AzTrials
AzTrials

MelanomaPhase 3NCT04657991

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

A Phase 3 study testing Encorafenib, Binimetinib and Pembrolizumab in people with Melanoma, run by Pfizer at 151 sites in 27 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Melanoma
What is being tested?
Encorafenib, Binimetinib and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
257 participants
Where
151 sitesin 27 countries
Study dates
15 Jan 2021to 30 Oct 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

151 sites in 27 countries.

151 sites in 27 countries

United States27 sites

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Ophthalmic Consultants of Boston Inc (OCB)

    Boston, Massachusetts, 02114

  • University of Cincinnati Medical Center

    Cincinnati, Ohio, 45219

  • Tennessee Oncology, PLLC

    Dickson, Tennessee, 37055

  • The University of Kansas Clinical Research Center

    Fairway, Kansas, 66205

  • Tennessee Oncology PLLC

    Franklin, Tennessee, 37067

  • Tennessee Oncology PLLC

    Gallatin, Tennessee, 37066

  • Tenessee Oncology, PLLC

    Hendersonville, Tennessee, 37075

  • Tennessee Oncology PLLC

    Hermitage, Tennessee, 37076

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Tennessee Oncology PLLC

    Lebanon, Tennessee, 37090

  • Tennessee Oncology PLLC

    Murfreesboro, Tennessee, 37129

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37203

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37203

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37205

  • Tennessee Oncology PLLC

    Nashville, Tennessee, 37207

  • Tennessee Oncology, PLLC

    Nashville, Tennessee, 37211

  • AdventHealth Hematology and Oncology

    Orlando, Florida, 32804

  • AdventHealth Orlando Infusion Center

    Orlando, Florida, 32804

  • AdventHealth Orlando, Investigational Drug Services

    Orlando, Florida, 32804

  • The University of Kansas Cancer Center - Overland Park

    Overland Park, Kansas, 66210

  • KU Eye Center

    Prairie Village, Kansas, 66208

  • Tennessee Oncology, PLLC

    Shelbyville, Tennessee, 37160

  • Tennessee Oncology PLLC

    Smyrna, Tennessee, 37167

  • West Chester Hospital

    West Chester, Ohio, 45069

  • The University of Kansas Cancer Center - Investigational Drug Services

    Westwood, Kansas, 66205

  • The University of Kansas Cancer Center

    Westwood, Kansas, 66205

Other trials in United States

Germany22 sites

  • Charité Universitaetsmedizin Berlin - Campus Mitte

    Berlin, 10117

  • Universitätsklinikum Bonn

    Bonn, North Rhine-Westphalia, 53127

  • Universitaetsklinikum Carl Gustav Carus, Technischen Universitaet Dresden

    Dresden, Saxony, 01307

  • HELIOS Klinikum Erfurt

    Erfurt, 99089

  • Universitätsklinikum Essen (AöR)

    Essen, 45147

  • SRH Wald-Klinikum Gera

    Gera, Thuringia, 07548

  • Universitaetsklinikum Halle - Universitaetsklinik und Poliklinik fuer Dermatologie und Venerologie

    Halle, 06120

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel

    Kiel, Schleswig-Holstein, 24105

  • Universitätsklinikum Leipzig

    Leipzig, Saxony, 04103

  • Zentrum fuer Radiologie und Nuklearmedizin am Johannisplatz

    Leipzig, 04103

  • Universitätsklinikum Schleswig-Holstein

    Lübeck, Schleswig-Holstein, 23538

  • Universitätsmedizin Johannes Gutenberg Universität Mainz

    Mainz, Rhineland-Palatinate, 55131

  • Johannes Wesling Klinikum Minden

    Minden, North Rhine-Westphalia, 32429

  • Klinik und Poliklinik für Dermatologie und Allergologie

    München, Bavaria, 80337

  • University Hospital Muenster

    Münster, 48149

  • Fachklinik Hornheide

    Münster, 48157

  • Klinikum Nürnberg Nord

    Nuremberg, 90419

  • Universitätsklinikum Regensburg

    Regensburg, 93053

  • Universitaetsklinikum Tuebingen

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Spain17 sites

  • CHUAC-Hospital Teresa Herrera

    A Coruña, 15006

  • ICO-Badalona Hospital Germans Trias i Pujol

    Badalona, Barcelona, 08916

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

    Barcelona, 08035

  • Hospital Clinic Barcelona

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Universitario Reina Sofía

    Córdoba, 14004

  • Hospital Clinico Universitario Virgen de la Arrixaca

    El Palmar, Murcia, 30120

  • Complejo Hospitalario de Jaen

    Jaén, 23007

  • Hospital Universitario Arnau de Vilanova

    Lleida, 25198

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

  • Hospital Universitario Puerta de Hierro Majadahonda

    Majadahonda, Madrid, 28222

  • Hospital Regional Universitario de Malaga - Hospital Civil

    Málaga, 29011

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Fundacion Instituto Valenciano de Oncologia

