A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma
NCT ID: NCT01667419
Last Updated: 2019-07-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
498 participants
INTERVENTIONAL
2012-09-24
2018-07-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort 1 Vemurafenib
Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib, 960 milligrams (mg) twice daily, in 28-day cycles, for up to 52 weeks
Vemurafenib
4 tablets of vemurafenib 240 mg each (total 960 mg) were administered orally as per the schedule specified in the respective arm.
Cohort 1 Placebo
Participants with completely resected Stage IIC, IIIA, or IIIB cutaneous melanoma) received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Placebo
Placebo matching to vemurafenib were administered orally as per the schedule specified in the respective arm.
Cohort 2 Vemurafenib
Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
Vemurafenib
4 tablets of vemurafenib 240 mg each (total 960 mg) were administered orally as per the schedule specified in the respective arm.
Cohort 2 Placebo
Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Placebo
Placebo matching to vemurafenib were administered orally as per the schedule specified in the respective arm.
Interventions
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Vemurafenib
4 tablets of vemurafenib 240 mg each (total 960 mg) were administered orally as per the schedule specified in the respective arm.
Placebo
Placebo matching to vemurafenib were administered orally as per the schedule specified in the respective arm.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants with BRAFV600 mutation-positive, cutaneous melanoma (either pathologic Stage IIC or Stage III according to AJCC Staging Criteria version 7 that has been completely resected
* BRAF V600 mutation status of the current primary tumor or involved lymph node determined to be positive using the cobas BRAF V600 mutation test
* Surgically rendered free of disease within 90 days of randomization
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
* Life expectancy of at least 5 years
* Fully recovered from the effects of any major surgery or significant traumatic injury prior to the first dose of study treatment
* Adequate hematologic, hepatic, and renal function
Exclusion Criteria
* History of limb perfusion therapy
* History of radiotherapy for the treatment of melanoma
* Invasive malignancy other than melanoma at the time of enrollment or within 5 years prior to first dose of study treatment
* Family history of inherited colon cancer syndromes
* Known personal history of \>3 adenomatous colorectal polyps or a personal history of adenomatous colorectal polyp(s) \>2 centimeters (cm) in size
* History of or current clinical, radiographic, or pathologic evidence of in-transit metastases, satellite, or microsatellite lesions
* History of or current clinical, radiographic, or pathologic evidence of recurrent lymph node involvement after resection of a primary melanoma with lymph node involvement at any time in the past
* History of local and/or regional and/or distant melanoma recurrence
* History or current radiographic or pathologic evidence of distant metastases
* History of clinically significant cardiac or pulmonary dysfunction
* Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study treatment
* Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
UCLA Department of Medicine; Division of Hematology / Oncology
California City, California, United States
Kaiser Permanente - Hayward
Hayward, California, United States
UCLA Hematology Oncology - Irvine
Irvine, California, United States
UCSD Moores Cancer Center
La Jolla, California, United States
The Angeles Clinic and Research Institute - W LA Office
Los Angeles, California, United States
Cancer Center Of Santa Barbara; Network Clinical Research Specialist
Los Angeles, California, United States
TRIO-US Network Administration; Network Clinical Research Specialist
Los Angeles, California, United States
Kaiser Foundation Hospital - Oakland (W. MacArthur)
Oakland, California, United States
Kaiser Permanente - Oakland
Oakland, California, United States
UCLA Healthcare/Pasadena Oncology
Pasadena, California, United States
Kaiser Permanente - Roseville
Roseville, California, United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, United States
Kaiser Permanente
San Francisco, California, United States
K. Permanente - San Jose
San Jose, California, United States
Coastal Integrative Cancer Care
San Luis Obispo, California, United States
Kaiser Permanente - Santa Clara
Santa Clara, California, United States
Kaiser Permanente - South San Francisco
South San Francisco, California, United States
Stanford University School of Medicine; Stanford Hospital Pharmacy
Stanford, California, United States
UCLA Cancer Center Hema/Oncol
Valencia, California, United States
Kaiser Permanente - Vallejo
Vallejo, California, United States
Kaiser Permanente - Walnut Creek
Walnut Creek, California, United States
UCLA Hematology Oncology - Westlake
Westlake Village, California, United States
University Of Colorado
Aurora, Colorado, United States
St. Mary's Hospital Regional Cancer Center
Grand Junction, Colorado, United States
Florida Cancer Specialists - Broadway
Fort Myers, Florida, United States
Memorial Healthcare System
Hollywood, Florida, United States
GulfCoast Oncology
Sarasota, Florida, United States
Oncology Specialists, S.C.
