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

  • Resize font
  • Print
  • Email
  • Facebook
  • Twitter
  • Google+
  • Pinterest

Basic Trial Information

PhaseTypeStatusAgeTrial IDs
Phase IIIBiomarker/Laboratory analysis, TreatmentActive18 and overGO27826
NCI-2012-03085, 2011-004011-24, G027826, NCT01667419

Trial Description

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 randomized to

receive oral doses of vemurafenib 960 milligrams (mg) twice daily or matching placebo. The

anticipated time on study treatment is 52 weeks.

Eligibility Criteria

Inclusion Criteria:

Histologically confirmed melanoma of cutaneous origin

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

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 (HIV), hepatitis B, or hepatitis C virus

Trial Contact Information

Trial Lead Organizations / Sponsors / Collaborators

F Hoffmann-La Roche Limited

    Trial Sites

    U.S.A.

    Alabama
    Birmingham

    University of Alabama at Birmingham Cancer Center

    Robert Martin Conry
    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

    Michigan
    Detroit

    Barbara Ann Karmanos Cancer Institute

    Lawrence E. Flaherty
    Principal Investigator

    New York
    New York

    Memorial Sloan-Kettering Cancer Center

    Paul B. Chapman
    Principal Investigator

    Link to the current ClinicalTrials.gov record.
    NLM Identifier 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.