Clinical trial NCT01763164: Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Unresectable or Metastatic NRAS Mutation-positive Melanoma
Official title: The NEMO Trial (NRAS Melanoma and MEK Inhibitor):A Randomized Phase III, Open Label, Multicenter, Two-arm Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Patients With Advanced Unresectable or Metastatic NRAS Mutation-positive Melanoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metastatic or Unresectable Cutaneous Melanoma
Keywords: Melanoma
Cutaneous melanoma
Skin disease
Skin cancer
Skin Neoplasms
Neoplasm Metastasis
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2013-01-08
Enrollment: 402
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: Two-arm, randomized, prospective, open-label, multi-center, phase III study to compare the efficacy and safety of MEK162 (45 mg BID) versus dacarbazine (1000 mg/m2 IV every 3 weeks) in patients with advanced (Stage IIIC) unresectable or metastatic (Stage IV) NRAS Q61 mutation-positive cutaneous or unknown primary melanoma. The mutation analysis will be performed at a central laboratory. Only those patients with Q61 mutation per central laboratory and meet all eligibility criteria will be randomized. A total of 393 patients will be randomized 2:1 to receive either MEK162 or dacarbazine. Patients will be stratified according to AJCC stage (IIIC, IVM1a, and IVM1b versus IVM1c), ECOG Performance status (0 versus 1) and any prior number of lines of immunotherapy (immunotherapies versus none). This study will use an Interactive Response Technology (IRT). The primary end point of the study is progression-free survival. Key secondary end point is overall survival


Eligibility criteria: Inclusion Criteria:

* Diagnosis of locally advanced, unresectable or metastatic cutaneous or melanoma of unknown primary AJCC Stage IIIC or IV (uveal and mucosal melanoma are excluded)
* Presence of NRAS Q61 mutation in tumor tissue prior to randomization as determined by a Novartis designated central laboratory
* Naïve untreated patients or patients who have progressed on or after any number of prior lines of immunotherapy for unresectable locally advanced or metastatic melanoma
* Evidence of at least one measurable lesion as detected by radiological or photographic methods
* Adequate bone marrow, organ function, cardiac and laboratory parameters
* Normal functioning of daily living activities

Exclusion Criteria:

* Any untreated CNS metastases
* Uveal or mucosal melanoma
* History of or current evidence of retinal vein occlusion (RVO) or risk factors of RVO
* Patients with washout period \< 6 weeks from the last dose of ipilimumab or other immunotherapy.
* Previous systemic chemotherapy for unresectable locally advanced or metastatic melanoma.
* History of Gilbert's syndrome
* Prior therapy with a MEK- inhibitor
* Impaired cardiovascular function or clinically significant cardiovascular diseases
* Uncontrolled arterial hypertension despite medical treatment
* HIV positive or active Hepatitis A or B
* Impairment of gastrointestinal function
* Patients who have undergone major surgery or radiotherapy ≤ 3 weeks prior to starting study drug or who have not recovered from side effects of such procedure;
* Patients with neuromuscular disorders that are associated with elevated CK.
