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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

831

Participants

Timeline

Start Date

December 21, 2020

Primary Completion Date

December 8, 2025

Study Completion Date

December 28, 2027

Conditions
Neoplasms
Interventions
DRUG

Encorafenib

75 mg capsules

DRUG

Cetuximab

Injection for intravenous use 100 mg/vial, 200 mg/vial, or 500 mg/vial

DRUG

Oxaliplatin

Powder for solution for intravenous use 50 mg/vial, 100 mg/vial, or 200 mg/vial

DRUG

Irinotecan

Solution for intravenous infusion 40 mg/vial, 100 mg/vial, or 300 mg/vial

DRUG

Leucovorin

Injection 50 mg/vial, 100 mg/vial, 200 mg/vial, or 350 mg/vial

DRUG

5-FU

Injection for intravenous use 250 mg/vial, 500 mg/vial, or 1000 mg/vial

DRUG

Capecitabine

150 mg or 500 mg Tablet

DRUG

Bevacizumab

Optional Injection for intravenous use 100 mg/vial or 400 mg/vial

Trial Locations (268)

100

National Taiwan University Hospital, Taipei

112

Taipei Veterans General Hospital, Taipei

333

Chang Gung Medical Foundation-Linkou Branch, Taoyuan District

404

China Medical University Hospital, Taichung

704

National Cheng-Kung University Hospital, Tainan City

807

Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung City

1023

Auckland City Hospital, Auckland

1070

Université Libre de Bruxelles - Hôpital Erasme, Brussels

1200

Cliniques universitaires Saint-Luc, Brussels

1303

Medical Center Nadezhda Clinical EOOD, Sofia

1407

Acibadem City Clinic MHAT Tokuda, Sofia

1426

Instituto Médico Especializado Alexander Fleming, Buenos Aires

1750

University Multiprofile Hospital for Active Treatment Sofiamed, Sofia

2020

ZNA Middelheim, Antwerp

2050

Chris O'Brien Lifehouse, Camperdown

2065

GenesisCare - North Shore, St Leonards

GenesisCare North Shore, St Leonards

2100

Rigshospitalet, Copenhagen

2170

Liverpool Hospital, Liverpool

2193

Wits Health Consortium (Pty) Ltd, Johannesburg

2610

GZA Hospitals Campus Sint Augustinus, Wilrijk

2730

Herlev and Gentofte Hospital, Herlev

3000

Peter MacCallum Cancer Centre, Melbourne

UZ Leuven, Leuven

3004

Alfred Health, Melbourne

3084

Austin Health, Heidelberg

3168

Monash Health, Clayton

4000

Centro Medico San Roque, San Miguel de Tucumán

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman, Liège

MHAT Central Onco Hospital OOD, Plovdiv

4004

Complex Oncology Center - Plovdiv EOOD, Plovdiv

4029

Royal Brisbane & Women's Hospital, Herston

4102

Princess Alexandra Hospital, Woolloongabba

4500

MHAT Uni Hospital OOD, Panagyurishte

5000

Odense University Hospital, Odense C

5011

The Queen Elizabeth Hospital, Adelaide

5300

"MHAT Dr. Tota Venkova AD", Gabrovo

6045

Cancercare Langenhoven Drive Oncology Centre, Port Elizabeth

6060

Grand Hôpital de Charleroi, Charleroi

7030

St. Olavs hospital, Trondheim

7100

Vejle Hospital-Sygehus Lillebaelt, Vejle

Vejle Sygehus, Vejle

7700

Cancercare Rondebosch Oncology, Rondebosch

8500

AZ Groeninge Campus Kennedylaan, Kortrijk

9000

Aalborg Universitetshospital, Syd, Aalborg

10022

Memorial Sloan Kettering Cancer Center, New York

10043

Azienda Ospedaliero Universitaria San Luigi Gonzaga, Orbassano

10060

Fondazione del Piemonte per l'Oncologia - Istituto di Candiolo IRCCS, Candiolo

10065

