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NCT04607421

Un estudio de encorafenib más cetuximab, con o sin quimioterapia, en pacientes con cáncer colorrectal metastásico no tratado previamente.

Activo, No Reclutando Fase 3

Descripción

El objetivo de este estudio es evaluar dos fármacos en investigación (encorafenib más cetuximab) administrados solos o en combinación con la quimioterapia estándar para el posible tratamiento del cáncer colorrectal que:

* se ha extendido a otras partes del cuerpo (metastásico);
* presenta un determinado tipo de gen anormal denominado "BRAF"; y
* no ha recibido tratamiento previo.

Los participantes en este estudio recibirán uno de los siguientes tratamientos en investigación:

* Encorafenib más cetuximab: Estos participantes recibirán encorafenib por vía oral en casa todos los días y cetuximab una vez cada dos semanas mediante infusión intravenosa (IV) (una inyección en la vena) en la clínica del estudio.
* Encorafenib más cetuximab con quimioterapia: Estos participantes recibirán encorafenib y cetuximab de la manera descrita en el punto anterior. Además, recibirán quimioterapia estándar mediante infusión IV y tratamiento oral en casa.
* Quimioterapia sola: Estos participantes recibirán quimioterapia, el tratamiento estándar para esta afección, mediante infusión IV en las clínicas del estudio y tratamiento oral en casa.

Actualmente, el estudio está reclutando participantes que recibirán encorafenib más cetuximab con quimioterapia o quimioterapia sola.

El equipo del estudio controlará la respuesta de cada participante al tratamiento en investigación durante un máximo de aproximadamente 3 años.

Evidencia de la diana molecular en cáncer colorrectal (BRAF)

Fármaco / régimen ORR SLP (m) Fase / n Evidencia Fuente
Encorafenib + Cetuximab + mFOLFOX6 este fármaco — 12.8 Phase 3 1 PMID 40444708 · 2026
Encorafenib + Cetuximab + mFOLFOX6 este fármaco 60.9% 12.8 Phase 3 / n=236 1 Kopetz S, et al. N Engl J Med. 2025. doi · 2025
Encorafenib + Cetuximab + Chemo este fármaco 60.9% 12.8 Phase 3 / n=95 1 BREAKWATER · 2024
Encorafenib + Binimetinib + Cetuximab este fármaco 26% 4.5 Phase 3 / n=224 1 PMID 33503393 · 2021
Encorafenib + Cetuximab este fármaco 20% 4.3 Phase 3 / n=220 1 PMID 33503393 · 2021
Encorafenib + Cetuximab (Doublet) este fármaco 19.5% 4.2 Phase 3 / n=220 1 PMID 33503393 · 2021

Criterios de Elegibilidad

Criterios de inclusión:

  • Fase de evaluación de seguridad: hombres/mujeres ≥ 18 años de edad
  • Fase 3 y Cohorte 3: hombres/mujeres ≥ 16 años de edad (cuando esté permitido a nivel local)
  • Cáncer colorrectal en estadio IV confirmado histológica o citológicamente que contenga la mutación BRAF V600E
  • Tratamiento sistémico previo en el entorno metastásico: 0-1 regímenes para la fase de evaluación de seguridad; ninguno para la fase 3 y la cohorte 3. (Nota: la terapia adyuvante o neoadyuvante previa se considera tratamiento metastásico si la recurrencia/metástasis ocurre a los < 6 meses del final del tratamiento adyuvante/neoadyuvante)
  • Enfermedad medible (fase 3 y cohorte 3) / Enfermedad medible o evaluable (fase de evaluación de seguridad)
  • ECOG PS 0-1
  • Función orgánica adecuada

Criterios de exclusión:

  • Tumores que son localmente confirmados o de MSI-H o dMMR desconocido, a menos que el participante no sea elegible para recibir inhibidores de puntos de control inmunitarios debido a una condición médica preexistente
  • Infecciones bacterianas o virales activas en las 2 semanas previas al inicio del tratamiento
  • Metástasis cerebrales sintomáticas

