Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma (COLUMBUS)

February 8, 2024 updated by: Pfizer

A 2-part Phase III Randomized, Open Label, Multicenter Study of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma

This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately 900 patients will be randomized.

Part 1:

Patients will be randomized in a 1:1:1 ratio to one of 3 treatment arms:

LGX818 450 mg QD plus MEK162 45 mg BID (denoted as Combo 450 arm)
LGX818 300 mg QD monotherapy (denoted as LGX818 arm) or
vemurafenib 960 mg BID (denoted as vemurafenib arm)

Part 2:

Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms:

LGX818 300 mg QD plus MEK162 45 mg BID (denoted as Combo 300 arm) or
LGX818 300 mg QD monotherapy (denoted as LGX818 arm)

Study Overview

Status

Active, not recruiting

Conditions

Melanoma

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

922

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- Buenos Aires
  - Caba, Buenos Aires, Argentina, C1125ABD
    - Fundacion CENIT para la Investigacion en Neurociencias
- Ciudad Autónoma DE Buenosaires
  - Buenos Aires, Ciudad Autónoma DE Buenosaires, Argentina, C1050AAK
    - Sanatorio de La Providencia
  - Buenos Aires, Ciudad Autónoma DE Buenosaires, Argentina, C1015ABO
    - Organizacion Medica de Investigacion
  - Buenos Aires, Ciudad Autónoma DE Buenosaires, Argentina, C1025ABI
    - Fundación Investigar
  - Buenos Aires, Ciudad Autónoma DE Buenosaires, Argentina, C1181ACH
    - Hospital Italiano de Buenos Aires
  - Buenos Aires, Ciudad Autónoma DE Buenosaires, Argentina, C1426ANZ
    - Instituto Médico Especializado Alexander Fleming
  - Buenos Aires, Ciudad Autónoma DE Buenosaires, Argentina, C1428DDO
    - Centro de Diagnóstico Dr. Enrique Rossi
Australia
- New South Wales
  - Gateshead, New South Wales, Australia, 02290
    - Lake Macquarie Private Hospital
- Queensland
  - Southport, Queensland, Australia, 4215
    - HPS Pharmacy
  - Southport, Queensland, Australia, 4215
    - Tasman Oncology Research
  - Southport, Queensland, Australia, 4215
    - Vision Optical
  - Woolloongabba, Queensland, Australia, 4102
    - Princess Alexandra Hospital
- Victoria
  - Melbourne, Victoria, Australia, 3004
    - The Alfred Hospital
  - Prahran, Victoria, Australia, 3004
    - The Alfred Hospital
- Western Australia
  - Nedlands, Western Australia, Australia, 6009
    - Sir Charles Gairdner Hospital
  - Nedlands, Western Australia, Australia, 6009
    - Sir Charles Gairdner Hospital Pharmacy Department
Brazil
- - Natal, Brazil, 59062-000
    - Liga Norte Riograndense Contra O Câncer
  - Rio de Janeiro, Brazil, 20220-410
    - INCA Instituto Nacional de Cancer
  - Sao Paulo, Brazil, 01321-001
    - Hospital BP Mirante
- Pernambuco
  - Recife, Pernambuco, Brazil, 50070-550
    - Instituto de Medicina Integral Professor Fernando Figueira
- RIO Grande DO SUL
  - Ijuí, RIO Grande DO SUL, Brazil, 98700-000
    - Associação Hospital de Caridade Ijuí
  - Porto Alegre, RIO Grande DO SUL, Brazil, 90035-003
    - Hospital de Clinicas de Porto Alegre (HCPA) - PPDS
- SÃO Paulo
  - Barretos, SÃO Paulo, Brazil, 14784-400
    - Fundação PIO XII
Canada
- - Quebec, Canada, G1R 2J6
    - Centre Hospitalier Universitaire de Quebec - Hotel - Dieu de Quebec - Universite Laval
  - Quebec, Canada, G1R 2J6
    - CHU de Quebec-Universite Laval - L' Hotel - Dieu de Quebec
- Alberta
  - Calgary, Alberta, Canada, T2N 4N2
    - Tom Baker Cancer Centre
- Ontario
  - Toronto, Ontario, Canada, M4N 3M5
    - Sunnybrook Health Sciences Centre
  - Toronto, Ontario, Canada, M5G 2M9
    - Princess Margaret Cancer Centre
  - Toronto, Ontario, Canada, M5G 2C4
    - Toronto General Hospital
  - Toronto, Ontario, Canada, M4N 3M5
    - Sunnybrook Research Institute
- Quebec
  - Montreal, Quebec, Canada, H4A 3J1
    - McGill University Health Center
  - Montreal, Quebec, Canada, H2X 3E4
    - Centre Hospitalier de l'Université de Montréal
  - Montreal, Quebec, Canada, H2L 4M1
    - Centre Hospitalier De L'Universite De Montreal Hospital Notre Dame
  - Montreal, Quebec, Canada, H2L 4M1
    - CHUM Notrea Dame Hospital
  - Quebec City, Quebec, Canada, G1V 4G2
    - CHU de Quebec-Universite Laval
  - Québec, Quebec, Canada, G1R 2J6
    - CHU de Quebec- L'Hotel-Dieu de Quebec
  - Sainte Hyacinthe, Quebec, Canada, J2S 4Y8
    - Centre de Sante Et Services Sociaux Richelieu Yamaska
Colombia
- Distrito Capital DE Bogotá
  - Bogotá, Distrito Capital DE Bogotá, Colombia, 110311
    - Hospital Universitario San Ignacio
- Pbx (57-1)
  - Bogotá, Pbx (57-1), Colombia, 3208320
    - Hospital Universitario San Ignacio
Czechia
- - Brno, Czechia, 656 91
    - Fakultni Nemocnice u sv. Anny v Brne
  - Olomouc, Czechia, 775 20
    - Fakultní Nemocnice Olomouc
  - Ostrava Poruba, Czechia, 708 52
    - Fakultni Nemocnice Ostrava
  - Praha, Czechia, 128 08
    - Vseobecna fakultni nemocnice v Praze
  - Praha, Czechia, 128 08
    - Vseobecna Fakultni Nemocnice V Praze-U Nemocnice 499/2
- Jihomoravský KRAJ
  - Brno, Jihomoravský KRAJ, Czechia, 656 53
    - Mou/Mmci - Ppds
- Moravskoslezský KRAJ
  - Ostrava, Moravskoslezský KRAJ, Czechia, 70852
    - Fakultni Nemocnice Ostrava
- Praha, Hlavní Mesto
  - Praha 10, Praha, Hlavní Mesto, Czechia, 100 34
    - Fakultni nemocnice Kralovske Vinohrady
  - Praha 2, Praha, Hlavní Mesto, Czechia, 128 08
    - Vseobecna fakultni nemocnice v Praze
France
- - Boulogne-Billancourt, France, 92104
    - Centre Hospitalier Universitaire Ambroise Pare
  - Lille, France, 59042
    - Clinique de la Louvière
  - Lyon, France, 69003
    - Hopital d'Instruction des Armées Desgenettes
  - Nice, France, 06202
    - Groupe Hospitalier Archet I Et II
  - Paris, France, 75010
    - Hopital Lariboisiere
  - Paris, France, 75014
    - Institut Mutualiste Montsouris
  - Paris, France, 75475
    - Hopital Saint Louis
  - Paris, France, 75015
    - Ophtalmologist office
  - Pierre-bénite, France, 69495
    - Service de PneumologieCHU Lyon Sud
  - Strasbourg, France, 67091
    - Nouvel Hopital Civil
  - Templemars, France, 59175
    - Cardiologist Private Practice
  - Villejuif, France, 94805
    - Institut Gustave Roussy
- Alpes-maritimes
  - Nice, Alpes-maritimes, France, 06202
    - Chu de Nice
- Gironde
  - Bordeaux, Gironde, France, 33075
    - Hopital Saint-Andre
- Isère
  - Grenoble, Isère, France, 38043
    - CHU de Grenoble
- Marne
  - Reims, Marne, France, 51092
    - Hopital Robert Debre
- Nord
  - Lille, Nord, France, 59037
    - CHRU de Lille - Hôpital Huriet
- Rhone
  - Lyon, Rhone, France, 69373
    - Centre Léon Bérard Centre Régional de Lutte Contre Le Cancer Rhône Alpes
- Rhône
  - Lyon, Rhône, France, 69004
    - Hopital de la Croix Rousse
- Sarthe
  - Le Mans, Sarthe, France, 72037
    - Centre Hospitalier Le Mans
- Val-de-marne
  - Villejuif, Val-de-marne, France, 94805
    - Institut Gustave Roussy
Germany
- - Berlin, Germany, 10117
    - Charite-Universitaetsmedizin Berlin
  - Bonn, Germany, 53127
    - Universitätsklinikum Bonn
  - Bonn, Germany, 53105
    - Universitätsklinikum Bonn
  - Dresden, Germany, 01307
    - Universitätsklinikum Carl Gustav Carus an der TU Dresden
  - Dresden, Germany, 01309
    - Überörtliche Radiologische Gemeinschaftspraxis Dresden
  - Dresden, Germany, 01307
    - University Hospital Carl Gustav Carus at the Technical University of Dresden
  - Erfurt, Germany, 99089
    - Helios Klinikum Erfurt
  - Erfurt, Germany, 99089
    - Diagnostische und interventionelle Radiologie und Neuroradiologie
  - Essen, Germany, 45147
    - Universitätsklinikum Essen
  - Frankfurt/Main, Germany, 60590
    - Goethe-University Frankfurt/Main
  - Freiburg, Germany, 79106
    - Universitätsklinikum Freiburg, Klinik für Radiologie
  - Gera, Germany, 07548
    - Srh Wald-Klinikum Gera Gmbh
  - Gera, Germany, 07548
    - Institut für diagnostische und interventionelle Radiologie
  - Gera, Germany, 75478
    - Klinik für Augenheilkunde
  - Hamburg, Germany, 20246
    - Universitätsklinik Hamburg Eppendorf
  - Hannover, Germany, 30625
    - Medizinische Hochschule Hannover (Hannover Medical School)
  - Hannover, Germany, 30159
    - Augenärzte am Kröpcke
  - Hannover, Germany, 30626
    - Institut für Diagnostische und Interventionelle Radilogie
  - Heidelberg, Germany, 69120
    - University Clinic Heidelberg - PPDS
  - Homburg, Germany, 66421
    - Universität des Saarlandes
