEW South Wales (nsw), Australia
St Vincent's Hospital Sydney
Darlinghurst, NEW South Wales (nsw), Australia
Marsden Eye Specialists
Parramatta, NEW South Wales (nsw), Australia
Newcastle Eye Centre
Sydney, NEW South Wales (nsw), Australia
Mater Misericordiae Limited
South Brisbane, Queensland, Australia
Central Adelaide Local Health Network Inc. operating as Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Central Adelaide Local Health Network Inc. operating as The Queen Elizabeth Hospital
Woodville South, South Australia, Australia
Monash Health Translation Precinct - Monash Health
Clayton, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Klinikum Wels - Grieskirchen GmbH, Abteilung fuer Innere Medizin IV
Wels, Upper Austria, Austria
Klinikum Wels-Grieskirchen GmbH, Abteilung fuer Augenheilkunde und Optometrie
Wels, Upper Austria, Austria
Klinikum Wels-Grieskirchen GmbH, Abteilung fuer Innere Medizin II
Wels, Upper Austria, Austria
Klinikum Wels-Grieskirchen GmbH, Institut fuer Nuklearmedizin
Wels, Upper Austria, Austria
Klinikum Wels-Grieskirchen GmbH, Institut fuer Radiologie I
Wels, Upper Austria, Austria
DZU, Diagnose Zentrum Urania GmbH
Vienna, , Austria
AKH Wien
Vienna, , Austria
Medizinische Universitaet Wien/AKH Wien
Vienna, , Austria
Medizinische Universität Wien/AKH Wien
Vienna, , Austria
Centre Hospitalier de l'Ardenne - Site de Libramont
Libramont-Chevigny, Luxembourg, Belgium
AZ Sint-Jan Brugge - Oostende AV - Campus Sint-Jan - Oncology
Bruges, WEST Vlaanderen, Belgium
Imelda Ziekenhuis
Bonheiden, , Belgium
Grand Hopital de Charleroi (GHdC)
Charleroi, , Belgium
UZ Antwerpen
Edegem, , Belgium
AZ Maria Middelares
Ghent, , Belgium
University Hospital Gasthuisberg (UZ Leuven)
Leuven, , Belgium
Centre Hospitalier Universitaire (CHU) de Liege
Liège, , Belgium
CHC Saint Joseph
Liège, , Belgium
AZ Delta Roeselaere-Menen
Roeselaere, , Belgium
Centre Hospitalier Regional (CHR) - Verviers
Verviers, , Belgium
CEMES Centro Medico Especializado em Oftalmologia
Cachoeiro de Itapemirim, Espírito Santo, Brazil
Centro de Pesquisas Clínicas em Oncologia
Cachoeiro de Itapemirim, Espírito Santo, Brazil
Hospital Evangelico de Cachoeiro de Itapemirim
Cachoeiro de Itapemirim, Espírito Santo, Brazil
Hospital do Olho
Salvador, Estado de Bahia, Brazil
CENOB - Centro de Oncologia da Bahia SS Ltda / Oncovida
Salvador, Estado de Bahia, Brazil
Instituto Vizibelli
Belo Horizonte, Minas Gerais, Brazil
CENANTRON - Centro Avancado de Tratamento Oncologic
Belo Horizonte, Minas Gerais, Brazil
Fundação Universidade de Caxias do Sul
Caxias do Sul, Rio Grande do Sul, Brazil
Daniel Lubisco Pandolfi
Lajeado, Rio Grande do Sul, Brazil
Sociedade Beneficencia e Cardade de Lajeado/Hospital Bruno Born
Lajeado, Rio Grande do Sul, Brazil
Sociedade Beneficencia e Cardade de Lajeado/Hospital Bruno Born
