AzTrials
AzTrials

Metastatic or Unresectable Cutaneous MelanomaPhase 3NCT01763164

Study Comparing the Efficacy of MEK162 Versus Dacarbazine in Unresectable or Metastatic NRAS Mutation-positive Melanoma

A Phase 3 study testing MEK162 and Dacarbazine in people with Metastatic or Unresectable Cutaneous Melanoma, run by Pfizer at 229 sites in 27 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MEK162 and Dacarbazine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
402 participants
Where
229 sitesin 27 countries
Study dates
12 Jul 2013to 4 Jun 2019
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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

Trial locations and contacts

229 sites in 27 countries.

229 sites in 27 countries

United States77 sites

  • Cancer Center Associates - Medical Oncology

    Allentown, Pennsylvania, 18104

  • St. Luke's Cancer Center - Allentown Campus

    Allentown, Pennsylvania, 18104

  • St. Luke's Hospital - Allentown Campus

    Allentown, Pennsylvania, 18104

  • Florida Cancer Specialists

    Altamonte Springs, Florida, 32701

  • Texas Oncology-Austin Central

    Austin, Texas, 78731

  • Harry and Jeannette Weinberg Cancer Institute @Franklin Square

    Baltimore, Maryland, 21237

  • Eastern Maine Medical Center

    Bangor, Maine, 04401

  • Cancer Center Associates - Medical Oncology

    Bethlehem, Pennsylvania, 18015

  • St. Luke's University Hospital - Bethlehem Campus

    Bethlehem, Pennsylvania, 18015

  • Kresge Eye Institute

    Bingham Farms, Michigan, 48025

  • Florida Cancer Specialists

    Bonita Springs, Florida, 34135

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Florida Cancer Specialists

    Bradenton, Florida, 34209

  • Florida Cancer Specialists

    Brandon, Florida, 33511

  • Florida Cancer Specialists

    Cape Coral, Florida, 33914

  • Florida Cancer Specialists

    Clearwater, Florida, 33756

  • Florida Cancer Specialists

    Clearwater, Florida, 33761

  • The Ohio State University James Cancer Hospital

    Columbus, Ohio, 43210

  • The Ohio State University Martha Morehouse Medical Plaza

    Columbus, Ohio, 43221

  • Elliot J. Ginchansky, MD, PA

    Dallas, Texas, 75230

  • Dennis B. Kay

    Dallas, Texas, 75231

  • Parkland Memorial Hospital

    Dallas, Texas, 75235

  • UT Southwestern University Hospital- St. Paul

    Dallas, Texas, 75235

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • UT Southwestern Medical Center at Dallas

    Dallas, Texas, 75390

  • UT Southwestern University Hospital - Zale Lipshy

    Dallas, Texas, 75390

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Kresge Eye Institute

    Detroit, Michigan, 48201

  • St. Luke's Cancer Center - Anderson Campus

    Easton, Pennsylvania, 18045

  • Karmanos Cancer Institute of Farmington Hills

    Farmington Hills, Michigan, 48334

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • Florida Cancer Specialists

    Fort Myers, Florida, 33905

  • Florida Cancer Specialists

    Fort Myers, Florida, 33908

  • US Oncology

    Fort Worth, Texas, 76177-3204

  • Florida Cancer Specialists

    Gainesville, Florida, 32605

  • Goshen Center For Cancer Care

    Goshen, Indiana, 46526

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • John Theurer Cancer Center at Hackensack University Medical Center

    Hackensack, New Jersey, 07601

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Florida Cancer Specialists

    Hudson, Florida, 34667

  • Florida Cancer Specialists

    Inverness, Florida, 34453

  • Florida Cancer Specialists

    Largo, Florida, 33770

  • Florida Cancer Specialists

    Largo, Florida, 33777

  • Florida Cancer Specialists

    Naples, Florida, 34102

  • Florida Cancer Specialists

    Naples, Florida, 34119

  • Sarah Cannon Research Institute

    Nashville, Tennessee, 37203

  • Florida Cancer Specialists

    New Port Richey, Florida, 34655

  • Oncology Specialists, SC

    Niles, Illinois, 60714

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Florida Cancer Specialists

    Orange City, Florida, 32763

  • Florida Cancer Specialists

    Orlando, Florida, 32806

  • Oncology Specialists, SC

    Park Ridge, Illinois, 60068

  • Hospital of the University of Pennsylvania, Perelman Center for Advanced Medicine