  - Kiel, Germany, 24105
    - Universitätsklinikum Schleswig-Holstein
  - Kiel, Germany, 24105
    - Universitatsklinikum Schleswig-Holstein - Kiel
  - Kiel, Germany, 24105
    - University Hospital Schleswig-Holstein, Campus Kiel
  - Lübeck, Germany, 23538
    - Universitätsklinikum Schleswig-Holstein
  - Magdeburg, Germany, 39120
    - Universitätsaugenklinik
  - Magdeburg, Germany, 39120
    - Universitätsklinik für Radiologie und Nuklearmedizin
  - Mainz, Germany, 55131
    - University Hospital Mainz
  - Mannheim, Germany, 68167
    - Augenklinik Universitätsklinikum Mannheim
  - Minden, Germany, 32427
    - Augen-Praxis_Minden
  - München, Germany, 80336
    - LMU Klinikum der Universität
  - München, Germany, 81677
    - Hautklinik, Klinikum Nürnberg, Universitätsklinik der Paracelsus Medizinischen Privatuniversität
  - Münster, Germany, 48157
    - Fachklinik Hornheide Abteilung für Internistische Onkologie und Hämatologie
  - Regensburg, Germany, 93053
    - Klinik & Poliklinik für Augenheilkunde
  - Tübingen, Germany, 72076
    - Universitätsklinikum Tübingen
  - Ulm, Germany, 89081
    - Universitätsklinikum Ulm
  - Ulm, Germany, 89073
    - Internistische Schwerpunktpraxis Kardiologie Hämatologie Onkologie
- Baden-württemberg
  - Freiburg im Breisgau, Baden-württemberg, Germany, 79104
    - Universitaetsklinikum Freiburg
  - Heidelberg, Baden-württemberg, Germany, 69120
    - University Clinic Heidelberg - PPDS
  - Mannheim, Baden-württemberg, Germany, 68135
    - Klinikum Mannheim Universitätsklinikum gGmbH
  - Tübingen, Baden-württemberg, Germany, 72076
    - Universitätsklinikum Tübingen
  - Ulm, Baden-württemberg, Germany, 89070
    - Universitätsklinikum Ulm
- Bavaria
  - Nuernberg, Bavaria, Germany, 90419
    - Hautklinik, Klinikum Nürnberg, Universitätsklinik der Paracelsus Medizinischen Privatuniversität
- Bayern
  - München, Bayern, Germany, 80337
    - LMU Klinikum der Universität München
  - München, Bayern, Germany, 80337
    - LMU Klinikum
  - Regensburg, Bayern, Germany, 93053
    - University Clinic Regensburg - PPDS
  - Regensburg, Bayern, Germany, 93053
    - Institut für Röntgendiagnostik
  - Würzburg, Bayern, Germany, 97080
    - Universitätsklinikum Würzburg
- Hessen
  - Frankfurt, Hessen, Germany, 60590
    - Universitatsklinikum Frankfurt
  - Kassel, Hessen, Germany, 34125
    - Klinikum Kassel
  - Kassel, Hessen, Germany, 34125
    - Zentrum für Radiologie
- Niedersachsen
  - Buxtehude, Niedersachsen, Germany, 21614
    - Augenarztzentrum Buxtehude
  - Buxtehude, Niedersachsen, Germany, 21614
    - Elben Klinken Stade ? Buxtehude
- Nordrhein-westfalen
  - Bonn, Nordrhein-westfalen, Germany, 53127
    - Augenklinik Universitätsklinikum Bonn
  - Minden, Nordrhein-westfalen, Germany, 32429
    - Johannes Wesling Klinikum Minden
  - Minden, Nordrhein-westfalen, Germany, 32429
    - Institut für Diagnostische Radiologie, Neuroradiologie und Nuklearmedizin
- Rheinland-pfalz
  - Mainz, Rheinland-pfalz, Germany, 55131
    - Universitätsmedizin der Johannes Gutenberg-Universität Mainz
- Sachsen
  - Dresden, Sachsen, Germany, 01307
    - Klinik und Poliklinik für Augenheilkunde
  - Leipzig, Sachsen, Germany, 04103
    - Universitätsklinikum Leipzig
  - Leipzig, Sachsen, Germany, 04103
    - Universitätsklinikum Leipzig AöR
- Sachsen-anhalt
  - Magdeburg, Sachsen-anhalt, Germany, 39120
    - Universitätsklinik Magdeburg
- Schleswig-holstein
  - Kiel, Schleswig-holstein, Germany, 24105
    - University Hospital Schleswig-Holstein, Campus Kiel
  - Luebeck, Schleswig-holstein, Germany, 23562
    - Universitätsklinikum Schleswig-Holstein
  - Lübeck, Schleswig-holstein, Germany, 23538
    - Universitatsklinikum Schleswig-Holstein - Kiel
  - Lübeck, Schleswig-holstein, Germany, 23538
    - Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Greece
- - Athens, Greece, 115 27
    - Laiko General Hospital of Athens
  - Athens, Greece, 11527
    - Laiko General Hospital of Athens
  - Athens, Greece, 185 47
    - Metropolitan Hospital
  - Piraeus, Greece, 185 47
    - Metropolitan Hospital
- Attiki
  - Athens, Attiki, Greece, 15123
    - Hygeia Diagnostic and Therapeutic Centre of Athens
Hungary
- - Budapest, Hungary, H-1122
    - Országos Onkológiai Intézet
  - Budapest, Hungary, 01062
    - Magyar Honvedseg Egeszsegugyi Kozpont
  - Debrecen, Hungary, 4032
    - Debreceni Egyetem Klinikai Kozpont
  - Szolnok, Hungary, 05004
    - Jász-Nagykun-Szolnok Megyei Hetényi Géza Kórház-Rendelointézet
- Hajdú-bihar
  - Debrecen, Hajdú-bihar, Hungary, 4032
    - Debreceni Egyetem Klinikai Kozpont
Israel
- - Haifa, Israel, 3109600
    - Rambam Health Care Campus
  - Jerusalem, Israel, 91120
    - Hadassah Medical Center - PPDS
- Hatsafon
  - Haifa, Hatsafon, Israel, 3109601
    - Rambam Health Care Campus
- Heifa
  - Haifa, Heifa, Israel, 31096
    - Rambam Health Care Campus
- Tel-aviv
  - Ramat Gan, Tel-aviv, Israel, 5262100
    - Sheba Medical Center - PPDS
- Ḥeifā
  - Haifa, Ḥeifā, Israel, 3109601
    - Rambam Health Care Campus
Italy
- - Bari, Italy, 70126
    - IRCCS Giovanni Paolo II Cancer Institute
  - Bergamo, Italy, 24127
    - ASST Papa Giovanni XXIII - Azienda Ospedaliera Papa Giovanni XXIII
  - Bologna, Italy, 40138
    - Azienda Ospedaliero Universitaria Di Bologna - Policlinico S.Orsola Malpighi
  - Genoa, Italy, 16132
    - IRCCS Az. Osp. Universitaria San Martino- IST
  - Milano, Italy, 20141
    - Istituto Europeo di Oncologia
  - Napoli, Italy, 80131
    - Istituto Nazionale per lo studio e la cura dei tumori Fondazione Giovanni Pascale
  - Padova, Italy, 16132
    - Istituto Oncologico Veneto - I.R.C.C.S.
  - Pavia, Italy, 27100
    - Fondazione IRCCS Policlinico San Matteo di Pavia
  - Ragusa, Italy, 97100
    - Azienda Ospedaliera Civile Maria Paternò Arezzo Ragusa
  - Ragusa, Italy, 97100
    - S. C. Oncologia Medica Presidio Ospedaliero Maria Paterno Arezzo
  - Rome, Italy, 00128
    - Policlinico Universitario Campus Biomedico
  - Siena, Italy, 53100
    - Azienza Ospedaliera Universitaria Senese
  - Torino, Italy, 10134
    - Ospedale Koelliker
  - Udine, Italy, 33100
    - Azienda Sanitaria Universitaria Integrata di Udine - PO Universitario Santa Maria della Misericordia
- Ancona
  - Torrette Site, Ancona, Italy, 60126
    - Azienda Ospedaliero Universitaria Ospedali Riuniti di Ancona-Umberto I G.M. Lancisi G. Salesi
- Campania
  - Napoli, Campania, Italy, 80131
    - Azienda Ospedaliera Universitaria Federico II
- Emilia-romagna
  - Bologna, Emilia-romagna, Italy, 40138
    - Azienda Ospedaliero Universitaria Di Bologna Policlinico S Orsola Malpighi-Via Massarenti
  - Bologna, Emilia-romagna, Italy, 40138
    - Azienda Ospedaliero Universitaria di Bologna Policlinico S Orsola Malpighi
- Lazio
  - Roma, Lazio, Italy, 00189
    - Azienda Ospedaliera Sant'Andrea
  - Roma, Lazio, Italy, 00128
    - Policlinico Universitario Campus Biomedico Di Roma
  - Roma, Lazio, Italy, 00144
    - Istituto Nazionale Tumori Regina Elena
  - Roma, Lazio, Italy, 128
    - Policlinico Universitario Campus Biomedico Di Roma
- Lombardia
  - Lecco, Lombardia, Italy, 23900
    - Azienda Ospedaliera Ospedale Di Lecco
  - Milan, Lombardia, Italy, 20141
    - Istituto Europeo di Oncologia
  - Monza, Lombardia, Italy, 20900
    - ASST di Monza - Azienda Ospedaliera San Gerardo
  - Monza, Lombardia, Italy, 20900
    - Azienda Ospedaliera San Gerardo
  - Rozzano, Lombardia, Italy, 20089
    - Istituto Clinico Humanitas - Humanitas Cancer Center
  - Rozzano, Lombardia, Italy, 20089
    - Istituto Clinico Humanitas
- Torino
  - Candiolo, Torino, Italy, 10060
    - Fondazione del Piemonte per l'Oncologia (IRCCS)
- Toscana
  - Pisa, Toscana, Italy, 56126
    - Azienda Ospedaliero Universitaria Pisana
- Umbria
  - Terni, Umbria, Italy, 05100
    - Azienda Ospedaliera S Maria Di Terni
- Veneto
  - Padua, Veneto, Italy, 35128
    - Clinica Oculistica
Japan
- - Niigata, Japan, 951-8566
    - Niigata Cancer Center Hospital
- Fukuoka
  - Fukuoka-shi, Fukuoka, Japan, 812-8582
    - Kyushu University Hospital
- Nagano
  - Matsumoto, Nagano, Japan, 390-8621
    - Shinshu University Hospital
- Niigata
  - Niigata-Shi, Niigata, Japan, 951-8133
    - Niigata Cancer Center Hospital
  - Niigata-shi, Niigata, Japan, 951-8566
    - Niigata Cancer Center Hospital
- Tokyo
  - Chuo-ku, Tokyo, Japan, 104-0045
    - National Cancer Center Hospital
- Ôsaka