* Pregnant or nursing (lactating) women
* Medical, psychiatric, cognitive or other conditions that may compromise the patient's ability to understand the patient information, give informed consent, comply with the study protocol or complete the study

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Progression-Free Survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
timeFrame: From the date of randomization to the date of the first documented PD or death, whichever occurred first (maximum up to 77 weeks for binimetinib arm; maximum up to 61 weeks for dacarbazine arm)
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: From the date of randomization to the date of death (maximum up to 107 weeks for binimetinib arm; maximum up to 88 weeks for dacarbazine arm)
measure: Overall Response Rate (ORR)
timeFrame: From date of randomization until first documented response of CR or PR (maximum up to 77 weeks for binimetinib arm; maximum up to 61 weeks for dacarbazine arm)
measure: Time to Response (TTR)
timeFrame: From date of randomization until first documented response of CR or PR (maximum up to 77 weeks for binimetinib arm; maximum up to 61 weeks for dacarbazine arm)
measure: Duration of Objective Response (DOR)
timeFrame: From the date of first documented response (CR or PR) to the first documented progression or death (maximum up to 77 weeks for binimetinib arm; maximum up to 61 weeks for dacarbazine arm)
measure: Disease Control Rate (DCR)
timeFrame: From date of randomization until first documented response of CR, PR, SD or non-CR/non-PD (maximum up to 77 weeks for binimetinib arm; maximum up to 61 weeks for dacarbazine arm)
measure: Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: From baseline up to 219.4 weeks for binimetinib arm; From baseline up to 123.9 weeks for dacarbazine arm
measure: Number of Participants With Clinically Notable Hematology Shifts Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.03
timeFrame: From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm
measure: Number of Participants With Clinically Notable Clinical Chemistry/Biochemistry Shifts Based on NCI-CTCAE Grade, Version 4.03
timeFrame: From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm
measure: Number of Participants With Clinically Notable Vital Signs
timeFrame: From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm
measure: Number of Participants With Notable Electrocardiogram (ECG) Values
timeFrame: From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm
measure: Number of Participants With Adverse Events of Special Interest: Cardiac Events
timeFrame: From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm
measure: Number of Participants With Clinically Significant Findings in Physical Examination
timeFrame: From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm
measure: Number of Participants With Adverse Events of Special Interest: Ocular Events
timeFrame: From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm
measure: Plasma Concentration of Binimetinib
timeFrame: Day 1 of Week 1: Pre-dose, 1, 1.5, 2, 10 hours post-dose; Day 1 of Weeks 4, 7: Pre-dose, 1.5 hours post-dose; Day 1 of Weeks 10, 13: Pre-dose
measure: Time to Definitive 10% Deterioration in Global Health Status Score of European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (QLQ-C30)
timeFrame: From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm
measure: Change From Baseline in Global Health Status Score of EORTC QLQ-C30 at Weeks 4, 7, 13, 19, 25, 34, 43, 52, 61, 70, End of Treatment, Safety Follow-up Visit, Post-Treatment Follow-up Visit 1, 2, 3, 4, 5 and 6
timeFrame: Both arms: Baseline, Day 1 Treatment Week (TW) 4,7,13,19,25,34,43,52; Post-treatment follow-up Visit (FUV) 1 to 6; Binimetinib: Day 1 TW61,70; End of treatment (EOT= TW73); Safety FUV=30 days post TW73; Dacarbazine: EOT=TW 57;Safety FUV=30 days post TW57
measure: Change From Baseline in EuroQoL-5 Dimensions- 5 Levels (EQ-5D-5L) Index Score at Weeks 4, 7, 13, 19, 25, 34, 43, 52, 61, 70, End of Treatment, Safety Follow-up Visit, Post-treatment Follow-up Visit 1, 2, 3, 4, 5 and 6
timeFrame: Both arms: Baseline, Day 1 Treatment Week (TW) 4,7,13,19,25,34,43,52; Post-treatment follow-up Visit (FUV) 1 to 6; Binimetinib: Day 1 TW61,70; End of treatment (EOT= TW73); Safety FUV=30 days post TW73; Dacarbazine: EOT=TW 57;Safety FUV=30 days post TW57
measure: Time to Definitive 1 Point Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
timeFrame: From baseline up to 73 weeks 3 days for binimetinib arm; From baseline up to 57 weeks 3 days for dacarbazine arm
measure: Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
timeFrame: For both arms: Baseline, Weeks 4, 7, 10, 13, 16, 19, 22, 25, 28, 31, 34, 37, 40, 43, 46, 49, 52, 55 and 30-day Follow-up For binimetinib only: Weeks 58, 61, 64, 67, 70, 73
