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BRIM8: A Study of Vemurafenib Adjuvant Therapy in Patients With Resected Cutaneous BRAF Mutant Melanoma

Basic Trial Information
Trial Description
     Summary
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentActive18 and overPharmaceutical / IndustryGO27826
2011-004011-24, NCT01667419

Trial Description

Summary

This multi-center, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in patients with completely resected, cutaneous BRAF-mutation positive melanoma at high risk for recurrence. Patients will be randomized to receive oral doses of vemurafenib 960 mg twice daily or matching placebo. The anticipated time on study treatment is 52 weeks.

Eligibility Criteria

Inclusion Criteria:

  • Patients with completely resected, histologically confirmed, Stage IIC or Stage III, cutaneous melanoma where the BRAFV600 mutation status of the current primary tumor or involved lymph node is determined to be positive using the cobas® BRAF V600 Mutation Test. Patients with Stage IIIA disease must have at least one lymph node metastasis measuring > 1 mm in diameter
  • Patients must have been surgically rendered free of disease within 70 days of randomization
  • Eastern Cooperative Oncology Group performance status of 0 or 1
  • Life expectancy of at least 5 years
  • Patients must have 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 therapy for the treatment of melanoma
  • 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 3 years prior to first dose of study treatment
  • Family history of colon cancer syndromes
  • History of clinically significant cardiac or pulmonary dysfunction
  • Major surgical procedure within 4 weeks prior to first dose of study treatment
  • Infection with human immunodeficiency virus, hepatitis B or hepatitis C virus

Trial Contact Information

Trial Lead Organizations/Sponsors

F. Hoffmann - La Roche, Limited

Clinical TrialsStudy Director

Reference Study ID Number: GO27826 www.roche.com/about_roche/roche_worldwide.htmPh: 888-662-6728 (U.S. Only)
  Email: global.rochegenentechtrials@roche.com