  - Osaka, Ôsaka, Japan, 540-0006
    - National Hospital Organization Osaka National Hospital
Korea, Republic of
- - Seoul, Korea, Republic of, 03080
    - Seoul National University Hospital
  - Seoul, Korea, Republic of, 110-744
    - Seoul National University Hospital
  - Seoul, Korea, Republic of, 05505
    - Asan Medical Center - PPDS
  - Seoul, Korea, Republic of, 03722
    - Severance Hospital Yonsei University Health System - PPDS
  - Seoul, Korea, Republic of, 120-752
    - Severance Hospital Yonsei University Health System - PPDS
  - Seoul, Korea, Republic of, 135-710
    - Samsung Medical Center - PPDS
  - Seoul, Korea, Republic of, 06351
    - Samsung Medical Center - PPDS
- Seoul Teugbyeolsi
  - Gangnam-Gu, Seoul Teugbyeolsi, Korea, Republic of, 06351
    - Samsung Medical Center - PPDS
  - Songpa-Gu, Seoul Teugbyeolsi, Korea, Republic of, 05505
    - Asan Medical Center - PPDS
- Seoul-teukbyeolsi [seoul]
  - Seoul, Seoul-teukbyeolsi [seoul], Korea, Republic of, 03080
    - Seoul National University Hospital
Mexico
- - Mexico, Mexico, 14080
    - Instituto Nacional de Cardiologia Ignacio Chavez
  - Mexico, Mexico, 14050
    - Medica Sur, S. A. B de C. V. (Centro de Investigación Farmacológica y Biotecnológica CIF-BIOTEC)
- DF
  - Mexico, DF, Mexico, 14080
    - Instituto Nacional de Cancerologia
Netherlands
- - Ariënsplein Enschede, Netherlands, 7513 JX
    - Medisch Spectrum Twente - Hospital
  - Enschede, Netherlands, 7512 KZ
    - Medisch Spectrum Twente
  - Groningen, Netherlands, 9713 GZ
    - Universitair Medisch Centrum Groningen
  - Leiden, Netherlands, 2300 RC
    - Leids Universitair Medisch Centrum
  - Maastricht, Netherlands, 6229 HX
    - Maastricht University Medical Center
  - Rotterdam, Netherlands, 3015 CE
    - Erasmus MC
  - Rotterdam, Netherlands, 3075 EA
    - Erasmus MC-Daniel den Hoed Oncologisch Centrum
  - Sittard-Geleen, Netherlands, 6162 BG
    - Zuyerland Medisch Centrum
- Gelderland
  - Nijmegen, Gelderland, Netherlands, 6525 GA
    - Radboud University Nijmegen Medical Centre
- Limburg
  - Heerlen, Limburg, Netherlands, 6419 PC
    - Zuyderland Medisch Centrum
- Noord Holland
  - Amsterdam, Noord Holland, Netherlands, 1081 HV
    - VU Medisch Centrum
- Noord-brabant
  - Breda, Noord-brabant, Netherlands, 4818 CK
    - Amphia Ziekenhuis
  - Breda, Noord-brabant, Netherlands, 4818CK
    - Amphia Ziekenhuis
  - Eindhoven, Noord-brabant, Netherlands, 5631 BM
    - Máxima Medisch Centrum
  - Veldhoven, Noord-brabant, Netherlands, 5504 DB
    - Máxima Medisch Centrum
- Overijssel
  - Enschede, Overijssel, Netherlands, 7513 ER
    - Medisch Spectrum Twente
  - Zwolle, Overijssel, Netherlands, 8025 AB
    - Isala Klinieken
Norway
- - Oslo, Norway, 379
    - Oslo universitetssykehus HF, Utprøvingsenheten
  - Oslo, Norway, 379
    - Oslo universitetssykehus HF
  - Oslo, Norway, NO-0424
    - Oslo Myeloma Center - PPDS
Poland
- - Warszawa, Poland, 00-001
    - Lux Med
- Mazowieckie
  - Warsaw, Mazowieckie, Poland, 02-781
    - Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
  - Warszawa, Mazowieckie, Poland, 01-673
    - Centrum Medyczne MAVIT Sp. z o.o.
Portugal
- - Almada, Portugal, 2801-951
    - Hospital Garcia de Orta*E.P.E.
  - Lisboa, Portugal, 1649-035
    - Hospital de Santa Maria
  - Lisboa, Portugal, 1099-023
    - Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
  - Lisboa, Portugal, 1099-023
    - Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
  - Lisboa, Portugal, 1649-035
    - Centro Hospitalar de Lisboa Norte E.P.E - Hospital Pulido Valente - PPDS
  - Lisboa, Portugal, 1649-035
    - Hospital de Santa Maria-Avenida Prof. Egas Moniz - PPDS
  - Lisboa, Portugal, 1649-035
    - Centro Hospitalar de Lisboa Norte, E.P.E- Hospital de Santa Maria
  - Porto, Portugal, 4200-072
    - Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
- Lisboa
  - Lisbon, Lisboa, Portugal, 1099-023
    - Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.
- Proto
  - Porto, Proto, Portugal, 4200-072
    - Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe - PPDS
Russian Federation
- - Moscow, Russian Federation, 115478
    - Russian Oncology Research Center n a N N Blokhin
  - Ryazan, Russian Federation, 390011
    - Ryazan Regional Clinical Oncology Dispensary
  - Ryazan, Russian Federation, 390005
    - Ryazan Clinical Hospital n.a. Semashko
  - Ryazan', Russian Federation, 390027
    - Ryazan Regional Clinical Oncology Dispensary
  - St. Petersburg, Russian Federation, 197758
    - Scientific Research Institute of Oncology n.a. N.N. Petrov
Singapore
- - Singapore, Singapore, 169610
    - National Cancer Centre Singapore
  - Singapore, Singapore, 169608
    - Singapore General Hospital (SGH)
  - Singapore, Singapore, 169610
    - Singapore National Eye Research Centre
  - Singapore, Singapore, 169610
    - National Cancer Centre - 30 Hospital Blvd
Slovakia
- - Bratislava, Slovakia, 811 08
    - Nemocnica svateho Michala, a.s.
  - Bratislava, Slovakia, 842 29
    - BIONT, a.s.
  - Bratislava, Slovakia, 833 01
    - Narodny onkologicky ustav - PPDS
  - Bratislava, Slovakia, 833 10
    - Narodny onkologicky ustav - PPDS
  - Poprad, Slovakia, 058 01
    - POKO Poprad, s.r.o.
South Africa
- - Pretoria, South Africa, 00002
    - Steve Biko Academic Hospital
  - Pretoria, South Africa, 27
    - Mary Potter Oncology Centre
Spain
- - Alicante, Spain, 03010
    - Hospital General Universitario de Alicante
  - Alicante, Spain, 3010
    - Hospital General Universitario Dr. Balmis
  - Badalona, Spain, 08916
    - Hospital Universitario Germans Trias i Pujol
  - Barcelona, Spain, 08036
    - Hospital Clinic de Barcelona
  - Barcelona, Spain, 08041
    - Hospital de la Santa Creu i Sant Pau
  - Barcelona, Spain, 08035
    - Hospital Universitario Vall d'Hebron - PPDS
  - Barcelona, Spain, 8036
    - Hospital Clinic de Barcelona
  - Barcelona, Spain, 8041
    - Hospital de la Santa Creu i Sant Pau
  - Barcelona, Spain, 08036
    - Hospital Clinic Provincial de Barcelona
  - Barcelona, Spain, 08021
    - Centro de Oftalmologia Barraquer
  - Donostia-san Sebastián, Spain, 20014
    - Onkologikoa
  - Granada, Spain, 18014
    - Hospital Universitario Virgen de las Nieves
  - La Coruna, Spain, 15006
    - Hospital Universitario A Coruña
  - Lleida, Spain, 25198
    - Hospital Universitari Arnau de Vilanova
  - Lleida, Spain, 25198
    - Hospital Arnau de Vilanova
  - Madrid, Spain, 28034
    - Hospital Universitario Ramon Y Cajal
  - Madrid, Spain, 28041
    - Hospital Universitario 12 de Octubre
  - Madrid, Spain, 28007
    - Hospital General Universitario Gregorio Marañon
  - Madrid, Spain, 28009
    - Hospital General Universitario Gregorio Marañon
  - Madrid, Spain, 28026
    - Hospital Universitario 12 de Octubre
  - Majadahonda, Spain, 28222
    - Hospital Universitario Puerta de Hierro - Majadahonda
  - Malaga, Spain, 29011
    - Hospital Regional Universitario de Malaga ? Hospital General
  - Malaga, Spain, 29011
    - Hospital Civil (Hospital Regional Universitario de Malaga)
  - Sevilla, Spain, 41013
    - Hospital Universitario Virgen del Rocio - PPDS
  - Valencia, Spain, 46009
    - Fundación Instituto Valenciano de Oncología
- Andalucía
  - Jerez De La Frontera, Andalucía, Spain, 11407
    - Hospital Universitario De Jerez
- Asturias
  - Oviedo, Asturias, Spain, 33011
    - Hospital Universitario Central de Asturias
- Barcelona
  - Badalona, Barcelona, Spain, 08916
    - Hospital Universitario Germans Trias i Pujol
- Cataluña
  - Barcelona, Cataluña, Spain, 08029
    - Cetir, Centre Mèdic, S.L
- Madrid
  - Majadahonda, Madrid, Spain, 28222
    - Hospital Universitario Puerta de Hierro - Majadahonda
  - Majadahonda, Madrid, Spain, 28220
    - Hospital Universitario Puerta de Hierro Majadahonda
  - Majadahonda, Madrid, Spain, 28850
    - Hospital Universitario Puerta de Hierro Majadahonda
- Murcia
  - El Palmar, Murcia, Spain, 30120
    - Hospital Clínico Universitario Virgen de la Arrixaca
- Navarra
  - Pamplona, Navarra, Spain, 31008
    - Complejo Hospitalario de Navarra
  - Pamplona, Navarra, Spain, 31008
    - Clinica Universidad de Navarra
  - Pamplona, Navarra, Spain, 31008
    - Clínica Universidad Navarra
  - Pamplona, Navarra, Spain, 31008
    - Hospital Universitario de Navarra
  - Pamplona, Navarra, Spain, 31005
    - Clínica Universidad Navarra
- Sevilla
  - Seville, Sevilla, Spain, 41014
