Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Unresectable or Metastatic NRAS Mutation-positive Melanoma
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
3 other identifiers
interventional
402
26 countries
224
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2013
Longer than P75 for phase_3
224 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 4, 2013
CompletedFirst Posted
Study publicly available on registry
January 8, 2013
CompletedStudy Start
First participant enrolled
July 12, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 4, 2019
CompletedResults Posted
Study results publicly available
March 22, 2021
CompletedMarch 22, 2021
March 1, 2021
2.4 years
January 4, 2013
February 11, 2021
March 18, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression-Free Survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1
PFS: time from randomization to first documented PD or death due to any cause, whichever occurred first. RECIST 1.1, PD: \>=20% increase in sum of diameter of target lesions (TLs) taking as reference the smallest sum on study (including baseline sum), sum must also be an absolute increase of \>=5 mm; unequivocal progression of existing non-TLs; appearance of \>=1 lesion. Complete response (CR): disappearance of all lesions; any pathological lymph nodes (TLs) or non-pathological (non-TLs) must have reduction in short axis to \<10 mm; normalization of tumor marker level for non-TLs. Partial response (PR): \>=30% decrease in sum of diameter of all TLs, referring baseline sum of diameters. Stable disease (SD): neither sufficient shrinkage to qualify for PR nor increase in lesions qualified for PD referring smallest sum diameter. With no event at time of analysis cut-off or at start of any new anti-neoplastic therapy, PFS censored at date of last adequate tumor assessment of CR, PR or SD.
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 (20)
Overall Survival (OS)
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)
Overall Response Rate (ORR)
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)
Time to Response (TTR)
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)
Duration of Objective Response (DOR)
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)
Disease Control Rate (DCR)
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)
- +15 more secondary outcomes
Study Arms (2)
MEK162
EXPERIMENTALDacarbazine
ACTIVE COMPARATORInterventions
MEK162 will be administered as a fixed dose of 45 mg (3 x 15 mg tablets) BID, with a glass of water and taken with or without food.
Patients randomized to dacarbazine will receive an IV infusion of dacarbazine 1000 mg/m2 over the course of 1 hour on day 1 and then every three weeks.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (229)
Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
Highlands Oncology Group
Rogers, Arkansas, 72758, United States
Florida Cancer Specialists
Altamonte Springs, Florida, 32701, United States
Florida Cancer Specialists
Bonita Springs, Florida, 34135, United States
Florida Cancer Specialists
Bradenton, Florida, 34209, United States
Florida Cancer Specialists
Brandon, Florida, 33511, United States
Florida Cancer Specialists
Cape Coral, Florida, 33914, United States
Florida Cancer Specialists
Clearwater, Florida, 33756, United States
Florida Cancer Specialists
Clearwater, Florida, 33761, United States
Florida Cancer Specialists
Fort Myers, Florida, 33905, United States
Florida Cancer Specialists
Fort Myers, Florida, 33908, United States
Florida Cancer Specialists
Gainesville, Florida, 32605, United States
Florida Cancer Specialists