Park Ridge, Illinois, United States
Indiana University Health; Goshen Center for Cancer Care
Goshen, Indiana, United States
Indiana University Department of Medicine; Division of Infectious Diseases
Indianapolis, Indiana, United States
U of L - Physicians Pulmonology; Dept of Neuroradiology and Dept of Diagnostic Radiology
Louisville, Kentucky, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
St. Luke's Hospital
Kansas City, Missouri, United States
University of Kansas Medical Center; Cancer Center
Kansas City, Missouri, United States
Washington University; Dept of Medicine/Div of Medical Oncology
St Louis, Missouri, United States
Atlantic Health Systems; Pediatrics
Randolph Township, New Jersey, United States
New York University Medical Center PRIME; NYU Clinical Cancer Center
New York, New York, United States
Memorial Sloan Kettering Cancer Center
New York, New York, United States
Duke University Medical Center; Oncology
Durham, North Carolina, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, United States
MUSC Hollings Cancer Center/cannon Park Place; Attn: Tamara Saunders
Charleston, South Carolina, United States
West Clinic
Germantown, Tennessee, United States
Tennessee Oncology PLLC - Nashville (20th Ave)
Nashville, Tennessee, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Mary Babb Randolph Cancer Center
Morgantown, West Virginia, United States
Fundación CIDEA
Buenos Aires, , Argentina
Instituto Medico Especializado Alexander Fleming
Ciudad Autonoma Buenos Aires, , Argentina
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, , Argentina
Hospital Universitario Austral
Derqui-Pilar, , Argentina
Centro de Investigacion Pergamino SA
Pergamino, , Argentina
Instituto de Oncología de Rosario
Rosario, , Argentina
ISIS Clinica Especializada
Santa Fe, , Argentina
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia
Melanoma Institute Australia
North Sydney, New South Wales, Australia
Calvary Mater Newcastle
Waratah, New South Wales, Australia
Border Medical Oncology
Wodonga, New South Wales, Australia
Southern Medical Day Care Centre
Wollongong, New South Wales, Australia
Cairns Base Hospital
Cairns, Queensland, Australia
The Townsville Hospital; Townsville Cancer Centre
Townsville, Queensland, Australia
Royal Adelaide Hospital; Hepatology
Adelaide, South Australia, Australia
Queen Elizabeth Hospital
Woodville, South Australia, Australia
Launceston General Hospital; Gastroenterology Research
Launceston, Tasmania, Australia
Box Hill Hospital
Box Hill, Victoria, Australia
Peninsula Oncology Centre; Frankston Private
Frankston, Victoria, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, Australia
Alfred Hospital
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Medizinische Universität Innsbruck
Innsbruck, , Austria
Krankenanstalt Rudolfstiftung Wien
Vienna, , Austria
Medizinische Universität Wien
Vienna, , Austria
Klinikum Wels-Grieskirchen
Wels, , Austria
ZNA Middelheim
Antwerp, , Belgium
Institut Jules Bordet
Brussels, , Belgium
UZ Antwerpen
Edegem, , Belgium
UZ Gent
Ghent, , Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt, , Belgium
AZ Groeninge, Apotheek
Kortrijk, , Belgium
Trymed Clinical Research
Belo Horizonte, Minas Gerais, Brazil
CITO - Centro Integrado de Terapia Onco-Hematológica - Hospital da Cidade de Passo Fundo
Passo Fundo, Rio Grande do Sul, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, Brazil
Clinica de Oncologia de Porto Alegre - CliniOnco
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Caridade de Ijuí
Ijuí, Rondônia, Brazil
Hospital Sírio-Libanês
São Paulo, São Paulo, Brazil
BC Cancer Agency Vancouver Centre - PARENT; BC Cancer Agency
Vancouver, British Columbia, Canada
Saint Boniface General Hospital; Section of Nephrology BG 007
Winnipeg, Manitoba, Canada
Saint John Regional Hospital; Department of Oncology
Saint John, New Brunswick, Canada
LHSC - Victoria Hospital; Department of Pediatrics
London, Ontario, Canada
The Ottawa Hospital Cancer Center; General Campus
Ottawa, Ontario, Canada
Toronto Sunnybrook Hospital
Toronto, Ontario, Canada