    Valencia, 46009

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Italy14 sites

  • Istituto Tumori Giovanni Paolo II

    Bari, 70124

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

    Candiolo, Torino, 10060

  • IRCCS Azienda Ospedaliera Metropolitana (IRCCS AOM)

    Genova, 16132

  • Fondazione IRCCS Istituto Nazionale dei Tumori

    Milan, MI, 20133

  • Istituto Europeo di Oncologia IRCCS

    Milan, 20141

  • Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"

    Naples, 80131

  • Istituto Oncologico Veneto IOV - IRCCS

    Padova, 35128

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

    Perugia, 06132

  • Istituto Dermopatico dell'Immacolata (IDI-IRCCS)

    Roma, RM, 00167

  • Istituto Nazionale Tumori Regina Elena

    Roma, 00144

  • Istituti Fisioterapici Ospitalieri

    Rome, ROMA, 00144

  • Dipartimento di Medicina e Chirurgia dell' Universita

    San Sisto, Perugia, 06132

  • A.O.U.S. Policlinico "Le Scotte"

    Siena, SI, 53100

  • Azienda Sanitaria Universitaria Friuli Centrale

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Brazil7 sites

  • Fundação Pio XII - Hospital de Câncer de Barretos

    Barretos, São Paulo, 14784-400

  • Instituto de Oncologia do Paraná - IOP Matriz Mateus Leme

    Curitiba, Paraná, 80520-174

  • Instituto de Oncologia do Paraná - IOP Oncoville

    Curitiba, Paraná, 82305-100

  • Hospital de Clínicas de Passo Fundo

    Passo Fundo, Rio Grande do Sul, 99010-260

  • Hospital de Clinicas de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-903

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

    Rio de Janeiro, Rio de Janeiro, 20220-410

  • Hospital Sírio-Libanês - Unidade Bela Vista

    São Paulo, 01308-050

Other trials in Brazil

Hungary7 sites

  • Semmelweis Egyetem

    Budapest, 1085

  • Orszagos Onkologiai Intezet

    Budapest, 1122

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • University of Debrecen

    Debrecen, 4032

  • Pécsi Tudományegyetem Klinikai Központ

    Pécs, Baranya, 7632

  • Szent-Gyorgyi Albert Klinikai Kozpont

    Szeged, 6720

  • Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház

    Szolnok, Jász-Nagykun-Szolnok, 5004

Other trials in Hungary

Mexico5 sites

  • ONCARE Viaducto Nápoles

    Benito Juárez, Mexico City, 03810

  • Preparaciones Oncológicas S.C.

    León, Guanajuato, 37178

  • BRCR Global Mexico - CDMX

    Mexico City, 01120

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

    Monterrey, Nuevo León, 64710

  • Boca Clinical Trials Mexico Sc.

    Puebla City, 72160

Other trials in Mexico

Slovakia5 sites

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

    Bratislava, 812 50

  • Narodny onkologicky ustav

    Bratislava, 833 10

  • Vychodoslovensky onkologicky ustav, a.s.

    Košice, 04191

  • Nemocnica na okraji mesta, n.o.

    Partizánske, 95801

  • POKO Poprad, s.r.o.

    Poprad, 058 01

Other trials in Slovakia

South Africa5 sites

  • WCR Office

    Johannesburg, Gauteng, 2193

  • Wits Clinical Research

    Johannesburg, Gauteng, 2193

  • Sandton Oncology Medical Group (Pty) Ltd

    Johannesburg, Gauteng, 2196

  • Drs Alberts, Bouwer and Jordaan Inc.