measure: Number of Participants With Neuroblastoma RAS Viral (V-ras) Oncogene Homolog (NRAS) Mutation Status at Baseline
timeFrame: Baseline
Other outcomes:
Locations:
city: Fayetteville
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Rogers
country: United States
facility: Highlands Oncology Group
state: Arkansas
city: Altamonte Springs
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Bonita Springs
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Bradenton
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Brandon
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Cape Coral
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Clearwater
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Clearwater
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Fort Myers
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Gainesville
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Hudson
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Inverness
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Largo
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Largo
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Naples
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Naples
country: United States
facility: Florida Cancer Specialists
state: Florida
city: New Port Richey
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Orange City
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Orlando
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Port Charlotte
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Saint Petersburg
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Sarasota
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Sarasota
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Spring Hill
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Tampa
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Tampa
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Tavares
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Venice
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Venice
country: United States
facility: Florida Cancer Specialists
state: Florida
city: Niles
country: United States
facility: Oncology Specialists, SC
state: Illinois
city: Park Ridge
country: United States
facility: Oncology Specialists, SC
state: Illinois
city: Goshen
country: United States
facility: Goshen Center For Cancer Care
state: Indiana
city: Bangor
country: United States
facility: Eastern Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: Harry and Jeannette Weinberg Cancer Institute @Franklin Square
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Bingham Farms
country: United States
facility: Kresge Eye Institute
state: Michigan
city: Detroit
country: United States
facility: Barbara Ann Karmanos Cancer Institute
state: Michigan
city: Detroit
country: United States
facility: Kresge Eye Institute
state: Michigan
city: Farmington Hills
country: United States
facility: Karmanos Cancer Institute of Farmington Hills
state: Michigan
city: Omaha
country: United States
facility: Nebraska Methodist Hospital
state: Nebraska
city: Hackensack
country: United States
facility: Hackensack University Medical Center
state: New Jersey
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center
state: New Jersey
city: Voorhees
country: United States
facility: Cooper University Hospital
state: New Jersey
city: Columbus
country: United States
facility: The Ohio State University James Cancer Hospital
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Martha Morehouse Medical Plaza
state: Ohio
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
city: Portland
country: United States
facility: Kaiser Permanente Northwest Region Oncology/Hematology
state: Oregon
city: Portland
country: United States
facility: OHSU Center for Health and Healing
state: Oregon
city: Portland
country: United States
facility: OHSU
state: Oregon
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Allentown
country: United States
facility: Cancer Center Associates - Medical Oncology
state: Pennsylvania
city: Allentown
country: United States
facility: St. Luke's Cancer Center - Allentown Campus
state: Pennsylvania
city: Allentown
country: United States
facility: St. Luke's Hospital - Allentown Campus
state: Pennsylvania
city: Bethlehem
country: United States
facility: Cancer Center Associates - Medical Oncology
state: Pennsylvania
city: Bethlehem
country: United States
facility: St. Luke's University Hospital - Bethlehem Campus
state: Pennsylvania
city: Easton
country: United States
facility: St. Luke's Cancer Center - Anderson Campus
state: Pennsylvania
city: Hershey
country: United States
