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

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:

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

randomization

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

Hoffmann-La Roche

    Trial Sites

    U.S.A.

    Alabama
    Birmingham

    University of Alabama at Birmingham Cancer Center

    Robert Martin Conry
    Principal Investigator

    California
    Los Angeles

    UCLA / Jonsson Comprehensive Cancer Center

    Antoni Ribas
    Principal Investigator

    Colorado
    Aurora

    University of Colorado Cancer Center - Anschutz Cancer Pavilion

    Karl D. Lewis
    Principal Investigator

    Indiana
    Indianapolis

    Indiana University/Melvin and Bren Simon Cancer Center

    Leslie A. Fecher
    Principal Investigator

    Kansas
    Kansas City

    University of Kansas Cancer Center

    Gary C. Doolittle
    Principal Investigator

    Michigan
    Detroit

    Barbara Ann Karmanos Cancer Institute

    Lawrence E. Flaherty
    Principal Investigator

    Missouri
    Saint Louis

    Siteman Cancer Center at Washington University

    Gerald P. Linette
    Principal Investigator

    New York
    New York

    Memorial Sloan-Kettering Cancer Center

    Paul B. Chapman
    Principal Investigator

    North Carolina
    Durham

    Duke University Medical Center

    April K.S. Salama
    Principal Investigator

    Tennessee
    Nashville

    Vanderbilt University/Ingram Cancer Center

    Jeffrey A. Sosman
    Principal Investigator

    Link to the current ClinicalTrials.gov record.
    NLM Identifer NCT01667419

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