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

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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:

  • All patients should have histologically confirmed melanoma of cutaneous origin
  • Patients must have been surgically rendered free of disease within 90 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 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 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 Trials, Study Director
    Reference Study ID Number: GO27826 www.roche.com/about_roche/roche_worldwide.htm
    Ph: 888-662-6728 (U.S. Only)
    Email: global.rochegenentechtrials@roche.com

    Link to the current ClinicalTrials.gov record.
    NLM Identifier NCT01667419
    ClinicalTrials.gov processed this data on May 19, 2015

    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.