facility: Penn State Milton S. Hershey Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson Medical Oncology
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Quakertown
country: United States
facility: St. Luke's Hospital - Quakertown Campus
state: Pennsylvania
city: Nashville
country: United States
facility: Sarah Cannon Research Institute
state: Tennessee
city: Austin
country: United States
facility: Texas Oncology-Austin Central
state: Texas
city: Dallas
country: United States
facility: Elliot J. Ginchansky, MD, PA
state: Texas
city: Dallas
country: United States
facility: Dennis B. Kay
state: Texas
city: Dallas
country: United States
facility: Parkland Memorial Hospital
state: Texas
city: Dallas
country: United States
facility: UT Southwestern University Hospital- St. Paul
state: Texas
city: Dallas
country: United States
facility: Texas Oncology-Baylor Charles A. Sammons Cancer Center
state: Texas
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
city: Dallas
country: United States
facility: UT Southwestern University Hospital - Zale Lipshy
state: Texas
city: Fort Worth
country: United States
facility: US Oncology
state: Texas
city: The Woodlands
country: United States
facility: US Oncology
state: Texas
city: Buenos Aires
country: Argentina
facility: Sanatorio de La Providencia
state: Ciudad Autónoma DE Buenosaires
city: Viedma
country: Argentina
facility: Centro de Investigación Clínica ? Clínica Viedma
state: RÍO Negro
city: Rosario
country: Argentina
facility: Centro Oncologico de Rosario
state: Santa FE
city: Buenos Aires
country: Argentina
facility: Fundacion CIDEA
city: Camperdown
country: Australia
facility: Chris O'Brien Lifehouse Hospital
state: New South Wales
city: Gateshead
country: Australia
facility: Lake Macquarie Private Hospital
state: New South Wales
city: North Sydney
country: Australia
facility: Melanoma Institute Australia
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital
state: South Australia
city: Graz
country: Austria
facility: LKH-Universitätsklinikum Klinikum Graz
state: Steiermark
city: Innsbruck
country: Austria
facility: Universitätsklinikum Innsbruck
state: Tirol
city: Salzburg
country: Austria
facility: Salzburger Landeskliniken
city: Vienna
country: Austria
facility: Allgemeines Krankenhaus der Stadt Wien
city: Wilrijk
country: Belgium
facility: Sint-Augustinuskliniek
state: Antwerpen
city: Leuven
country: Belgium
facility: UZ Gasthuisberg
city: Liege
country: Belgium
facility: CHU Sart Tilman
city: Passo Fundo
country: Brazil
facility: Hospital de Clinicas de Passo Fundo
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: RIO Grande DO SUL
city: Porto Alegre
country: Brazil
facility: Hospital Moinhos de Vento
state: RIO Grande DO SUL
city: Rio de Janeiro
country: Brazil
facility: INCA Instituto Nacional de Cancer
city: Sao Paulo
country: Brazil
facility: Hospital São José
city: Edmonton
country: Canada
facility: Alberta Health Services - Cross Cancer Institute
state: Alberta
city: London
country: Canada
facility: London Regional Cancer Program
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Research Institute Centre
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Center / Royal Victoria Hospital
state: Quebec
city: Quebec
country: Canada
facility: CHU de Quebec - L'Hotel-Dieu de Quebec
city: Brno
country: Czechia
facility: Mou/Mmci - Ppds
state: Jihomoravský KRAJ
city: Ostrava
country: Czechia
facility: Fakultni nemocnice Ostrava
city: Praha 10
country: Czechia
facility: Fakultni nemocnice Kralovske Vinohrady
city: Praha 2
country: Czechia
facility: Vseobecna Fakultni Nemocnice V Praze
city: Angers
country: France
facility: CHU Angers
state: Maine-et-loire
city: Lille
country: France
facility: CHRU de Lille - Hôpital Huriet
state: Nord
city: Lyon
country: France
facility: Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
state: Rhône
city: Bordeaux
country: France
facility: Hôpital Saint-André
city: Boulogne Billancourt
country: France
facility: Centre Hospitalier Universitaire Ambroise Pare
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans
city: Marseille
country: France
facility: Hopitaux de La Timone
city: Nice
country: France
facility: Groupe Hospitalier Archet I Et II
city: Paris
country: France
facility: Hôpital Saint Louis
city: Pierre Benite
country: France
facility: Service de PneumologieCHU Lyon Sud
city: Reims
country: France
facility: Hôpital Robert Debré
city: Rouen
country: France
facility: Centre Hospitalier Universitaire Hopitaux de Rouen
city: Freiburg im Breisgau
country: Germany
facility: Universitaetsklinikum Freiburg
state: Baden-württemberg
city: Mannheim
country: Germany
facility: Klinikum Mannheim Universitätsklinikum gGmbH
state: Baden-württemberg
city: München
country: Germany