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson Medical Oncology

    Philadelphia, Pennsylvania, 19107

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Florida Cancer Specialists

    Port Charlotte, Florida, 33980

  • OHSU Knight Cancer Institute

    Portland, Oregon, 97201

  • Kaiser Permanente Northwest Region Oncology/Hematology

    Portland, Oregon, 97227

  • OHSU Center for Health and Healing

    Portland, Oregon, 97239

  • OHSU

    Portland, Oregon, 97239

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • St. Luke's Hospital - Quakertown Campus

    Quakertown, Pennsylvania, 18951

  • Highlands Oncology Group

    Rogers, Arkansas, 72758

  • Florida Cancer Specialists

    Sarasota, Florida, 34232

  • Florida Cancer Specialists

    Sarasota, Florida, 34236

  • Florida Cancer Specialists

    Spring Hill, Florida, 34608

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33705

  • Florida Cancer Specialists

    St. Petersburg, Florida, 33707

  • Florida Cancer Specialists

    Tampa, Florida, 33607

  • Florida Cancer Specialists

    Tampa, Florida, 33613

  • Florida Cancer Specialists

    Tavares, Florida, 32778

  • US Oncology

    The Woodlands, Texas, 77380

  • Florida Cancer Specialists

    Venice, Florida, 34285

  • Florida Cancer Specialists

    Venice, Florida, 34292

  • Cooper University Hospital

    Voorhees Township, New Jersey, 08043

Other trials in United States

Germany25 sites

  • Charite Campus Mitte

    Berlin, Schleswig-Holstein, 10117

  • Elben Klinken Stade Buxtehude

    Buxtehude, Lower Saxony, 21614

  • Uniklinik Köln

    Cologne, 50937

  • Universitätsklinikum Carl Gustav Carus an der TU Dresden

    Dresden, 01307

  • Helios Klinikum Erfurt

    Erfurt, Thuringia, 99089

  • Universitätsklinikum Essen

    Essen, 45147

  • Institut für Diagnostische und Interventionelle Radiologie Frankfurt

    Frankfurt am Main, Hesse, 60590

  • Universitätsklinikum Frankfurt

    Frankfurt am Main, Hesse, 60590

  • Universitaetsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79104

  • SRH Wald-Klinikum Gera GmbH

    Gera, 07548

  • Medizinische Hochschule Hannover (Hannover Medical School)

    Hanover, 30625

  • University Clinic Heidelberg - PPDS

    Heidelberg, 69120

  • Universitatsklinikum Schleswig-Holstein

    Kiel, 24105

  • Universitatsklinikum Leipzig

    Leipzig, Saxony, 04103

  • Universitatsklinikum Schleswig-Holstein

    Lübeck, 23538

  • Klinikum Mannheim Universitätsklinikum gGmbH

    Mannheim, Baden-Wurttemberg, 68135

  • Johannes Wesling Klinikum Minden

    Minden, North Rhine-Westphalia, 32429

  • LMU Klinikum der Universität München

    München, Bavaria, 80337

  • Fachklinik Hornheide

    Münster, 48157

  • Klinikum Nuernberg Nord

    Nuremberg, 90419

  • Klinikum Dorothea Christiane Erxleben Quedlinburg GmbH

    Quedlinburg, Saxony-Anhalt, 06484

  • University Clinic Regensburg - PPDS

    Regensburg, Bavaria, 93053

  • Universitätsklinikum Tübingen

    Tübingen, 72076

  • Universit*ätsklinikum Ulm

    Ulm, 89081

  • Universitätsklinikum Würzburg

    Würzburg, Bavaria, 97080

Other trials in Germany

Spain16 sites

  • Hospital Universitario A Coruña

    A Coruña, 15006

  • Hospital Universitario Vall d'Hebrón - PPDS

    Barcelona, 08035

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • ICO l'Hospitalet - Hospital Duran i Reynals

    Barcelona, 08907

  • Complejo Hospitalario Universitario Insular - Materno Infantil

    Gran Canaria, 35001

  • ICO l'Hospitalet - Hospital Duran i Reynals

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28009

  • MD Anderson Cancer Center

    Madrid, 28033

  • Hospital Universitario Fundacion Jimenez Diaz

    Madrid, 28040

  • Hospital Universitario HM Sanchinarro - CIOCC

    Madrid, 28050

  • Hospital Regional Universitario de Malaga Hospital General

    Málaga, Málaga, 29010

  • Clinica Universidad Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Virgen de La Salud