Lajeado, Rio Grande do Sul, Brazil
Associacao Hospitalar Beneficente Sao Vicente de Paulo / Hospital Sao Vicente de Paulo
Passo Fundo, Rio Grande do Sul, Brazil
Consultorio Medico de Oftalmologia - Dr. Ricardo Tres
Passo Fundo, Rio Grande do Sul, Brazil
Hospital Sao Vicente de Paulo
Passo Fundo, Rio Grande do Sul, Brazil
Thiago Vernetti Ferreira
Pelotas, Rio Grande do Sul, Brazil
Leandro Becker
Pelotas, Rio Grande do Sul, Brazil
Fernanda Mendes
Pelotas, Rio Grande do Sul, Brazil
UPCO - Unidade de Pesquisas Clinicas em Oncologia
Pelotas, Rio Grande do Sul, Brazil
Fernanda Lauermann
Pelotas, Rio Grande do Sul, Brazil
Diogo Duarte Torre
Porto Alegre, Rio Grande do Sul, Brazil
Farmacia Central da Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Irmandade da Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Nucleo de Novos Tratamentos em Cancer
Porto Alegre, Rio Grande do Sul, Brazil
Centro de Pesquisa Clínica de Oncologia e Hematologia - Hospital Mãe de Deus/AESC
Porto Alegre, Rio Grande do Sul, Brazil
Clinica de Oftalmologia Lavinsky
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Mãe de Deus
Porto Alegre, Rio Grande do Sul, Brazil
Giuliano Santos Borges - ME / Clinica de Neoplasias Litoral - Centro de Novos Tratamentos Itajai
Itajaí, Santa Catarina, Brazil
Clinica Toller
Barretos, São Paulo, Brazil
Olhos Centro Diagnostico e Laser LTDA
Barretos, São Paulo, Brazil
Fundacao Pio XII
Barretos, São Paulo, Brazil
FUNDAÇÃO DO ABC - Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil
FUNDAÇÃO DO ABC - Faculdade de Medicina do ABC
Santo André, São Paulo, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose do Rio Preto
São José do Rio Preto, São Paulo, Brazil
CEPOS - Centro de Estudos e Pesquisas Oncologicas de Sorocaba
Sorocaba, São Paulo, Brazil
Instituto de Oncologia de Sorocaba "Dr. Gilson Delgado"
Sorocaba, São Paulo, Brazil
Karen Miyuki Kubokawa Shorer
Sorocaba, São Paulo, Brazil
Oftalmologia Diagnostica de Sorocaba (ODS)
Sorocaba, São Paulo, Brazil
Instituto de Ensino e Pesquisa São Lucas
São Paulo, , Brazil
Instituto de Ensino e Pesquisa São Lucas - Pharmacy
São Paulo, , Brazil
Hospital Leforte
São Paulo, , Brazil
IPEPO - Instituto da Visao
São Paulo, , Brazil
Eye Care Centre, Vancouver General Hospital
Vancouver, British Columbia, Canada
BC Cancer, Vancouver Center
Vancouver, British Columbia, Canada
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, Canada
Sunnybrook Research Institute
Toronto, Ontario, Canada
Mount Sinai Hospital
Toronto, Ontario, Canada
Centre integre universitaire de sante et de services sociaux de l'Ouest-de-l'Ile-de-Montreal
Montreal, Quebec, Canada
Instituto Clinico Oncologico del Sur (ICOS)
Temuco, Región de la Araucanía, Chile
Hospital Clinico Vina Del Mar
Viña del Mar, V Region Valparaiso, Chile
Ocni ordinace Oftalpro s.r.o.
