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A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma
Sponsor: Pfizer
Summary
The purpose of this study is to learn about the effects of three study medicines (encorafenib, binimetinib, and pembrolizumab) given together for the treatment of melanoma that: * is advanced or metastatic (spread to other parts of the body); * has a certain type of abnormal gene called "BRAF"; and * has not received prior treatment. All participants in this study will receive pembrolizumab at the study clinic once every 3 weeks as an intravenous (IV) infusion (given directly into a vein). In addition, half of the participants will take encorafenib and binimetinib orally (by mouth) at home every day. Participants may receive pembrolizumab for up to two years. Those participants taking encorafenib and binimetinib can continue until their melanoma is no longer responding. The study team will monitor how each participant is doing with the study treatment during regular visits at the study clinic.
Official title: A PHASE 3, RANDOMIZED, DOUBLE-BLIND STUDY OF ENCORAFENIB AND BINIMETINIB PLUS PEMBROLIZUMAB VERSUS PLACEBO PLUS PEMBROLIZUMAB IN PARTICIPANTS WITH BRAF V600E/K MUTATION-POSITIVE METASTATIC OR UNRESECTABLE LOCALLY ADVANCED MELANOMA
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
257
Start Date
2021-01-15
Completion Date
2026-08-31
Last Updated
2026-04-07
Healthy Volunteers
No
Conditions
Interventions
Encorafenib
Encorafenib
Binimetinib
Binimetinib
Pembrolizumab
Pembrolizumab
Locations (143)
Adventist Health System/Sunbelt, Inc.
Orlando, Florida, United States
AdventHealth Hematology and Oncology
Orlando, Florida, United States
AdventHealth Orlando Infusion Center
Orlando, Florida, United States
AdventHealth Orlando, Investigational Drug Services
Orlando, Florida, United States
The University of Kansas Clinical Research Center
Fairway, Kansas, United States
The University of Kansas Cancer Center - Overland Park
Overland Park, Kansas, United States
KU Eye Center
Prairie Village, Kansas, United States
The University of Kansas Cancer Center - Investigational Drug Services
Westwood, Kansas, United States
The University of Kansas Cancer Center
Westwood, Kansas, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Ophthalmic Consultants of Boston Inc (OCB)
Boston, Massachusetts, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
University of Cincinnati Medical Center
West Chester, Ohio, United States
West Chester Hospital
West Chester, Ohio, United States
University of Tennessee Medical Center
Knoxville, Tennessee, United States
Sarah Cannon Research Institute
Nashville, Tennessee, United States
Tennessee Oncology, PLLC
Nashville, Tennessee, United States
Instituto Alexander Fleming
CABA, Buenos Aires, Argentina
Clinica Viedma S. A
Viedma, Río Negro Province, Argentina
Medizinische Universität Graz
Graz, Austria
Cliniques universitaires Saint-Luc
Brussels, Belgium
Instituto de Oncologia do Paraná - IOP Matriz Mateus Leme
Curitiba, Paraná, Brazil
Instituto de Oncologia do Paraná - IOP Oncoville
Curitiba, Paraná, Brazil
Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA
Rio de Janeiro, Rio de Janeiro, Brazil
Hospital de Clínicas de Passo Fundo
Passo Fundo, Rio Grande do Sul, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Fundação Pio XII - Hospital de Câncer de Barretos
Barretos, São Paulo, Brazil
Hospital Sírio-Libanês - Unidade Bela Vista
São Paulo, Brazil
Complex Oncology Center - Plovdiv EOOD
Plovdiv, Bulgaria
Medical Center Nadezhda Clinical EOOD
Sofia, Bulgaria
Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD
Sofia, Bulgaria
Umhato Ead
Sofia, Bulgaria
CIUSSS du Saguenay-Lac-Saint-Jean
Chicoutimi, Quebec, Canada
Olomouc University Hospital
Olomouc, Olomoucký kraj, Czechia
Fakultni nemocnice Ostrava
Ostrava-Poruba, Czechia
Fakultni nemocnice Bulovka
Praha 8-Liben, Czechia
Tampereen yliopistollinen sairaala
Tampere, Pirkanmaa, Finland
Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
Helsinki, Finland
CHU d'Amiens - Hôpital Nord
Amiens, France
CHU Grenoble Alpes
La Tronche, France
Hôpital Lyon Sud
Pierre-Bénite, France
CHU de Poitiers
Poitiers, France
Universitaetsklinikum Tuebingen
Tübingen, Baden-Wurttemberg, Germany
Klinik und Poliklinik für Dermatologie und Allergologie
München, Bavaria, Germany
Universitätsklinikum Bonn
Bonn, North Rhine-Westphalia, Germany
Johannes Wesling Klinikum Minden
Minden, North Rhine-Westphalia, Germany
Universitätsmedizin Johannes Gutenberg Universität Mainz
Mainz, Rhineland-Palatinate, Germany
Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden
Dresden, Saxony, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel, Schleswig-Holstein, Germany
Universitätsklinikum Schleswig-Holstein
Lübeck, Schleswig-Holstein, Germany
SRH Wald-Klinikum Gera
Gera, Thuringia, Germany
Charité Universitaetsmedizin Berlin - Campus Mitte
Berlin, Germany
HELIOS Klinikum Erfurt
Erfurt, Germany
Universitätsklinikum Essen (AöR)
Essen, Germany
Universitaetsklinikum Halle - Universitaetsklinik und Poliklinik fuer Dermatologie und Venerologie