Memorial Sloan Kettering Cancer Center - Main Campus, New York

10408

National Cancer Center, Goyang-si

10604

Memorial Sloan Kettering Cancer Center - Westchester, Harrison

10707

Onkologische Schwerpunktpraxis Kurfuerstendamm, Berlin

10719

Radiologie Berlin, Charlottenburg

11031

Taipei Medical University Hospital, Taipei

11553

Memorial Sloan Kettering Cancer Center- Nassau, Uniondale

11725

Memorial Sloan Kettering Cancer Center Commack, Commack

13125

HELIOS Klinikum Berlin Buch GmbH, Berlin

14059

Fakultni Thomayerova nemocnice, Prague

15232

UPMC Hillman Cancer Center, Pittsburgh

15706

Complejo Hospitalario Universitario Santiago de Compostela, Santiago de Compostela

20141

Istituto Europeo di Oncologia IRCCS, Milan

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

20249

Facharztzentrum Eppendorf, Hamburg

20520

Turku University Hospital, Turku

21565

Gachon University Gil Medical Center, Incheon

22045

ZytoService Deutschland GmbH, Standort-Hamburg-Jenfeld, Hamburg

22297

Radiologie im Israelitischen Krankenhaus, Hamburg

23219

Virginia Commonwealth University, Richmond

25124

Fondazione Poliambulanza Istituto Ospedaliero, Brescia

28007

Hospital General Universitario Gregorio Marañon, Madrid

28034

Hospital Universitario Ramon Y Cajal, Madrid

28041

Hospital Universitario 12 de octubre, Madrid

28500

Satakunnan Keskussairaala, Pori

30625

Medizinische Hochschule Hannover, Hanover

33140

Mount Sinai Comprehensive Cancer Center, Miami Beach

Mount Sinai Medical Center, Miami Beach

33180

Mount Sinai Comprehensive Cancer Center, Aventura, Aventura

33322

BRCR Global, Plantation

BRCR Medical Center Inc., Plantation

33520

Tampereen yliopistollinen sairaala, Tampere

35128

IRCCS Istituto Oncologico Veneto (IOV), Padua

37232

Henry-Joyce Cancer Center, Nashville

Vanderbilt-Ingram Cancer Center, Nashville

38138

The West Clinic. PLLC. dba West Cancer Center, Germantown

41013

Hospital Universitario Virgen Del Rocio, Seville

41404

Kyungpook National University Hospital, Daegu

Kyungpook National University Chilgok Hospital, Daegu

42123

Azienda USL - IRCCS di Reggio Emilia - Arcispedale Santa Maria Nuova, Reggio Emilia

43210

The Ohio State University James Cancer Hospital and Solove Research Institute, Columbus

43212

Stefanie Spielman Comprehensive Breast Cancer, Columbus

43221

Martha Morehouse Medical Plaza, Columbus

The James Outpatient Care West Campus, Columbus

44195

Cleveland Clinic Taussig Cancer Center Investigational Pharmacy, Cleveland

Cleveland Clinic, Cleveland

46010

Hospital Clinico Universitario de Valencia, Valencia

46014

Hospital General Universitario de Valencia, Valencia

49102

"Municipal Non-profit Enterprise City Clinical Hospital #4 of Dnipro City Council", Dnipro

49201

Dong-A University Hospital, Busan

50009

Hospital Universitario Miguel Servet, Zaragoza

50048

"Communal enterprise Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council", Kryvyi Rih

53792

University of Wisconsin Clinical Science Center, Madison

55905

Mayo Clinic Rochester, Rochester

60422

UChicago Medicine at Ingalls - Flossmoor, Flossmoor

60426

UChicago Medicine Ingalls Memorial, Harvey

60451

University of Chicago Comprehensive Cancer Center at Silver Cross Hospital, New Lenox