    Toledo, 45004

  • Fundacion Instituto Valenciano de Oncologia

    Valencia, 46009

  • Consorcio Hospital General Universitario de Valencia

    Valencia, 46014

Other trials in Spain

Italy13 sites

  • IRCCS Giovanni Paolo II Istituto Oncologico

    Bari, 70126

  • ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24129

  • ASST degli Spedali Civili di Brescia - Spedali Civili di Brescia

    Brescia, Lombardy, 25123

  • IRCCS Az. Osp. Universitaria San Martino- IST

    Genova, 16132

  • Ospedale San Raffaele S.r.l. - PPDS

    Milan, 20132

  • Fondazione IRCCS 'Istituto Nazionale dei Tumori' di Milano

    Milan, 20133

  • AOU dell'Università degli Studi della Campania Luigi Vanvitelli

    Naples, Campania, 80138

  • Istituto Nazionale per lo studio e la cura dei tumori Fondazione Giovanni Pascale

    Naples, Naples, 80131

  • Istituto Oncologico Veneto - I.R.C.C.S.

    Padova, Veneto, 35128

  • Istituto Nazionale Tumori Regina Elena

    Roma, 00144

  • Istituto Dermopatico dell'Immacolata IRCCS

    Rome, Lazio, 00167

  • Azienza Ospedaliera Universitaria Senese

    Siena, 53100

  • A.O.U. Città della Salute e della Scienza di Torino - Presidio S. Lazzaro

    Torino, 10126

Other trials in Italy

France12 sites

  • CHU Angers

    Angers, Maine-et-loire, 49033

  • Hôpital Saint-André

    Bordeaux, 33000

  • Centre Hospitalier Universitaire Ambroise Pare

    Boulogne-Billancourt, 92100

  • Centre Hospitalier Le Mans

    Le Mans, 72037

  • CHRU de Lille - Hôpital Huriet

    Lille, NORD, 59037

  • Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes

    Lyon, Rhône, 69373

  • Hopitaux de La Timone

    Marseille, 13385

  • Groupe Hospitalier Archet I Et II

    Nice, 06202

  • Hôpital Saint Louis

    Paris, 75010

  • Service de PneumologieCHU Lyon Sud

    Pierre-Bénite, 69495

  • Hôpital Robert Debré

    Reims, 51092

  • Centre Hospitalier Universitaire Hopitaux de Rouen

    Rouen, 76031

Other trials in France

United Kingdom10 sites

  • Queen Elizabeth Hospital

    Birmingham, B15 2TH

  • The Royal Sussex County Hospital

    Brighton, EAST Sussex, BN2 5BE

  • Bristol Haematology and Oncology Centre

    Bristol, Bristol, CITY of, BS2 8ED

  • Broomfield Hospital

    Chelmsford, Essex, CM1 7ET

  • St James s Institute of Clinical Oncology

    Leeds, LS9 7TF

  • Royal Marsden Hospital - Surrey

    London, London, CITY of, SW3 6JJ

  • Clatterbridge Hospital

    Metropolitan Borough of Wirral, CH63 4JY

  • Royal Preston Hospital

    Preston, Lancashire, PR2 9HT

  • Singleton Hospital - PPDS

    Swansea, Glamorgan, SA2 8QA

  • Royal Cornwall Hospital

    Truro, Cornwall, TR1 3LJ

Other trials in United Kingdom

Canada6 sites

  • Alberta Health Services - Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • London Regional Cancer Program