Hudson, Florida, 34667, United States
Florida Cancer Specialists
Inverness, Florida, 34453, United States
Florida Cancer Specialists
Largo, Florida, 33770, United States
Florida Cancer Specialists
Largo, Florida, 33777, United States
Florida Cancer Specialists
Naples, Florida, 34102, United States
Florida Cancer Specialists
Naples, Florida, 34119, United States
Florida Cancer Specialists
New Port Richey, Florida, 34655, United States
Florida Cancer Specialists
Orange City, Florida, 32763, United States
Florida Cancer Specialists
Orlando, Florida, 32806, United States
Florida Cancer Specialists
Port Charlotte, Florida, 33980, United States
Florida Cancer Specialists
Sarasota, Florida, 34232, United States
Florida Cancer Specialists
Sarasota, Florida, 34236, United States
Florida Cancer Specialists
Spring Hill, Florida, 34608, United States
Florida Cancer Specialists
St. Petersburg, Florida, 33705, United States
Florida Cancer Specialists
St. Petersburg, Florida, 33707, United States
Florida Cancer Specialists
Tampa, Florida, 33607, United States
Florida Cancer Specialists
Tampa, Florida, 33613, United States
Florida Cancer Specialists
Tavares, Florida, 32778, United States
Florida Cancer Specialists
Venice, Florida, 34285, United States
Florida Cancer Specialists
Venice, Florida, 34292, United States
Oncology Specialists, SC
Niles, Illinois, 60714, United States
Oncology Specialists, SC
Park Ridge, Illinois, 60068, United States
Goshen Center For Cancer Care
Goshen, Indiana, 46526, United States
Eastern Maine Medical Center
Bangor, Maine, 04401, United States
Harry and Jeannette Weinberg Cancer Institute @Franklin Square
Baltimore, Maryland, 21237, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Kresge Eye Institute
Bingham Farms, Michigan, 48025, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
Kresge Eye Institute
Detroit, Michigan, 48201, United States
Karmanos Cancer Institute of Farmington Hills
Farmington Hills, Michigan, 48334, United States
Nebraska Methodist Hospital
Omaha, Nebraska, 68114, United States
Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
John Theurer Cancer Center at Hackensack University Medical Center
Hackensack, New Jersey, 07601, United States
Cooper University Hospital
Voorhees Township, New Jersey, 08043, United States
The Ohio State University James Cancer Hospital
Columbus, Ohio, 43210, United States
The Ohio State University Martha Morehouse Medical Plaza
Columbus, Ohio, 43221, United States
OHSU Knight Cancer Institute
Portland, Oregon, 97201, United States
Kaiser Permanente Northwest Region Oncology/Hematology
Portland, Oregon, 97227, United States
OHSU Center for Health and Healing
Portland, Oregon, 97239, United States
OHSU
Portland, Oregon, 97239, United States
Oregon Health and Science University
Portland, Oregon, 97239, United States
Cancer Center Associates - Medical Oncology
Allentown, Pennsylvania, 18104, United States
St. Luke's Cancer Center - Allentown Campus
Allentown, Pennsylvania, 18104, United States
St. Luke's Hospital - Allentown Campus
Allentown, Pennsylvania, 18104, United States
Cancer Center Associates - Medical Oncology
Bethlehem, Pennsylvania, 18015, United States
St. Luke's University Hospital - Bethlehem Campus
Bethlehem, Pennsylvania, 18015, United States
St. Luke's Cancer Center - Anderson Campus
Easton, Pennsylvania, 18045, United States
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033, United States
Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson Medical Oncology
Philadelphia, Pennsylvania, 19107, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
