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Triple threat: new drug cocktail targets tough melanoma

NCT ID NCT04657991

Disease control Sponsor: Pfizer Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 2 times

Summary

This study tests whether adding two targeted pills (encorafenib and binimetinib) to standard immunotherapy (pembrolizumab) works better than immunotherapy alone for people with advanced melanoma that has a BRAF gene mutation. About 257 adults with untreated, advanced or spreading melanoma will take part. The goal is to see if the combination shrinks tumors and how safe it is.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

257 people

The number who actually took part.

Started

Jan 2021

Expected to finish

Oct 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Male or female participants ≥ 18 years at the time of informed consent. * Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures. * Histologically confirmed unresectable (Stage IIIB, IIIC, or IIID) or metastatic (Stage IV) cutaneous melanoma, according to the AJCC 8th edition. * Presence of at least 1 measurable lesion as detected by radiological and/or photographic methods according to RECIST v1.1. * ECOG performance status 0 or 1. * Documented evidence of a BRAF V600E or V600K mutation in melanoma tumor tissue as previously determined by either PCR or NGS-based local laboratory assay (eg, US FDA-approved test, CE-marked \[European conformity\] in vitro diagnostic in EU countries, or equivalent), obtained during the course of normal clinical care, in a CLIA- or similarly certified laboratory. * Submission of adequate tumor tissue (archival or newly obtained; block or slides to the sponsor central laboratory(ies) during the screening period and prior to enrollment (SLI)/randomization (Phase 3). * Have not received prior first-line systemic therapy for metastatic or unresectable locally advanced melanoma. * Adequate bone marrow function, hepatic and renal function. * Capable of giving signed informed consent. Exclusion Criteria * Other medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study (including, but not limited to, a participant who is rapidly progressing or has clinically significant tumor related symptoms, in the judgment of the investigator). * Mucosal or ocular melanoma. * Diagnosis of immunodeficiency or an active autoimmune disease that required systemic treatment in the past 2 years (ie, with use of disease modifying agents, corticosteroids, or immunosuppressive drugs). * Clinically significant multiple or severe drug allergies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions (including, but not limited to, erythema multiforme major, linear IgA dermatosis, toxic epidermal necrolysis, and exfoliative dermatitis). * Unable to swallow, retain, and absorb oral medications. * Impairment of GI function or disease which may significantly alter the absorption of oral study intervention (eg, uncontrolled nausea, vomiting or diarrhea, malabsorption syndrome, including malabsorption syndrome secondary to prior GI surgery). * Clinically significant cardiovascular diseases, * History of thromboembolic or cerebrovascular events ≤ 12 weeks prior to enrollment (SLI)/randomization (Phase 3). Examples include transient ischemic attacks, cerebrovascular accidents, hemodynamically significant (ie, massive or sub-massive) deep vein thrombosis or pulmonary emboli. * History or current evidence of RVO or current risk factors for RVO (eg, uncontrolled glaucoma or ocular hypertension, history of hyperviscosity or hypercoagulability syndromes) * Concurrent neuromuscular disorder that is associated with the potential of elevated CK (eg, inflammatory myopathies, muscular dystrophy, amyotrophic lateral sclerosis, spinal muscular atrophy). * Current noninfectious pneumonitis or history of noninfectious pneumonitis requiring steroids, or history of radiation pnuemonitis * Evidence of HBV or HCV infection. * Known history of a positive test for HIV or known AIDS. * Any active infection requiring systemic therapeutic treatment within 2 weeks prior to enrollment (SLI)/ randomization (Phase 3). * Participants with prior or current symptomatic brain metastasis, leptomeningeal disease or other active CNS metastases. * Concurrent or previous other malignancy within 2 years of study entry, except curatively treated basal or squamous cell skin cancer, prostate intraepithelial neoplasm, carcinoma in-situ of the cervix, Bowen's disease and Gleason ≤ 6 prostate cancer. Participants with a history of other curatively treated cancers must be reviewed with the sponsor or designee prior to entering the study. * Participants who previously received and subsequently discontinued encorafenib and/or binimetinib and/or anti-PD-1/-L1 due to severe toxicity. * For participants in the SLI only: Current use or anticipated need for food or drugs that are known moderate or strong CYP3A4 inhibitors during screening and through the DLT-evaluation period * Participant has not recovered to Grade ≤ 1 from toxic effects of prior therapy and/or complications from prior surgical intervention before enrollment (SLI)/ randomization (Phase 3). * Receipt of protocol defined medications or treatments outside of required intervals before enrollment (SLI)/randomization (Phase 3): * Previous administration with an investigational drug ≤ 6 months prior to enrollment (SLI)/randomization (Phase 3). * Known sensitivity or contraindication to any component of study intervention (encorafenib, binimetinib and pembrolizumab), or their excipients. * Pregnant, confirmed by a positive β-hCG laboratory test result, or is breastfeeding (lactating). * Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.

