Clinical trial NCT04657991: A Clinical Trial of Three Study Medicines (Encorafenib, Binimetinib, and Pembrolizumab) in Patients With Advanced or Metastatic Melanoma
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Melanoma
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
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
Collaborators: name: Merck Sharp & Dohme LLC
First posted: 2020-12-08
Enrollment: 256
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Safety Lead In (SLI): Incidence of Dose Limiting Toxicities (DLTs)
timeFrame: First 2 Cycles of Treatment (cycles are 21 days)
measure: Phase 3: Objective Response (OR) by Blinded Independent Central Review (BICR)
timeFrame: 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:
measure: 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.
timeFrame: Time from first dose of study intervention through 28 days after the last dose of study intervention.
measure: Safety Lead in (SLI) and Phase 3: Objective Response (OR)
timeFrame: 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).
measure: Safety Lead in (SLI) and Phase 3: Disease Control (DC)
timeFrame: 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)
measure: Safety Lead in (SLI) and Phase 3: Time to Response (TTR)
timeFrame: 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)
measure: Phase 3: Overall Survival (OS)
timeFrame: Time from the date of randomization to the date of death due to any cause.
measure: Safety Lead In (SLI) and Phase 3: Progression Free Survival (PFS) by Investigator and BICR assessment
timeFrame: 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)
measure: Phase 3: Duration of Response (DOR)
timeFrame: 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)
measure: Safety Lead in (SLI): Plasma concentration-time profiles and Pharmacokinetic (PK) parameter estimates for encorafenib and binimetinib.
timeFrame: Cycle 2, Day 1
measure: Phase 3: Plasma concentrations of encorafenib and binimetinib.
timeFrame: Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1 (Each Cycle is 21 days)
measure: 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.
timeFrame: 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
measure: Phase 3: Change from baseline in Functional Assessment of Cancer Therapy-Melanoma (FACT-M) subscale score.
timeFrame: 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
measure: Phase 3: Change from baseline in 5-level EuroQol-5D (EQ-5D-5L) index score and visual analog scale (VAS)
timeFrame: 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
measure: Phase 3: Change from baseline in Patient Global Impression of Severity (PGIS) score
timeFrame: 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
measure: Phase 3: Patient Global Impression of Change (PGIC) score
timeFrame: 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
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA - Hematology/Oncology - Administrative Office
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center Drug Information Center , Dept. of Pharmaceutical Services (Drug
state: California
city: Los Angeles
country: United States
facility: Ronald Reagan UCLA Medical Center, Drug Information Center, Dept. of Pharmaceutical Services (Main O
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Westwood (Building 100)
state: California
city: Aurora
country: United States
facility: UCHealth Sue Anschutz-Rodgers Eye Center
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Denver CTO/CTRC
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital - Anschutz Cancer Pavilion (ACP)
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital - Anschutz Inpatient Pavilion (AIP)
state: Colorado
city: Aurora
country: United States
facility: University of Colorado Hospital - Anschutz Outpatient Pavilion (AOP)
state: Colorado
city: Cape Coral
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando Infusion Center
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando, Investigational Drug Services
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Park Ridge
country: United States
facility: Advocate Medical Group-Park Ridge, Luther Lane-Oncology
state: Illinois
city: Westwood
country: United States
facility: The University of Kansas Cancer Center
state: Kansas
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston Inc (OCB)
state: Massachusetts
city: Farmington Hills
country: United States
facility: Revive Research Institute, Inc.