    Pretoria, Gauteng, 0081

  • Drs Alberts Bouwer Jordaan

    Pretoria

Other trials in South Africa

Bulgaria4 sites

  • Complex Oncology Center - Plovdiv EOOD

    Plovdiv, 4004

  • Medical Center Nadezhda Clinical EOOD

    Sofia, 1373

  • Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD

    Sofia, 1407

  • Umhato Ead

    Sofia, 1756

Other trials in Bulgaria

France4 sites

  • CHU d'Amiens - Hôpital Nord

    Amiens, 80054

  • CHU Grenoble Alpes

    La Tronche, 38700

  • Hôpital Lyon Sud

    Pierre-Bénite, 69310

  • CHU de Poitiers

    Poitiers, 86000

Other trials in France

Russia4 sites

  • Ars Medika Center, LLC

    Kaliningrad, 236006

  • BIH of Omsk Region "Clinical Oncological Dispensary"

    Omsk, 644046

  • Private Medical Institution "Euromedservice"

    Pushkin, Sankt-Peterburg, 196603

  • Eurocityclinic LLC

    Saint Petersburg, 197022

Other trials in Russia

Ukraine4 sites

  • CNI KRC "Regional Cardiology Centre"

    Kharkiv, 61166

  • National Cancer Institute

    Kyiv, 03022

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

    Lviv, 79031

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

    M. Kharkiv, 61103

Other trials in Ukraine

Czechia3 sites

  • Olomouc University Hospital

    Olomouc, Olomouc Region, 779 00

  • Fakultni nemocnice Ostrava

    Ostrava-Poruba, 708 52

  • Fakultni nemocnice Bulovka

    Praha 8-Liben, 180 81

Other trials in Czechia

Poland3 sites

  • Jagiellońskie Centrum Innowacji Sp. z o .o.

    Krakow, 30-348

  • Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu

    Poznan, 60-780

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

    Warsaw, 02-781

Other trials in Poland

Turkey (Türkiye)3 sites

  • Memorial Ankara Hastanesi

    Ankara, 06520

  • Istanbul University Cerrahpasa Medical Faculty Hospital

    Istanbul, İ̇stanbul, 34098

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

    Istanbul, İ̇stanbul, 34722

Other trials in Turkey (Türkiye)

United Kingdom3 sites

  • Barts Health NHS Trust.

    London, E1 1FR

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

    London, EC1A 7BE

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

    Swansea, SA2 8QA

Other trials in United Kingdom

Argentina2 sites

  • Instituto Alexander Fleming

    CABA, Buenos Aires, C1426ANZ

  • Clinica Viedma S. A

    Viedma, Río Negro Province, 8500

Other trials in Argentina

Finland2 sites

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

    Helsinki, 00029

  • Tampereen yliopistollinen sairaala

    Tampere, Pirkanmaa, 33520

Other trials in Finland

Greece2 sites

  • General Hospital of Athens "Laiko"

    Athens, Attikí, 11527

  • Laiko Hospital

    Athens, Attikí, 11527

Other trials in Greece

Israel2 sites

  • Soroka University Medical Center

    Beersheba, 8410101

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

    Jerusalem, 9112001

Other trials in Israel

Austria1 site

  • Medizinische Universität Graz

    Graz, 8036

Other trials in Austria

Belgium1 site

  • Cliniques universitaires Saint-Luc

    Brussels, 1200

Other trials in Belgium

Canada1 site

  • CIUSSS du Saguenay-Lac-Saint-Jean

    Chicoutimi, Quebec, G7H 5H6

Other trials in Canada

New Zealand1 site

  • Palmerston North Hospital

    Palmerston North, Manawatu, 4414

Other trials in New Zealand

Norway1 site

  • Oslo universitetssykehus, Radiumhospitalet

    Oslo, 0379

Other trials in Norway

Switzerland1 site

  • UniversitätsSpital Zürich

    Zürich Flughafen, 8058

Other trials in Switzerland

About this study

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

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.
Read more

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.

Read the detailed description

This study will compare the efficacy, safety, and tolerability of encorafenib and binimetinib plus pembrolizumab (Triplet Arm) versus placebo plus pembrolizumab (Control Arm) in participants with metastatic or unresectable locally advanced BRAF V600E/K mutation-positive melanoma. The study will have an open-label safety lead-in (SLI) phase to determine the safety recommend Phase 3 dose (RP3D) and pharmacokinetics (PK) of encorafenib and binimetinib plus pembrolizumab combination therapy prior to initiation of the randomized Phase 3 part of the study. Two dose levels of encorafenib in combination with binimetinib plus pembrolizumab will be explored in parallel. A minimum of 12 evaluable participants will be enrolled per dose level. During the double-blind randomized Phase 3 part of the study, approximately 216 eligible participants will be randomized in a 1:1 ratio to the Triplet Arm (at RP3D determined in the SLI) or Control Arm (approximately 108 participants per arm). Randomization will be stratified by prior systemic adjuvant therapy and stage of disease by AJCC (ED8).