Brno, , Czechia
Masarykuv onkologicky ustav
Brno, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Fingerlanduv ustav patologie
Hradec Králové, , Czechia
I. interni kardioangiologicka klinika
Hradec Králové, , Czechia
Klinika nemoci koznich a pohlavnich
Hradec Králové, , Czechia
Nemocnicni lekarna - Usek klinickych studii
Hradec Králové, , Czechia
Ocni klinika
Hradec Králové, , Czechia
Radiologicka klinika
Hradec Králové, , Czechia
Fakultni nemocnice Olomouc, I. interni klinika - kardiologicka
Olomouc, , Czechia
Fakultni nemocnice Olomouc, Lekarna
Olomouc, , Czechia
Fakultni nemocnice Olomouc
Olomouc, , Czechia
Odense University Hospital (OUH)
Odense C, , Denmark
Hopital Jean Minjoz
Besançon, , France
CHU Morvan
Brest, , France
Centre Ophtalmologique - Pole Vision - Clinique Val d'Ouest
Écully, , France
Centre Leon Berard
Lyon, , France
ICM Val d'Aurelle
Montpellier, , France
CHU HOTEL-Dieu
Nantes, , France
Hopital Georges Pompidou
Paris, , France
Centre hospitalier national d'ophtalmologie des Quinze-Vingts
Paris, , France
Centre Hospitalier National d'Opthalmologie des Quinze-Vingts (CHNO des XV-XX)
Paris, , France
CHU Robert Debre
Reims, , France
SCM Centre d'ophtalmologie
Saint Jeand de Vedas, , France
CHU Toulouse - Purpan, hopital Pierre-Paul Riquet
Toulouse, , France
CHU Toulouse-Institut Inuversitaire du Cancer Toulouse
Toulouse, , France
CHU Toulouse-Rangueil
Toulouse, , France
Gustave Roussy
Villejuif, , France
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Augenklinik der Universitaet Muenchen
Munich, Bavaria, Germany
LMU Klinikum der Universitaet Muenchen, Campus Grosshadern
Munich, Bavaria, Germany
Augenarzt-Gemeinschaftspraxis Dr.med.Andreas Kind & Dr.med. Ute Kariger-Schweigert
Falkensee, Brandenburg, Germany
Medizinische Hochschule Hannover (MHH)
Hanover, Lower Saxony, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Institut f. Pathologie - Ruhr-Universitaet Bochum, Prof. Dr. med. Andrea Tannapfel
Bochum, North Rhine Westfalia, Germany
Kliniken Essen Mitte / Knappschaftskrankenhaus
Essen, North Rhine-Westphalia, Germany
Praxis fuer Augenheilkunde Dr. Edmund Meyer-Schwickerath
Essen, North Rhine-Westphalia, Germany
Kliniken Essen-Mitte
Essen, North Rhine-Westphalia, Germany
Universitaetsklinikum Essen (AoeR), Innere Klinik (Tumorforschung), Westdeutsches Tumorzentrum
Essen, North Rhine-Westphalia, Germany
Universitaetsklinikum Essen; Diagnostischeu. Interventionelle Radiologie u. Neuroradiologie
Essen, North Rhine-Westphalia, Germany
Universitaetsklinikum Essen; Nuklearmedizin
Essen, North Rhine-Westphalia, Germany
Universitaetsklinikum Essen; Zentralapotheke
Essen, North Rhine-Westphalia, Germany
Evang. Krankenhaus Essen - Werden; Klinik fuer Augenheilkunde
Essen, North Rhine-Westphalia, Germany
Kliniken Essen Mitte / Knappschaftskrankenhaus
Essen, North Rhine-Westphalia, Germany
Augentagesklinik Maria-Hilf Krankenhaus
Mönchengladbach, North Rhine-Westphalia, Germany
Kliniken Maria Hilf GmbH - Franziskuskrankenhaus
Mönchengladbach, North Rhine-Westphalia, Germany
Kliniken Maria Hilf GmbH; Klinik fuer Radiologie
Mönchengladbach, North Rhine-Westphalia, Germany
Lukaskrankenhaus Neuss; Zentrale Apotheke
Neuss, North Rhine-Westphalia, Germany
Augenarzt Praxis Dr. med. Petra Huelsmann
Worms, Rhineland-Palatinate, Germany