    - Hospital Nuestra Señora de Valme
Sweden
- - Gavle, Sweden, SE-801 87
    - Gavle Sjukhus
  - Göteborg, Sweden, SE-41345
    - Sahlgrenska Universitetssjukhuset
  - Lund, Sweden, 22221
    - Skånes universitetssjukhus Lund
  - Solna, Sweden, 171 64
    - Karolinska Universitetssjukhuset Solna
  - Uppsala, Sweden, 751 85
    - Uppsala Universitet
Switzerland
- - Bern, Switzerland, 3010
    - Inselspital Bern
  - Zurich Flughafen, Switzerland, 8058
    - Universitatsspital Zurich
  - Zürich, Switzerland, 8091
    - Institut für diagnostische und interventionelle Radiologie
  - Zürich, Switzerland, 8044
    - Dr. med. Nicole Gasser
  - Zürich, Switzerland, 8044
    - Dr.med. Ursula Urner
- Zürich (DE)
  - Zurich, Zürich (DE), Switzerland, 8091
    - Universitatsspital Zurich
Turkey
- - Bornova, Turkey, 35100
    - Ege University Medical Faculty
  - Izmir, Turkey, 35100
    - Ege University Medical aculty
  - Izmir, Turkey, 35100
    - Sifa Universitesi Bornova Egitim Arastirma Hastanesi
United Kingdom
- - Broomfield, United Kingdom, CM1 7ET
    - Broomfield Hospital
  - Cambridge, United Kingdom, CB2 0QQ
    - Cambridge University Hospitals NHS Foundation Trust
  - Leeds, United Kingdom, LS9 7TF
    - St James University Hospital
  - London, United Kingdom, NW32QG
    - Royal Free Hospital
  - Manchester, United Kingdom, M20 4BX
    - The Christie NHS Foundation Trust - PPDS
  - Oxford, United Kingdom, OX3 7LE
    - Churchill Hospital
  - Oxford, United Kingdom, OX2 7JL
    - Churchill Hospital
  - Preston, United Kingdom, PR2 9HT
    - Royal Preston Hospital - PPDS
- Cambridgeshire
  - Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
    - Addenbrookes Hospital
- Chelmsford, Essex
  - Broomfield, Chelmsford, Essex, United Kingdom, CM1 7ET
    - Mid Essex Hospital Services NHS Trust
- Chelsea
  - London, Chelsea, United Kingdom, SW3 6JJ
    - The Royal Marsden NHS Foundation Trust
- Lancashire
  - Preston, Lancashire, United Kingdom, PR2 9HT
    - Royal Preston Hospital
- London, CITY OF
  - London, London, CITY OF, United Kingdom, SW3 6JJ
    - Royal Marsden Hospital - Surrey
  - London, London, CITY OF, United Kingdom, SW3 6JJ
    - The Royal Marsden in Sutton, Surrey - Downs Rd
- Surrey
  - Guildford, Surrey, United Kingdom, GU2 7XX
    - Royal Surrey County Hospital
- Wirral
  - Bebington, Wirral, United Kingdom, CH63 4JY
    - Clatterbridge Hospital
  - Bebington, Wirral, United Kingdom, CH63 4JY
    - Clatterbridge Hospital - PPDS
- York
  - Sheffield, York, United Kingdom, S10 2SJ
    - Weston Park Hospital
United States
- Alabama
  - Birmingham, Alabama, United States, 35294
    - University of Alabama At Birmingham
  - Birmingham, Alabama, United States, 35243
    - University of Alabama At Birmingham
  - Birmingham, Alabama, United States, 35233
    - Retinal Consultants of Alabama P.C.
  - Birmingham, Alabama, United States, 35233
    - UAB Callahan Eye Hospital
  - Birmingham, Alabama, United States, 35243
    - Uab Comprehensive Cancer Center
  - Birmingham, Alabama, United States, 35233-1932
    - Uab Comprehensive Cancer Center
  - Birmingham, Alabama, United States, 35233-1932
    - UAB The Kirklin Clinic
- Arkansas
  - Fayetteville, Arkansas, United States, 72703
    - Highlands Oncology Group
  - Rogers, Arkansas, United States, 72758
    - Highlands Oncology Group
- California
  - Orange, California, United States, 92868
    - UC Irvine Medical Center
  - Orange, California, United States, 92868-3201
    - UC Irvine Medical Center
- Colorado
  - Aurora, Colorado, United States, 80012-5405
    - Rocky Mountain Cancer Centers (Williams) - USOR
  - Boulder, Colorado, United States, 80303
    - Rocky Mountain Cancer Centers
  - Colorado Springs, Colorado, United States, 80907
    - Rocky Mountain Cancer Centers
  - Denver, Colorado, United States, 80218
    - Rocky Mountain Cancer Centers (Williams) - USOR
  - Lakewood, Colorado, United States, 80228
    - Rocky Mountain Cancer Centers
  - Parker, Colorado, United States, 80134
    - Specialty Eye Care
  - Pueblo, Colorado, United States, 81008
    - Rocky Mountain Cancer Centers
- Illinois
  - Chicago, Illinois, United States, 60612
    - University of Illinois Hospital and Health Sciences System
  - Chicago, Illinois, United States, 60612
    - University of Illinois Medical Center
  - Chicago, Illinois, United States, 60612-4325
    - University of Illinois at Chicago
  - Chicago, Illinois, United States, 60612-7234
    - University of Illinois Hospital and Health Sciences System - Investigational Drug Service
  - Chicago, Illinois, United States, 60612
    - Eye & Ear Infirmary- Opthalmology
- Indiana
  - Goshen, Indiana, United States, 46526-4810
    - Goshen Center for Cancer Care
- Michigan
  - Grand Rapids, Michigan, United States, 49525
    - Retina Specialists of Michigan
  - Grand Rapids, Michigan, United States, 49503
    - Lack's Cancer Center at Mercy Health Saint Mary's
  - Grand Rapids, Michigan, United States, 49503
    - Mercy Health Hauenstein Neuroscience Center Neuro-Ophthalmology (Clinic)
- Mississippi
  - Jackson, Mississippi, United States, 39216
    - Jackson Oncology Associates, PLLC
  - Jackson, Mississippi, United States, 39202
    - Jackson Oncology Associates - St. Dominic Hospital
  - Jackson, Mississippi, United States, 39216-4608
    - Jackson Oncology Associates - St. Dominic Hospital
- New Jersey
  - Hackensack, New Jersey, United States, 07601
    - Hackensack University Medical Center
  - Hackensack, New Jersey, United States, 7601
    - Hackensack University Medical Center
  - Hackensack, New Jersey, United States, 7601
    - Hackensack University Medical Cente
- New York
  - Rochester, New York, United States, 14642
    - University of Rochester Medical Center - PPDS
  - Rochester, New York, United States, 14642
    - Investigational Drug Service, Department of Pharmacy (Investigational Product)
- Texas
  - Dallas, Texas, United States, 75246
    - Texas Oncology - Baylor Charles A. Sammons Cancer Center
  - Dallas, Texas, United States, 75231
    - Dr. Dennis B. Kay (Ophthalmologist)
- Vermont
  - Burlington, Vermont, United States, 05401
    - University of Vermont Medical Center
  - Burlington, Vermont, United States, 05401-1473
    - University of Vermont Medical Center
  - Burlington, Vermont, United States, 05405
    - University of Vermont Cancer Center
- Virginia
  - Alexandria, Virginia, United States, 22304
    - Virginia Cancer Specialists, PC
  - Arlington, Virginia, United States, 22205
    - Virginia Cancer Specialists
  - Fairfax, Virginia, United States, 22031
    - Virginia Cancer Specialists, PC
  - Fairfax, Virginia, United States, 22031
    - Virginia Cancer Specialists
  - Fairfax, Virginia, United States, 22031
    - Virginia Cancer Specialists (Leesburg) - USOR
  - Fairfax, Virginia, United States, 22033
    - Northern Virginia Ophthalmology Associates
  - Falls Church, Virginia, United States, 22044
    - Northern Virginia Ophthalmology Associates
  - Gainesville, Virginia, United States, 20155
    - Virginia Cancer Specialists, PC
  - Leesburg, Virginia, United States, 20176
    - Virginia Cancer Specialists (Leesburg) - USOR
  - Leesburg, Virginia, United States, 20176
    - Virginia Cancer Specialists, PC
- Washington
  - Wenatchee, Washington, United States, 98801
    - Wenatchee Valley Medical Center
  - Wenatchee, Washington, United States, 98801
    - Wenatchee Valley Hospital & Clinics
  - Wenatchee, Washington, United States, 98801
    - Wenatchee Valley Hospitals & Clinics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Diagnosis of locally advanced, unresectable or metastatic cutaneous melanoma or unknown primary melanoma (AJCC Stage IIIB, IIIC, or IV)
Presence of BRAF V600E or V600K mutation in tumor tissue prior to randomization
Naïve untreated patients or patients who have progressed on or after prior first line immunotherapy for resectable locally advanced or metastatic melanoma; prior adjuvant therapy is permitted (e.g. IFN, IL-2 therapy, any other immunotherapy, radiotherapy or chemotherapy), except the administration of BRAF or MEK inhibitors
Evidence of at least one measurable lesion as detected by radiological or photographic methods
ECOG performance status of 0 or 1
Adequate bone marrow, organ function, cardiac and laboratory parameters
Normal functioning of daily living activities