    London, Ontario, N6A 4L6

  • McGill University Health Center / Royal Victoria Hospital

    Montreal, Quebec, H4A 3J1

  • CHU de Quebec - L'Hotel-Dieu de Quebec

    Québec, G1R 2J6

  • Sunnybrook Research Institute Centre

    Toronto, Ontario, M4N 3M5

  • Princess Margaret Cancer Centre

    Toronto, Ontario, M5G 2M9

Other trials in Canada

Australia5 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 05000

  • Chris O'Brien Lifehouse Hospital

    Camperdown, New South Wales, 2050

  • Lake Macquarie Private Hospital

    Gateshead, New South Wales, 02290

  • Melanoma Institute Australia

    North Sydney, New South Wales, 2060

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Brazil5 sites

  • Hospital de Clinicas de Passo Fundo

    Passo Fundo, Rio Grande do Sul, 99010-260

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-903

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90560-030

  • INCA Instituto Nacional de Cancer

    Rio de Janeiro, 20220410

  • Hospital São José

    São Paulo, 01321-001

Other trials in Brazil

South Africa5 sites

  • University of The Free State

    Bloemfontein, Free State, 09301

  • Sandton Oncology Medical Group

    Johannesburg, Gauteng, 02196

  • Sandton Oncology Medical Research

    Johannesburg, Gauteng, 02199

  • Steve Biko Academic Hospital

    Pretoria, Gauteng, 00002

  • Mary Potter Oncology Centre

    Pretoria, Gauteng, 00027

Other trials in South Africa

Turkey (Türkiye)5 sites

  • Adana Ba?kent Hastanesi K??la Yerle?kesi

    Adana, 01230

  • Hacettepe University Medical Faculty

    Ankara, 06100

  • Baskent University Medical Faculty Ankara Hospital

    Ankara, 06490

  • Ege University Medical Faculty

    Bornova, İzmir, 35100

  • Istanbul University Cerrahpasa Medical Faculty Hospital

    Istanbul, 34098

Other trials in Turkey (Türkiye)

Argentina4 sites

  • Sanatorio de La Providencia

    Buenos Aires, Ciudad Autónoma de Buenosaires, C1050AAK

  • Fundacion CIDEA

    Buenos Aires, C1125ABE

  • Centro Oncologico de Rosario

    Rosario, Santa Fe Province, S2000KZE

  • Centro de Investigación Clínica ? Clínica Viedma

    Viedma, Río Negro Province, 08500

Other trials in Argentina

Austria4 sites

  • LKH-Universitätsklinikum Klinikum Graz

    Graz, Styria, 08036

  • Universitätsklinikum Innsbruck

    Innsbruck, Tyrol, 06020

  • Salzburger Landeskliniken

    Salzburg, 05020

  • Allgemeines Krankenhaus der Stadt Wien

    Vienna, 01090

Other trials in Austria

Czechia4 sites

  • Mou/Mmci - Ppds

    Brno, South Moravian, 656 53

  • Fakultni nemocnice Ostrava

    Ostrava, 708 52

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Vseobecna Fakultni Nemocnice V Praze

    Prague, 128 08

Other trials in Czechia

Hungary4 sites

  • Magyar Honvédség Egészségügyi Központ

    Budapest, 01062

  • Orszagos Onkologiai Intezet

    Budapest, H-1122

  • Somogy Megyei Kaposi Mór Oktató Kórház

    Kaposvár, 07400

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz-Rendelointezet

    Szolnok, 05004

Other trials in Hungary

Netherlands4 sites

  • Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis

    Amsterdam, North Holland, 1066 CX

  • Leids Universitair Medisch Centrum

    Leiden, South Holland, 2333ZA

  • Radboud University Nijmegen Medical Centre

    Nijmegen, Gelderland, 6525 GA

  • Isala Klinieken

    Zwolle, 8025 AB

Other trials in Netherlands

Portugal4 sites

  • Hospital Garcia de Orta*E.P.E.

    Almada, 2801-951

  • Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

    Lisbon, Lisbon District, 1099-023

  • Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria

    Lisbon, 1649-035

  • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS

    Porto, 4200-072

Other trials in Portugal

South Korea4 sites

  • Asan Medical Center - PPDS

    Seoul, 05505

  • Samsung Medical Center - PPDS

    Seoul, 06351

  • Seoul National University Hospital

    Seoul, 110-744

  • Severance Hospital Yonsei University Health System - PPDS

    Seoul, 3722

Other trials in South Korea

Belgium3 sites

  • UZ Gasthuisberg

    Leuven, 03000

  • CHU Sart Tilman

    Liège, 04000

  • Sint-Augustinuskliniek

    Wilrijk, Antwerpen, 2610

Other trials in Belgium

Israel3 sites

  • Rambam Medical Center - PPDS

    Haifa, 3109601

  • Hadassah Medical Center - PPDS

    Jerusalem, 91120

  • Sheba Medical Center - PPDS

    Ramat Gan, 5262100

Other trials in Israel

Japan3 sites

  • National Cancer Center Hospital

    Chūōku, 1040045

  • Kansai Medical University Hospital

    Hirakata, 573-1191

  • Shinshu University Hospital

    Matsumoto, Nagano, 390-8621

Other trials in Japan

Poland3 sites

  • Centrum Medyczne MAVIT Sp. z o.o.