Gemeinschaftspraxis fuer Radiologie und Nuklearmedizin, Standort Worms
Worms, Rhineland-Palatinate, Germany
Martin Apotheke
Worms, Rhineland-Palatinate, Germany
Onkologische Schwerpunktpraxis Worms
Worms, Rhineland-Palatinate, Germany
Praxisgemeinschaft Kruse + Hofstaetter
Worms, Rhineland-Palatinate, Germany
Evangelisches Waldkrankenhaus Spandau
Berlin, , Germany
Universitaetsklinikum Carl Gustav Carus der Technischen Universitaet Dresden
Dresden, , Germany
Universitaetsklinikum Hamburg Eppendorf, Klinik fuer Augenheilkunde
Hamburg, , Germany
Facharztzentrum Eppendorf
Hamburg, , Germany
Universitaetsklinikum Hamburg Eppendorf, Zentrum fuer Radiologie und Endoskopie
Hamburg, , Germany
ZytoService Deutschland GmbH, Standort-Hamburg-Jenfeld
Hamburg, , Germany
HKS Kardiologische Praxis am Israelitischen Krankenhaus
Hamburg, , Germany
Radiologie im Israelitischen Krankenhaus
Hamburg, , Germany
Zala Megyei Szent Rafael Korhaz - Onkologiai Osztaly
Zalaegerszeg, Zala County, Hungary
Szent Margit Kórház
Budapest, , Hungary
Eszak-Pesti Centrumkorhaz-Honvedkorhaz
Budapest, , Hungary
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, , Hungary
Egyesitett Szent Istvan es Szent Laszlo Korhaz-Rendelointezet
Budapest, , Hungary
Uzsoki Utcai Korhaz
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, , Hungary
Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar
Pécs, , Hungary
Pecsi Tudomanyegyetem Klinikai Kozpont
Pécs, , Hungary
Tel Aviv Sourasky Medical Center - Oncology
Tel Aviv, NAP, Israel
The Barzilai Medical Center - Oncology Institute
Ashkelon, , Israel
Soroka University Medical Center
Beersheba, , Israel
MOR Institute
Bnei Brak, , Israel
Ein-Karem Department of Medical Imaging of Hadassah Medical Organization, Hadassah Medical Center,
Jerusalem, , Israel
Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem
Jerusalem, , Israel
Pharmacy of Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem
Jerusalem, , Israel
Mt. Scopus Department of Medical Imaging of Hadassah Medical Organization,
Jerusalem, , Israel
Imaging Department of Meir Medical Center
Kfar Saba, , Israel
Meir Medical Center
Kfar Saba, , Israel
Pharmacy of Rabin Medical Center, Beilinson Hospital
Petah Tikva, , Israel
Rabin Medical Center, Beilinson Hospital
Petah Tikva, , Israel
The Chaim Sheba Medical Center
Tel Litwinsky, , Israel
Ospedali Riuniti Umberto I
Torrette Di Ancona, Ancona, Italy
ASST Bergamo Ovest, Ospedale Treviglio Caravaggio di Trevigl
Treviglio, Bergamo, Italy
Oculistica, ASST Papa Giovanni XXIII
Bergamo, BG, Italy
Oncologia, ASST Papa Giovanni XXIII
Bergamo, BG, Italy
Clinica di Oncologia Medica AOU di Cagliari Presidio Duilio Casula Monserrato
Monserrato, Cagliari, Italy
Farmacia AOU di Cagliari Presidio Duilio Casula Monserrato
Monserrato, Cagliari, Italy
Radiologia AOU di Cagliari Presidio Duilio Casula Monserrato
Monserrato, Cagliari, Italy
Oculistica - ASST Cremona, Ospedale di Cremona
Cremona, CR, Italy
SC Farmacia Aziendale - ASST Cremona, Ospedale di Cremona
Cremona, CR, Italy
SC Oncologia - ASST Cremona, Ospedale di Cremona
Cremona, CR, Italy
U.O. Oculistica, Istituto Clinico HUMANITAS
Rozzano, Milano, Italy
U.O. di Oncologia ed Ematologia, Istituto Clinico HUMANITAS
Rozzano (MI), Milan, Italy
IRCCS Ospedale San Raffaele - U.O. di Medicina Oncologica
