A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma
BRIM8
A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Vemurafenib (RO5185426) Adjuvant Therapy in Patients With Surgically Resected, Cutaneous BRAF-Mutant Melanoma at High Risk for Recurrence
2 other identifiers
interventional
498
26 countries
183
Brief Summary
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF mutation-positive melanoma at high risk for recurrence. Participants will be enrolled in two separate cohorts: Cohort 1 will include participants with completely resected Stage IIC, IIIA (participants with one or more nodal metastasis greater than \[\>\] 1 millimeter \[mm\] in diameter), or IIIB cutaneous melanoma, as defined by the American Joint Committee on Cancer (AJCC) Classification, Version 7; Cohort 2 will include participants with Stage IIIC cutaneous melanoma, as defined by this classification scheme. Within each cohort, participants will be randomized (1:1 ratio) to receive vemurafenib or matching placebo over a 52-week period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2012
Longer than P75 for phase_3
183 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 15, 2012
CompletedFirst Posted
Study publicly available on registry
August 17, 2012
CompletedStudy Start
First participant enrolled
September 24, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 13, 2018
CompletedResults Posted
Study results publicly available
October 17, 2018
CompletedJuly 23, 2019
July 1, 2019
4.7 years
August 15, 2012
June 5, 2018
July 11, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Disease-Free Survival (DFS) as Assessed Using Contrast-Enhanced Magnetic Resonance Imaging (MRI) or Contrast Enhanced Computed Tomography (CT)
DFS was defined as the time from randomization until the date of the first local, regional, or distant melanoma recurrence, occurrence of new primary melanoma, or death from any cause.
From randomization until the date of the first local, regional, or distant melanoma recurrence, occurrence of new primary melanoma, or death from any cause (up to the April 17, 2017 data cut-off, approximately 4.5 years)
Secondary Outcomes (5)
Distant Metastasis-Free Survival (DMFS) as Assessed Using Contrast-Enhanced MRI or Contrast Enhanced CT
From randomization until the date of diagnosis of distant (i.e., non-locoregional) metastases or death from any cause (up to the April 17, 2017 data cut-off, approximately 4.5 years)
Overall Survival (OS)
From randomization until the date of death from any cause (up until 13-July-2018, approximately 6 years)
Percentage of Participants With Adverse Events
From randomization up to study completion or discontinuation (up until 13-July-2018, approximately 6 years)
Change From Baseline in European Organisation for Research and Treatment of Cancer (EORTC) 30-Item Quality of Life Questionnaire (QLQ-C30) Score
Day 1, Day 8, Day 15, Day 22 of Cycle 1;Day 1, Day 15 of Cycle 2;Day 1 Cycles 3-13;end of treatment(up to 13 months);every 13 weeks thereafter until recurrence or occurrence of a new primary melanoma (up to 17-Apr-17 data cut-off,approximately 4.5 years)
Plasma Concentration of Vemurafenib
Pre-morning dose (0 hour [hr]) and 1 to 4 hrs post-dose on Days 1, 8, 15, and 22 of Cycle 1; pre-morning dose (0 hr) on Days 1 and 15 of Cycle 2; pre-morning dose (0 hr) on Day 1 of Cycles 3-13; at end of treatment (up to 13 months)
Study Arms (4)
Cohort 1 Vemurafenib
EXPERIMENTALParticipants 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
Cohort 1 Placebo
PLACEBO COMPARATORParticipants 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
Cohort 2 Vemurafenib
EXPERIMENTALParticipants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
Cohort 2 Placebo
PLACEBO COMPARATORParticipants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks
Interventions
4 tablets of vemurafenib 240 mg each (total 960 mg) were administered orally as per the schedule specified in the respective arm.
Placebo matching to vemurafenib were administered orally as per the schedule specified in the respective arm.