60462

The University of Chicago Medicine Center for Advanced Care Orland Park, Orland Park

60477

UChicago Medicine at Ingalls - Tinley Park, Tinley Park

60488

Institut für Klinisch Onkologische Forschung, Frankfurt am Main

60611

UChicago Medicine - River East, Chicago

60637

University of Chicago Medical Center, Chicago

63031

Siteman Cancer Center - North County, Florissant

63110

Barnes- Jewish Hospital, St Louis

Washington University School of Medicine, St Louis

63129

Siteman Cancer Center - South County, St Louis

63141

Siteman Cancer Center - West County, Creve Coeur

63376

Siteman Cancer Center - St Peters, City of Saint Peters

64000

Accelerium, S. de R.L. de C.V., Monterrey

68020

Centro de Investigacion Clinica de Oaxaca, Oaxaca City

68046

Oncology Hematology West PC dba Nebraska Cancer Specialists, Papillion

68114

Oncology Hematology West PC dba Nebraska Cancer Specialists, Omaha

68124

Oncology Hematology West PC dba Nebraska Cancer Specialists, Omaha

68130

Oncology Hematology West PC dba Nebraska Cancer Specialists, Omaha

70121

Ochsner Clinic Foundation, New Orleans

71013

IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo

73104

University of Oklahoma Health Sciences Center, OU Health Stephenson Cancer Center, Oklahoma City

73657

Chi Mei Hospital, Liouying, Tainan City

76018

Ivano-Frankivsk National Medical University, Ivano-Frankivsk

"MNPE Prykarpatski Clinical Oncological Center of Ivano-Frankivsk Regional Council", Ivano-Frankivsk

77030

The University of Texas MD Anderson Cancer Center, Houston

80131

"Azienda Ospedaliera Universitaria dell'Università Luigi Vanvitelli di Napoli", Napoli

81737

Muenchen Klinik Neuperlach, Klinik fuer Haematologie und Onkologie, Munich

85054

Mayo Clinic Hospital, Phoenix

85259

Mayo Clinic in Arizona - Scottsdale, Scottsdale

90033

Keck Hospital of USC, Los Angeles

LAC & USC Medical Center, Los Angeles

USC / Norris Comprehensive Cancer Center, Los Angeles

USC/Norris Comprehensive Cancer Center/Investigational Drug Services, Los Angeles

USC/Norris Comprehensive Cancer Center, Los Angeles

90185

Norrlands universitetssjukhus, Umeå

90220

Oulu University Hospital, Oulu

91105

Keck Hospital of USC Pasadena, Pasadena

97213

Providence Cancer Institute Franz Clinic, Portland

Providence Portland Medical Center, Portland

97225

Providence Onc and Heme Care Clinic - Westside, Portland

Providence St Vincent Medical Center, Portland

98109

Seattle Cancer Care Alliance, Seattle

98195

University of Washington Medical Center, Seattle

100021

Cancer Hospital Chinese Academy of Medical Science, Beijing

100034

Peking University First Hospital, Beijing

100142

Beijing Cancer hospital, Beijing

100730

Beijing Hospital, Beijing

110022

Shengjing Hospital Of China Medical University, Shenyang

110085

Rajiv Gandhi Cancer Institute And Research Centre, New Delhi

119991

FSAEI HE I.M Sechenov First MSMU MoH Russia (Sechenovskiy University),, Moscow

150054

SHI YR Regional Clinical Oncology Hospital, Yaroslavl

191025

"LLC Medicina Severnoy Stolitsy", Saint Petersburg

192007

"LLC Severo-Zapadny Medical Center", Saint Petersburg

195271

"Private Healthcare Institution Clinical Hospital RZD-Medicine of St. Petersburg", Saint Petersburg

196603

"Private Medical Institution Euromedservice", Pushkin

197022

"LLC EuroCityClinic", Saint Petersburg

197758

"FSBI Russian Scientific Center For Radiology and Surgical Technologies n.a. Academician A.M. Granov", Saint Petersburg