facility: LMU Klinikum der Universität München
state: Bayern
city: Regensburg
country: Germany
facility: University Clinic Regensburg - PPDS
state: Bayern
city: Würzburg
country: Germany
facility: Universitätsklinikum Würzburg
state: Bayern
city: Frankfurt
country: Germany
facility: Institut für Diagnostische und Interventionelle Radiologie Frankfurt
state: Hessen
city: Frankfurt
country: Germany
facility: Universitätsklinikum Frankfurt
state: Hessen
city: Buxtehude
country: Germany
facility: Elben Klinken Stade Buxtehude
state: Niedersachsen
city: Minden
country: Germany
facility: Johannes Wesling Klinikum Minden
state: Nordrhein-westfalen
city: Quedlinburg
country: Germany
facility: Klinikum Dorothea Christiane Erxleben Quedlinburg GmbH
state: Sachsen-anhalt
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig
state: Sachsen
city: Berlin
country: Germany
facility: Charite Campus Mitte
state: Schleswig-holstein
city: Erfurt
country: Germany
facility: Helios Klinikum Erfurt
state: Thüringen
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus an der TU Dresden
city: Essen
country: Germany
facility: Universitätsklinikum Essen
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera GmbH
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover (Hannover Medical School)
city: Heidelberg
country: Germany
facility: University Clinic Heidelberg - PPDS
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig-Holstein
city: Koeln
country: Germany
facility: Uniklinik Köln
city: Lübeck
country: Germany
facility: Universitatsklinikum Schleswig-Holstein
city: Münster
country: Germany
facility: Fachklinik Hornheide
city: Nürnberg
country: Germany
facility: Klinikum Nuernberg Nord
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen
city: Ulm
country: Germany
facility: Universit*ätsklinikum Ulm
city: Athens
country: Greece
facility: Laiko General Hospital of Athens
city: Budapest
country: Hungary
facility: Magyar Honvédség Egészségügyi Központ
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet
city: Kaposvár
country: Hungary
facility: Somogy Megyei Kaposi Mór Oktató Kórház
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
city: Haifa
country: Israel
facility: Rambam Medical Center - PPDS
city: Jerusalem
country: Israel
facility: Hadassah Medical Center - PPDS
city: Ramat Gan
country: Israel
facility: Sheba Medical Center - PPDS
city: Napoli
country: Italy
facility: AOU dell'Università degli Studi della Campania Luigi Vanvitelli
state: Campania
city: Roma
country: Italy
facility: Istituto Dermopatico dell'Immacolata IRCCS
state: Lazio
city: Brescia
country: Italy
facility: ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
state: Lombardia
city: Napoli
country: Italy
facility: Istituto Nazionale per lo studio e la cura dei tumori Fondazione Giovanni Pascale
state: Naples
city: Padova
country: Italy
facility: Istituto Oncologico Veneto - I.R.C.C.S.
state: Veneto
city: Bari
country: Italy
facility: IRCCS Giovanni Paolo II Istituto Oncologico
city: Bergamo
country: Italy
facility: ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII
city: Genova
country: Italy
facility: IRCCS Az. Osp. Universitaria San Martino- IST
city: Milano
country: Italy
facility: Ospedale San Raffaele S.r.l. - PPDS
city: Milano
country: Italy
facility: Fondazione IRCCS 'Istituto Nazionale dei Tumori' di Milano
city: Roma
country: Italy
facility: Istituto Nazionale Tumori Regina Elena
city: Siena
country: Italy
facility: Azienza Ospedaliera Universitaria Senese
city: Torino
country: Italy
facility: A.O.U. Città della Salute e della Scienza di Torino - Presidio S. Lazzaro
city: Matsumoto
country: Japan
facility: Shinshu University Hospital
state: Nagano
city: Chuo-ku
country: Japan
facility: National Cancer Center Hospital
city: Hirakata-city
country: Japan
facility: Kansai Medical University Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center - PPDS
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center - PPDS
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System - PPDS
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
state: Gelderland
city: Amsterdam
country: Netherlands
facility: Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
state: Noord-holland
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum
state: Zuid-holland
city: Zwolle
country: Netherlands
facility: Isala Klinieken
city: Warszawa
country: Poland
facility: Centrum Medyczne MAVIT Sp. z o.o.
state: Mazowieckie
city: Warszawa
country: Poland
facility: Lux Med
city: Warszawa
country: Poland
facility: Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie
city: Lisbon
country: Portugal
facility: Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
state: Lisboa
city: Almada
country: Portugal
facility: Hospital Garcia de Orta*E.P.E.