Eligibility Criteria
You may qualify if:
- Histologically confirmed melanoma of cutaneous origin
- 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
You may not qualify if:
- History of any systemic or local therapy (e.g., chemotherapy, biologic or targeted therapy, hormonal therapy, or photodynamic therapy) for the treatment or prevention of melanoma, including interferon alpha-2b and pegylated interferon alpha-2b
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (207)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
UCLA Department of Medicine; Division of Hematology / Oncology
California City, California, 90095, United States
Kaiser Permanente - Hayward
Hayward, California, 94545, United States
UCLA Hematology Oncology - Irvine
Irvine, California, 92604, United States
UCSD Moores Cancer Center
La Jolla, California, 92093, United States
The Angeles Clinic and Research Institute - W LA Office
Los Angeles, California, 90025, United States
Cancer Center Of Santa Barbara; Network Clinical Research Specialist
Los Angeles, California, 90095, United States
TRIO-US Network Administration; Network Clinical Research Specialist
Los Angeles, California, 90095, United States
Kaiser Foundation Hospital - Oakland (W. MacArthur)
Oakland, California, 94611, United States
Kaiser Permanente - Oakland
Oakland, California, 94611, United States
UCLA Healthcare/Pasadena Oncology
Pasadena, California, 91105, United States
Kaiser Permanente - Roseville
Roseville, California, 95661, United States
Kaiser Permanente Sacramento Medical Center
Sacramento, California, 95814, United States
Kaiser Permanente
San Francisco, California, 94115, United States
K. Permanente - San Jose
San Jose, California, 95119, United States
Coastal Integrative Cancer Care
San Luis Obispo, California, 93401, United States
Kaiser Permanente - Santa Clara
Santa Clara, California, 95051, United States
Kaiser Permanente - South San Francisco
South San Francisco, California, 94080, United States
Stanford University School of Medicine; Stanford Hospital Pharmacy
Stanford, California, 94305, United States
UCLA Cancer Center Hema/Oncol
Valencia, California, 91355, United States
Kaiser Permanente - Vallejo
Vallejo, California, 94589, United States
Kaiser Permanente - Walnut Creek
Walnut Creek, California, 94596, United States
UCLA Hematology Oncology - Westlake
Westlake Village, California, 91361, United States
University Of Colorado
Aurora, Colorado, 80045, United States
St. Mary's Hospital Regional Cancer Center
Grand Junction, Colorado, 81501, United States
Florida Cancer Specialists - Broadway
Fort Myers, Florida, 33901, United States
Memorial Healthcare System
Hollywood, Florida, 33021, United States
GulfCoast Oncology
Sarasota, Florida, 34232, United States
Oncology Specialists, S.C.
Park Ridge, Illinois, 60068, United States
Indiana University Health; Goshen Center for Cancer Care
Goshen, Indiana, 46526, United States
Indiana University Department of Medicine; Division of Infectious Diseases
Indianapolis, Indiana, 46202, United States
U of L - Physicians Pulmonology; Dept of Neuroradiology and Dept of Diagnostic Radiology
Louisville, Kentucky, 40202, United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201, United States
St. Luke's Hospital
Kansas City, Missouri, 64111, United States
University of Kansas Medical Center; Cancer Center
Kansas City, Missouri, 64131, United States
Washington University; Dept of Medicine/Div of Medical Oncology
St Louis, Missouri, 63110, United States
Atlantic Health Systems; Pediatrics
Randolph Township, New Jersey, 07869, United States
New York University Medical Center PRIME; NYU Clinical Cancer Center
New York, New York, 10016, United States
Memorial Sloan Kettering Cancer Center
New York, New York, 10065, United States
Duke University Medical Center; Oncology
Durham, North Carolina, 27710, United States
University of Pennsylvania Health System
Philadelphia, Pennsylvania, 19104, United States
MUSC Hollings Cancer Center/cannon Park Place; Attn: Tamara Saunders
