A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma (BRIM8)
Melanoma

About this trial
This is an interventional treatment trial for Melanoma
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University of Alabama at Birmingham
- UCLA Department of Medicine; Division of Hematology / Oncology
- Kaiser Permanente - Hayward
- UCLA Hematology Oncology - Irvine
- UCSD Moores Cancer Center
- The Angeles Clinic and Research Institute - W LA Office
- Cancer Center Of Santa Barbara; Network Clinical Research Specialist
- TRIO-US Network Administration; Network Clinical Research Specialist
- Kaiser Foundation Hospital - Oakland (W. MacArthur)
- Kaiser Permanente - Oakland
- UCLA Healthcare/Pasadena Oncology
- Kaiser Permanente - Roseville
- Kaiser Permanente Sacramento Medical Center
- Kaiser Permanente
- K. Permanente - San Jose
- Coastal Integrative Cancer Care
- Kaiser Permanente - Santa Clara
- Kaiser Permanente - South San Francisco
- Stanford University School of Medicine; Stanford Hospital Pharmacy
- UCLA Cancer Center Hema/Oncol
- Kaiser Permanente - Vallejo
- Kaiser Permanente - Walnut Creek
- UCLA Hematology Oncology - Westlake
- University Of Colorado
- St. Mary's Hospital Regional Cancer Center
- Florida Cancer Specialists - Broadway
- Memorial Healthcare System
- GulfCoast Oncology
- Oncology Specialists, S.C.
- Indiana University Health; Goshen Center for Cancer Care
- Indiana University Department of Medicine; Division of Infectious Diseases
- U of L - Physicians Pulmonology; Dept of Neuroradiology and Dept of Diagnostic Radiology
- Barbara Ann Karmanos Cancer Institute
- St. Luke's Hospital
- University of Kansas Medical Center; Cancer Center
- Washington University; Dept of Medicine/Div of Medical Oncology
- Atlantic Health Systems; Pediatrics
- New York University Medical Center PRIME; NYU Clinical Cancer Center
- Memorial Sloan Kettering Cancer Center
- Duke University Medical Center; Oncology
- University of Pennsylvania Health System
- MUSC Hollings Cancer Center/cannon Park Place; Attn: Tamara Saunders
- West Clinic
- Tennessee Oncology PLLC - Nashville (20th Ave)
- Vanderbilt University Medical Center
- MD Anderson Cancer Center
- Mary Babb Randolph Cancer Center
- Fundación CIDEA
- Instituto Medico Especializado Alexander Fleming
- Hospital Britanico de Buenos Aires
- Hospital Universitario Austral
- Centro de Investigacion Pergamino SA
- Instituto de Oncología de Rosario
- ISIS Clinica Especializada
- Chris O'Brien Lifehouse
- Melanoma Institute Australia
- Calvary Mater Newcastle
- Border Medical Oncology
- Southern Medical Day Care Centre
- Cairns Base Hospital
- The Townsville Hospital; Townsville Cancer Centre
- Royal Adelaide Hospital; Hepatology
- Queen Elizabeth Hospital
- Launceston General Hospital; Gastroenterology Research
- Box Hill Hospital
- Peninsula Oncology Centre; Frankston Private
- Peter Maccallum Cancer Centre
- Alfred Hospital
- Fiona Stanley Hospital
- Medizinische Universität Innsbruck
- Klinikum Wels-Grieskirchen
- Krankenanstalt Rudolfstiftung Wien
- Medizinische Universität Wien
- ZNA Middelheim
- Institut Jules Bordet
- UZ Antwerpen
- UZ Gent
- Jessa Zkh (Campus Virga Jesse)
- AZ Groeninge, Apotheek
- Trymed Clinical Research
- Hospital de Caridade de Ijuí
- CITO - Centro Integrado de Terapia Onco-Hematológica - Hospital da Cidade de Passo Fundo
- Hospital das Clinicas - UFRGS
- Clinica de Oncologia de Porto Alegre - CliniOnco
- Hospital Sírio-Libanês
- BC Cancer Agency Vancouver Centre - PARENT; BC Cancer Agency
- Saint Boniface General Hospital; Section of Nephrology BG 007
- Saint John Regional Hospital; Department of Oncology
- LHSC - Victoria Hospital; Department of Pediatrics
- The Ottawa Hospital Cancer Center; General Campus
- Toronto Sunnybrook Hospital
- Princess Margaret Hospital; Department of Med Oncology
- CHUM Hôpital Notre-Dame
- Mcgill University - Royal Victoria Hospital; Oncology
- CHUQ - Hôtel-Dieu de Québec
- General Hospital Pula
- General Hospital Varazdin
- Clinical Hospital Center Sestre Milosrdnice
- Clinical Hospital Centre Zagreb
- Masarykuv onkologicky ustav
- Fakultni nemocnice Hradec Kralove
- Fakultní nemocnice Olomouc
- Fakultni nemocnice Ostrava
- Nemocnice Na Bulovce
- Vseobecna fakultni nemocnice v Praze
- Fakultni nemocnice Kralovske Vinohrady
- East Tallinn Central Hospital; Clinic of Internal Medicine
- North Estonia Medical Centre Foundation
- Tartu University Hospital; Clinic of Hematology and Oncology
- CHU Besançon - Hôpital Jean Minjoz