Princess Margaret Hospital; Department of Med Oncology
Toronto, Ontario, Canada
CHUM Hôpital Notre-Dame
Montreal, Quebec, Canada
Mcgill University - Royal Victoria Hospital; Oncology
Montreal, Quebec, Canada
CHUQ - Hôtel-Dieu de Québec
Ste-Foy, Quebec, Canada
General Hospital Pula
Pula, , Croatia
General Hospital Varazdin
Varaždin, , Croatia
Clinical Hospital Center Sestre Milosrdnice
Zagreb, , Croatia
Clinical Hospital Centre Zagreb
Zagreb, , Croatia
Masarykuv onkologicky ustav
Brno, , Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, , Czechia
Fakultní nemocnice Olomouc
Olomouc, , Czechia
Fakultni nemocnice Ostrava
Ostrava - Poruba, , Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Nemocnice Na Bulovce
Prague, , Czechia
East Tallinn Central Hospital; Clinic of Internal Medicine
Tallinn, , Estonia
North Estonia Medical Centre Foundation
Tallinn, , Estonia
Tartu University Hospital; Clinic of Hematology and Oncology
Tartu, , Estonia
CHU Besançon - Hôpital Jean Minjoz
Besançon, , France
Groupe Hospitalier Saint André - Hôpital Saint André
Bordeaux, , France
Hôpital Ambroise Paré - Boulogne-Billancourt; Respiratory
Boulogne-Billancourt, , France
Hopital Claude Huriez - CHU Lille
Lille, , France
Hopital de la Timone
Marseille, , France
CHU NANTES - Hôtel Dieu; Pharmacy
Nantes, , France
CHU Nice - Hopital de l'Archet 2
Nice, , France
Hôpital Saint-Louis
Paris, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
CHU de Rouen Hopital; Service de Neurologie
Rouen, , France
CHU de Toulouse - Hôpital Larrey
Toulouse, , France
St. Josef-Hospital Universitaetsklinikum
Bochum, , Germany
Elbekliniken Buxtehude GmbH
Buxtehude, , Germany
Universitätsklinikum Koeln
Cologne, , Germany
Universitätsklinikum Essen
Essen, , Germany
Universitaetsklinikum Frankfurt
Frankfurt, , Germany
Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel; Klinik fuer Allgemeine Innere Medizin
Kiel, , Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz; Apotheke
Mainz, , Germany
Klinikum Mannheim GmbH Universitätsklinikum
Mannheim, , Germany
Fachklinik Hornheide
Münster, , Germany
Universitätsklinikum Tübingen
Tübingen, , Germany
Universitätsklinikum Wurzburg
Würzburg, , Germany
Cork University Hospital
Cork, , Ireland
Mater Private Hospital
Dublin, , Ireland
The Mater Misericordiae Hospital
Dublin, , Ireland
University College Hospital
Galway, , Ireland
Soroka Medical Center
Beersheba, , Israel
Rambam Health Care Campus
Haifa, , Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, , Israel
Rabin Medical Center-Beilinson Campus
Petah Tikva, , Israel
Chaim Sheba Medical Center
Ramat Gan, , Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, , Israel
Istituto Tumori Giovanni Paolo II IRCSS; Ospedale Oncologico Bari
Bari, Apulia, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, Campania, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, Lazio, Italy
Istituto Nazionale Tumori Regina Elena IRCCS
Rome, Lazio, Italy
IDI-Istituto Dermopatico dell'Immacolata IRCCS
Rome, Lazio, Italy
Istituto Nazionale per la Ricerca sul Cancro di Genova
Genoa, Liguria, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo, Lombardy, Italy
Asst Degli Spedali Civili Di Brescia
Brescia, Lombardy, Italy
Ospedale San Raffaele
Milan, Lombardy, Italy
Istituto Europeo Di Oncologia
Milan, Lombardy, Italy
IRCCS Istituto Clinico Humanitas; Farmacia
Rozzano, Lombardy, Italy
A.O.U. Senese Policlinico Santa Maria Alle Scotte
Siena, Tuscany, Italy
IOV - Istituto Oncologico Veneto IRCCS
Padua, Veneto, Italy
Centro Oncologico Belenus
Cuernavaca, , Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, , Mexico
Centro Regiomontano de Investigación Clínica
Monterrey, , Mexico
Sanatorio la Luz
Morelia, , Mexico
Universitair Medisch Centrum Groningen
Groningen, , Netherlands
Leids Universitair Medisch Centrum; Cardiology
Leiden, , Netherlands
Christchurch Hospital NZ
Christchurch, , New Zealand
Wellington Hospital
Wellington, , New Zealand
Stavanger Universitetssykehus, Helse Stavanger HF
Stavanger, , Norway
SPZOZ MSW zWarmińsko-MazurskimCen.Onko.wOlsztynie
Olsztyn, , Poland
Przychodnia Med-Polonia Sp. z o.o.