Charleston, South Carolina, 29425, United States
West Clinic
Germantown, Tennessee, 38138, United States
Tennessee Oncology PLLC - Nashville (20th Ave)
Nashville, Tennessee, 37203, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232, United States
MD Anderson Cancer Center
Houston, Texas, 77030, United States
Mary Babb Randolph Cancer Center
Morgantown, West Virginia, 26506, United States
Fundación CIDEA
Buenos Aires, C1425DTG, Argentina
Instituto Medico Especializado Alexander Fleming
Ciudad Autonoma Buenos Aires, 1426, Argentina
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, C1284AEB, Argentina
Hospital Universitario Austral
Derqui-Pilar, B1629ODT, Argentina
Centro de Investigacion Pergamino SA
Pergamino, B2700CPM, Argentina
Instituto de Oncología de Rosario
Rosario, S2000KZE, Argentina
ISIS Clinica Especializada
Santa Fe, S3000, Argentina
Chris O'Brien Lifehouse
Camperdown, New South Wales, 2050, Australia
Melanoma Institute Australia
North Sydney, New South Wales, 2060, Australia
Calvary Mater Newcastle
Waratah, New South Wales, 2298, Australia
Border Medical Oncology
Wodonga, New South Wales, 3690, Australia
Southern Medical Day Care Centre
Wollongong, New South Wales, 2500, Australia
Cairns Base Hospital
Cairns, Queensland, 4870, Australia
The Townsville Hospital; Townsville Cancer Centre
Townsville, Queensland, 4812, Australia
Royal Adelaide Hospital; Hepatology
Adelaide, South Australia, 5000, Australia
Queen Elizabeth Hospital
Woodville, South Australia, 5011, Australia
Launceston General Hospital; Gastroenterology Research
Launceston, Tasmania, 7250, Australia
Box Hill Hospital
Box Hill, Victoria, 3128, Australia
Peninsula Oncology Centre; Frankston Private
Frankston, Victoria, 3199, Australia
Peter Maccallum Cancer Centre
Melbourne, Victoria, 3000, Australia
Alfred Hospital
Melbourne, Victoria, 3004, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Medizinische Universität Innsbruck
Innsbruck, 6020, Austria
Krankenanstalt Rudolfstiftung Wien
Vienna, 1030, Austria
Medizinische Universität Wien
Vienna, 1090, Austria
Klinikum Wels-Grieskirchen
Wels, 4600, Austria
ZNA Middelheim
Antwerp, 2020, Belgium
Institut Jules Bordet
Brussels, 1000, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
UZ Gent
Ghent, 9000, Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt, 3500, Belgium
AZ Groeninge, Apotheek
Kortrijk, 8500, Belgium
Trymed Clinical Research
Belo Horizonte, Minas Gerais, 30150-281, Brazil
CITO - Centro Integrado de Terapia Onco-Hematológica - Hospital da Cidade de Passo Fundo
Passo Fundo, Rio Grande do Sul, 99010-260, Brazil
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, 90035-003, Brazil
Clinica de Oncologia de Porto Alegre - CliniOnco
Porto Alegre, Rio Grande do Sul, 90430-090, Brazil
Hospital de Caridade de Ijuí
Ijuí, Rondônia, 98700-000, Brazil
Hospital Sírio-Libanês
São Paulo, São Paulo, 01308-050, Brazil
BC Cancer Agency Vancouver Centre - PARENT; BC Cancer Agency
Vancouver, British Columbia, V5Z 4E6, Canada
Saint Boniface General Hospital; Section of Nephrology BG 007
Winnipeg, Manitoba, R2H 2A6, Canada
Saint John Regional Hospital; Department of Oncology
Saint John, New Brunswick, E2L 4L2, Canada
LHSC - Victoria Hospital; Department of Pediatrics
London, Ontario, N6A 4G5, Canada
The Ottawa Hospital Cancer Center; General Campus
Ottawa, Ontario, K1H 1C4, Canada
Toronto Sunnybrook Hospital
Toronto, Ontario, M4N3M50, Canada
Princess Margaret Hospital; Department of Med Oncology
Toronto, Ontario, M5G 2M9, Canada
CHUM Hôpital Notre-Dame
Montreal, Quebec, H2L 4M1, Canada
Mcgill University - Royal Victoria Hospital; Oncology
Montreal, Quebec, H3A 1A1, Canada
CHUQ - Hôtel-Dieu de Québec
Ste-Foy, Quebec, G1V 4G2, Canada
General Hospital Pula
Pula, 52100, Croatia
General Hospital Varazdin
Varaždin, 42000, Croatia
Clinical Hospital Center Sestre Milosrdnice
Zagreb, 10000, Croatia
Clinical Hospital Centre Zagreb
Zagreb, 10000, Croatia
Masarykuv onkologicky ustav
Brno, 656 53, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Fakultní nemocnice Olomouc