state: Michigan
city: Farmington Hills
country: United States
facility: Michigan Health Professionals
state: Michigan
city: Billings
country: United States
facility: St. Vincent Healthcare
state: Montana
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center
state: Montana
city: Cincinnati
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: West Chester
country: United States
facility: University of Cincinnati Medical Center
state: Ohio
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Nashville
country: United States
facility: Tennessee Oncology, PLLC
state: Tennessee
city: Carrollton
country: United States
facility: Texas Oncology - Carrollton
state: Texas
city: Flower Mound
country: United States
facility: North Dallas Eye Associates
state: Texas
city: Flower Mound
country: United States
facility: Texas Oncology - Flower Mound
state: Texas
city: Houston
country: United States
facility: Baylor Clinic
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: CHI St. Luke's Health Baylor College of Medicine Medical Center
state: Texas
city: Houston
country: United States
facility: Harris Health System - Ben Taub Hospital
state: Texas
city: Houston
country: United States
facility: Harris Health System - Smith Clinic
state: Texas
city: Paris
country: United States
facility: Dan Brown O.D.
state: Texas
city: Paris
country: United States
facility: Texas Oncology-Paris
state: Texas
city: Temple
country: United States
facility: Baylor Scott & White Medical Center - Temple
state: Texas
city: American Fork
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Bountiful
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Layton
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Murray
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Ogden
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Provo
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Salt Lake City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: West Jordan
country: United States
facility: Utah Cancer Specialists
state: Utah
city: West Valley City
country: United States
facility: Utah Cancer Specialists
state: Utah
city: Caba
country: Argentina
facility: Instituto Alexander Fleming
state: Buenos Aires
city: Viedma
country: Argentina
facility: Clinica Viedma S. A
state: RÍO Negro
city: Rosario
country: Argentina
facility: Instituto de Oncologia de Rosario
state: Santa FE
city: St. Pölten
country: Austria
facility: Universitätsklinikum St. Pölten
state: Niederösterreich
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen
state: Oberösterreich
city: Vienna
country: Austria
facility: Medizinische Universität Wien
state: Wien
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Brussels
country: Belgium
facility: UZ Brussel
state: Bruxelles-capitale, Région DE
city: Gent
country: Belgium
facility: UZ Gent
state: Oost-vlaanderen
city: Brugge
country: Belgium
facility: AZ Sint-Jan Brugge-Oostende AV
state: West-vlaanderen
city: Brussels
country: Belgium
facility: Cliniques universitaires Saint-Luc
city: Haine Saint Paul
country: Belgium
facility: Centre Hospitalier de Jolimont
city: Sint-Niklaas
country: Belgium
facility: VITAZ
city: Curitiba
country: Brazil
facility: Instituto de Oncologia do Paraná - IOP Matriz Mateus Leme
state: Paraná
city: Curitiba
country: Brazil
facility: Instituto de Oncologia do Paraná - IOP Oncoville
state: Paraná
city: Porto Alegre
country: Brazil
facility: Hospital de Clinicas de Porto Alegre
state: RIO Grande DO SUL
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA
state: RJ
city: Passo Fundo
country: Brazil
facility: Hospital de Clínicas de Passo Fundo
state: RS
city: Barretos
country: Brazil
facility: Fundação Pio XII - Hospital de Câncer de Barretos
state: SÃO Paulo
city: São Paulo
country: Brazil
facility: Hospital Sírio-Libanês - Unidade Bela Vista
city: Plovdiv
country: Bulgaria
facility: Complex Oncology Center - Plovdiv EOOD
city: Ruse
country: Bulgaria
facility: Complex Oncology Center-Ruse EOOD
city: Sofia
country: Bulgaria
facility: Medical Center Nadezhda Clinical EOOD
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Multiprofile Hospital for Active Treatment Tokuda EAD
city: Sofia
country: Bulgaria
facility: Umhato Ead
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre-Kingston General Hospital Site
state: Ontario
city: Chicoutimi
country: Canada
facility: CIUSSS du Saguenay-Lac-Saint-Jean
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre - Glen Site