city: Lisboa
country: Portugal
facility: Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
city: Porto
country: Portugal
facility: Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
city: Moscow
country: Russian Federation
facility: Russian Oncology Research Center n a N N Blokhin
city: Ryazan
country: Russian Federation
facility: Ryazan Regional Clinical Oncology Dispensary
city: St. Petersburg
country: Russian Federation
facility: Scientific Research Institute of Oncology n.a. N.N. Petrov
city: Bratislava
country: Slovakia
facility: Narodny onkologicky ustav
city: Bloemfontein
country: South Africa
facility: University of The Free State
state: FREE State
city: Johannesburg
country: South Africa
facility: Sandton Oncology Medical Group
state: Gauteng
city: Johannesburg
country: South Africa
facility: Sandton Oncology Medical Research
state: Gauteng
city: Pretoria
country: South Africa
facility: Steve Biko Academic Hospital
state: Gauteng
city: Pretoria
country: South Africa
facility: Mary Potter Oncology Centre
state: Gauteng
city: L'Hospitalet de Llobregat
country: Spain
facility: ICO l'Hospitalet - Hospital Duran i Reynals
state: Barcelona
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga Hospital General
state: Málaga
city: Pamplona
country: Spain
facility: Clinica Universidad Navarra
state: Navarra
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebrón - PPDS
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
city: Barcelona
country: Spain
facility: ICO l'Hospitalet - Hospital Duran i Reynals
city: Gran Canaria
country: Spain
facility: Complejo Hospitalario Universitario Insular - Materno Infantil
city: La Coruna
country: Spain
facility: Hospital Universitario A Coruña
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Madrid
country: Spain
facility: MD Anderson Cancer Center
city: Madrid
country: Spain
facility: Hospital Universitario Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital Universitario HM Sanchinarro - CIOCC
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Toledo
country: Spain
facility: Hospital Virgen de La Salud
city: Valencia
country: Spain
facility: Fundacion Instituto Valenciano de Oncologia
city: Valencia
country: Spain
facility: Consorcio Hospital General Universitario de Valencia
city: Lund
country: Sweden
facility: Skanes Universitetssjukhus Lund
state: Skane LAN
city: Lund
country: Sweden
facility: Skanes Universitetssjukhus Lund
city: Zurich
country: Switzerland
facility: Universitätsspital Zürich
state: Zürich (DE)
city: Genève
country: Switzerland
facility: Hôpitaux Universitaires de Genève
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
city: Bornova
country: Turkey
facility: Ege University Medical Faculty
state: Izmir
city: Adana
country: Turkey
facility: Adana Ba?kent Hastanesi K??la Yerle?kesi
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Ankara
country: Turkey
facility: Baskent University Medical Faculty Ankara Hospital
city: Istanbul
country: Turkey
facility: Istanbul University Cerrahpasa Medical Faculty Hospital
city: Bristol
country: United Kingdom
facility: Bristol Haematology and Oncology Centre
state: Bristol, CITY OF
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
state: Cornwall
city: Brighton
country: United Kingdom
facility: The Royal Sussex County Hospital
state: EAST Sussex
city: Chelmsford
country: United Kingdom
facility: Broomfield Hospital
state: Essex
city: Swansea
country: United Kingdom
facility: Singleton Hospital - PPDS
state: Glamorgan
city: Preston
country: United Kingdom
facility: Royal Preston Hospital
state: Lancashire
city: London
country: United Kingdom
facility: Royal Marsden Hospital - Surrey
state: London, CITY OF
city: Birmingham
country: United Kingdom
facility: Queen Elizabeth Hospital
city: Leeds
country: United Kingdom
facility: St James s Institute of Clinical Oncology
city: Wirral
country: United Kingdom
facility: Clatterbridge Hospital
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Dummer R, Schadendorf D, Ascierto PA, Arance A, Dutriaux C, Di Giacomo AM, Rutkowski P, Del Vecchio M, Gutzmer R, Mandala M, Thomas L, Demidov L, Garbe C, Hogg D, Liszkay G, Queirolo P, Wasserman E, Ford J, Weill M, Sirulnik LA, Jehl V, Bozon V, Long GV, Flaherty K. Binimetinib versus dacarbazine in patients with advanced NRAS-mutant melanoma (NEMO): a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Apr;18(4):435-445. doi: 10.1016/S1470-2045(17)30180-8. Epub 2017 Mar 9.