NCT03693170 - Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

January 17, 2019

Primary Completion Date

June 29, 2020

Study Completion Date

April 27, 2023

Conditions

BRAF V600E-mutant Metastatic Colorectal Cancer

Interventions

DRUG

encorafenib

300 mg administered orally once daily (QD)

DRUG

Binimetinib

Binimetinib 45 mg administered orally twice daily (BID)

DRUG

Cetuximab

"Standard of care for the 28 first weeks(\*) and then every 2 weeks (\*\*) :~(\*) 400 mg/m2 administered as a 120-min infusion on Cycle 1 Day 1, followed by 250 mg/m2 administered as a 60-min infusion once weekly (QW) for the first 28 weeks. (\*\*) 500 mg/m2 administered as a 120-min infusion twice weekly (Q2W) from Week 29 (Cycle 8 Day 1) onward.~Following implementation of an Urgent Safety Measure on 26 Mar 2020 due to the outbreak of COVID-19 pandemic, cetuximab infusions could be administered Q2W regardless of the cycle number, after investigator's evaluation of the benefit/risk ratio for the subject, with regards to COVID-19 pandemic."

Trial Locations (45)

1020

Krankenhaus der Barmherzigen Brüder, Vienna

1200

Cliniques universitaires Saint-Luc, Brussels

3000

Trial DIO, UZ Gasthuisberg, Leuven

9000

UZ Gent, Gastro-Enterology, Ghent

10060

Fondazione del Piemonte per l'Oncologia IRCC Candiolo, Candiolo

10065

Memorial Sloan Kettering Cancer Center, New York

13005

AP-HM CHU Timone, Marseille

16132

Ospedale Policlinic San Martin, Genova

28009

Hospital General Universitario Gregorio Marañón, Madrid

28050

Hospital Universitario HM Sanchinarro, Madrid

28220

Hospital Puerta de Hierro, Madrid

29200

Hôpital Morvan CHRU de Brest Institut de cancérologie et d'hematologie, Brest

31008

Complejo Hospitalario De Navarra S Oncologia Medica, Pamplona

33604

HOPITAL HAUT-LEVEQUE, Av de MAGELLAN, Pessac

34298

ICM- VAL d 'Aurelle, Montpellier

36312

Hospital Alvaro Cunqueiro, Vigo

38138

PC dba West Cancer Center, Germantown

44805

ICO- Site René Gauducheau, Saint-Herblain

46010

Hospital Clínico Universitario de, Valencia

46026

Hospital Universitario y Politécnico La FE, Valencia

47014

Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori, Meldola

50009

Hospital Universitario Miguel Servet, Zaragoza

71013

IRCCS Ospedale Casa Sollievo della Sofferenza, San Giovanni Rotondo

75014

Hôpital Cochin Gastroenterology, Paris

75015

Hôpital Europeen Georges Pompidou, Paris

75571

Hôpital Saint Antoine, Paris

Unknown

CHU TOULOUSE Rangueil, Toulouse

Hospital de la Santa Creu i Santa Pau, Barcelona

06129

Ospedale S.M. Misericordia, Perugia

464-8681

Pierre Fabre Investigative Site, Nagoya

277-8577

Pierre Fabre Investigative Site, Kashiwa

811-1395

Pierre Fabre Investigative Site, Fukuoka

540-0006

Pierre Fabre Investigative Site, Osaka

411-8777

Pierre Fabre Investigative Site, Nagaizumi-cho

135-8550

Pierre Fabre Investigative Site, Koto-ku,

3543 AZ

St Antonius Ziekenhuis, Utrecht

08035

Hospital Vall d'Hebron, Barcelona

08036

Hospital Clínic I Provincial de Barcelona, Barcelona

08908

Institut Català d'Oncologia (ICO L'Hospitalet), Barcelona

TQ2 7AA

Torbay Hospital, Lowes Bridge, Torquay

SM2 5PT

The Royal Marsden NHS Foundation Trust, Sutton

G12 0YN

Beatson West of Scotland Cancer Centre, Glasgow

LS9 7TF

St James Hospital, Leeds

SE1 9RT

GI research team, OHCT, Guy's Hospital, London

M20 4BX

GI Research Team, The Christie NHS Foundation Trust, Manchester