Poznan, , Poland
Centrum Onkologii- Instytut; im. M.Skłodowskiej-Curie
Warsaw, , Poland
Dolnoslaskie Centrum Onkologii
Wroclaw, , Poland
IPO de Coimbra; Servico de Oncologia Medica
Coimbra, , Portugal
Hospital do Espirito Santo; Servico de Oncologia Medica
Evora, , Portugal
Hospital de Santa Maria; Servico de Oncologia Medica
Lisbon, , Portugal
IPO do Porto; Servico de Oncologia Medica
Porto, , Portugal
Moscow City Oncology Hospital #62
Moscovskaya Oblast, Moscow Oblast, Russia
Krasnodar City Oncology Center
Krasnodar, , Russia
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
Moscow, , Russia
Scientific Research Oncology Institute named after N.N. Petrov
Saint Petersburg, , Russia
Institute of Oncology and Radiology of Serbia
Belgrade, , Serbia
Military Medical Academy
Belgrade, , Serbia
Clinical Center Bezanijska Kosa
Belgrade, , Serbia
Institute for oncology of Vojvodina
Kamenitz, , Serbia
GVI Rondebosch Oncology Centre
Cape Town, , South Africa
Mary Potter Oncology Centre
Groenkloof, , South Africa
Groote Schuur Hospital Radiation Oncology Department; Department of Radiation Oncology
Observatory, , South Africa
University of Pretoria Oncology Department
Pretoria, , South Africa
Sandton Oncology Medical Group
Sandton, , South Africa
Hospital Clinico Universitario de Santiago
Santiago de Compostela, LA Coruña, Spain
Hospital Costa del Sol; Servicio de Oncologia
Marbella, Malaga, Spain
Hospital de la Santa Creu; i Sant Pau
Barcelona, , Spain
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Universitari i Politecnic La Fe
Valencia, , Spain
Länssjukhuset Ryhov
Jönköping, , Sweden
Norrlands Universitetssjukhus
Umeå, , Sweden
Centrallasarettet Växjö
Vaxjo, , Sweden
CHUV; Departement d'Oncologie
Lausanne, , Switzerland
CI Dnipropetrovsk CMCH 4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU
Dnipropetrovsk, , Ukraine
Lviv State Oncological Regional Treatment and Diagnostic Center
Lviv, , Ukraine
Bristol Haematology and Oncology Centre
Bristol, , United Kingdom
Addenbrooke's Hospital
Cambridge, , United Kingdom
Velindre Cancer Centre
Cardiff, , United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Queen Elizabeth Hospital
Kings Lynn, , United Kingdom
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London, , United Kingdom
Nottingham University Hospitals City Campus
Nottingham, , United Kingdom
Churchill Hospital
Oxford, , United Kingdom
Royal Cornwall Hospital
Truro, , United Kingdom
New Cross Hospital
Wolverhampton, , United Kingdom
Countries
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References
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Ascierto PA, Lewis KD, Di Giacomo AM, Demidov L, Mandala M, Bondarenko I, Herbert C, Mackiewicz A, Rutkowski P, Guminski A, Simmons B, Ye C, Hooper G, Wongchenko MJ, Goodman GR, Yan Y, Schadendorf D. Prognostic impact of baseline tumour immune infiltrate on disease-free survival in patients with completely resected, BRAFv600 mutation-positive melanoma receiving adjuvant vemurafenib. Ann Oncol. 2020 Jan;31(1):153-159. doi: 10.1016/j.annonc.2019.10.002.
Maio M, Lewis K, Demidov L, Mandala M, Bondarenko I, Ascierto PA, Herbert C, Mackiewicz A, Rutkowski P, Guminski A, Goodman GR, Simmons B, Ye C, Yan Y, Schadendorf D; BRIM8 Investigators. Adjuvant vemurafenib in resected, BRAFV600 mutation-positive melanoma (BRIM8): a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial. Lancet Oncol. 2018 Apr;19(4):510-520. doi: 10.1016/S1470-2045(18)30106-2. Epub 2018 Feb 21.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2011-004011-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GO27826
Identifier Type: -
Identifier Source: org_study_id
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