Exclusion Criteria:

Any untreated central nervous system (CNS) lesion
Uveal and mucosal melanoma
History of leptomeningeal metastases
History of or current evidence of central serous retinopathy (CSR), retinal vein occlusion (RVO) or history of retinal degenerative disease
Any previous systemic chemotherapy treatment, extensive radiotherapy or investigational agent other than immunotherapy, or patients who have received more than one line of immunotherapy for locally advanced unresectable or metastatic melanoma; Ipilimumab (adjuvant) or other immunotherapy treatment must have ended at least 6 weeks prior to randomization
History of Gilbert's syndrome
Prior therapy with a BRAF inhibitor and/or a MEK- inhibitor
Impaired cardiovascular function or clinically significant cardiovascular diseases
Uncontrolled arterial hypertension despite medical treatment
HIV positive or active Hepatitis B, and/or active Hepatitis C
Impairment of gastrointestinal function
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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LGX818 450 mg + MEK162 LGX818 450 mg QD + MEK162 45 mg BID	Drug: LGX818 LGX818- Orally 100 mg and 50 mg capsules Drug: MEK162 MEK162- Orally 15 mg tablets
Active Comparator: Vemurafenib Vemurafenib 960 mg BID	Drug: vemurafenib Tablets in bottles or blisters 240 mg Other Names: PLX4032 Zelboraf RO5185426
Experimental: LGX818 300 mg + MEK162 LGX818 300 mg QD + MEK162 45 mg BID	Drug: LGX818 LGX818- Orally 100 mg and 50 mg capsules Drug: MEK162 MEK162- Orally 15 mg tablets
Experimental: LGX818 LGX818 300 mg QD	Drug: LGX818 LGX818- Orally 100 mg and 50 mg capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Progression Free Survival (PFS) by Blinded Independent Review Committee (BIRC) in Combo 450 Group as Compared to Vemurafenib Group Time Frame: From randomization until documented disease progression (PD), initiation of new anti-cancer therapy, censoring date or death, whichever occurred first (up to 29 months)	PFS was defined as the time from the date of randomization to the date of the first documented disease progression (PD) or death due to any cause, whichever occurs first. PFS was determined based on tumor assessment (RECIST version 1.1 criteria) as per BIRC/central review and survival information. If a participant did not had an event at the time of the analysis cut-off or at the start of any new anti-cancer therapy, data was censored at the date of last adequate tumor assessment. PD was defined as at least a 20% increase in the 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. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 square millimeter (mm^2).	From randomization until documented disease progression (PD), initiation of new anti-cancer therapy, censoring date or death, whichever occurred first (up to 29 months)
Part 1: Progression Free Survival (PFS) by Blinded Independent Review Committee (BIRC) in Combo 450 Group as Compared to LGX818 Group Time Frame: From randomization until documented disease progression (PD), initiation of new anti-cancer therapy, censoring date or death, whichever occurred first (up to 29 months), excluding Part 1: LGX818 300 mg group; up to 35 months for Part 1: LGX 300 mg group	PFS was defined as the time from the date of randomization to the date of the first documented disease progression (PD) or death due to any cause, whichever occurs first. PFS was determined based on tumor assessment (RECIST version 1.1 criteria) as per BIRC and survival information. If a participant did not had an event at the time of the analysis cut-off or at the start of any new anti-cancer therapy, data was censored at the date of last adequate tumor assessment. PD was defined as at least a 20% increase in the 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. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm^2.	From randomization until documented disease progression (PD), initiation of new anti-cancer therapy, censoring date or death, whichever occurred first (up to 29 months), excluding Part 1: LGX818 300 mg group; up to 35 months for Part 1: LGX 300 mg group

Secondary Outcome Measures

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Investigators

Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2013

Primary Completion (Actual)

November 9, 2016

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

July 24, 2013

First Submitted That Met QC Criteria

July 24, 2013

First Posted (Estimated)

July 26, 2013

Study Record Updates

Last Update Posted (Actual)

March 5, 2024

Last Update Submitted That Met QC Criteria

February 8, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

CMEK162B2301
C4221004 (Other Identifier: Alias Study Number)
2013-001176-38 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Metastatic Melanoma | Conjunctival Melanoma | Ocular Melanoma | Unresectable Melanoma | Uveal Melanoma | Cutaneous Melanoma | Mucosal Melanoma | Iris Melanoma | Acral Melanoma | Non-Cutaneous Melanoma

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University of Southern California
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Vaccine Therapy in Treating Patients With Stage IIC-IV Melanoma

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Vaccine Therapy in Treating HLA-A2 Positive Patients With Melanoma

Recurrent Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IA Melanoma | Stage IB Melanoma | Stage IIA Melanoma

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Interactive Tailored Website to Promote Sun Protection and Skin Self-Check Behaviors in Patients With Melanoma

Stage IIIB Skin Melanoma | Stage IIIC Skin Melanoma | Stage III Skin Melanoma | Stage IIA Skin Melanoma | Stage IIB Skin Melanoma | Stage IIC Skin Melanoma | Stage IIIA Skin Melanoma | Stage IA Skin Melanoma | Stage IB Skin Melanoma | Stage 0 Skin Melanoma | Stage I Skin Melanoma | Stage II Skin Melanoma

United States
MelanomaPRO, Russia

Recruiting

Clinical Outcomes and Biomarkers in Patients With Stage 0-IV Melanoma in Real Clinical Practice (ISABELLA)

Melanoma | Melanoma (Skin) | Melanoma Stage IV | Melanoma Stage III | Melanoma, Stage II | Melanoma, Uveal | Melanoma in Situ | Melanoma, Ocular

Russian Federation
Mayo Clinic
National Cancer Institute (NCI)

Completed

Vaccine Therapy and Resiquimod in Treating Patients With Stage II-IV Melanoma That Has Been Removed By Surgery

Recurrent Melanoma | Stage IV Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Stage IIB Melanoma | Stage IIC Melanoma | Stage IIA Melanoma

United States
National Cancer Institute (NCI)

Completed

Vaccine Therapy With or Without Sargramostim in Treating Patients Who Have Undergone Surgery for Melanoma

Stage IV Melanoma | Ciliary Body and Choroid Melanoma, Medium/Large Size | Iris Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Extraocular Extension Melanoma | Stage IIB Melanoma | Stage IIC Melanoma

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Roswell Park Cancer Institute
National Cancer Institute (NCI); National Comprehensive Cancer Network

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Axitinib in Treating Patients With Melanoma That is Metastatic or Cannot Be Removed by Surgery

Recurrent Melanoma | Stage IV Melanoma | Metastatic Intraocular Melanoma | Recurrent Intraocular Melanoma | Stage IV Intraocular Melanoma | Stage IIIA Melanoma | Stage IIIB Melanoma | Stage IIIC Melanoma | Extraocular Extension Melanoma | Stage IIIA Intraocular Melanoma | Stage IIIB Intraocular Melanoma | Stage...