Halle, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, Germany
Medizinische Hochschule Hannover
Hanover, Germany
Universitätsklinikum Heidelberg
Heidelberg, Germany
Zentrum fuer Radiologie und Nuklearmedizin am Johannisplatz
Leipzig, Germany
University Hospital Muenster
Münster, Germany
Fachklinik Hornheide
Münster, Germany
Klinikum Nürnberg Nord
Nuremberg, Germany
Universitätsklinikum Regensburg
Regensburg, Germany
General Hospital of Athens "Laiko"
Athens, Attikí, Greece
Laiko Hospital
Athens, Attikí, Greece
Pécsi Tudományegyetem Klinikai Központ
Pécs, Baranya, Hungary
Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház
Szolnok, Jász-Nagykun-Szolnok, Hungary
Semmelweis Egyetem
Budapest, Hungary
Orszagos Onkologiai Intezet
Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary
University of Pecs, Clinical Center
Pécs, Hungary
Szent-Gyorgyi Albert Klinikai Kozpont
Szeged, Hungary
Soroka University Medical Center
Beersheba, Israel
Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem
Jerusalem, Israel
Azienda Sanitaria Universitaria Friuli Centrale
Udine, Friuli Venezia Giulia, Italy
Fondazione IRCCS Istituto Nazionale dei Tumori
Milan, MI, Italy
Dipartimento di Medicina e Chirurgia dell' Universita
San Sisto, Perugia, Italy
Istituto Dermopatico dell'Immacolata (IDI-IRCCS)
Roma, RM, Italy
Istituti Fisioterapici Ospitalieri
Rome, ROMA, Italy
A.O.U.S. Policlinico "Le Scotte"
Siena, SI, Italy
Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
Candiolo, Torino, Italy
Istituto Tumori Giovanni Paolo II
Bari, Italy
IRCCS Azienda Ospedaliera Metropolitana (IRCCS AOM)
Genova, Italy
Istituto Europeo di Oncologia IRCCS
Milan, Italy
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
Naples, Italy
Istituto Oncologico Veneto IOV - IRCCS
Padova, Italy
AO di Perugia - Ospedale S. Maria della Misericordia, S.C Oncologia Medica
Perugia, Italy
Istituto Nazionale Tumori Regina Elena
Roma, Italy
Preparaciones Oncológicas S.C.
León, Guanajuato, Mexico
ONCARE Viaducto Nápoles
Benito Juárez, Mexico City, Mexico
I Can Oncology Center S.A. de C.V.
Monterrey, Nuevo León, Mexico
Centro de Atencion Integral En Oncologia S.C
Guanajuato City, Mexico
BRCR Global Mexico - CDMX
Mexico City, Mexico
El Cielo Medical Center RSB, S.C
Puebla City, Mexico
Boca Clinical Trials Mexico Sc
Querétaro City, Mexico
Palmerston North Hospital
Palmerston North, Manawatu, New Zealand
Oslo universitetssykehus, Radiumhospitalet
Oslo, Norway
Jagiellońskie Centrum Innowacji Sp. z o .o.
Krakow, Poland
Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu
Poznan, Poland
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
Warsaw, Poland
Private Medical Institution "Euromedservice"
Pushkin, Sankt-Peterburg, Russia
Ars Medika Center, LLC
Kaliningrad, Russia
BIH of Omsk Region "Clinical Oncological Dispensary"
Omsk, Russia
Eurocityclinic LLC
Saint Petersburg, Russia
Onkologicky ustav sv. Alzbety, s.r.o.
Bratislava, Slovakia
Narodny onkologicky ustav
Bratislava, Slovakia
Vychodoslovensky onkologicky ustav, a.s.
Košice, Slovakia
Nemocnica na okraji mesta, n.o.
Partizánske, Slovakia
POKO Poprad, s.r.o.
Poprad, Slovakia
WCR Office
Johannesburg, Gauteng, South Africa
Wits Clinical Research
Johannesburg, Gauteng, South Africa
Sandton Oncology Medical Group (Pty) Ltd
Johannesburg, Gauteng, South Africa
Drs Alberts, Bouwer and Jordaan Inc.
Pretoria, Gauteng, South Africa
Drs Alberts Bouwer Jordaan
Pretoria, South Africa
ICO-Badalona Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, Spain
Hospital Clinico Universitario Virgen de la Arrixaca
El Palmar, Murcia, Spain
CHUAC-Hospital Teresa Herrera
A Coruña, Spain
Hospital Universitari Vall D'Hebron, Servicio de Oncología Médica
Barcelona, Spain
Hospital Clinic Barcelona
Barcelona, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
Hospital Universitario Reina Sofía
Córdoba, Spain
Complejo Hospitalario de Jaen
Jaén, Spain
Hospital Universitario Arnau de Vilanova
Lleida, Spain
Hospital Universitario Ramón y Cajal
Madrid, Spain
Hospital Regional Universitario de Malaga - Hospital Civil
Málaga, Spain
Hospital Universitario Virgen Macarena
Seville, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Fundacion Instituto Valenciano de Oncologia
Valencia, Spain
Hospital Universitario Miguel Servet
Zaragoza, Spain
UniversitätsSpital Zürich
Zürich Flughafen, Switzerland
Istanbul University Cerrahpasa Medical Faculty Hospital
Istanbul, İ̇stanbul, Turkey (Türkiye)
TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Istanbul, İ̇stanbul, Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, Turkey (Türkiye)
CNI KRC "Regional Cardiology Centre"
Kharkiv, Ukraine
National Cancer Institute
Kyiv, Ukraine
Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Oncological Regional Therapeutical
Lviv, Ukraine
Derzhavna ustanova Instytut zahalnoi ta nevidkladnoi khirurhii im.V.T.Zaitseva Natsionalnoi akademii
M. Kharkiv, Ukraine
Barts Health NHS Trust.
London, United Kingdom
St. Bartholomew's Hospital, Barts Health NHS Trust
London, United Kingdom
The South West Wales Cancer Institute, Swansea Bay University Health Board
Swansea, United Kingdom