    Warsaw, Masovian Voivodeship, 01-673

  • Lux Med

    Warsaw, 02-676

  • Centrum Onkologii Instytut im. Marii Sklodowskiej-Curie

    Warsaw, 02-781

Other trials in Poland

Russia3 sites

  • Russian Oncology Research Center n a N N Blokhin

    Moscow, 115478

  • Ryazan Regional Clinical Oncology Dispensary

    Ryazan, 390011

  • Scientific Research Institute of Oncology n.a. N.N. Petrov

    Saint Petersburg, 197758

Other trials in Russia

Switzerland3 sites

  • Hôpitaux Universitaires de Genève

    Geneva, 01211

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, 01011

  • Universitätsspital Zürich

    Zurich, Zürich (DE), 08091

Other trials in Switzerland

Sweden2 sites

  • Skanes Universitetssjukhus Lund

    Lund, Skåne County

  • Skanes Universitetssjukhus Lund

    Lund, 221 85

Other trials in Sweden

Greece1 site

  • Laiko General Hospital of Athens

    Athens, 115 27

Other trials in Greece

Slovakia1 site

  • Narodny onkologicky ustav

    Bratislava, 833 01

Other trials in Slovakia

About this study

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

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

Being tested
MEK162, Dacarbazine
Keywords
Melanoma, Cutaneous melanoma, Skin disease, Skin cancer, Skin Neoplasms, Neoplasm Metastasis
Medical subject headings
Neoplasm Metastasis, Melanoma, Skin Diseases, Skin Neoplasms

What participants receive

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

  • MEK162Drug

    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.

  • DacarbazineDrug

    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.

Study groups in NCT01763164
Study groupRoleWhat they receive
MEK162ExperimentalNot described
Receives: Drug: MEK162
DacarbazineActive comparatorNot described
Receives: Drug: Dacarbazine

What is being measured

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

  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.

    Measured: 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)

  1. Overall Survival (OS)

    Overall survival was defined as the time from the date of randomization to the date of death due to any cause. If a participant was not known to have died, overall survival was censored at the date of last known date participant alive.

    Measured: 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)

  2. Overall Response Rate (ORR)

    ORR: percentage of participants with best overall response (BOR) of CR or PR. BOR: best response recorded from start of treatment until CR or PR. RECIST V1.1, a) 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; b) PR: >=30% decrease in sum of diameter of all TLs, taking as reference baseline sum of diameters. ORR is reported for confirmed and unconfirmed responses. Confirmed CR or PR = at least 2 determinations of CR or PR at least 4 weeks apart before PD. PD: >=20% increase in sum of diameter of all measured target lesions, taking as reference smallest sum of diameter of all TLs recorded at or after baseline, sum must also be absolute increase of >=5 mm. Unequivocal progression of existing non TLs. Appearance of at least 1 new lesion.

    Measured: 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)

  3. Time to Response (TTR)

    TTR: time between date of randomization until first documented response of CR or PR. RECIST V1.1, a) 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; b) PR: >=30% decrease in sum of diameter (dia) of all TLs, referring baseline sum of dia; c) PD: >=20% increase in sum of diameter of all measured TLs taking as reference smallest sum of diameter of all TLs recorded at or after baseline, sum must also be absolute increase of >=5 mm. Unequivocal progression of existing non-TLs. Appearance of >=1 new lesion. Participants who did not achieve PR or CR censored at last adequate tumor assessment date when they did not have PFS event (time from date of randomization to date of first documented PD or death due to any cause, whichever occur first) or at maximum follow-up when they had PFS event.

    Measured: 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)

  4. Duration of Objective Response (DOR)

    DOR: time from date of first documented response (CR or PR) to first documented progression or death due to underlying cancer. RECIST V1.1, a) 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; b) PR: >=30% decrease in sum of diameter (dia) of all TLs, referring baseline sum of dia; c) PD: >=20% increase in sum of diameter of all measured target lesions taking as reference smallest sum of diameter of all target lesions recorded at or after baseline, sum must also be absolute increase of >=5 mm. Unequivocal progression of existing non-target lesions. Appearance of at least 1 new lesion. If a participant with a CR or PR had no PD or death due to underlying cancer, participants was censored at date of last adequate tumor assessment.