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BRAF Inhibitor, LGX818, Utilizing a Pulsatile Schedule in Patients With Stage IV or Unresectable Stage III Melanoma Characterized by a BRAFV600 Mutation

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Array Biopharma, now a wholly owned subsidiary...

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A Phase I Study of Oral LGX818 in Adult Patients With Advanced or Metastatic BRAF Mutant Melanoma

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Array BioPharma

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LGX818 in Combination With Agents (MEK162; BKM120; LEE011; BGJ398; INC280) in Advanced BRAF Melanoma (LOGIC)

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Array BioPharma

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Jonsson Comprehensive Cancer Center
National Cancer Institute (NCI)

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Intermittent LGX818 and MEK162 in Treating Patients With Metastatic Melanoma Who Have BRAFV600 Mutations

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Memorial Sloan Kettering Cancer Center
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A Study of Binimetinib and Encorafenib in Advanced BRAF Mutant Cancers

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Outcome Measure	Measure Description	Time Frame
Part 2: Progression Free Survival (PFS) by BIRC in Combo 300 Group as Compared to LGX818 Group Time Frame: From randomization until documented disease progression (PD), initiation of new anti-cancer therapy, censoring date or death, whichever occurred first (up to 35 months)	PFS was defined as the time from the date of randomization to the date of the first documented disease progression (PD) or death due to any cause, whichever occurs first. PFS was determined based on tumor assessment (RECIST version 1.1 criteria) as per BIRC and survival information. If a participant did not had an event at the time of the analysis cut-off or at the start of any new anti-cancer therapy, data was censored at the date of last adequate tumor assessment. PD was defined as at least a 20% increase in the 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. In addition to the relative increase of 20%, the sum must demonstrate an absolute increase of at least 5 mm^2.	From randomization until documented disease progression (PD), initiation of new anti-cancer therapy, censoring date or death, whichever occurred first (up to 35 months)
Part 1: Overall Survival (OS) Time Frame: From randomization until documented disease progression (PD), initiation of new anti-cancer therapy, censoring date or death, whichever occurred first (up to 38 months)	Overall survival was defined as the time from the date of randomization to the date of death due to any cause. If a death had not been observed by the date of analysis cutoff, OS was censored at the date of last contact.	From randomization until documented disease progression (PD), initiation of new anti-cancer therapy, censoring date or death, whichever occurred first (up to 38 months)
Part 1: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) as Graded by National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03 Time Frame: Baseline up to 30 days from last dose of study drug (up to 30 months), excluding Part 1: LGX818 300 mg group; up to 36 months for Part 1 LGX 300 mg group	AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that results in death; is life-threatening; requires inpatient hospitalization/prolongation of existing hospitalization; results in persistent/significant disability/incapacity; results in congenital anomaly/birth defect or that is considered to be important medical event. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical/diagnostic observations only; Grade 2: moderate, minimal, local/noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe/medically significant but not immediately life-threatening, hospitalization/prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence; Grade 5: death. AEs of all grades were reported.	Baseline up to 30 days from last dose of study drug (up to 30 months), excluding Part 1: LGX818 300 mg group; up to 36 months for Part 1 LGX 300 mg group
Part 1: Number of Participants With Clinically Notable Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.03 Time Frame: Baseline up to 30 days from last dose of study drug (up to 30 months), excluding Part 1: LGX818 300 mg group; up to 36 months for Part 1 LGX 300 mg group	Number of participants with clinically notable shift from baseline in laboratory parameter values based on national cancer institute common terminology criteria (NCI-CTCAE) grade, Version 4.03 were graded from Grades 1 to 5. Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death. Clinically notable shift from baseline in laboratory parameter = worsening by at least 2 grades or to >=grade 3.	Baseline up to 30 days from last dose of study drug (up to 30 months), excluding Part 1: LGX818 300 mg group; up to 36 months for Part 1 LGX 300 mg group
Part 1: Number of Participants With Newly Occurring Notably Abnormal Vital Signs Time Frame: Baseline up to 30 days from last dose of study drug (up to 30 months), excluding Part 1: LGX818 300 mg group; up to 36 months for Part 1 LGX 300 mg group	Notably abnormal vital signs were: Low/high systolic blood pressure (SBP) (millimeter of mercury [mmHg]): less than or equal to (<=) 90 mmHg with decrease from baseline of greater than or equal to (>=) 20 mmHg/>= 160 mmHg with increase from baseline of >=20 mmHg. Low/high diastolic blood pressure (DBP) [mmHg]: <= 50 mmHg with decrease from baseline of >=15 mmHg/>=100 mmHg with increase from baseline of >=15 mmHg. Low/high Pulse rate: <=50 beats per minute (bpm) with decrease from baseline of >=15 bpm/>= 120 bpm with increase from baseline of >=15 bpm. Low/high Weight [kilogram]: >=20 percent (%) decrease from baseline/>= 10% increase from baseline. Low/high Body temperature degree Celsius (C): <= 36 degree C/>= 37.5 degree C.	Baseline up to 30 days from last dose of study drug (up to 30 months), excluding Part 1: LGX818 300 mg group; up to 36 months for Part 1 LGX 300 mg group
Part 1: Number of Participants With Newly Occurring Notable Electrocardiogram (ECG) Values Time Frame: Baseline up to 30 days from last dose of study drug (up to 30 months), excluding Part 1: LGX818 300 mg group; up to 36 months for Part 1 LGX 300 mg group	Newly occurring notable ECG values were reported for QT (millisecond [ms]), QTcF (millisecond), QTcB (millisecond) and heart rate (beats per minute). Newly occurring was defined as participants not meeting criterion at baseline and meeting criterion post-baseline. Ranges for newly occurring notable ECG values (QT, QTcF, QTcB) are New greater than (>) 450, New >480, New >500, Increase from baseline >30, Increase from baseline >60. Heart rate: New <60, New >100 was considered as newly occurring notable value.	Baseline up to 30 days from last dose of study drug (up to 30 months), excluding Part 1: LGX818 300 mg group; up to 36 months for Part 1 LGX 300 mg group
Part 1: Number of Participants With Worst Post-baseline Left Ventricular Dysfunction Events (LVEF) Values by Multigated Acquisition (MUGA) Scans or Transthoracic Echocardiograms (ECHO), by CTCAE Grade Time Frame: Baseline up to 30 days from last dose of study drug (up to 30 months), excluding Part 1: LGX818 300 mg group; up to 36 months for Part 1 LGX 300 mg group	Participants with worst post-baseline LVEF Values were graded as Grade 0: Non missing value below Grade 2; Grade 2: LVEF between 40% and 50% or absolute reduction from baseline >=10% and < 20%; Grade 3: LVEF between 20% and 39% or absolute reduction from baseline >=20%; Grade 4: LVEF lower than 20%. Baseline was defined as the last non-missing value prior to the first dose of study treatment. Missing data were due to participants who died or withdrew consent prior to the first scheduled evaluation or missed evaluations as protocol deviations.	Baseline up to 30 days from last dose of study drug (up to 30 months), excluding Part 1: LGX818 300 mg group; up to 36 months for Part 1 LGX 300 mg group
Part 1: Number of Participants With Dermatologic-related Adverse Events of Special Interest (AESI) Graded According to the National Cancer Institute Common Terminology Criteria (NCI-CTCAE) v4.03 Time Frame: Baseline up to 30 days from last dose of study drug (up to 30 months), excluding Part 1: LGX818 300 mg group; up to 36 months for Part 1 LGX 300 mg group	AESI consisted of events for which there was a specific clinical interest with regard to LGX818 and/or MEK162 treatment. Dermatologic-related AESI included rash, photosensitivity, nail disorders, skin infections, severe cutaneous adverse reactions and Palmar-plantar erythrodysaesthesia (PPE) syndrome. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical/diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local/noninvasive intervention indicated, limiting age-appropriate instrumental ADL; Grade 3: severe/medically significant but not immediately life-threatening, hospitalization/prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. AEs of grade 3 or 4 are reported in this outcome measure.	Baseline up to 30 days from last dose of study drug (up to 30 months), excluding Part 1: LGX818 300 mg group; up to 36 months for Part 1 LGX 300 mg group
Part 1: Number of Participants With Ocular-related Adverse Events of Special Interest (AESI) Graded According to the National Cancer Institute Common Terminology Criteria (NCI-CTCAE) v4.03 Time Frame: Baseline up to 30 days from last dose of study drug (up to 30 months), excluding Part 1: LGX818 300 mg group; up to 36 months for Part 1 LGX 300 mg group	AESI consisted of events for which there was a specific clinical interest with regard to LGX818 and/or MEK162 treatment. Ocular-related AESI included retinopathy excluding retinal vein occlusion (RVO), RVO and uveitis-type events. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical/diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local/noninvasive intervention indicated, limiting age-appropriate instrumental ADL; Grade 3: severe/medically significant but not immediately life-threatening, hospitalization/prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. AEs of grade 3 or 4 are reported in this outcome measure.	Baseline up to 30 days from last dose of study drug (up to 30 months), excluding Part 1: LGX818 300 mg group; up to 36 months for Part 1 LGX 300 mg group