Olomouc, 775 20, Czechia
Fakultni nemocnice Ostrava
Ostrava - Poruba, 708 52, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34, Czechia
Vseobecna fakultni nemocnice v Praze
Prague, 128 08, Czechia
Nemocnice Na Bulovce
Prague, 180 01, Czechia
East Tallinn Central Hospital; Clinic of Internal Medicine
Tallinn, 11312, Estonia
North Estonia Medical Centre Foundation
Tallinn, 13419, Estonia
Tartu University Hospital; Clinic of Hematology and Oncology
Tartu, 50406, Estonia
CHU Besançon - Hôpital Jean Minjoz
Besançon, 25030, France
Groupe Hospitalier Saint André - Hôpital Saint André
Bordeaux, 33075, France
Hôpital Ambroise Paré - Boulogne-Billancourt; Respiratory
Boulogne-Billancourt, 92104, France
Hopital Claude Huriez - CHU Lille
Lille, 59037, France
Hopital de la Timone
Marseille, 13005, France
CHU NANTES - Hôtel Dieu; Pharmacy
Nantes, 44093, France
CHU Nice - Hopital de l'Archet 2
Nice, 06202, France
Hôpital Saint-Louis
Paris, 75475, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
CHU de Rouen Hopital; Service de Neurologie
Rouen, 76031, France
CHU de Toulouse - Hôpital Larrey
Toulouse, 31059, France
St. Josef-Hospital Universitaetsklinikum
Bochum, 44791, Germany
Elbekliniken Buxtehude GmbH
Buxtehude, 21614, Germany
Universitätsklinikum Koeln
Cologne, 50937, Germany
Universitätsklinikum Essen
Essen, 45147, Germany
Universitaetsklinikum Frankfurt
Frankfurt, 60528, Germany
Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
Universitaetsklinikum Schleswig-Holstein - Campus Kiel; Klinik fuer Allgemeine Innere Medizin
Kiel, 24105, Germany
Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz; Apotheke
Mainz, 55131, Germany
Klinikum Mannheim GmbH Universitätsklinikum
Mannheim, 68167, Germany
Fachklinik Hornheide
Münster, 48157, Germany
Universitätsklinikum Tübingen
Tübingen, 72076, Germany
Universitätsklinikum Wurzburg
Würzburg, 97080, Germany
Cork University Hospital
Cork, Ireland
Mater Private Hospital
Dublin, 7, Ireland
The Mater Misericordiae Hospital
Dublin, 7, Ireland
University College Hospital
Galway, Ireland
Soroka Medical Center
Beersheba, 8410101, Israel
Rambam Health Care Campus
Haifa, 3109600, Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, 9112001, Israel
Rabin Medical Center-Beilinson Campus
Petah Tikva, 4941492, Israel
Chaim Sheba Medical Center
Ramat Gan, 5265601, Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Istituto Tumori Giovanni Paolo II IRCSS; Ospedale Oncologico Bari
Bari, Apulia, 70126, Italy
Istituto Nazionale Tumori Fondazione G. Pascale
Napoli, Campania, 80131, Italy
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Rome, Lazio, 00133, Italy
Istituto Nazionale Tumori Regina Elena IRCCS
Rome, Lazio, 00144, Italy
IDI-Istituto Dermopatico dell'Immacolata IRCCS
Rome, Lazio, 00167, Italy
Istituto Nazionale per la Ricerca sul Cancro di Genova
Genoa, Liguria, 16132, Italy
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
Bergamo, Lombardy, 24127, Italy
Asst Degli Spedali Civili Di Brescia
Brescia, Lombardy, 25100, Italy
Ospedale San Raffaele
Milan, Lombardy, 20132, Italy
Istituto Europeo Di Oncologia
Milan, Lombardy, 20141, Italy
IRCCS Istituto Clinico Humanitas; Farmacia
Rozzano, Lombardy, 20089, Italy
A.O.U. Senese Policlinico Santa Maria Alle Scotte
Siena, Tuscany, 53100, Italy
IOV - Istituto Oncologico Veneto IRCCS
Padua, Veneto, 35128, Italy
Centro Oncologico Belenus
Cuernavaca, 62290, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, 44280, Mexico
Centro Regiomontano de Investigación Clínica
Monterrey, 64710, Mexico
Sanatorio la Luz
Morelia, 58260, Mexico
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ, Netherlands
Leids Universitair Medisch Centrum; Cardiology
Leiden, 2333 ZA, Netherlands
Christchurch Hospital NZ
Christchurch, 8011, New Zealand
Wellington Hospital
Wellington, 6012, New Zealand
Stavanger Universitetssykehus, Helse Stavanger HF
Stavanger, 4011, Norway
SPZOZ MSW zWarmińsko-MazurskimCen.Onko.wOlsztynie
Olsztyn, 10-228, Poland
Przychodnia Med-Polonia Sp. z o.o.