Milan, MI, Italy
Servizio di Farmacia - IRCCS Ospedale San Raffaele
Milan, MI, Italy
S.C. Radiologia diagnostica e interventistica - Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, MI, Italy
SC Oncologia Medica 1, SS Oncologia Medica Gastroenterologica
Milan, MI, Italy
Cardiologia per i pazienti oncologici - Istituto Oncologico Veneto I.R.C.C.S
Padua, PD, Italy
Clinica Oculistica - Azienda Ospedaliera di Padova
Padua, PD, Italy
U.O. Oncologia Medica 1 - Istituto Oncologico Veneto I.R.C.C.S
Padua, PD, Italy
Policlinico S.Orsola Malpighi, AOU di Bologna - Oncologia Medica
Bologna, , Italy
Divisione Anatomia Patologica Presidio San Giovanni di Dio
Cagliari, , Italy
Oculistica AOU di Cagliari Presidio San Giovanni di Dio
Cagliari, , Italy
Dipartimento Neuromuscoloscheletrico e Organi di Senso, "Oncologia Oculare Unit"
Florence, , Italy
SC oncologia Medica I - Azienda Ospedaliero Universitaria Careggi
Florence, , Italy
Radiologia
Milan, , Italy
Unita di Oncologia Medica Gastrointestinale e Tumori Neuroendocrini
Milan, , Italy
Grande Ospedale Metropolitano Niguarda
Milan, , Italy
Dipartimento Interaziendale Farmaceutico - AOU Policlinico di Modena
Modena, , Italy
SC di Oftalmologia - AOU Policlinico di Modena
Modena, , Italy
SC di Radiologia, Dipartimento Interaziendale integrato Diagnostica per Immagini
Modena, , Italy
SSD Day Hospital Oncologico - Dipartimento ad attivita integrata di Oncologia, Ematologia
Modena, , Italy
AOU Universita degli Studi della Campania L. Vanvitelli - DAI di Medicina Interna e Specialistica
Napoli, , Italy
AOU Universita degli Studi della Campania L. Vanvitelli - U. Ma.Ca.
Napoli, , Italy
AOU Universita degli Studi della Campania L. Vanvitelli
Napoli, , Italy
AOU Universita degli Studi della Campania L. Vanvitelli
Napoli, , Italy
UO Oculistica - AOU Pisana, Stabilimento Ospedaliero di Cisanello
Pisa, , Italy
SOD Radiodiagnostica 3 - AOU Pisana, Stabilimento Ospedaliero di Santa Chiara
Pisa, , Italy
UO Farmaceutica, Gestione del Farmaco - AOU Pisana, Stabilimento Ospedaliero di Santa Chiara
Pisa, , Italy
UO Oncologia Medica 2 - AOU Pisana, Stabilimento Ospedaliero di Santa Chiara
Pisa, , Italy
U.O.S.D. Oncologia Medica, Dipartimento di Medicina - Fondazione PTV Policlinico Tor Vergata
Roma, , Italy
U.O.S.D. Patologie Retiniche - Fondazione PTV Policlinico Tor Vergata
Roma, , Italy
Chayagasaka Eye Clinic
Nagoya, Aichi-ken, Japan
Aichi Cancer Center Hospital
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital East
Kashiwa-shi, Chiba, Japan
Hokkaido University Hospital
Sapporo, Hokkaido, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, Japan
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagawa, Japan
Tsukahara Eye Clinic
Yokohama, Kanagawa, Japan
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan
Osaka University Hospital Laboratory for Clinical Investigation
Suita, Osaka, Japan
National Cancer Center Hospital
Chuo-ku, Tokyo, Japan
National Hospital Organization Kyushu Cancer Center
Fukuoka, , Japan
Kyushu Central Hospital of the Mutual Aid Association of Public School Teachers
Fukuoka, , Japan
National Hospital Organization Osaka National Hospital
Osaka, , Japan
Consultorio dentro de la Torre Medica Dalinde (Oncologia Medica)
Mexico City, Cuauhtemoc, Mexico
Superare Centro de Infusion S.A. de C.V.