Part 2: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) as Graded by National Cancer Institute Common Terminology Criteria (NCI-CTCAE), Version 4.03 Time Frame: Baseline up to 30 days after last dose of study drug (up to 36 months)	AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was any untoward medical occurrence at any dose that results in death; is life-threatening; requires inpatient hospitalization/prolongation of existing hospitalization; results in persistent/significant disability/incapacity; results in congenital anomaly/birth defect or that is considered to be important medical event. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical/diagnostic observations only; Grade 2: moderate, minimal, local/noninvasive intervention indicated, limiting age-appropriate instrumental activities of daily life (ADL); Grade 3: severe/medically significant but not immediately life-threatening, hospitalization/prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence; Grade 5: death. AEs of all grades were reported.	Baseline up to 30 days after last dose of study drug (up to 36 months)
Part 2: Number of Participants With Clinically Notable Shift From Baseline in Laboratory Parameter Values Based on National Cancer Institute Common Terminology Criteria (NCI-CTCAE) Grade, Version 4.0 Time Frame: Baseline up to 30 days after last dose of study drug (up to 36 months)	Number of participants with clinically notable shift from baseline in laboratory parameter values based on national cancer institute common terminology criteria (NCI-CTCAE) grade, Version 4.0 were graded from Grades 1 to 5. Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2: Moderate; minimal, local or noninvasive intervention indicated. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated. Grade 4: Life-threatening consequences; urgent intervention indicated. Grade 5: Death. Clinically notable shift from baseline in laboratory parameter = worsening by at least 2 grades or to >=grade 3.	Baseline up to 30 days after last dose of study drug (up to 36 months)
Part 2: Number of Participants With Newly Occurring Notably Abnormal Vital Signs Time Frame: Baseline up to 30 days after last dose of study drug (up to 36 months)	Notably abnormal vital signs were: Low/high systolic blood pressure (SBP) in millimeter of mercury (mmHg): less than or equal to (<=) 90 mmHg with decrease from baseline of greater than or equal to (>=) 20 mmHg/>= 160 mmHg with increase from baseline of >=20 mmHg, Low/high diastolic blood pressure (DBP) [mmHg]: <=50 mmHg with decrease from baseline of >=15 mmHg/>=100 mmHg with increase from baseline of >=15 mmHg, Low/high pulse rate [bpm]: <=50 bpm with decrease from baseline of >=15 bpm/>=120 bpm with increase from baseline of >=15 bpm, Low/high weight (kg): >=20 % decrease from baseline/>= 10% increase from baseline Low/high Body temperature degree C): <= 36°C/>= 37.5 degree C.	Baseline up to 30 days after last dose of study drug (up to 36 months)
Part 2: Number of Participants With Newly Occurring Notable ECG Values Time Frame: Baseline up to 30 days after last dose of study drug (up to 36 months)	Newly occurring notable ECG values were reported for QT (ms), QTcF (ms), QTcB (ms) and heart rate (bpm). Newly occurring was defined as participants not meeting criterion at baseline and meeting criterion post-baseline. Ranges for newly occurring notable ECG values (QT, QTcF, QTcB) are New >450, New >480, New >500, increase from baseline >30, Increase from baseline >60. Heart rate: New < 60, New >100 was considered as newly occurring notable value.	Baseline up to 30 days after last dose of study drug (up to 36 months)
Part 2: Number of Participants With Worst Post-baseline Left Ventricular Dysfunction Events (LVEF) Values by Multigated Acquisition (MUGA) Scans or Transthoracic Echocardiograms (ECHO), by CTCAE Grade Time Frame: Baseline up to 30 days after last dose of study drug (up to 36 months)	Participants with worst post-baseline LVEF Values were graded as Grade 0: Non missing value below Grade 2; Grade 2: LVEF between 40% and 50% or absolute reduction from baseline >=10% and < 20%;Grade 3: LVEF between 20% and 39% or absolute reduction from baseline >=20%; Grade 4: LVEF lower than 20%. Baseline was defined as the last non-missing value prior to the first dose of study treatment. Missing data were due to participants who died or withdrew consent prior to the first scheduled evaluation or missed evaluations as protocol deviations.	Baseline up to 30 days after last dose of study drug (up to 36 months)
Part 2: Number of Participants With Dermatologic-related Adverse Events of Special Interest (AESI) Graded According to the National Cancer Institute Common Terminology Criteria (NCI-CTCAE) v4.03 Time Frame: Baseline up to 30 days after last dose of study drug (up to 36 months)	AESI consisted of events for which there was a specific clinical interest with regard to LGX818 and/or MEK162 treatment. Dermatologic-related AESI included rash, photosensitivity, nail disorders, skin infections, severe cutaneous adverse reactions and PPE syndrome. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical/diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local/noninvasive intervention indicated, limiting age-appropriate instrumental ADL; Grade 3: severe/medically significant but not immediately life-threatening, hospitalization/prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. AEs of grade 3 or 4 are reported are reported in this outcome measure.	Baseline up to 30 days after last dose of study drug (up to 36 months)
Part 2: Number of Participants With Ocular-related Adverse Events of Special Interest (AESI) Graded According to the National Cancer Institute Common Terminology Criteria (NCI-CTCAE) v4.03 Time Frame: Baseline up to 30 days after last dose of study drug (up to 36 months)	AESI consisted of events for which there was a specific clinical interest with regard to LGX818 and/or MEK162 treatment. Ocular-related AESI included retinopathy excluding RVO, RVO and uveitis-type events. As per NCI-CTCAE version 4.03, severity was graded as Grade 1: asymptomatic/mild symptoms, clinical/diagnostic observations only, intervention not indicated; Grade 2: moderate, minimal, local/noninvasive intervention indicated, limiting age-appropriate instrumental ADL; Grade 3: severe/medically significant but not immediately life-threatening, hospitalization/prolongation of existing hospitalization indicated, disabling, limiting self-care ADL; Grade 4: life-threatening consequence, urgent intervention indicated; Grade 5: death related to AE. AEs of grade 3 or 4 are reported in this outcome measure.	Baseline up to 30 days after last dose of study drug (up to 36 months)
Part 2: Overall Survival (OS) Time Frame: From randomization until documented disease progression (PD), initiation of new anti-cancer therapy, censoring date or death, whichever occurred first (up to 38 months)		From randomization until documented disease progression (PD), initiation of new anti-cancer therapy, censoring date or death, whichever occurred first (up to 38 months)
Part 1 and Part 2: Objective Response Rate (ORR) Time Frame: From randomization until disease progression, censoring date or death, whichever occurred first (up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)	ORR, calculated as the percentage of participants with a best overall response of complete response (CR) or partial response (PR). CR was defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm. PR was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Results are reported for confirmed BIRC response.	From randomization until disease progression, censoring date or death, whichever occurred first (up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)
Part 1 and Part 2: Time to Objective Response (TTR) Time Frame: From randomization until disease progression, censoring date or death, whichever occurred first (up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)	TTR was the time between date of randomization until first documented response of CR or PR. Participants who did not achieve a PR or CR were censored at the last adequate tumor assessment date when they did not have a PFS event or at maximum follow-up (i.e. first patient first visit [FPFV] to last patient last visit [LPLV] used for the analysis) when they had a PFS event. CR was defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. TTR was estimated in the treatment arms using a Kaplan-Meier method. TTR was based on central review.	From randomization until disease progression, censoring date or death, whichever occurred first (up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)
Part 1 and Part 2: Disease Control Rate (DCR) Time Frame: From randomization until disease progression or death, whichever occurred first (up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)	DCR was calculated as the percentage of participants with a best overall response (BOR) of CR, PR, or stable disease (SD). CR was defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. Two sets of DCR were considered, one for confirmed and one for unconfirmed responses. Results are reported for confirmed and unconfirmed responses combined. SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for PD. DCR was based on central review.	From randomization until disease progression or death, whichever occurred first (up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)
Part 1 and Part 2: Duration of Response (DOR) Time Frame: From randomization until disease progression, censoring date or death, whichever occurred first (up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)	DOR was calculated, as the time from the date of first documented response (CR or PR) to the first documented progression or death due to underlying cancer. DOR was estimated for responders (i.e. participants achieving at least once CR or PR) only using a Kaplan-Meier method. CR was defined as disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to <10 mm. PR was defined as at least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters. If a participant with a CR or PR had no progression or death due to underlying disease, the participant was censored at the date of last adequate tumor assessment. Results are based on confirmed BIRC response.	From randomization until disease progression, censoring date or death, whichever occurred first (up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)