Poznan, 60-693, Poland
Centrum Onkologii- Instytut; im. M.Skłodowskiej-Curie
Warsaw, 02-781, Poland
Dolnoslaskie Centrum Onkologii
Wroclaw, 53-439, Poland
IPO de Coimbra; Servico de Oncologia Medica
Coimbra, 3000-075, Portugal
Hospital do Espirito Santo; Servico de Oncologia Medica
Evora, 7000-811, Portugal
Hospital de Santa Maria; Servico de Oncologia Medica
Lisbon, 1649-035, Portugal
IPO do Porto; Servico de Oncologia Medica
Porto, 4200-072, Portugal
Moscow City Oncology Hospital #62
Moscovskaya Oblast, Moscow Oblast, 143423, Russia
Krasnodar City Oncology Center
Krasnodar, 350040, Russia
FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
Moscow, 115478, Russia
Scientific Research Oncology Institute named after N.N. Petrov
Saint Petersburg, 197758, Russia
Institute of Oncology and Radiology of Serbia
Belgrade, 11000, Serbia
Military Medical Academy
Belgrade, 11040, Serbia
Clinical Center Bezanijska Kosa
Belgrade, 11070, Serbia
Institute for oncology of Vojvodina
Kamenitz, 21204, Serbia
GVI Rondebosch Oncology Centre
Cape Town, 7700, South Africa
Mary Potter Oncology Centre
Groenkloof, 0181, South Africa
Groote Schuur Hospital Radiation Oncology Department; Department of Radiation Oncology
Observatory, 7925, South Africa
University of Pretoria Oncology Department
Pretoria, 0001, South Africa
Sandton Oncology Medical Group
Sandton, 2196, South Africa
Hospital Clinico Universitario de Santiago
Santiago de Compostela, LA Coruña, 15706, Spain
Hospital Costa del Sol; Servicio de Oncologia
Marbella, Malaga, 29600, Spain
Hospital de la Santa Creu; i Sant Pau
Barcelona, 08025, Spain
Institut Catala d Oncologia Hospital Duran i Reynals
Barcelona, 08908, Spain
Hospital General Universitario Gregorio Marañon
Madrid, 28007, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Länssjukhuset Ryhov
Jönköping, 551 85, Sweden
Norrlands Universitetssjukhus
Umeå, 901 850, Sweden
Centrallasarettet Växjö
Vaxjo, 351 85, Sweden
CHUV; Departement d'Oncologie
Lausanne, 1011, Switzerland
CI Dnipropetrovsk CMCH 4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU
Dnipropetrovsk, 49102, Ukraine
Lviv State Oncological Regional Treatment and Diagnostic Center
Lviv, 79031, Ukraine
Bristol Haematology and Oncology Centre
Bristol, BS2 8ED, United Kingdom
Addenbrooke's Hospital
Cambridge, CB2 0QQ, United Kingdom
Velindre Cancer Centre
Cardiff, CF14 2TL, United Kingdom
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
Queen Elizabeth Hospital
Kings Lynn, PE30 4ET, United Kingdom
Guys and St Thomas NHS Foundation Trust, Guys Hospital
London, SE1 9RT, United Kingdom
Nottingham University Hospitals City Campus
Nottingham, NG5 1PB, United Kingdom
Churchill Hospital
Oxford, OX3 7LJ, United Kingdom
Royal Cornwall Hospital
Truro, TR1 3LQ, United Kingdom
New Cross Hospital
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (2)
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.
PMID: 31912791DERIVEDMaio 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.
PMID: 29477665DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 15, 2012
First Posted
August 17, 2012
Study Start
September 24, 2012
Primary Completion
June 23, 2017
Study Completion
July 13, 2018
Last Updated
July 23, 2019
Results First Posted
October 17, 2018
Record last verified: 2019-07