Información del Ensayo

NCT04607421
Activo, No Reclutando
Fase 3
841 participantes
Dic 2020
Mar 2025

Ubicaciones272

Argentina (4)
Instituto Médico Especializado Alexander Fleming
Buenos Aires
Clinica Universitaria Reina Fabiola
Córdoba
Hospital Privado Centro Médico de Córdoba
Córdoba
Centro Medico San Roque
San Miguel de Tucumán
Australia (12)
Central Adelaide Local Health Network Incorporated
Adelaide
The Queen Elizabeth Hospital
Adelaide
Chris O'Brien Lifehouse
Camperdown
Monash Health
Clayton
Austin Health
Heidelberg
Royal Brisbane and Women's Hospital
Herston
Liverpool Hospital
Liverpool
Alfred Health
Melbourne
Peter MacCallum Cancer Centre
Melbourne
GenesisCare - North Shore
St Leonards
GenesisCare North Shore
St Leonards
Princess Alexandra Hospital
Woolloongabba
Belgium (8)
ZNA Middelheim
Antwerp
Cliniques universitaires Saint-Luc
Brussels
Université Libre de Bruxelles - Hôpital Erasme
Brussels
Grand Hôpital de Charleroi
Charleroi
AZ Groeninge Campus Kennedylaan
Kortrijk
UZ Leuven
Leuven
Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
Liège
ZAS Augustinus
Wilrijk
Brazil (9)
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos
Reichow - Centro de Ensino e Pesquisa
Blumenau
Clínica de Neoplasias Litoral
Itajaí
Hospital de Clinicas de Porto Alegre
Porto Alegre
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA
Rio de Janeiro
CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC
Santo André
FUNDAÇÃO DO ABC - Faculdade de Medicina do ABC - Centro de Estudos e Pesquisas de Hematologia e Onco
Santo André
Fundação Faculdade Regional de Medicina de São José do Rio Preto
São José do Rio Preto
Bulgaria (7)
MHAT "Dr. Tota Venkova" AD
Gabrovo
MHAT Uni Hospital OOD
Panagyurishte
Complex Oncology Center - Plovdiv EOOD
Plovdiv
MHAT Central Onco Hospital OOD
Plovdiv
Acibadem City Clinic MHAT Tokuda
Sofia
Medical Center Nadezhda Clinical EOOD
Sofia
University Multiprofile Hospital for Active Treatment Sofiamed
Sofia
Canada (7)
Alberta Health Services - Cancer Care, Tom Baker Cancer Centre
Calgary
Arthur J.E. Child Comprehensive Cancer Centre
Calgary
Alberta Health Services and The Governors of The University of Alberta
Edmonton
Cross Cancer Institute
Edmonton
London Regional Cancer Program, London Health Sciences Centre
London
Jewish General Hospital
Montreal
Sunnybrook Health Sciences Centre
Toronto
China (21)
Beijing Cancer hospital
Beijing
Beijing Hospital
Beijing
Cancer Hospital Chinese Academy of Medical Science
Beijing
Peking University First Hospital
Beijing
The Second Xiangya Hospital of Central South University
Changsha
The Third Xiangya Hospital of Central South University
Changsha
Sichuan Province Cancer Hospital
Chengdu
Chongqing University Cancer Hospital
Chongqing
Fujian Medical University Union Hospital
Fuzhou
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou
The second Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou
Shandong province cancer hospital
Jinan
Yunnan Cancer Hospital(The Third Affiliated Hospital of Kunming Medical University)
Kunming
Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
Nanjing
Affiliated Tumor Hospital of Guangxi Medical University
Nanning
Fudan University Shanghai Cancer Center
Shanghai
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai
Shanghai General Hospital
Shanghai
Shengjing Hospital Of China Medical University
Shenyang
Tianjin Union Medical Center
Tianjin
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan
Czechia (5)
Fakultní nemocnice Brno Bohunice
