Encorafenib, Binimetinib and Cetuximab in Subjects With Previously Untreated BRAF-mutant ColoRectal Cancer

COMPLETED

NCT03693170

PHASE2

Sponsor: Pierre Fabre Medicament

Summary

The purpose of this study is to evaluate the efficacy and safety of the combination of study drugs encorafenib, binimetinib and cetuximab in patients who have BRAF V600 mutant metastatic colorectal cancer and have not received any prior treatment for their metastatic disease.

Official title: Phase II, Open-label, Single Arm, Multicenter Study of Encorafenib, Binimetinib Plus Cetuximab in Subjects With Previously Untreated BRAF V600E -Mutant Metastatic Colorectal Cancer

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

95

Start Date

2019-01-17

Completion Date

2023-04-27

Last Updated

2026-07-16

Healthy Volunteers

No

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.

Locations (45)

Memorial Sloan Kettering Cancer Center

New York, New York, United States

PC dba West Cancer Center

Germantown, Tennessee, United States

Krankenhaus der Barmherzigen Brüder

Vienna, Austria

UZ Gent, Gastro-Enterology

Ghent, East Flanders, Belgium

Trial DIO, UZ Gasthuisberg

Leuven, Flemish Brabant, Belgium

Cliniques universitaires Saint-Luc

Brussels, Belgium

ICM- VAL d 'Aurelle

Montpellier, Cedex 5, France

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

Brest, France

AP-HM CHU Timone

Marseille, France

Hôpital Cochin Gastroenterology

Paris, France

Hôpital Europeen Georges Pompidou

Paris, France

Hôpital Saint Antoine

Paris, France

HOPITAL HAUT-LEVEQUE, Av de MAGELLAN

Pessac, France

ICO- Site René Gauducheau

Saint-Herblain, France

CHU TOULOUSE Rangueil

Toulouse, France

IRCCS Ospedale Casa Sollievo della Sofferenza

San Giovanni Rotondo, Foggia, Italy

Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori

Meldola, Forlì-Cesena, Italy

Fondazione del Piemonte per l'Oncologia IRCC Candiolo

Candiolo, Italy

Ospedale Policlinic San Martin

Genova, Italy

Ospedale S.M. Misericordia

Perugia, Italy