state: Quebec
city: Saskatoon
country: Canada
facility: Saskatoon Cancer Center
state: Saskatchewan
city: Olomouc
country: Czechia
facility: Fakultni nemocnice Olomouc
state: Olomoucký KRAJ
city: Olomouc
country: Czechia
facility: Olomouc University Hospital
state: Olomoucký KRAJ
city: Brno
country: Czechia
facility: Masarykuv Onkologicky Ustav
city: Hradec Kralove
country: Czechia
facility: Fakultni nemocnice Hradec Kralove
city: Ostrava-Poruba
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Praha 2
country: Czechia
facility: Všeobecná fakultní nemocnice
city: Praha 8-Liben
country: Czechia
facility: Fakultni nemocnice Bulovka
city: Tampere
country: Finland
facility: Tampereen yliopistollinen sairaala
state: Pirkanmaa
city: Helsinki
country: Finland
facility: Helsinki University Hospital - Comprehensive Cancer Center (HYKS - Syöpäkeskus)
city: Le Mans
country: France
facility: CHG Le Mans
state: Cedex 9
city: Rouen
country: France
facility: Chu Charles Nicolle
state: Haute-normandie
city: Lille
country: France
facility: CHU de Lille - Hôpital Claude Huriez Service
state: Nord
city: Amiens
country: France
facility: CHU d'Amiens - Hôpital Nord
city: Angers
country: France
facility: CHU d'Angers
city: Bordeaux
country: France
facility: Hôpital Saint André
city: Boulogne-Billancourt
country: France
facility: Hôpital Ambroise Paré
city: Boulogne-Billancourt
country: France
facility: Hôpital Ambroise Paré
city: Dijon Cedex
country: France
facility: CHU de Dijon Bourgogne
city: La Tronche
country: France
facility: CHU Grenoble Alpes
city: Le Mans
country: France
facility: CHG Le Mans
city: Lille
country: France
facility: CHU de Lille - Hôpital Claude Huriez Service
city: Marseille
country: France
facility: Hôpital de la Timone
city: Pierre-Bénite
country: France
facility: Hôpital Lyon Sud
city: Poitiers
country: France
facility: CHU de Poitiers
city: Rouen
country: France
facility: Hôpital Charles Nicolle - CHU de Rouen
city: Saint-Etienne Cedex 2
country: France
facility: CHU de Saint-Etienne - Hôpital Nord
city: Villejuif
country: France
facility: Gustave Roussy
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
state: Baden-württemberg
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen
state: Bayern
city: München
country: Germany
facility: Klinik und Poliklinik für Dermatologie und Allergologie
state: Bayern
city: Buxtehude
country: Germany
facility: Elbe Kliniken Stade-Buxtehude, Klinikum Buxtehude
state: Niedersachsen
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn
state: Nordrhein-westfalen
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
state: Nordrhein-westfalen
city: Mainz
country: Germany
facility: Universitätsmedizin Johannes Gutenberg Universität Mainz
state: Rheinland-pfalz
city: Dresden
country: Germany
facility: Universitaetsklinikum Carl Gustav Carus Dresden
state: Sachsen
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
state: Sachsen
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel
state: Schleswig-holstein
city: Lübeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein
state: Schleswig-holstein
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera
state: Thüringen
city: Berlin
country: Germany
facility: Charité Universitaetsmedizin Berlin - Campus Mitte
city: Berlin
country: Germany
facility: Vivantes Klinikum Neukölln
city: Erfurt
country: Germany
facility: HELIOS Klinikum Erfurt
city: Essen
country: Germany
facility: Universitätsklinikum Essen (AöR)
city: Halle
country: Germany
facility: Universitaetsklinikum Halle - Universitaetsklinik und Poliklinik fuer Dermatologie und Venerologie
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Heidelberg
country: Germany
facility: Universitätsklinikum Heidelberg
city: Muenster
country: Germany
facility: University Hospital Muenster
city: Münster
country: Germany
facility: Fachklinik Hornheide
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Nord
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Athens
country: Greece
facility: General Hospital of Athens "Laiko"
state: Attikí
city: Athens
country: Greece
facility: Laiko Hospital
state: Attikí
city: Piraeus
country: Greece
facility: Metropolitan Hospital
state: Attikí
city: Heraklion
country: Greece
facility: University General Hospital of Heraklion
state: Irakleío
city: Thessaloniki
country: Greece
facility: Bioclinic Thessalonikis Private Clinic Single Member S.A.