Delegacion Cuauhtemoc, Mexico City, Mexico
Rijnstate Hospital Arnhem
Arnhem, Gelderland, Netherlands
Rijnstate Hospital Velp
Velp, Gelderland, Netherlands
Maastricht University Medical Center (MUMC)
Maastricht, Limburg, Netherlands
The Netherlands Cancer Institute
Amsterdam, North Holland, Netherlands
Onze Lieve Vrouwen Gasthuis
Amsterdam, North Holland, Netherlands
Haga Ziekenhuis
The Hague, South Holland, Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Universitair Medisch Centrum Utrecht
Utrecht, , Netherlands
Colosseum Øyelegesenter C/O LB Holdings AS
Lommedalen, , Norway
Colosseum Øyelegesenter C/O LB Holdings AS
Oslo, , Norway
Oslo universitetssykehus, Radiumhospitalet
Oslo, , Norway
Sykehusapoteket Oslo, Radiumhospitalet
Oslo, , Norway
Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Brzozów, , Poland
Wojewodzki Szpital Zespolony, Oddzial Onkologiczny
Elblag, , Poland
Szpital Specjalistyczny im. L. Rydygiera w Krakowie Sp.z.o.o.
Krakow, , Poland
Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina
Otwock, , Poland
NZOZ Centrum Medyczne HCP
Poznan, , Poland
NZOZ Przychodnia Specjalistyczna GUTMED
Poznan, , Poland
MAGODENT Sp. z o.o. Szpital Elblaska
Warsaw, , Poland
Regional Budgetary Healthcare Institution Kursk Regional Clinical
Kursk, Kursk Oblast, Russia
Evimed Llc
Chelyabinsk, , Russia
Federal State Budget Institution "N.N. Blokhin Russian Cancer Research Center" of the
Moscow, , Russia
Federal State Budget Institution "N.N. Blokhin Russian Cancer Research Center"
Moscow, , Russia
A. Tsyb Medical Radiological Research Center - branch of the
Obninsk, , Russia
State Budgetary Educational Institution of Higher Professional Education First Saint Petersburg
Saint Petersburg, , Russia
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, South Korea
Hallym University Sacred Heart Hospital
Anyang, Gyeonggido, South Korea
Chonnam National University Hwasun Hospital
Hwasun-gun, Jeollanam-do, South Korea
Korea University Guro Hospital
Seoul, Seoul Teugbyeolsi, South Korea
Dong-A University Hospital
Busan, , South Korea
Gachon University Gil Medical Center
Incheon, , South Korea
Korea University Anam Hospital IRB
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, , South Korea
Complejo Hospitalario de Jaen
Jaén, Andalusia, Spain
Sercosa - Clinica de las Nieves
Jaén, Andalusia, Spain
Hospital Universitario Son Espases
Palma de Mallorca, Balearic Islands, Spain
Institut Catala d'Oncologia
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitari Parc Tauli
Sabadell, Barcelona, Spain
Hospital Universitario Reina Sofía
Córdoba, Cordona, Spain
Hospital Nuestra Señora del Rosario
Madrid, Madrid, Communidad Delaware, Spain
Hospital Universitari Sant Joan de Reus
Reus, Tarragona, Spain
Hospital del Mar
Barcelona, , Spain
Clinica Corachan
Barcelona, , Spain
Hospital Quiron Salud Barcelona
Barcelona, , Spain
Cetir Centre Medic S.L.