    Measured: 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)

  5. Disease Control Rate (DCR)

    DCR was calculated as the percentage of participants with a BOR of CR, PR, SD RECIST V1.1, a) 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; b) PR: >=30% decrease in sum of diameter of all target lesions, taking as reference the baseline sum of diameters; c) SD: neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD taking as reference the smallest sum diameters; d) PD: >=20% increase in sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline, sum must also be absolute increase of >=5 mm. Unequivocal progression of existing non-target lesions. Appearance of at least 1 new lesion.

    Measured: 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)

  6. Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. SAE was defined as one of the following: was fatal or life-threatening; resulted in persistent or significant disability/incapacity; constituted a congenital anomaly/birth defect; was medically significant; required inpatient hospitalization or prolongation of existing hospitalization. Treatment-emergent AE was defined as an AE with onset date occurring during the on-treatment period. AEs included all SAEs and non-SAEs.

    Measured: From baseline up to 219.4 weeks for binimetinib arm; From baseline up to 123.9 weeks for dacarbazine arm

  7. Number of Participants With Clinically Notable Hematology Shifts Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.03

    Clinically notable shifts are defined as worsening by at least 2 grades or to >= grade 3. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.

    Measured: From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm

  8. Number of Participants With Clinically Notable Clinical Chemistry/Biochemistry Shifts Based on NCI-CTCAE Grade, Version 4.03

    Clinically notable shifts are defined as worsening by at least 2 grades or to >= grade 3. Severity was graded as Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental ADL; Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE.

    Measured: From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm

  9. Number of Participants With Clinically Notable Vital Signs

    Abnormalities criteria included: low/high pulse rate (beats per minute [bpm]):<=50bpm with decrease from baseline >=15bpm/>=120bpm with increase from baseline >=15bpm; Low/high systolic blood pressure (millimeters of mercury [mmHg]): <=90mmHg with decrease from baseline >=20mmHg/>=160mmHg with increase from baseline >=20mmHg; Low/high diastolic blood pressure [mmHg]: <=50mmHg with decrease from baseline >=15mmHg/>=100mmHg with increase from baseline >=15mmHg; Low/high body weight (kilogram [kg]): >=20% decrease from baseline / >=10% increase from baseline; Low/high body temperature (degree Celsius [°C]): <=36°C / >= 37.5°C

    Measured: From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm

  10. Number of Participants With Notable Electrocardiogram (ECG) Values

    Criteria for notable ECG values were as follow: QT interval (in millisecond [msec]) new (newly occurring post-baseline value) greater than (>) 450, 480, 500, increase from baseline >30, increase from baseline >60; corrected QT interval by Fredericia formula (QTcF) in msec new (newly occurring post-baseline value) > 450, 480, 500, increase from baseline >30, increase from baseline >60; corrected QT interval by Bazett's formula (QTcB) in msec new (newly occurring post-baseline value) > 450, 480, 500, increase from baseline >30, increase from baseline >60; heart rate in bpm new (newly occurring post-baseline value) <60 and >100.

    Measured: From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm

  11. Number of Participants With Adverse Events of Special Interest: Cardiac Events

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. Grade 1: asymptomatic or mild symptoms, clinical or diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local or noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe or medically significant but not immediately life-threatening, hospitalization or prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. Here, in this outcome measure data is reported for events falling in any of the grades.

    Measured: From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm

  12. Number of Participants With Clinically Significant Findings in Physical Examination

    A complete physical examination included the examination of general appearance, skin, neck (including thyroid), eyes, ears, nose, throat, lungs, heart, abdomen, back, lymph nodes, extremities, vascular and neurological systems. If indicated based on medical history and/or symptoms, rectal, external genitalia, breast, and pelvic examinations were performed. Clinical significance in physical examination was reported as adverse events.

    Measured: From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm

  13. Number of Participants With Adverse Events of Special Interest: Ocular Events

    An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship with the study treatment. Grade 1: Asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2: Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental ADL; Grade 3: Severe or medically significant but not immediately sight threatening; Hospitalization or prolongation of existing hospitalization indicated; disabling; limiting self-care ADL; Grade 4: Sight-threatening consequences; urgent intervention indicated; blindness (20/200 or worse) in the affected eye. Here, in this outcome measure data is reported for events falling in any of the grades.