St. Luke's Hospital - Quakertown Campus
Quakertown, Pennsylvania, 18951, United States
Sarah Cannon Research Institute
Nashville, Tennessee, 37203, United States
Texas Oncology-Austin Central
Austin, Texas, 78731, United States
Elliot J. Ginchansky, MD, PA
Dallas, Texas, 75230, United States
Dennis B. Kay
Dallas, Texas, 75231, United States
Parkland Memorial Hospital
Dallas, Texas, 75235, United States
UT Southwestern University Hospital- St. Paul
Dallas, Texas, 75235, United States
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, 75390, United States
UT Southwestern University Hospital - Zale Lipshy
Dallas, Texas, 75390, United States
US Oncology
Fort Worth, Texas, 76177-3204, United States
US Oncology
The Woodlands, Texas, 77380, United States
Sanatorio de La Providencia
Buenos Aires, Ciudad Autónoma de Buenosaires, C1050AAK, Argentina
Centro de Investigación Clínica ? Clínica Viedma
Viedma, Río Negro Province, 08500, Argentina
Centro Oncologico de Rosario
Rosario, Santa Fe Province, S2000KZE, Argentina
Fundacion CIDEA
Buenos Aires, C1125ABE, Argentina
Chris O'Brien Lifehouse Hospital
Camperdown, New South Wales, 2050, Australia
Lake Macquarie Private Hospital
Gateshead, New South Wales, 02290, Australia
Melanoma Institute Australia
North Sydney, New South Wales, 2060, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 05000, Australia
LKH-Universitätsklinikum Klinikum Graz
Graz, Styria, 08036, Austria
Universitätsklinikum Innsbruck
Innsbruck, Tyrol, 06020, Austria
Salzburger Landeskliniken
Salzburg, 05020, Austria
Allgemeines Krankenhaus der Stadt Wien
Vienna, 01090, Austria
Sint-Augustinuskliniek
Wilrijk, Antwerpen, 2610, Belgium
UZ Gasthuisberg
Leuven, 03000, Belgium
CHU Sart Tilman
Liège, 04000, Belgium
Hospital de Clinicas de Passo Fundo
Passo Fundo, Rio Grande do Sul, 99010-260, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90560-030, Brazil
INCA Instituto Nacional de Cancer
Rio de Janeiro, 20220410, Brazil
Hospital São José
São Paulo, 01321-001, Brazil
Alberta Health Services - Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
Sunnybrook Research Institute Centre
Toronto, Ontario, M4N 3M5, Canada
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 2M9, Canada
McGill University Health Center / Royal Victoria Hospital
Montreal, Quebec, H4A 3J1, Canada
CHU de Quebec - L'Hotel-Dieu de Quebec
Québec, G1R 2J6, Canada
Mou/Mmci - Ppds
Brno, South Moravian, 656 53, Czechia
Fakultni nemocnice Ostrava
Ostrava, 708 52, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
Vseobecna Fakultni Nemocnice V Praze
Prague, 128 08, Czechia
CHU Angers
Angers, Maine-et-loire, 49033, France
CHRU de Lille - Hôpital Huriet
Lille, NORD, 59037, France
Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
Lyon, Rhône, 69373, France
Hôpital Saint-André
Bordeaux, 33000, France
Centre Hospitalier Universitaire Ambroise Pare
Boulogne-Billancourt, 92100, France
Centre Hospitalier Le Mans
Le Mans, 72037, France
Hopitaux de La Timone
Marseille, 13385, France
Groupe Hospitalier Archet I Et II
Nice, 06202, France
Hôpital Saint Louis
Paris, 75010, France
Service de PneumologieCHU Lyon Sud
Pierre-Bénite, 69495, France
Hôpital Robert Debré
Reims, 51092, France
Centre Hospitalier Universitaire Hopitaux de Rouen
Rouen, 76031, France
Universitaetsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, 79104, Germany
Klinikum Mannheim Universitätsklinikum gGmbH
Mannheim, Baden-Wurttemberg, 68135, Germany
LMU Klinikum der Universität München
München, Bavaria, 80337, Germany
University Clinic Regensburg - PPDS
Regensburg, Bavaria, 93053, Germany