Brno
Fakultni nemocnice Hradec Kralove
Hradec Králové
Fakultni nemocnice Olomouc
Olomouc
Fakultni nemocnice Bulovka
Prague
Fakultni Thomayerova nemocnice
Prague
Denmark (6)
Aalborg Universitetshospital, Syd
Aalborg
Rigshospitalet
Copenhagen
Herlev and Gentofte Hospital
Herlev
Odense University Hospital
Odense C
Vejle Hospital-Sygehus Lillebaelt
Vejle
Vejle Sygehus
Vejle
Finland (8)
Docrates Syöpäsairaala
Helsinki
Helsinki University Central Hospital
Helsinki
Oulu University Hospital
Oulu
Satakunnan Keskussairaala
Pori
Tampereen yliopistollinen sairaala
Tampere
Tampereen yliopistollinen sairaala
Tampere
Turku University Hospital
Turku
Turku University Hospital
Turku
Germany (12)
HELIOS Klinikum Berlin Buch GmbH
Berlin
Onkologische Schwerpunktpraxis Kurfuerstendamm
Berlin
Radiologie Berlin
Charlottenburg
Technische Universität Dresden, Medizinische Fakultät Carl Gustav Carus
Dresden
Universitätsklinikum Carl Gustav Carus Dresden
Dresden
Institut für Klinisch Onkologische Forschung
Frankfurt am Main
Facharztzentrum Eppendorf
Hamburg
Radiologie im Israelitischen Krankenhaus
Hamburg
ZytoService Deutschland GmbH, Standort-Hamburg-Jenfeld
Hamburg
Medizinische Hochschule Hannover
Hanover
Universitätsklinikum Leipzig
Leipzig
Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie
Munich
India (6)
Sawai Man Singh Medical College Hospital (SMS Hospital)
Jaipur
Tata Memorial Hospital
Mumbai
Rajiv Gandhi Cancer Institute And Research Centre
New Delhi
Deenanath Mangeshkar Hospital & Research Centre
Pune
Sahyadri Speciality Hospital
Pune
Bhakti Vedanta Hospital and Research Institute
Thane
Italy (10)
Fondazione Poliambulanza Istituto Ospedaliero
Brescia
Fondazione del Piemonte per l'Oncologia - Istituto di Candiolo IRCCS
Candiolo
ASST Grande Ospedale Metropolitano Niguarda
Milan
Istituto Europeo di Oncologia IRCCS
Milan
Azienda Ospedaliera Universitaria di Cagliari - Presidio Policlinico Universitario "D.Casula"
Monserrato (CA)
Azienda Ospedaliera Universitaria dell'Università "Luigi Vanvitelli" di Napoli
Naples
Azienda Ospedaliero Universitaria San Luigi Gonzaga
Orbassano
IRCCS Istituto Oncologico Veneto (IOV)
Padova
Azienda USL - IRCCS di Reggio Emilia - Arcispedale Santa Maria Nuova
Reggio Emilia
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo
Japan (19)
Chiba cancer center
Chiba
National Cancer Center Hospital
Chuo-ku
National Hospital Organization Kyushu Cancer Center
Fukuoka
Saitama Medical University International Medical Center
Hidaka
Saitama Prefectural Cancer Center
Ina-machi
Kanazawa University Hospital
Kanazawa
National Cancer Center Hospital East
Kashiwa
St. Marianna University Hospital
Kawasaki
The Cancer Institute Hospital of JFCR
Koto-ku
Aichi Cancer Center Hospital
Nagoya
Shizuoka Cancer Center
Nakatogari
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research
Osaka
Osaka Prefectural Hospital Organization Osaka International Cancer Institute
Osaka
Hokkaido University Hospital
Sapporo
Kindai University Hospital
Sayama
Keio university hospital
Shinjuku-ku
Osaka University Hospital
Suita
Osaka Medical and Pharmaceutical University Hospital
Takatsuki
Kanagawa cancer center
Yokohama
Mexico (2)
Accelerium, S. de R.L. de C.V.
Monterrey
Centro de Investigacion Clinica de Oaxaca
Oaxaca City
Netherlands (3)
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL)
Amsterdam
Catharina Ziekenhuis
Eindhoven
Universitair Medisch Centrum Utrecht
Utrecht
New Zealand (1)
Auckland City Hospital
Auckland
Norway (4)