    Measured: From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm

  14. Plasma Concentration of Binimetinib

    Measured: 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

  15. 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)

    The time to definitive 10% deterioration was defined as the time from the date of randomization to the date of event, which was defined as death due to any cause or at least 10% worsening of the corresponding scale score, relative to baseline, with no later improvement above this threshold observed during the course of the study or death due to any cause. If a participant had no event prior to analysis cut-off or start of another anticancer therapy, time to deterioration was censored at the date of the last adequate health related quality of life (HRQoL) evaluation. EORTC QLQ-C30: 5 functional scales (physical, role, cognitive, emotional, and social), a global health status scale, 3 symptom scales (nausea/vomiting, pain, fatigue) and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). All scales and single-item measures range =0 to 100. High score for global health status = high quality of life.

    Measured: From baseline up to 77 weeks in binimetinib arm; From baseline up to 61 weeks for dacarbazine arm

  16. 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

    EORTC QLQ-C30: 5 functional scales (physical, role, cognitive, emotional, and social), a h global health status scale, 3 symptom scales (nausea/vomiting, pain, fatigue) and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties). All scales and single-item measures range =0 to 100. High score for global health status = high quality of life. Post-treatment tumor assessments follow up visits occurred at every 9 weeks if participants started new anticancer therapy.

    Measured: 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

  17. 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

    EQ-5D-5L, is a standardized measure of health utility that provides a single index value for one's health status. EQ-5D-5L contained 1 item for each of 5 dimensions: mobility, self-care, usual activities, pain/discomfort, anxiety/depression. Each dimension has 5 levels: 1= no problems, 2= slight problems, 3= moderate problems, 4= severe problems, and 5= extreme problems. Index score: participant responses to the 5 dimensions reflected a specific health state that corresponded to a population preference weight for that state on a continuous scale of 0 (death) to 1 (perfect health). Higher index scores = better health state. Post-treatment tumor assessments follow up visits occurred at every 9 weeks if participants started new anticancer therapy.

    Measured: 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

  18. Time to Definitive 1 Point Deterioration in Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

    ECOG PS was used to assess the physical health of participants, and ranged from 0 (most active) to 5 (dead). ECOG PS grades: 0= fully active, able to carry on all pre-disease performance without restriction, 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work, 2= ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours, 3= capable of only limited self-care, confined to bed or chair more than 50% of waking hours, 4=completely disabled. cannot carry on any selfcare. Totally confined to bed or chair and 5= dead. Definitive deterioration is defined as on treatment death due to any cause or decrease in ECOG PS by at least one category from baseline score.

    Measured: From baseline up to 73 weeks 3 days for binimetinib arm; From baseline up to 57 weeks 3 days for dacarbazine arm

  19. Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

    ECOG PS was used to assess the physical health of participants, and ranged from 0 (most active) to 5 (dead). ECOG PS grades: 0= fully active, able to carry on all pre-disease performance without restriction, 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work, 2= ambulatory and capable of all self-care but unable to carry out any work activities. Up and about more than 50% of waking hours, 3= capable of only limited self-care, 4=completely disabled. cannot carry on any selfcare. Totally confined to bed or chair confined to bed or chair more than 50% of waking hours and 5= dead. Post-treatment tumor assessments follow up visits occurred at every 9 weeks if participants started new anticancer therapy.

    Measured: 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

  20. Number of Participants With Neuroblastoma RAS Viral (V-ras) Oncogene Homolog (NRAS) Mutation Status at Baseline

    Number of participants with NRAS mutation status at baseline were reported.

    Measured: Baseline

Timeline

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

  1. First posted8 Jan 2013 (estimated)
  2. Study start12 Jul 2013
  3. Primary completion1 Dec 2015
  4. Study completion4 Jun 2019

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
None (open label)
Enrolment
402 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01763164
Sponsor's protocol ID
CMEK162A2301
Other IDs
C4211002, 2012-003593-51
Status last verified
Mar 2021
First submitted
4 Jan 2013
Last updated
22 Mar 2021
Data monitoring committee
Yes
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

  • 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.

    PubMed 28284557

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MEK162 and Dacarbazine in people with Metastatic or Unresectable Cutaneous Melanoma, run by Pfizer at 229 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 6 inclusion and 16 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: finished, as of the sponsor's last update on 22 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 229 sites in United States, Germany, Spain, Italy, France 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?

Yes. Results are posted in the registry (first posted 22 Mar 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression-Free Survival (PFS) by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (time frame: 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)). 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 NCT01763164, which also lists 1 linked publication.

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 22 Mar 2021.

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