Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
ACTIVE NOT RECRUITING
NCT04657991
PHASE3

A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma

Sponsor: Pfizer

View on ClinicalTrials.gov

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

DRUG

Encorafenib

Encorafenib

DRUG

Binimetinib

Binimetinib

DRUG

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