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Conditions

The condition(s) this trial relates to.

melanoma metastatic melanoma skin neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Melanoma

Contacts and locations

Locations

  • A.O.U.S. Policlinico "Le Scotte"

    Siena, SI, 53100, Italy

  • AO di Perugia - Ospedale S. Maria della Misericordia, S.C Oncologia Medica

    Perugia, 06132, Italy

  • Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD

    Sofia, 1407, Bulgaria

  • AdventHealth Hematology and Oncology

    Orlando, Florida, 32804, United States

  • AdventHealth Orlando Infusion Center

    Orlando, Florida, 32804, United States

  • AdventHealth Orlando, Investigational Drug Services

    Orlando, Florida, 32804, United States

  • Ars Medika Center, LLC

    Kaliningrad, 236006, Russia

  • Azienda Sanitaria Universitaria Friuli Centrale

    Udine, Friuli Venezia Giulia, 33100, Italy

  • BIH of Omsk Region "Clinical Oncological Dispensary"

    Omsk, 644046, Russia

  • BRCR Global Mexico - CDMX

    Mexico City, 01120, Mexico

  • Barts Health NHS Trust.

    London, E1 1FR, United Kingdom

  • Boca Clinical Trials Mexico Sc.

    Puebla City, 72160, Mexico

  • CHU Grenoble Alpes

    La Tronche, 38700, France

  • CHU d'Amiens - Hôpital Nord

    Amiens, 80054, France

  • CHU de Poitiers

    Poitiers, 86000, France

  • CHUAC-Hospital Teresa Herrera

    A Coruña, 15006, Spain

  • CIUSSS du Saguenay-Lac-Saint-Jean

    Chicoutimi, Quebec, G7H 5H6, Canada

  • CNI KRC "Regional Cardiology Centre"

    Kharkiv, 61166, Ukraine

  • Charité Universitaetsmedizin Berlin - Campus Mitte

    Berlin, 10117, Germany

  • Clinica Viedma S. A

    Viedma, Río Negro Province, 8500, Argentina

  • Cliniques universitaires Saint-Luc

    Brussels, 1200, Belgium

  • Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Oncological Regional Therapeutical

    Lviv, 79031, Ukraine

  • Complejo Hospitalario de Jaen

    Jaén, 23007, Spain

  • Complex Oncology Center - Plovdiv EOOD

    Plovdiv, 4004, Bulgaria

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032, Hungary

  • Derzhavna ustanova Instytut zahalnoi ta nevidkladnoi khirurhii im.V.T.Zaitseva Natsionalnoi akademii

    M. Kharkiv, 61103, Ukraine

  • Dipartimento di Medicina e Chirurgia dell' Universita

    San Sisto, Perugia, 06132, Italy

  • Drs Alberts Bouwer Jordaan

    Pretoria, South Africa

  • Drs Alberts, Bouwer and Jordaan Inc.

    Pretoria, Gauteng, 0081, South Africa

  • Eurocityclinic LLC

    Saint Petersburg, 197022, Russia

  • Fachklinik Hornheide

    Münster, 48157, Germany

  • Fakultni nemocnice Bulovka

    Praha 8-Liben, 180 81, Czechia

  • Fakultni nemocnice Ostrava

    Ostrava-Poruba, 708 52, Czechia

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, MI, 20133, Italy

  • Fundacion Instituto Valenciano de Oncologia

    Valencia, 46009, Spain

  • Fundação Pio XII - Hospital de Câncer de Barretos

    Barretos, São Paulo, 14784-400, Brazil

  • General Hospital of Athens "Laiko"

    Athens, Attikí, 11527, Greece

  • HELIOS Klinikum Erfurt

    Erfurt, 99089, Germany

  • Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem

    Jerusalem, 9112001, Israel

  • Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)