Universitätsklinikum Würzburg
Würzburg, Bavaria, 97080, Germany
Institut für Diagnostische und Interventionelle Radiologie Frankfurt
Frankfurt am Main, Hesse, 60590, Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, Hesse, 60590, Germany
Elben Klinken Stade Buxtehude
Buxtehude, Lower Saxony, 21614, Germany
Johannes Wesling Klinikum Minden
Minden, North Rhine-Westphalia, 32429, Germany
Universitatsklinikum Leipzig
Leipzig, Saxony, 04103, Germany
Klinikum Dorothea Christiane Erxleben Quedlinburg GmbH
Quedlinburg, Saxony-Anhalt, 06484, Germany
Charite Campus Mitte
Berlin, Schleswig-Holstein, 10117, Germany
Helios Klinikum Erfurt
Erfurt, Thuringia, 99089, Germany
Uniklinik Köln
Cologne, 50937, Germany
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, 01307, Germany
Universitätsklinikum Essen
Essen, 45147, Germany
SRH Wald-Klinikum Gera GmbH
Gera, 07548, Germany
Medizinische Hochschule Hannover (Hannover Medical School)
Hanover, 30625, Germany
University Clinic Heidelberg - PPDS
Heidelberg, 69120, Germany
Universitatsklinikum Schleswig-Holstein
Kiel, 24105, Germany
Universitatsklinikum Schleswig-Holstein
Lübeck, 23538, Germany
Fachklinik Hornheide
Münster, 48157, Germany
Klinikum Nuernberg Nord
Nuremberg, 90419, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
Universit*ätsklinikum Ulm
Ulm, 89081, Germany
Laiko General Hospital of Athens
Athens, 115 27, Greece
Magyar Honvédség Egészségügyi Központ
Budapest, 01062, Hungary
Orszagos Onkologiai Intezet
Budapest, H-1122, Hungary
Somogy Megyei Kaposi Mór Oktató Kórház
Kaposvár, 07400, Hungary
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet
Szolnok, 05004, Hungary
Rambam Medical Center - PPDS
Haifa, 3109601, Israel
Hadassah Medical Center - PPDS
Jerusalem, 91120, Israel
Sheba Medical Center - PPDS
Ramat Gan, 5262100, Israel
AOU dell'Università degli Studi della Campania Luigi Vanvitelli
Napoli, Campania, 80138, Italy
Istituto Dermopatico dell'Immacolata IRCCS
Rome, Lazio, 00167, Italy
ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia
Brescia, Lombardy, 25123, Italy
Istituto Nazionale per lo studio e la cura dei tumori Fondazione Giovanni Pascale
Napoli, Naples, 80131, Italy
Istituto Oncologico Veneto - I.R.C.C.S.
Padua, Veneto, 35128, Italy
IRCCS Giovanni Paolo II Istituto Oncologico
Bari, 70126, Italy
ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII
Bergamo, 24129, Italy
IRCCS Az. Osp. Universitaria San Martino- IST
Genova, 16132, Italy
Ospedale San Raffaele S.r.l. - PPDS
Milan, 20132, Italy
Fondazione IRCCS 'Istituto Nazionale dei Tumori' di Milano
Milan, 20133, Italy
Istituto Nazionale Tumori Regina Elena
Roma, 00144, Italy
Azienza Ospedaliera Universitaria Senese
Siena, 53100, Italy
A.O.U. Città della Salute e della Scienza di Torino - Presidio S. Lazzaro
Torino, 10126, Italy
Shinshu University Hospital
Matsumoto, Nagano, 390-8621, Japan
National Cancer Center Hospital
Chūōku, 1040045, Japan
Kansai Medical University Hospital
Hirakata, 573-1191, Japan
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, 6525 GA, Netherlands
Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis
Amsterdam, North Holland, 1066 CX, Netherlands
Leids Universitair Medisch Centrum
Leiden, South Holland, 2333ZA, Netherlands
Isala Klinieken
Zwolle, 8025 AB, Netherlands
Centrum Medyczne MAVIT Sp. z o.o.
Warsaw, Masovian Voivodeship, 01-673, Poland
Lux Med
Warsaw, 02-676, Poland
Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie
Warsaw, 02-781, Poland
Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
Lisbon, Lisbon District, 1099-023, Portugal
Hospital Garcia de Orta*E.P.E.