state: Kentrikí Makedonía
city: Pécs
country: Hungary
facility: Pécsi Tudományegyetem Klinikai Központ
state: Baranya
city: Budapest
country: Hungary
facility: Semmelweis Egyetem
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont
city: Szeged
country: Hungary
facility: Szent-Gyorgyi Albert Klinikai Kozpont
city: Szolnok
country: Hungary
facility: Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház
city: Afula
country: Israel
facility: Ha'emek Medical Center.
state: Hatsafon
city: Be'er-Sheva
country: Israel
facility: Soroka University Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Organization, Hadassah Medical Center, Ein-Karem
city: Petah Tikva
country: Israel
facility: Rabin Medical Center, Beilinson Hospital
city: Tel Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
city: Tel-Aviv
country: Israel
facility: Tel Aviv Sourasky Medical Center
city: Udine
country: Italy
facility: Azienda Sanitaria Universitaria Friuli Centrale
state: Friuli Venezia Giulia
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori
state: MI
city: Roma
country: Italy
facility: Istituto Dermopatico dell'Immacolata (IDI-IRCCS)
state: RM
city: Siena
country: Italy
facility: A.O.U.S. Policlinico "Le Scotte"
state: SI
city: Candiolo
country: Italy
facility: Istituto di Candiolo IRCCS - Fondazione del Piemonte per l'Oncologia
state: Torino
city: Bari
country: Italy
facility: Istituto Tumori Giovanni Paolo II
city: Genova
country: Italy
facility: IRCCS Ospedale Policlinico San Martino
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia IRCCS
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IOV - IRCCS
city: Perugia
country: Italy
facility: AO di Perugia - Ospedale S. Maria della Misericordia, S.C Oncologia Medica
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
city: Benito Juárez
country: Mexico
facility: ONCARE Viaducto Nápoles
state: Ciudad DE México
city: León
country: Mexico
facility: Preparaciones Oncológicas S.C.
state: Guanajuato
city: Monterrey
country: Mexico
facility: I Can Oncology Center S.A. de C.V.
state: Nuevo LEÓN
city: Ciudad de México
country: Mexico
facility: BRCR Global Mexico - CDMX
city: Puebla
country: Mexico
facility: El Cielo Medical Center RSB, S.C
city: Puebla
country: Mexico
facility: El Cielo Medical Center
city: Christchurch
country: New Zealand
facility: New Zealand Clinical Research (Christchurch)
state: Canterbury
city: Palmerston North
country: New Zealand
facility: Palmerston North Hospital
state: Manawatu
city: Auckland
country: New Zealand
facility: Auckland City Hospital
city: Lørenskog
country: Norway
facility: Akershus Universitetssykehus
state: Akershus
city: Oslo
country: Norway
facility: Oslo universitetssykehus, Radiumhospitalet
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Krakow
country: Poland
facility: Jagiellońskie Centrum Innowacji Sp. z o .o.
city: Krakow
country: Poland
facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie Sp. z o .o.
city: Poznan
country: Poland
facility: Szpital Kliniczny im. Heliodora Święcickiego UM w Poznaniu
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy
city: Pushkin
country: Russian Federation
facility: Private Medical Institution "Euromedservice"
state: Saint-petersburg
city: Kaliningrad
country: Russian Federation
facility: Ars Medika Center, LLC
city: Omsk
country: Russian Federation
facility: BIH of Omsk Region "Clinical Oncological Dispensary"
city: St.Petersburg
country: Russian Federation
facility: Eurocityclinic LLC
city: Banska Bystrica
country: Slovakia
facility: Fakultná nemocnica s poliklinikou F.D. Roosevelta Banská Bystrica
city: Bratislava
country: Slovakia
facility: Onkologicky ustav sv. Alzbety, s.r.o.
