46
Participants
Start Date
July 5, 2022
Primary Completion Date
July 31, 2029
Study Completion Date
July 31, 2029
Binimetinib only treatment
Binimetinib will be administered at the same dose level (15 mg to 45 mg) as that received in the Parent Studies C4211001 and C4211003 with water irrespective of food, continuously, starting on Day 1.
Encorafenib only Treatment
Encorafenib will be self-administered at the same dose level as that received in the C4221010 Parent Study.
Encorafenib & Binimetinib Treatment
Encorafenib will be administered on a 300 mg QD schedule and binimetinib will be administered on a 45 mg BID schedule, both orally as a flat fixed dose. Cetuximab will be administered at either 400 mg/m2 or 500 mg/m2 IV every 2 weeks on Days 1 and 15 of every cycle.
Treatment of Encorafenib & Binimetinib & Ribociclib
Encorafenib capsule and ribociclib capsules or tablets will be co-administered orally QD with binimetinib tablets BID. The study drugs will be administered as a flat-fixed dose, and not by body weight or body surface area.
Treatment of Encorafenib & Binimetinib & Cetuximab
Encorafenib will be administered on a 300 mg QD schedule and binimetinib will be administered on a 45 mg BID schedule, both orally as a flat fixed dose. Cetuximab will be administered at either 400 mg/m2 or 500 mg/m2 IV every 2 weeks on Days 1 and 15 of every cycle.
RECRUITING
Peter MacCallum Cancer Centre, Melbourne
RECRUITING
Debreceni Egyetem Klinikai Kozpont, Debrecen
RECRUITING
Rockefeller Outpatient Pavilion (53rd Street), New York
RECRUITING
Memorial Sloan Kettering Cancer Center, New York
RECRUITING
Charité Universitaetsmedizin Berlin - Campus Mitte, Berlin
RECRUITING
Vseobecna fakultni nemocnice v Praze, Prague
RECRUITING
CHUAC-Hospital Teresa Herrera, A Coruña
ACTIVE_NOT_RECRUITING
Istituto Europeo di Oncologia IRCCS, Milan
RECRUITING
Hospital Universitario Arnau de Vilanova de Lleida, Lleida
RECRUITING
Hospital Universitario HM Sanchinarro, Madrid
RECRUITING
Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda
RECRUITING
H.R.U Málaga - Hospital General, Málaga
RECRUITING
Emory University Hospital Midtown, Atlanta
RECRUITING
Emory University Hospital, Atlanta
RECRUITING
Investigational Drug Service Emory University Clinic, Atlanta
RECRUITING
Winship Cancer Institute of Emory University, Atlanta
RECRUITING
Hospital Universitario Central de Asturias, Oviedo
ACTIVE_NOT_RECRUITING
Otto-von-Guericke-Universitat Magdeburg, Magdeburg
RECRUITING
IRCCS Azienda Ospedaliero-Universitaria di Bologna, Policlinico di Sant'Orsola, Bologna
RECRUITING
HealthPartners Cancer Research Center, Saint Paul
RECRUITING
Regions Hospital Pharmacy, Saint Paul
RECRUITING
HealthPartners Specialty Center, Saint Paul
ACTIVE_NOT_RECRUITING
Hopital Claude Huriez - CHU de Lille, Lille
RECRUITING
Siteman Cancer Center, St Louis
RECRUITING
Barnes-Jewish Hospital, St Louis
RECRUITING
Washington University School of Medicine, St Louis
RECRUITING
Instituto Tumori Giovanni Paolo II, Bari
ACTIVE_NOT_RECRUITING
Universitaetsklinikum Tuebingen, Tübingen
RECRUITING
Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli
RECRUITING
St. Joseph's Hospital and Medical Center, Phoenix
RECRUITING
St. Joseph's Hospital and Medical Center, Phoenix
ACTIVE_NOT_RECRUITING
Gustave Roussy, Villejuif
RECRUITING
"Fed State Budgetary Inst N.N. Blokhin Med Center of Oncology MHRF", Moscow
RECRUITING
N.N.Petrov Research Institute of Oncology, Saint Petersburg
RECRUITING
N.N.Petrov Research Institute of Oncology, Saint Petersburg
RECRUITING
Rambam Health Care Campus, Haifa
RECRUITING
Fundação Pio XII - Hospital de Câncer de Barretos, Barretos
RECRUITING
Massachusetts General Hospital, Boston
RECRUITING
MSK Basking Ridge, Basking Ridge
RECRUITING
Liga Norte Riograndense Contra o Câncer, Natal
RECRUITING
ONCOSITE - Centro de Pesquisa Clinica em Oncologia, Ijuí
RECRUITING
BP - A Beneficencia Portuguesa de São Paulo, São Paulo
RECRUITING
Real e Benemerita Associacao Portuguesa de Beneficencia, São Paulo
RECRUITING
Princess Margaret Cancer Centre, Toronto
RECRUITING
Jewish General Hospital, Montreal
RECRUITING
Debreceni Egyetem Klinikai Kozpont, Debrecen
RECRUITING
Istituto Nazionale Tumori Regina Elena, Rome
RECRUITING
Radboudumc, Nijmegen
RECRUITING
Nederlands Kanker Instituut - Antoni van Leeuwenhoek (NKI-AVL), Amsterdam
RECRUITING
Nederlands Kanker Instituut Antoni van Leeuwenhoek (NKI AVL), Amsterdam
ACTIVE_NOT_RECRUITING
Isala, locatie Zwolle, Zwolle
RECRUITING
Instituto Português de Oncologia de Lisboa Francisco Gentil, Lisbon
RECRUITING
Instituto Português de Oncologia do Porto Francisco Gentil, EPE, Porto
ACTIVE_NOT_RECRUITING
Narodny onkologicky ustav, Bratislava
RECRUITING
Seoul National University Hospital, Seoul
RECRUITING
Severance Hospital, Yonsei University Health System, Seoul
RECRUITING
Samsung Medical Center, Seoul
RECRUITING
Institut Català d'Oncologia (ICO) - Badalona, Badalona
RECRUITING
Hospital Universitari Vall d'Hebron, Barcelona
RECRUITING
Hospital Universitari Vall d'Hebron, Barcelona
RECRUITING
Hospital Clinic de Barcelona, Barcelona
RECRUITING
Hospital Clínic de Barcelona, Barcelona
RECRUITING
Lancashire Teaching Hospitals NHS Foundation Trust - Royal Preston Hospital, Preston
Lead Sponsor
Pfizer
INDUSTRY