- Groupe Hospitalier Saint André - Hôpital Saint André
- Hôpital Ambroise Paré - Boulogne-Billancourt; Respiratory
- Hopital Claude Huriez - CHU Lille
- Hopital de la Timone
- CHU NANTES - Hôtel Dieu; Pharmacy
- CHU Nice - Hopital de l'Archet 2
- Hôpital Saint-Louis
- Centre Hospitalier Lyon Sud
- CHU de Rouen Hopital; Service de Neurologie
- CHU de Toulouse - Hôpital Larrey
- St. Josef-Hospital Universitaetsklinikum
- Elbekliniken Buxtehude GmbH
- Universitätsklinikum Essen
- Universitaetsklinikum Frankfurt
- Universitätsklinikum Heidelberg
- Universitaetsklinikum Schleswig-Holstein - Campus Kiel; Klinik fuer Allgemeine Innere Medizin
- Universitätsklinikum Koeln
- Universitaetsmedizin der Johannes Gutenberg-Universitaet Mainz; Apotheke
- Klinikum Mannheim GmbH Universitätsklinikum
- Fachklinik Hornheide
- Universitätsklinikum Tübingen
- Universitätsklinikum Wurzburg
- Cork University Hospital
- Mater Private Hospital
- The Mater Misericordiae Hospital
- University College Hospital
- Soroka Medical Center
- Rambam Health Care Campus
- Hadassah University Hospital - Ein Kerem
- Rabin Medical Center-Beilinson Campus
- Chaim Sheba Medical Center
- Tel-Aviv Sourasky Medical Center
- Istituto Nazionale Tumori Fondazione G. Pascale
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata
- Istituto Nazionale Tumori Regina Elena IRCCS
- IDI-Istituto Dermopatico dell'Immacolata IRCCS
- Istituto Nazionale per la Ricerca sul Cancro di Genova
- Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni XXIII)
- Asst Degli Spedali Civili Di Brescia
- Ospedale San Raffaele
- Istituto Europeo Di Oncologia
- IRCCS Istituto Clinico Humanitas; Farmacia
- Istituto Tumori Giovanni Paolo II IRCSS; Ospedale Oncologico Bari
- A.O.U. Senese Policlinico Santa Maria Alle Scotte
- IOV - Istituto Oncologico Veneto IRCCS
- Centro Oncologico Belenus
- Hospital Civil de Guadalajara Fray Antonio Alcalde
- Centro Regiomontano de Investigación Clínica
- Sanatorio la Luz
- Universitair Medisch Centrum Groningen
- Leids Universitair Medisch Centrum; Cardiology
- Christchurch Hospital NZ
- Wellington Hospital
- Stavanger Universitetssykehus, Helse Stavanger HF
- SPZOZ MSW zWarmińsko-MazurskimCen.Onko.wOlsztynie
- Przychodnia Med-Polonia Sp. z o.o.
- Centrum Onkologii- Instytut; im. M.Skłodowskiej-Curie
- Dolnoslaskie Centrum Onkologii
- IPO de Coimbra; Servico de Oncologia Medica
- Hospital do Espirito Santo; Servico de Oncologia Medica
- Hospital de Santa Maria; Servico de Oncologia Medica
- IPO do Porto; Servico de Oncologia Medica
- Moscow City Oncology Hospital #62
- Krasnodar City Oncology Center
- FSBSI "Russian Oncological Scientific Center n.a. N.N. Blokhin"
- Scientific Research Oncology Institute named after N.N. Petrov
- Institute of Oncology and Radiology of Serbia
- Military Medical Academy
- Clinical Center Bezanijska Kosa
- Institute for oncology of Vojvodina
- GVI Rondebosch Oncology Centre
- Mary Potter Oncology Centre
- Groote Schuur Hospital Radiation Oncology Department; Department of Radiation Oncology
- University of Pretoria Oncology Department
- Sandton Oncology Medical Group
- Hospital Clinico Universitario de Santiago
- Hospital Costa del Sol; Servicio de Oncologia
- Hospital de la Santa Creu; i Sant Pau
- Institut Catala d Oncologia Hospital Duran i Reynals
- Hospital General Universitario Gregorio Marañon
- Hospital Universitari i Politecnic La Fe
- Länssjukhuset Ryhov
- Norrlands Universitetssjukhus
- Centrallasarettet Växjö
- CHUV; Departement d'Oncologie
- CI Dnipropetrovsk CMCH 4 of Dnipropetrovsk RC Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU
- Lviv State Oncological Regional Treatment and Diagnostic Center
- Bristol Haematology and Oncology Centre
- Addenbrooke's Hospital
- Velindre Cancer Centre
- Western General Hospital
- Queen Elizabeth Hospital
- Guys and St Thomas NHS Foundation Trust, Guys Hospital
- Nottingham University Hospitals City Campus
- Churchill Hospital
- Royal Cornwall Hospital
- New Cross Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Cohort 1 Vemurafenib
Cohort 1 Placebo
Cohort 2 Vemurafenib
Cohort 2 Placebo
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
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
Participants with Stage IIIC cutaneous melanoma received vemurafenib, 960 mg twice daily, in 28-day cycles, for up to 52 weeks
Participants with Stage IIIC cutaneous melanoma received vemurafenib-matching placebo twice daily, in 28-day cycles, for up to 52 weeks