Conditions
Melanoma
Being tested
Encorafenib, Binimetinib, Pembrolizumab
Keywords
BRAF V600E/K Melanoma, BRAF, Melanoma, Advanced Melanoma, Metastatic Melanoma, Skin Cancer, Advanced Skin Cancer, Starboard, Stage 3 Melanoma, Stage 4 Melanoma, BRAF Melanoma
Medical subject headings
Melanoma, Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EncorafenibDrug

    Also called BRAFTOVI

    Encorafenib

  • BinimetinibDrug

    Also called MEKTOVI

    Binimetinib

  • PembrolizumabDrug

    Also called KEYTRUDA

    Pembrolizumab

Study groups in NCT04657991
Study groupRoleWhat they receive
Triplet ArmExperimentalEncorafenib and Binimetinib in combination with Pembrolizumab
Receives: Drug: Encorafenib; Drug: Binimetinib; Drug: Pembrolizumab
Control ArmActive comparatorPembrolizumab
Receives: Drug: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety Lead In (SLI): Incidence of Dose Limiting Toxicities (DLTs)

    A DLT is defined as any adverse event or laboratory value that is assessed as unrelated to disease, disease progression, intercurrent illness or concomitant medications/therapies occurring within the first 2 cycles of treatment.

    Measured: First 2 Cycles of Treatment (cycles are 21 days)

  2. Phase 3: Objective Response (OR) by Blinded Independent Central Review (BICR)

    OR is defined as confirmed Best Overall response (BOR) of either CR or PR as determined by BICR assessment per RECIST 1.1

    Measured: Time from the date of randomization until documented PD, start of subsequent anticancer therapy, or death due to any cause (approximately every 9 weeks).

Secondary outcomes (14)

  1. Safety Lead in (SLI) and Phase 3: Incidence and severity of Adverse Events (AEs) and changes in clinical laboratory parameters, vital signs, and cardiac assessments.

    AEs, laboratory parameters, vital signs and cardiac abnormalities will be graded according to the National Cancer Institute [NCI] Common Terminology Criteria for Adverse Events [CTCAE], version 4.03).

    Measured: Time from first dose of study intervention through 28 days after the last dose of study intervention.

  2. Safety Lead in (SLI) and Phase 3: Objective Response (OR)

    OR is defined as confirmed Best Overall Response (BOR) of either CR or PR as determined by investigator assessment per RECIST v1.1

    Measured: Time from the date after the first dose of first dose (SLI) or the date of randomization (Phase 3) until documented PD, or start of subsequent anticancer therapy (approximately every 9 weeks).

  3. Safety Lead in (SLI) and Phase 3: Disease Control (DC)

    DC is defined as confirmed BOR of CR, PR or SD, as determined by BICR and investigator assessment per RECIST v1.1.

    Measured: Time from the date after the first dose of first dose (SLI) or the date of randomization (Phase 3) until documented PD, or start of subsequent anticancer therapy (approximately every 9 weeks)

  4. Safety Lead in (SLI) and Phase 3: Time to Response (TTR)

    TTR is defined as the time from the date of randomization to the date of first documented response (CR or PR), as determined by BICR and investigator or assessment per RECIST v1.1.

    Measured: Time from the date of randomization to the date of first documented response (CR or PR), as determined by investigator assessment per RECIST v1 (approximately every 9 weeks)

  5. Phase 3: Overall Survival (OS)

    OS is defined as the time from the date of randomization to the date of death due to any cause

    Measured: Time from the date of randomization to the date of death due to any cause.

  6. Safety Lead In (SLI) and Phase 3: Progression Free Survival (PFS) by Investigator and BICR assessment

    PFS by investigator is defined as the time from the date of randomization to the first date of documented disease progression as determined by investigator and BICR assessment per RECIST 1.1 or death due to any cause, whichever occurs first.

    Measured: The time from the date of randomization to the date of first documented disease progression, as determined by investigator and BICR assessment per RECIST v1.1, or death due to any cause, whichever occurs first (approximately every 9 weeks)

  7. Phase 3: Duration of Response (DOR)

    DOR is defined as the time from the date of first documented response to the date of first documented disease progression, as determined by BICR and investigator assessment or death due to any cause, whichever occurs first.

    Measured: Time from date of first documented response (CR or PR) to the date of first documented disease progression, as determined by BICR and investigator assessment per RECIST v1.1, or death due to any cause, whichever occurs first (approximately every 9 weeks)

  8. Safety Lead in (SLI): Plasma concentration-time profiles and Pharmacokinetic (PK) parameter estimates for encorafenib and binimetinib.