    Helsinki, 00029, Finland

  • Hospital Clinic Barcelona

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario Virgen de la Arrixaca

    El Palmar, Murcia, 30120, Spain

  • Hospital Regional Universitario de Malaga - Hospital Civil

    Málaga, 29011, Spain

  • Hospital Sírio-Libanês - Unidade Bela Vista

    São Paulo, 01308-050, Brazil

  • Hospital Universitari Vall D'Hebron, Servicio de Oncología Médica

    Barcelona, 08035, Spain

  • Hospital Universitario Arnau de Vilanova

    Lleida, 25198, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008, Spain

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009, Spain

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222, Spain

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034, Spain

  • Hospital Universitario Reina Sofía

    Córdoba, 14004, Spain

  • Hospital Universitario Virgen Macarena

    Seville, 41009, Spain

  • Hospital Universitario Virgen del Rocio

    Seville, 41013, Spain

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903, Brazil

  • Hospital de Clínicas de Passo Fundo

    Passo Fundo, Rio Grande do Sul, 99010-260, Brazil

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041, Spain

  • Hôpital Lyon Sud

    Pierre-Bénite, 69310, France

  • I Can Oncology Center S.A. de C.V.

    Monterrey, Nuevo León, 64710, Mexico

  • ICO-Badalona Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916, Spain

  • IRCCS Azienda Ospedaliera Metropolitana (IRCCS AOM)

    Genova, 16132, Italy

  • Instituto Alexander Fleming

    CABA, Buenos Aires, C1426ANZ, Argentina

  • Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA

    Rio de Janeiro, Rio de Janeiro, 20220-410, Brazil

  • Instituto de Oncologia do Paraná - IOP Matriz Mateus Leme

    Curitiba, Paraná, 80520-174, Brazil

  • Instituto de Oncologia do Paraná - IOP Oncoville

    Curitiba, Paraná, 82305-100, Brazil

  • Istanbul University Cerrahpasa Medical Faculty Hospital

    Istanbul, İ̇stanbul, 34098, Turkey (Türkiye)

  • Istituti Fisioterapici Ospitalieri

    Rome, ROMA, 00144, Italy

  • Istituto Dermopatico dell'Immacolata (IDI-IRCCS)

    Roma, RM, 00167, Italy

  • Istituto Europeo di Oncologia IRCCS

    Milan, 20141, Italy

  • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

    Naples, 80131, Italy

  • Istituto Nazionale Tumori Regina Elena

    Roma, 00144, Italy

  • Istituto Oncologico Veneto IOV - IRCCS

    Padova, 35128, Italy

  • Istituto Tumori Giovanni Paolo II

    Bari, 70124, Italy

  • Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia

    Candiolo, Torino, 10060, Italy

  • Jagiellońskie Centrum Innowacji Sp. z o .o.

    Krakow, 30-348, Poland

  • Johannes Wesling Klinikum Minden

    Minden, North Rhine-Westphalia, 32429, Germany

  • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház

    Szolnok, Jász-Nagykun-Szolnok, 5004, Hungary

  • KU Eye Center

    Prairie Village, Kansas, 66208, United States

  • Klinik und Poliklinik für Dermatologie und Allergologie

    München, Bavaria, 80337, Germany

  • Klinikum Nürnberg Nord

    Nuremberg, 90419, Germany

  • Laiko Hospital

    Athens, Attikí, 11527, Greece

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Medical Center Nadezhda Clinical EOOD

    Sofia, 1373, Bulgaria

  • Medizinische Hochschule Hannover

    Hanover, 30625, Germany

  • Medizinische Universität Graz

    Graz, 8036, Austria

  • Memorial Ankara Hastanesi

    Ankara, 06520, Turkey (Türkiye)

  • Narodny onkologicky ustav

    Bratislava, 833 10, Slovakia

  • Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy

    Warsaw, 02-781, Poland

  • National Cancer Institute

    Kyiv, 03022, Ukraine

  • Nemocnica na okraji mesta, n.o.

    Partizánske, 95801, Slovakia

  • ONCARE Viaducto Nápoles

    Benito Juárez, Mexico City, 03810, Mexico

  • Olomouc University Hospital

    Olomouc, Olomouc Region, 779 00, Czechia

  • Onkologicky ustav sv. Alzbety, s.r.o.

    Bratislava, 812 50, Slovakia

  • Ophthalmic Consultants of Boston Inc (OCB)

    Boston, Massachusetts, 02114, United States

  • Orszagos Onkologiai Intezet

    Budapest, 1122, Hungary

  • Oslo universitetssykehus, Radiumhospitalet

    Oslo, 0379, Norway

  • POKO Poprad, s.r.o.