200025

Ruijin Hospital Shanghai Jiaotong University School of Medicine, Shanghai

200080

Shanghai General Hospital, Shanghai

201321

Fudan University Shanghai Cancer Center, Shanghai

210008

Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School, Nanjing

248007

Kaluga Regional Clinical Oncology Center, Kaluga

250117

Shandong province cancer hospital, Jinan

300000

Tianjin Union Medical Center, Tianjin

302004

R K Birla Cancer Center, SMS Hospital, Jaipur

Sawai Man Singh Medical College Hospital (SMS Hospital), Jaipur

310000

The second Affiliated Hospital of College of Medicine, Zhejiang University, Hangzhou

350001

Fujian Medical University Union Hospital, Fuzhou

400012

Tata Memorial Hospital, Mumbai

400030

Chongqing University Cancer Hospital, Chongqing

401107

Bhakti Vedanta Hospital and Research Institute, Thāne

410011

The Second Xiangya Hospital of Central South University, Changsha

410013

The Third Xiangya Hospital of Central South University, Changsha

430030

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan

454087

GBUZ, Chelyabinsk

510655

The Sixth Affiliated Hospital of Sun Yat-sen University, Guangzhou

530021

Affiliated Tumor Hospital of Guangxi Medical University, Nanning

530200

Affiliated Tumor Hospital of Guangxi Medical University, Nanning

610041

Sichuan Province Cancer Hospital, Chengdu

644013

"BHI of Omsk Region Clinical Oncology Dispensary", Omsk

644046

"BHI of Omsk Region Clinical Oncology Dispensary", Omsk

650118

Yunnan Cancer Hospital(The Third Affiliated Hospital of Kunming Medical University), Kunming

1600035

Keio university hospital, Tokyo

2418515

Kanagawa cancer center, Yokohama

5418567

Osaka Prefectural Hospital Organization Osaka International Cancer Institute, Osaka

14784400

Fundação Pio XII - Hospital de Câncer de Barretos, Barretos

15090000

Fundação Faculdade Regional de Medicina de São José do Rio Preto, São José do Rio Preto

07920

Memorial Sloan Kettering Cancer Center - Basking Ridge, Basking Ridge

07922

Summit Medical Group, Berkeley Heights

07932

Summit Medical Group, Florham Park

07748

Memorial Sloan Kettering Cancer Center- Monmouth, Middletown

07645

Memorial Sloan Kettering Cancer Center- Bergen, Montvale

X5004FHP

Clinica Universitaria Reina Fabiola, Córdoba

X5016KEH

Hospital Privado Centro Médico de Córdoba, Córdoba

20230-130

Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA, Rio de Janeiro

90035-903

Hospital de Clinicas de Porto Alegre, Porto Alegre

89010-340

Reichow - Centro de Ensino e Pesquisa, Blumenau

88301-220

Clínica de Neoplasias Litoral, Itajaí

09060-650

CEPHO - Centro de Estudos e Pesquisas de Hematologia e Oncologia - Faculdade de Medicina do ABC, Santo André

09060-870

FUNDAÇÃO DO ABC - Faculdade de Medicina do ABC - Centro de Estudos e Pesquisas de Hematologia e Onco, Santo André

T3N 4N1

Arthur J.E. Child Comprehensive Cancer Centre, Calgary

T6G 1Z2

Cross Cancer Institute, Edmonton

N6A 5W9

London Regional Cancer Program, London Health Sciences Centre, London

M4N 3M5

Sunnybrook Health Sciences Centre, Toronto

H3T 1E2

Jewish General Hospital, Montreal

625 00

Fakultní nemocnice Brno Bohunice, Brno

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

779 00

Fakultni nemocnice Olomouc, Olomouc

180 81

Fakultni nemocnice Bulovka, Prague

00180

Docrates Syöpäsairaala, Helsinki

00029

Helsinki University Central Hospital, Helsinki

04103

Universitätsklinikum Leipzig, Leipzig

01307

Technische Universität Dresden, Medizinische Fakultät Carl Gustav Carus, Dresden

Universitätsklinikum Carl Gustav Carus Dresden, Dresden

411 004

Deenanath Mangeshkar Hospital & Research Centre, Pune

Sahyadri Speciality Hospital, Pune

09042

"Azienda Ospedaliera Universitaria di Cagliari - Presidio Policlinico Universitario D.Casula", Monserrato (CA)