city: Bratislava
country: Slovakia
facility: Narodny onkologicky ustav
city: Kosice
country: Slovakia
facility: Vychodoslovensky onkologicky ustav, a.s.
city: Partizanske
country: Slovakia
facility: Nemocnica na okraji mesta, n.o.
city: Poprad
country: Slovakia
facility: POKO Poprad, s.r.o.
city: Johannesburg
country: South Africa
facility: Wits Clinical Research
state: Gauteng
city: Johannesburg
country: South Africa
facility: Sandton Oncology Medical Group (Pty) Ltd
state: Gauteng
city: Pretoria
country: South Africa
facility: Drs Alberts, Bouwer and Jordaan Inc.
state: Gauteng
city: Pretoria
country: South Africa
facility: Mary Potter Oncology Centre
city: Santiago De Compostela
country: Spain
facility: CHUS - Hospital Clinico Universitario
state: A Coruna
city: Badalona
country: Spain
facility: ICO-Badalona Hospital Germans Trias i Pujol
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: El Palmar
country: Spain
facility: Hospital Clinico Universitario Virgen de la Arrixaca
state: Murcia
city: Pamplona
country: Spain
facility: Complejo Hospitalario De Navarra
state: Navarra
city: A Coruña
country: Spain
facility: CHUAC-Hospital Teresa Herrera
city: Barcelona
country: Spain
facility: Hospital Universitari Vall D'Hebron, Servicio de Oncología Médica
city: Barcelona
country: Spain
facility: Hospital Clinic Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Jaen
country: Spain
facility: Complejo Hospitalario de Jaen
city: Lleida
country: Spain
facility: Hospital Universitario Arnau de Vilanova
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañón
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Malaga - Hospital Civil
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Valencia
country: Spain
facility: Fundacion Instituto Valenciano de Oncologia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
city: Winterthur
country: Switzerland
facility: Kantonsspital Winterthur
city: Zürich Flughafen
country: Switzerland
facility: UniversitätsSpital Zürich
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty Hospital
state: İ̇stanbul
city: İstanbul
country: Turkey
facility: Medipol Mega Universite Hastanesi
state: İ̇stanbul
city: Istanbul
country: Turkey
facility: TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
state: İ̇stanbul
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi
city: Ankara
country: Turkey
facility: Ankara Şehir Hastanesi
city: Pliuty Village
country: Ukraine
facility: Medical and diagnostic center of MedX-Ray International Group Limited Liability Company Israeli
state: KYIV Region, Obukhiv District
city: Dnipro
country: Ukraine
facility: Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council
city: Khmelnytskyi
country: Ukraine
facility: Municipal non-profit enterprise Khmelnytsky regional antitumor center of Khmelnytsky regional
city: Kyiv
country: Ukraine
facility: Municipal non-profit enterprise "Kyiv City Clinical Hospital No. 2" of the executive body of the
city: Kyiv
country: Ukraine
facility: National Cancer Institute
city: Lviv
country: Ukraine
facility: Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Oncological Regional Therapeutical
city: M. Kharkiv
country: Ukraine
facility: Derzhavna ustanova Instytut zahalnoi ta nevidkladnoi khirurhii im.V.T.Zaitseva Natsionalnoi akademii
city: M. Kharkiv
country: Ukraine
facility: Komunalne nekomertsiine pidpryiemstvo Kharkivskoi oblasnoi rady "Oblasnyi klinichnyi spetsializovany
city: Zaporizhzhia
country: Ukraine
facility: Municipal non-profit enterprise "Zaporizhzhia Regional Antitumor Center" Zaporizhzhya Regional Counc
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
state: Nottinghamshire
city: London
country: United Kingdom
facility: St. Bartholomew's Hospital, Barts Health NHS Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Swansea
country: United Kingdom
facility: The South West Wales Cancer Institute, Swansea Bay University Health Board
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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 Oct 13;158:72-84. doi: 10.1016/j.ejca.2021.09.011. Online ahead of print.