    Poprad, 058 01, Slovakia

  • Palmerston North Hospital

    Palmerston North, Manawatu, 4414, New Zealand

  • Preparaciones Oncológicas S.C.

    León, Guanajuato, 37178, Mexico

  • Private Medical Institution "Euromedservice"

    Pushkin, Sankt-Peterburg, 196603, Russia

  • Pécsi Tudományegyetem Klinikai Központ

    Pécs, Baranya, 7632, Hungary

  • SRH Wald-Klinikum Gera

    Gera, Thuringia, 07548, Germany

  • Sandton Oncology Medical Group (Pty) Ltd

    Johannesburg, Gauteng, 2196, South Africa

  • Semmelweis Egyetem

    Budapest, 1085, Hungary

  • Soroka University Medical Center

    Beersheba, 8410101, Israel

  • St. Bartholomew's Hospital, Barts Health NHS Trust

    London, EC1A 7BE, United Kingdom

  • Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, 6720, Hungary

  • Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu

    Poznan, 60-780, Poland

  • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

    Istanbul, İ̇stanbul, 34722, Turkey (Türkiye)

  • Tampereen yliopistollinen sairaala

    Tampere, Pirkanmaa, 33520, Finland

  • Tenessee Oncology, PLLC

    Hendersonville, Tennessee, 37075, United States

  • Tennessee Oncology PLLC

    Franklin, Tennessee, 37067, United States

  • Tennessee Oncology PLLC

    Gallatin, Tennessee, 37066, United States

  • Tennessee Oncology PLLC

    Hermitage, Tennessee, 37076, United States

  • Tennessee Oncology PLLC

    Lebanon, Tennessee, 37090, United States

  • Tennessee Oncology PLLC

    Murfreesboro, Tennessee, 37129, United States

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37203, United States

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37205, United States

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37207, United States

  • Tennessee Oncology PLLC

    Smyrna, Tennessee, 37167, United States

  • Tennessee Oncology, PLLC

    Dickson, Tennessee, 37055, United States

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203, United States

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37211, United States

  • Tennessee Oncology, PLLC

    Shelbyville, Tennessee, 37160, United States

  • The South West Wales Cancer Institute, Swansea Bay University Health Board

    Swansea, SA2 8QA, United Kingdom

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205, United States

  • The University of Kansas Cancer Center - Investigational Drug Services

    Westwood, Kansas, 66205, United States

  • The University of Kansas Cancer Center - Overland Park

    Overland Park, Kansas, 66210, United States

  • The University of Kansas Clinical Research Center

    Fairway, Kansas, 66205, United States

  • Umhato Ead

    Sofia, 1756, Bulgaria

  • Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden

    Dresden, Saxony, 01307, Germany

  • Universitaetsklinikum Halle - Universitaetsklinik und Poliklinik fuer Dermatologie und Venerologie

    Halle, 06120, Germany

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246, Germany

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel

    Kiel, Schleswig-Holstein, 24105, Germany

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Wurttemberg, 72076, Germany

  • University Hospital Muenster

    Münster, 48149, Germany

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219, United States

  • University of Debrecen

    Debrecen, 4032, Hungary

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920, United States

  • UniversitätsSpital Zürich

    Zürich Flughafen, 8058, Switzerland

  • Universitätsklinikum Bonn

    Bonn, North Rhine-Westphalia, 53127, Germany

  • Universitätsklinikum Essen (AöR)

    Essen, 45147, Germany

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitätsklinikum Leipzig

    Leipzig, Saxony, 04103, Germany

  • Universitätsklinikum Regensburg

    Regensburg, 93053, Germany

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, Schleswig-Holstein, 23538, Germany

  • Universitätsmedizin Johannes Gutenberg Universität Mainz

    Mainz, Rhineland-Palatinate, 55131, Germany

  • Vychodoslovensky onkologicky ustav, a.s.

    Košice, 04191, Slovakia

  • WCR Office

    Johannesburg, Gauteng, 2193, South Africa

  • West Chester Hospital

    West Chester, Ohio, 45069, United States

  • Wits Clinical Research

    Johannesburg, Gauteng, 2193, South Africa

  • Zentrum fuer Radiologie und Nuklearmedizin am Johannisplatz

    Leipzig, 04103, Germany

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