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

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Basic Trial Information

PhaseTypeAgeTrial IDs
Phase IIIBiomarker/Laboratory analysis, Treatment18 and overGO27826
NCI-2012-03085, 2011-004011-24, G027826, NCT01667419

Trial Description


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:

Adequate hematologic, hepatic and renal function

Patients must have fully recovered from the effects of any major surgery or

significant traumatic injury prior to the first dose of study treatment

Life expectancy of at least 5 years

Eastern Cooperative Oncology Group performance status of 0 or 1

Patients must have been surgically rendered free of disease within 90 days of


All patients should have histologically confirmed melanoma of cutaneous origin

Exclusion Criteria:

Infection with human immunodeficiency virus, hepatitis B or hepatitis C virus

Major surgical procedure within 4 weeks prior to first dose of study treatment

History of clinically significant cardiac or pulmonary dysfunction

Family history of colon cancer syndromes

Invasive malignancy other than melanoma at the time of enrollment or within 5 years

prior to first dose of study treatment

History of radiotherapy for the treatment of melanoma

History of limb perfusion therapy

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

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

F Hoffmann-La Roche Limited

    Trial Sites



    University of Alabama at Birmingham Cancer Center

    Robert Martin Conry
    Principal Investigator

    Los Angeles

    UCLA / Jonsson Comprehensive Cancer Center

    Antoni Ribas
    Principal Investigator


    University of Colorado Cancer Center - Anschutz Cancer Pavilion

    Karl D. Lewis
    Principal Investigator


    Indiana University/Melvin and Bren Simon Cancer Center

    Leslie A. Fecher
    Principal Investigator

    Kansas City

    University of Kansas Cancer Center

    Gary C. Doolittle
    Principal Investigator


    Barbara Ann Karmanos Cancer Institute

    Lawrence E. Flaherty
    Principal Investigator

    New York
    New York

    Memorial Sloan-Kettering Cancer Center

    Paul B. Chapman
    Principal Investigator

    North Carolina

    Duke University Medical Center

    April K.S. Salama
    Principal Investigator


    Vanderbilt University/Ingram Cancer Center

    Jeffrey A. Sosman
    Principal Investigator

    Link to the current record.
    NLM Identifer NCT01667419

    Note: Information about participating sites on pharmaceutical industry trials may be incomplete. Please visit the record via the link above for more information about participating sites.