Part 1 and Part 2: Time to Definitive 10% Deterioration in the Function Assessment Cancer Therapy-melanoma (FACT-M) Subscale Time Frame: Date of randomization to date of event or death due to any cause, which ever occurred first (up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)	FACT-M:melanoma specific questionnaire to assess participant health-related quality of life. Melanoma specific subscale consists of 16 items related to signs,symptoms,physical/social activities most relevant to participants with advanced-stage melanoma. Other items include physical, functional and social/family well-being (7 items each),emotional well-being (6 items),surgery specific concerns related to melanoma(8 items,not included in this study). Each item range from 0(not at all) to 4(very much), combined to produce subscale scores.Total score range for FACT-M excluding surgery specific items is 0 to 172,higher scores represent better quality of life.Melanoma subscale score range from 0(worst response) to 64(best response),higher score indicated better quality of life. Time to definitive 10% deterioration:time from date of randomization to date of event with at least 10% relative to baseline worsening of corresponding scale score with no later improvement or death due to any cause.	Date of randomization to date of event or death due to any cause, which ever occurred first (up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)
Part 1 and Part 2: Time to Definitive 10% Deterioration in the Global Health Status Score of the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC QLQ-C30) Time Frame: Date of randomization to date of event or death due to any cause, which ever occurred first (maximum up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)	EORTC QLQ-C30 is 30 item questionnaire composed of 5 multi-item functional subscales (physical, role, cognitive, emotional, social functioning), 3 multi-item symptom scales (fatigue, nausea/vomiting, and pain), global health/quality of life (QOL) subscale and 6 single items assessing other cancer related symptoms (dyspnea, sleep disturbance, appetite, diarrhea, constipation and financial impact of cancer). It employed twenty-eight 4 point Likert scales with responses from "not at all" to "very much" and two 7 point Likert scales for global health and overall QOL. Global health status scale score ranged from 0 to 100. Higher score represented better level of functioning. Time to definitive 10% deterioration: time from date of randomization to date of event with at least 10% relative to baseline worsening of corresponding scale score with no later improvement or death due to any cause.	Date of randomization to date of event or death due to any cause, which ever occurred first (maximum up to 29 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 35 months for Part 2 and Part 1 LGX 300 mg group)
Part 1 and Part 2: Change From Baseline in the Function Assessment Cancer Therapy-melanoma (FACT-M) Subscale at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit Time Frame: Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)	FACT-M: melanoma specific questionnaire to assess participant health-related quality of life. Melanoma specific subscale consists of 16 items related to signs, symptoms, physical/social activities most relevant to participants with advanced-stage melanoma. Other items include physical, functional and social/family well-being (7 items each),emotional well-being (6 items),surgery specific concerns related to melanoma(8 items, not included in this study). Each item range from 0(not at all) to 4(very much), combined to produce subscale scores. Total score range for FACT-M excluding surgery specific items is 0 to 172,higher scores represented better quality of life. Melanoma subscale score range from 0(worst response) to 64(best response),higher score indicated better quality of life.	Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)
Part 1 and Part 2: Change From Baseline in EuroQoL-5 Dimension-5 Level (EQ-5D-5L) Index Score at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit Time Frame: Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)	EQ-5D-5L is a standardized participant completed questionnaire that measures health status in terms of a single index value or utility score. EQ-5D-5L consisted of two components: a health state profile (descriptive system) and a visual analogue scale (VAS) in which participants rate their overall health status from 0 (worst imaginable) to 100 (best imaginable), where higher scores indicated better health status. EQ-5D health state profile is comprised of 5 dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 response levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems and 5=extreme problems. EQ-5D-5L health status index score range between 0 to 1. Higher score indicated better health status.	Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)
Part 1 and Part 2: Change From Baseline in Global Health Status Score of EORTC QLQ-C30 at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit Time Frame: Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)	EORTC QLQ-C30 contains 30 items and is composed of multi-item and single-item measures. These include 5 functional scales (physical, role, emotional, cognitive and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/quality of life (QOL) scale. The questionnaire employs 28 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QOL. Responses to all items converted to 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represents more severe symptoms.	Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)
Part 1 and Part 2: Change From Baseline in Emotional Functioning Scale Score of the EORTC QLQ-C30 at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit Time Frame: Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)	EORTC QLQ-C30 contains 30 items and is composed of multi-item and single-item measures. These include 5 functional scales (physical, role, emotional, cognitive and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/quality of life (QOL) scale. The questionnaire employs 28 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QOL. Responses to all items converted to 0 to 100 scale. For functional and global QOL scales, higher scores represent a better level of functioning/QOL. For symptom-oriented scales, a higher score represented more severe symptoms.	Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)
Part 1 and Part 2: Change From Baseline in Physical Functioning Scale Score of the EORTC QLQ-C30 at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit Time Frame: Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)	EORTC QLQ-C30 contains 30 items and is composed of multi-item and single-item measures. These include 5 functional scales (physical, role, emotional, cognitive and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/quality of life (QOL) scale. The questionnaire employs 28 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QOL. Responses to all items converted to 0 to 100 scale. For functional and global QOL scales, higher scores represented a better level of functioning/QOL. For symptom-oriented scales, a higher score represented more severe symptoms.	Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)
Part 1 and Part 2: Change From Baseline in Social Functioning Scale Score of the EORTC QLQ-C30 at Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and End of Treatment Visit Time Frame: Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)	EORTC QLQ-C30 contains 30 items and is composed of multi-item and single-item measures. These include 5 functional scales (physical, role, emotional, cognitive and social functioning), 3 symptom scales (fatigue, nausea/vomiting, and pain), 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea and financial impact) and a global health status/quality of life (QOL) scale. The questionnaire employs 28 4-point Likert scales with responses from "not at all" to "very much" and two 7-point Likert scales for global health and overall QOL. Responses to all items converted to 0 to 100 scale. For functional and global QOL scales, higher scores represented a better level of functioning/QOL. For symptom-oriented scales, a higher score represented more severe symptoms.	Baseline (Day 1 of Cycle 1), Day 1 of Cycle 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 23, 25 and end of treatment visit (within14 days after the last dose of study drug)
Part 1 and Part 2: Number of Participants With Change From Baseline in Eastern Cooperative Oncology Group Performance Status (ECOG PS) Time Frame: Part 1 and Part 2: Baseline, Day 1 of each cycle (Cycle 2 to Cycle 31)	ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 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/chair >50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead.	Part 1 and Part 2: Baseline, Day 1 of each cycle (Cycle 2 to Cycle 31)
Part 1: Plasma Concentrations of LGX 818 Time Frame: Cycle 1 Day 1: pre-dose, 0.5, 1.5, 4 to 8 hours post dose; Cycle 2 Day 1: pre-dose; Cycle 3 Day 1: pre-dose		Cycle 1 Day 1: pre-dose, 0.5, 1.5, 4 to 8 hours post dose; Cycle 2 Day 1: pre-dose; Cycle 3 Day 1: pre-dose
Part 2: Plasma Concentrations of LGX 818 Time Frame: Cycle 1 Day 1: pre-dose, 0.5, 1.5, 4 to 8 hours post dose; Cycle 2 Day 1: pre-dose; Cycle 3 Day 1: pre-dose		Cycle 1 Day 1: pre-dose, 0.5, 1.5, 4 to 8 hours post dose; Cycle 2 Day 1: pre-dose; Cycle 3 Day 1: pre-dose
Part 1: Plasma Concentrations of MEK162 Time Frame: Cycle 1 Day 1: pre-dose, 0.5, 1.5, 4 to 8, hours post dose; Cycle 2 Day 1: pre-dose; Cycle 3 Day 1: pre-dose		Cycle 1 Day 1: pre-dose, 0.5, 1.5, 4 to 8, hours post dose; Cycle 2 Day 1: pre-dose; Cycle 3 Day 1: pre-dose
Part 2: Plasma Concentrations of MEK162 Time Frame: Cycle 1 Day 1: pre-dose, 0.5, 1.5, 4 to 8, hours post dose; Cycle 2 Day 1: pre-dose; Cycle 3 Day 1: pre-dose		Cycle 1 Day 1: pre-dose, 0.5, 1.5, 4 to 8, hours post dose; Cycle 2 Day 1: pre-dose; Cycle 3 Day 1: pre-dose
Part 1 and Part 2: Time to Definitive 1 Point Deterioration in Eastern Cooperative Oncology Group Performance Status (ECOG PS) Time Frame: Baseline up to 30 days from last dose of study drug (up to 30 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 36 months for Part 2 and Part 1 LGX 300 mg group)	ECOG: participant's performance status was measured on a 6-point scale: 0= fully active/able to carry on all pre-disease activities without restriction; 1= restricted in physically strenuous activity but ambulatory and able to carry out work of a light and sedentary nature; 2= ambulatory and capable of all self-care, but unable to carry out any work activities, up and about more than 50 percent (%) of waking hours; 3= capable of only limited self-care, confined to bed/chair >50% of waking hours; 4= completely disabled, cannot carry on any self-care, totally confined to bed/chair: 5= dead. Definitive deterioration was defined as death due to any cause or decrease in ECOG PS by at least one category from baseline score with no subsequent improvement.	Baseline up to 30 days from last dose of study drug (up to 30 months for Part 1, excluding Part 1: LGX818 300 mg group; up to 36 months for Part 2 and Part 1 LGX 300 mg group)

Study Comparing Combination of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in BRAF Mutant Melanoma (COLUMBUS)

A 2-part Phase III Randomized, Open Label, Multicenter Study of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma

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