    To measure plasma concentrations of encorafenib and its metabolite (LHY746), and binimetinib and its metabolite (AR00426032)

    Measured: Cycle 2, Day 1

  9. Phase 3: Plasma concentrations of encorafenib and binimetinib.

    To measure the plasma concentrations of encorafenib and its metabolite (LHY746), and binimetinib and its metabolite (AR00426032)

    Measured: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 (Each Cycle is 21 days)

  10. Phase 3: European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 (EORTC QLQ-C30): change from baseline in the global health status/QoL score.

    EORTC QLQ-30 includes 5 functional scales (physical, role, emotional, cognitive and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/Quality of Life scale

    Measured: Day 1 of every 3 cycles: C4D1, C7D1, C10D1, etc. for the first 24 months and then Day 1 of every 4 cycles after 24 months

  11. Phase 3: Change from baseline in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) subscale score.

    The FACT-M is a melanoma-specific quality of life questionnaire that is composed of items from the Functional Assessment of Cancer Therapy-General (FACT-G) questionnaire, melanoma-specific items, and items related to melanoma surgery

    Measured: Day 1 of every 3 cycles: C4D1, C7D1, C10D1, etc. for the first 24 months and then Day 1 of every 4 cycles after 24 months

  12. Phase 3: Change from baseline in 5-level EuroQol-5D (EQ-5D-5L) index score and visual analog scale (VAS)

    The EQ-5D-5L is a standardized measure of health utility that provides a single index value of health status and contains 1 item for each of 5 dimensions of HRQoL (ie, mobility, self-care, usual activities, pain or discomfort, and anxiety or depression).

    Measured: Day 1 of every 3 cycles: C4D1, C7D1, C10D1, etc. for the first 24 months and then Day 1 of every 4 cycles after 24 months

  13. Phase 3: Change from baseline in Patient Global Impression of Severity (PGIS) score

    The PGIS is a single 1-item questionnaire designed to assess participant's overall impression of disease severity at a given point in time by using a 4-point Likert scale that ranges from (1) = "none (no symptoms)" to (4) = "severe".

    Measured: Day 1 of every 3 cycles: C4D1, C7D1, C10D1, etc. for the first 24 months and then Day 1 of every 4 cycles after 24 months

  14. Phase 3: Patient Global Impression of Change (PGIC) score

    The PGIC is a single-item questionnaire designed to assess the participant's overall sense of whether there has been a change since starting treatment as rated on a 5-point Likert scale anchored by (1) "much better" to (5) "much worse", with (4) = "no change"

    Measured: Day 1 of every 3 cycles: C4D1, C7D1, C10D1, etc. for the first 24 months and then Day 1 of every 4 cycles after 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Dec 2020
  2. Study start15 Jan 2021
  3. Primary completion30 Oct 2026 (estimated)
  4. Study completion30 Oct 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
257 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04657991
Sponsor's protocol ID
C4221016
Other IDs
KEYNOTE-B80; STARBOARD, 2024-512038-13-00
Status last verified
Sep 2026
First submitted
1 Dec 2020
Last updated
3 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.

Publications

  • Schadendorf D, Dummer R, Robert C, Ribas A, Sullivan RJ, Panella T, McKean M, Santos ES, Brill K, Polli A, Pietro AD, Ascierto PA. STARBOARD: encorafenib + binimetinib + pembrolizumab for first-line metastatic/unresectable BRAF V600-mutant melanoma. Future Oncol. 2022 Jun;18(17):2041-2051. doi: 10.2217/fon-2021-1486. Epub 2022 Mar 11.

    PubMed 35272485

  • Zimmer L, Livingstone E, Krackhardt A, Schultz ES, Goppner D, Assaf C, Trebing D, Stelter K, Windemuth-Kieselbach C, Ugurel S, Schadendorf D. Encorafenib, binimetinib plus pembrolizumab triplet therapy in patients with advanced BRAFV600 mutant melanoma: safety and tolerability results from the phase I IMMU-TARGET trial. Eur J Cancer. 2021 Nov;158:72-84. doi: 10.1016/j.ejca.2021.09.011. Epub 2021 Oct 13.

    PubMed 34655839

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Encorafenib, Binimetinib and Pembrolizumab in people with Melanoma, run by Pfizer at 151 sites in 27 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 3 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 151 sites in United States, Germany, Spain, Italy, Brazil and 22 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety Lead In (SLI): Incidence of Dose Limiting Toxicities (DLTs) (time frame: First 2 Cycles of Treatment (cycles are 21 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04657991, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Sep 2026.

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