Trial Sites

U.S.A.
Alabama
  Birmingham
 Study Site
California
  California
 Study Site
  La Jolla
 Study Site
  Los Angeles
 Study Site
  San Luis Obispo
 Study Site
  Stanford
 Study Site
  Vallejo
 Study Site
Colorado
  Aurora
 Study Site
  Grand Junction
 Study Site
Florida
  Fort Myers
 Study Site
  Hollywood
 Study Site
  Saint Petersburg
 Study Site
Illinois
  Park Ridge
 Study Site
Indiana
  Goshen
 Study Site
  Indianapolis
 Study Site
Kentucky
  Louisville
 Study Site
Michigan
  Detroit
 Study Site
  St. Louis
 Study Site
Missouri
  Kansas City
 Study Site
New Jersey
  Randolph
 Study Site
New York
  New York
 Study Site
North Carolina
  Durham
 Study Site
Pennsylvania
  Philadelphia
 Study Site
South Carolina
  Charleston
 Study Site
Tennessee
  Memphis
 Study Site
  Nashville
 Study Site
Texas
  Houston
 Study Site
West Virginia
  Morgantown
 Study Site
Argentina
  Buenos Aires
 Study Site
  Ciudad Autonoma Buenos Aires
 Study Site
  Derqui-Pilar
 Study Site
  Pergamino
 Study Site
  Rosario
 Study Site
  Santa Fe
 Study Site
Australia
  Perth
 Study Site
New South Wales
  Camperdown
 Study Site
  North Sydney
 Study Site
  Waratah
 Study Site
  Wodonga
 Study Site
  Wollongong
 Study Site
Queensland
  Cairns
 Study Site
  Townsville
 Study Site
South Australia
  Adelaide
 Study Site
  Woodville
 Study Site
Tasmania
  Launceston
 Study Site
Victoria
  Box Hill
 Study Site
  East Melbourne
 Study Site
  Frankston
 Study Site
  Melbourne
 Study Site
Austria
  Innsbruck
 Study Site
  Wels
 Study Site
  Wien
 Study Site
Belgium
  Antwerpen
 Study Site
  Bruxelles
 Study Site
  Edegem
 Study Site
  Gent
 Study Site
  Hasselt
 Study Site
  Kortrijk
 Study Site
Brazil
  Belo Horizonte
 Study Site
  Ijui
 Study Site
  Passo Fundo
 Study Site
  Porto Alegre
 Study Site
Sao Paulo
  Sao Paulo
 Study Site
Canada
  Saint John
 Study Site
British Columbia
  Vancouver
 Study Site
Manitoba
  Winnipeg
 Study Site
Ontario
  London
 Study Site
  Ottawa
 Study Site
  Toronto
 Study Site
Quebec
  Montreal
 Study Site
  Montréall
 Study Site
  Ste-Foy
 Study Site
Croatia
  Pula
 Study Site
  Varazdin
 Study Site
  Zagreb
 Study Site
Czech Republic
  Brno
 Study Site
  Hradec Kralove
 Study Site
  Olomouc
 Study Site
  Ostrava - Poruba
 Study Site
  Prague
 Study Site
  Praha
 Study Site
Estonia
  Tallinn
 Study Site
  Tartu
 Study Site
France
  Besançon Cedex
 Study Site
  Bordeaux
 Study Site
  Boulogne Billancourt
 Study Site
  Lille
 Study Site
  Marseille
 Study Site
  Nantes
 Study Site
  Nice
 Study Site
  Paris
 Study Site
  Pierre Benite
 Study Site
  Rouen
 Study Site
  Toulouse
 Study Site
Germany
  Bochum
 Study Site
  Buxtehude
 Study Site
  Essen
 Study Site
  Frankfurt am Main
 Study Site
  Heidelberg
 Study Site
  Kiel
 Study Site
  Koeln
 Study Site
  Mainz
 Study Site
  Mannheim
 Study Site
  Muenster
 Study Site
  Tuebingen
 Study Site
  Wurzburg
 Study Site
Ireland
  Cork
 Study Site
  Dublin
 Study Site
  Galway
 Study Site
Israel
  Beer Sheva
 Study Site
  Haifa
 Study Site
  Jerusalem
 Study Site
  Petach Tikva
 Study Site
  Tel Aviv
 Study Site
  Tel Hashomer
 Study Site
Italy
  Bari
 Study Site
  Bergamo
 Study Site
  Brescia
 Study Site
  Genova
 Study Site
  Milano
 Study Site
  Napoli
 Study Site
  Padova
 Study Site
  Roma
 Study Site
  Rozzano
 Study Site
  Siena
 Study Site
Netherlands
  Groningen
 Study Site
  Leiden
 Study Site
New Zealand
  Christchurch
 Study Site
  Wellington
 Study Site
Norway
  Stavanger
 Study Site
Poland
  Olsztyn
 Study Site
  Poznan
 Study Site
  Warszawa
 Study Site
  Wroclaw
 Study Site
Portugal
  Evora
 Study Site
  Lisboa
 Study Site
  Porto
 Study Site
Republic of South Africa
  Cape Town
 Study Site
  Groenkloof
 Study Site
  Observatory
 Study Site
  Pretoria
 Study Site
  Sandton
 Study Site
Russia
  Krasnodar
 Study Site
  Moscow
 Study Site
  St. Petersburg
 Study Site
Serbia
  Belgrade
 Study Site
  Sremska Kamenica
 Study Site
Spain
  Barcelona
 Study Site
  L'Hospitalet de Llobregat
 Study Site
  Madrid
 Study Site
  Marbella
 Study Site
  Santiago de Compostela
 Study Site
  Valencia
 Study Site
Sweden
  Jönköping
 Study Site
  Umeå
 Study Site
  Växjö
 Study Site
Ukraine
  Kyiv
 Study Site
  Lviv
 Study Site
United Kingdom
  Bristol
 Study Site
  Cambridge
 Study Site
  Cardiff
 Study Site
  Edinburgh
 Study Site
  Kings Lynn
 Study Site
  London
 Study Site
  Nottingham
 Study Site
  Oxford
 Study Site
  Truro
 Study Site
  Wolverhampton
 Study Site

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT01667419
ClinicalTrials.gov processed this data on April 07, 2014

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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