260-8717

Chiba cancer center, Chiba

277-8577

National Cancer Center Hospital East, Kashiwa

060-8648

Hokkaido University Hospital, Sapporo

920-8641

Kanazawa University Hospital, Kanazawa

216-8511

St. Marianna University Hospital, Kawasaki

464-8681

Aichi Cancer Center Hospital, Nagoya

589-8511

Kindai University Hospital, Sayama

565-0871

Osaka University Hospital, Suita

569-8686

Osaka Medical and Pharmaceutical University Hospital, Takatsuki

350-1298

Saitama Medical University International Medical Center, Hidaka

362-0806

Saitama Prefectural Cancer Center, Ina-machi

411-8777

Shizuoka Cancer Center, Nakatogari

104-0045

National Cancer Center Hospital, Chuo-ku

135-8550

The Cancer Institute Hospital of JFCR, Koto-ku

811-1395

National Hospital Organization Kyushu Cancer Center, Fukuoka

540-0006

National Hospital Organization - Osaka National Hospital - Institute For Clinical Research, Osaka

5623 EJ

Catharina Ziekenhuis, Eindhoven

1066 CX

Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL), Amsterdam

3584 CX

Universitair Medisch Centrum Utrecht, Utrecht

N-4615

Sørlandet Sykehus Kristiansand, Kristiansand

0379

Oslo universitetssykehus, Radiumhospitalet, Oslo

0450

Oslo Universitetssykehus Ullevål, Oslo

62-500

Przychodnia Lekarska KOMED, Konin

36-200

Szpital Specjalistyczny W Brzozowie, Podkarpacki Osrodek Onkologiczny Im.Ks.B.Markiewicza, Brzozów

41-902

Wojewodzki Szpital Specjalistyczny Nr 4 w Bytomiu Oddzial Onkologii, Bytom

80-219

COPERNICUS PL sp. z. o. o. Wojewodzkie Centrum Onkologii w Gdansku Ambulatoryjna, Gdansk

COPERNICUS Podmiot Leczniczy Sp. z o.o. Wojewodzkie Centrum Onkologii, Gdansk

833 10

Narodny Onkologicky Ustav, Bratislava

04191

Vychodoslovensky onkologicky ustav, a.s., Košice

02841

Korea University Anam Hospital, Seoul

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital, Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

03203

Hospital General Universitario de Elche, Elche

08908

ICO L'Hospitalet (Hospital Duran i Reynals), L'Hospitalet de Llobregat

08035

Hospital Universitario Vall d'Hebron, Barcelona

08036

Hospital Clinic Barcelona, Barcelona

171 64

Karolinska Universitetssjukhuset Solna, Solna

751 85

Akademiska sjukhuset, Uppsala

413 45

Sahlgrenska Universitetssjukhuset, Gothenburg

NE7 7DN

Freeman Hospital, Newcastle upon Tyne

SM2 5PT

Royal Marsden NHS Foundation Trust, Sutton

B9 5SS

Heartlands Hospital, Birmingham

W12 0HS

Hammersmith Hospital, Imperial College Healthcare NHS Trust, London

W6 8RF

Hammersmith Hospital, London

OX3 7LE

Churchill Hospital - Oncology, Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Ono Pharmaceutical Co. Ltd

INDUSTRY

collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

collaborator

Eli Lilly and Company

INDUSTRY

lead

Pfizer

INDUSTRY