Almada, 2801-951, Portugal
Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
Lisbon, 1649-035, Portugal
Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
Porto, 4200-072, Portugal
Russian Oncology Research Center n a N N Blokhin
Moscow, 115478, Russia
Ryazan Regional Clinical Oncology Dispensary
Ryazan, 390011, Russia
Scientific Research Institute of Oncology n.a. N.N. Petrov
Saint Petersburg, 197758, Russia
Narodny onkologicky ustav
Bratislava, 833 01, Slovakia
University of The Free State
Bloemfontein, Free State, 09301, South Africa
Sandton Oncology Medical Group
Johannesburg, Gauteng, 02196, South Africa
Sandton Oncology Medical Research
Johannesburg, Gauteng, 02199, South Africa
Steve Biko Academic Hospital
Pretoria, Gauteng, 00002, South Africa
Mary Potter Oncology Centre
Pretoria, Gauteng, 00027, South Africa
Asan Medical Center - PPDS
Seoul, 05505, South Korea
Samsung Medical Center - PPDS
Seoul, 06351, South Korea
Seoul National University Hospital
Seoul, 110-744, South Korea
Severance Hospital Yonsei University Health System - PPDS
Seoul, 3722, South Korea
ICO l'Hospitalet - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Regional Universitario de Malaga Hospital General
Málaga, Málaga, 29010, Spain
Clinica Universidad Navarra
Pamplona, Navarre, 31008, Spain
Hospital Universitario A Coruña
A Coruña, 15006, Spain
Hospital Universitario Vall d'Hebrón - PPDS
Barcelona, 08035, Spain
Hospital Clinic de Barcelona
Barcelona, 08036, Spain
ICO l'Hospitalet - Hospital Duran i Reynals
Barcelona, 08907, Spain
Complejo Hospitalario Universitario Insular - Materno Infantil
Gran Canaria, 35001, Spain
Hospital General Universitario Gregorio Maranon
Madrid, 28009, Spain
MD Anderson Cancer Center
Madrid, 28033, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Hospital Universitario HM Sanchinarro - CIOCC
Madrid, 28050, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Virgen de La Salud
Toledo, 45004, Spain
Fundacion Instituto Valenciano de Oncologia
Valencia, 46009, Spain
Consorcio Hospital General Universitario de Valencia
Valencia, 46014, Spain
Skanes Universitetssjukhus Lund
Lund, Skåne County, Sweden
Skanes Universitetssjukhus Lund
Lund, 221 85, Sweden
Universitätsspital Zürich
Zurich, Zürich (DE), 08091, Switzerland
Hôpitaux Universitaires de Genève
Geneva, 01211, Switzerland
Centre Hospitalier Universitaire Vaudois
Lausanne, 01011, Switzerland
Ege University Medical Faculty
Bornova, İzmir, 35100, Turkey (Türkiye)
Adana Ba?kent Hastanesi K??la Yerle?kesi
Adana, 01230, Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, 06100, Turkey (Türkiye)
Baskent University Medical Faculty Ankara Hospital
Ankara, 06490, Turkey (Türkiye)
Istanbul University Cerrahpasa Medical Faculty Hospital
Istanbul, 34098, Turkey (Türkiye)
Bristol Haematology and Oncology Centre
Bristol, Bristol, CITY of, BS2 8ED, United Kingdom
Royal Cornwall Hospital
Truro, Cornwall, TR1 3LJ, United Kingdom
The Royal Sussex County Hospital
Brighton, EAST Sussex, BN2 5BE, United Kingdom
Broomfield Hospital
Chelmsford, Essex, CM1 7ET, United Kingdom
Singleton Hospital - PPDS
Swansea, Glamorgan, SA2 8QA, United Kingdom
Royal Preston Hospital
Preston, Lancashire, PR2 9HT, United Kingdom
Royal Marsden Hospital - Surrey
London, London, CITY of, SW3 6JJ, United Kingdom
Queen Elizabeth Hospital
Birmingham, B15 2TH, United Kingdom
St James s Institute of Clinical Oncology
Leeds, LS9 7TF, United Kingdom
Clatterbridge Hospital
Metropolitan Borough of Wirral, CH63 4JY, United Kingdom
Related Publications (1)
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.
PMID: 28284557DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Pfizer ClinicalTrials.gov Call Center
- Organization
- Pfizer Inc.
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 4, 2013
First Posted
January 8, 2013
Study Start
July 12, 2013
Primary Completion
December 1, 2015
Study Completion
June 4, 2019
Last Updated
March 22, 2021
Results First Posted
March 22, 2021
Record last verified: 2021-03
Data Sharing
- IPD Sharing
- Will share
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.