Sørlandet Sykehus Kristiansand
Kristiansand
Oslo Universitetssykehus Ullevål
Oslo
Oslo universitetssykehus, Radiumhospitalet
Oslo
St. Olavs hospital
Trondheim
Poland (5)
Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza
Brzozów
Wojewodzki Szpital Specjalistyczny Nr 4 w Bytomiu Oddzial Onkologii
Bytom
COPERNICUS PL sp. z. o. o. Wojewodzkie Centrum Onkologii w Gdansku Ambulatoryjna
Gdansk
COPERNICUS Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii
Gdansk
Przychodnia Lekarska KOMED
Konin
Russia (12)
GBUZ
Chelyabinsk
Kaluga Regional Clinical Oncology Center
Kaluga
FSAEI HE I.M Sechenov First MSMU MoH Russia (Sechenovskiy University),
Moscow
BHI of Omsk Region "Clinical Oncology Dispensary"
Omsk
BHI of Omsk Region "Clinical Oncology Dispensary"
Omsk
Private Medical Institution "Euromedservice"
Pushkin
FSBI "Russian Scientific Center For Radiology and Surgical Technologies n.a. Academician A.M. Granov
Saint Petersburg
LLC "EuroCityClinic"
Saint Petersburg
LLC "Medicina Severnoy Stolitsy"
Saint Petersburg
LLC "Severo-Zapadny Medical Center"
Saint Petersburg
Private Healthcare Institution "Clinical Hospital "RZD-Medicine" of St. Petersburg
Saint Petersburg
SHI YR Regional Clinical Oncology Hospital
Yaroslavl
Slovakia (2)
Narodny Onkologicky Ustav
Bratislava
Vychodoslovensky onkologicky ustav, a.s.
Košice
South Africa (3)
Wits Health Consortium (Pty) Ltd
Johannesburg
Cancercare Langenhoven Drive Oncology Centre
Port Elizabeth
Cancercare Rondebosch Oncology
Rondebosch
South Korea (9)
Dong-A University Hospital
Busan
Kyungpook National University Chilgok Hospital
Daegu
National Cancer Center
Goyang-si
Gachon University Gil Medical Center
Incheon
Asan Medical Center
Seoul
Korea University Anam Hospital
Seoul
Samsung Medical Center
Seoul
Seoul National University Hospital
Seoul
Severance Hospital, Yonsei University Health System
Seoul
Spain (12)
Hospital Clinic Barcelona
Barcelona
Hospital Universitario Vall d'Hebron
Barcelona
Hospital General Universitario de Elche
Elche
ICO L'Hospitalet (Hospital Duran i Reynals)
L'Hospitalet de Llobregat
Hospital General Universitario Gregorio Marañon
Madrid
Hospital Universitario 12 de Octubre
Madrid
Hospital Universitario Ramon Y Cajal
Madrid
Complejo Hospitalario Universitario Santiago de Compostela
Santiago de Compostela
Hospital Universitario Virgen Del Rocio
Seville
Hospital Clinico Universitario de Valencia
Valencia
Hospital General Universitario de Valencia
Valencia
Hospital Universitario Miguel Servet
Zaragoza
Sweden (5)
Sahlgrenska Universitetssjukhuset
Gothenburg
Karolinska Universitetssjukhuset Solna
Solna
Department of Pelvic cancer, colorecta section, Karolinska University Hospital
Stockholm
Norrlands universitetssjukhus
Umeå
Akademiska sjukhuset
Uppsala
Taiwan (8)
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City
China Medical University Hospital
Taichung
Chi Mei Hospital, Liouying
Tainan
National Cheng-Kung University Hospital
Tainan
National Taiwan University Hospital
Taipei
Taipei Medical University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Chang Gung Medical Foundation-Linkou Branch
Taoyuan
Ukraine (4)
Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council
Dnipro
Ivano-Frankivsk National Medical University
Ivano-Frankivsk
MNPE "Prykarpatski Clinical Oncological Center" of Ivano-Frankivsk Regional Council"
Ivano-Frankivsk
Communal enterprise "Kryvyi Rih Oncology Dispensary" of Dnipropetrovsk Regional Council
Kryvyi Rih
United Kingdom (6)
Heartlands Hospital