Barcelona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Universitario de Burgos
Burgos, , Spain
Consulta Dr. Juan Carlos Castillo Dominguez
Córdoba, , Spain
Gabinete Radiologico Dr. Pita
Madrid, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Universitario Ramón y Cajal
Madrid, , Spain
Hospital Clinico San Carlos
Madrid, , Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital HM Universitario Sanchinarro
Madrid, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Clinica Oftalvist
Valencia, , Spain
Fundacion Instituto Valenciano de Oncologia
Valencia, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital General Universitario de Valencia
Valencia, , Spain
Hospital Quiron Salud Zaragoza
Zaragoza, , Spain
Hospital Universitario Miguel Servet
Zaragoza, , Spain
Changhua Christian Hospital
Changhua, Changhua County, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Cheng Kung University Hospital
Tainan City, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Chang Gung Memorial Hospital, Linkou
Taoyuan, , Taiwan
Ege University Medical Faculty
Izmir, Bornova, Turkey (Türkiye)
Izmir Medical Park Hospital - Medical Oncology
Izmir, Izmir, Karsiyaka, Turkey (Türkiye)
Medeniyet University Goztepe Training and Research Hospital
Istanbul, Kadikoy, Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Uludag University Hospital
Bursa, , Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi
Edirne, , Turkey (Türkiye)
Inonu Universitesi Turgut Ozal Medical Center
Malatya, , Turkey (Türkiye)
Oftalmolohycheskyi tsentr "Vzghliad" MTs
Dnipropetrovsk, Dnipropetrovsk Oblast, Ukraine
Oftalmolohycheskyi tsentr "Vzghliad" MTs
Dnipropetrovsk, Dnipropetrovsk Oblast, Ukraine
Derzhavnyi zaklad, Dnipropetrovska medychna akademiia Ministerstva okhorony zdorovia Ukrainy
Dnipropetrovsk, Dnipropetrovsk Oblast, Ukraine
Komumalnyi zaklad, Dnipropetrovska miska bahatoprofilna klinichna likarnia Nº4
Dnipropetrovsk, Dnipropetrovsk Oblast, Ukraine
Kyivska klinichna likarnia na zaliznychnomu transporti No3 filii Tsentr okhorony zdorov'ia PAT
Kyiv, Kyivska Oblast', Ukraine
Natsionalnyi medychnyi universytet imeni O.O Bohomltsia, kafedra onkolohii
Kyiv, Kyivska Oblast', Ukraine
Natsionalnyi medychnyi universytet imeni O.O Bohomltsia, kafedra oftalmolohii
Kyiv, Kyivska Oblast, Ukraine
Oleksandrivska klinichna likarnia mista Kyieva
Kyiv, Kyivska Oblast, Ukraine
Kyivskyi miskyi klinichnyi onkotsentr
Kyiv, Kyivska Oblast, Ukraine
Vinnytskyi oblasnyi klinichnyi onkolohichnyi dyspanser, viddilennia khimioterapii
Vinnytsia, Vinnytsia Oblast, Ukraine
DVNZ "Uzhhorodskyi natsionalnyi universytet"
Uzhhorod, Zakarpattia Oblast, Ukraine
TOV "Zakarpatskyi Tsentr Mikrokhirurhii Oka"
Uzhhorod, Zakarpattia Oblast, Ukraine
Tsentralna miska klinichna likarnia, Miskyi onkolohichnyi tsentr
Uzhhorod, Zakarpattia Oblast, Ukraine
NHS Grampian - Aberdeen Royal Infirmary
Aberdeen, Aberdeenshire Scotland, United Kingdom
King Edward V11 Hospital
Windsor, Berkshire, United Kingdom
Beatson West of Scotland Cancer Centre
Glasglow, Glasglow City, Scotland, United Kingdom
University Hospitals Birmingham NHS Foundation Trust Queen Elizabeth Hospital
Birmingham, WEST Midlands, United Kingdom
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London, , United Kingdom
Imperial College Healthcare NHS Trust, Hammersmith Hospital
London, , United Kingdom
Sarah Cannon Research Institute UK
London, , United Kingdom
Imperial College Healthcare NHS Trust, Charing Cross Hospital
London, , United Kingdom
The Christie NHS Foundation Trust - Christie Hospital
Manchester, , United Kingdom
Countries
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References
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Kopetz S, Murphy DA, Pu J, Ciardiello F, Desai J, Van Cutsem E, Wasan HS, Yoshino T, Saffari H, Zhang X, Hamilton P, Xie T, Yaeger R, Tabernero J. Molecular profiling of BRAF-V600E-mutant metastatic colorectal cancer in the phase 3 BEACON CRC trial. Nat Med. 2024 Nov;30(11):3261-3271. doi: 10.1038/s41591-024-03235-9. Epub 2024 Sep 23.