Birmingham
Hammersmith Hospital
London
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London
Freeman Hospital
Newcastle upon Tyne
Churchill Hospital - Oncology
Oxford
Royal Marsden NHS Foundation Trust
Sutton
United States (62)
Mount Sinai Comprehensive Cancer Center, Aventura
Aventura
Memorial Sloan Kettering Cancer Center - Basking Ridge
Basking Ridge
Summit Medical Group
Berkeley Heights
UChicago Medicine - River East
Chicago
University of Chicago Medical Center
Chicago
Siteman Cancer Center - St Peters
City of Saint Peters
Cleveland Clinic
Cleveland
Cleveland Clinic Taussig Cancer Center Investigational Pharmacy
Cleveland
Martha Morehouse Medical Plaza
Columbus
Stefanie Spielman Comprehensive Breast Cancer
Columbus
The Ohio State University James Cancer Hospital and Solove Research Institute
Columbus
The Ohio State University Wexner Medical Center Investigational Drug Services
Columbus
Memorial Sloan Kettering Cancer Center Commack
Commack
Siteman Cancer Center - West County
Creve Coeur
Summit Medical Group
Florham Park
Siteman Cancer Center - North County
Florissant
UChicago Medicine at Ingalls - Flossmoor
Flossmoor
The West Clinic. PLLC. dba West Cancer Center
Germantown
Memorial Sloan Kettering Cancer Center - Westchester
Harrison
UChicago Medicine Ingalls Memorial
Harvey
The University of Texas MD Anderson Cancer Center
Houston
Keck Hospital of USC
Los Angeles
LAC & USC Medical Center
Los Angeles
USC / Norris Comprehensive Cancer Center
Los Angeles
USC/Norris Comprehensive Cancer Center
Los Angeles
USC/Norris Comprehensive Cancer Center/Investigational Drug Services
Los Angeles
University of Wisconsin Clinical Science Center
Madison
Mount Sinai Comprehensive Cancer Center
Miami Beach
Mount Sinai Medical Center
Miami Beach
Memorial Sloan Kettering Cancer Center- Monmouth
Middletown
Memorial Sloan Kettering Cancer Center- Bergen
Montvale
Henry-Joyce Cancer Clinic
Nashville
Vanderbilt-Ingram Cancer Center
Nashville
University of Chicago Comprehensive Cancer Center at Silver Cross Hospital
New Lenox
Ochsner Clinic Foundation
New Orleans
Memorial Sloan Kettering Cancer Center
New York
Memorial Sloan Kettering Cancer Center - Main Campus
New York
University of Oklahoma Health Sciences Center, OU Health Stephenson Cancer Center
Oklahoma City
Oncology Hematology West PC dba Nebraska Cancer Specialists
Omaha
Oncology Hematology West PC dba Nebraska Cancer Specialists
Omaha
Oncology Hematology West PC dba Nebraska Cancer Specialists
Omaha
The University of Chicago Medicine Center for Advanced Care Orland Park
Orland Park
Oncology Hematology West PC dba Nebraska Cancer Specialists
Papillion
Keck Hospital of USC Pasadena
Pasadena
Mayo Clinic Hospital
Phoenix
UPMC Hillman Cancer Center
Pittsburgh
BRCR Global
Plantation
BRCR Medical Center Inc.
Plantation
Providence Cancer Institute Franz Clinic
Portland
Providence Onc and Heme Care Clinic - Westside
Portland
Providence Portland Medical Center
Portland
Providence St Vincent Medical Center
Portland
Virginia Commonwealth University
Richmond
Mayo Clinic Rochester
Rochester
Mayo Clinic in Arizona - Scottsdale
Scottsdale
Seattle Cancer Care Alliance
Seattle
University of Washington Medical Center
Seattle
Barnes- Jewish Hospital
St Louis
Siteman Cancer Center - South County
St Louis
Washington University School of Medicine
St Louis
UChicago Medicine at Ingalls - Tinley Park
Tinley Park
Memorial Sloan Kettering Cancer Center- Nassau
Uniondale

Fuente Oficial

Ver en ClinicalTrials.gov