Taieb J, Lonardi S, Desai J, Folprecht G, Gallois C, Marques EP, Khan S, Castagne C, Wasan H. Adverse Events Associated with Encorafenib Plus Cetuximab in Patients with BRAFV600E-mutant Metastatic Colorectal Cancer: An in-depth Analysis of the BEACON CRC Study. Clin Colorectal Cancer. 2023 Mar;22(1):59-66. doi: 10.1016/j.clcc.2022.12.003. Epub 2022 Dec 24.
Stintzing S, Seufferlein T, Rose C, Reichenbach F, Luftner D. Encorafenib in Combination With Cetuximab After Systemic Therapy in Patients With BRAFV600E Mutant Metastatic Colorectal Cancer: German Health Technology Assessment-Driven Analyses From the BEACON CRC Study. Clin Colorectal Cancer. 2022 Sep;21(3):244-251. doi: 10.1016/j.clcc.2022.04.002. Epub 2022 May 5.
Kopetz S, Grothey A, Van Cutsem E, Yaeger R, Wasan H, Yoshino T, Desai J, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Belani A, Zhang X, Tabernero J. Quality of life with encorafenib plus cetuximab with or without binimetinib treatment in patients with BRAF V600E-mutant metastatic colorectal cancer: patient-reported outcomes from BEACON CRC. ESMO Open. 2022 Jun;7(3):100477. doi: 10.1016/j.esmoop.2022.100477. Epub 2022 May 30.
Tabernero J, Grothey A, Van Cutsem E, Yaeger R, Wasan H, Yoshino T, Desai J, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Elez E, Gollerkeri A, Maharry K, Christy-Bittel J, Kopetz S. Encorafenib Plus Cetuximab as a New Standard of Care for Previously Treated BRAF V600E-Mutant Metastatic Colorectal Cancer: Updated Survival Results and Subgroup Analyses from the BEACON Study. J Clin Oncol. 2021 Feb 1;39(4):273-284. doi: 10.1200/JCO.20.02088.
Kopetz S, Grothey A, Yaeger R, Van Cutsem E, Desai J, Yoshino T, Wasan H, Ciardiello F, Loupakis F, Hong YS, Steeghs N, Guren TK, Arkenau HT, Garcia-Alfonso P, Pfeiffer P, Orlov S, Lonardi S, Elez E, Kim TW, Schellens JHM, Guo C, Krishnan A, Dekervel J, Morris V, Calvo Ferrandiz A, Tarpgaard LS, Braun M, Gollerkeri A, Keir C, Maharry K, Pickard M, Christy-Bittel J, Anderson L, Sandor V, Tabernero J. Encorafenib, Binimetinib, and Cetuximab in BRAF V600E-Mutated Colorectal Cancer. N Engl J Med. 2019 Oct 24;381(17):1632-1643. doi: 10.1056/NEJMoa1908075. Epub 2019 Sep 30.
Van Cutsem E, Huijberts S, Grothey A, Yaeger R, Cuyle PJ, Elez E, Fakih M, Montagut C, Peeters M, Yoshino T, Wasan H, Desai J, Ciardiello F, Gollerkeri A, Christy-Bittel J, Maharry K, Sandor V, Schellens JHM, Kopetz S, Tabernero J. Binimetinib, Encorafenib, and Cetuximab Triplet Therapy for Patients With BRAF V600E-Mutant Metastatic Colorectal Cancer: Safety Lead-In Results From the Phase III BEACON Colorectal Cancer Study. J Clin Oncol. 2019 Jun 10;37(17):1460-1469. doi: 10.1200/JCO.18.02459. Epub 2019 Mar 20.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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BEACON CRC
Identifier Type: OTHER
Identifier Source: secondary_id
2015-005805-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
C4221009
Identifier Type: OTHER
Identifier Source: secondary_id
ARRAY-818-302
Identifier Type: -
Identifier Source: org_study_id