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A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma

Trial Status: Complete

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 enrolled in two separate cohorts: Cohort 1 will include participants with completely resected Stage IIC, IIIA (participants with one or more nodal metastasis greater than [>] 1 millimeter [mm] in diameter), or IIIB cutaneous melanoma, as defined by the American Joint Committee on Cancer (AJCC) Classification, Version 7; Cohort 2 will include participants with Stage IIIC cutaneous melanoma, as defined by this classification scheme. Within each cohort, participants will be randomized (1:1 ratio) to receive vemurafenib or matching placebo over a 52-week period.

Inclusion Criteria

  • Histologically confirmed melanoma of cutaneous origin
  • Participants with BRAFV600 mutation-positive, cutaneous melanoma (either pathologic Stage IIC or Stage III according to AJCC Staging Criteria version 7 that has been completely resected
  • BRAF V600 mutation status of the current primary tumor or involved lymph node determined to be positive using the cobas BRAF V600 mutation test
  • 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
  • Known personal history of >3 adenomatous colorectal polyps or a personal history of adenomatous colorectal polyp(s) >2 centimeters (cm) in size
  • History of or current clinical, radiographic, or pathologic evidence of in-transit metastases, satellite, or microsatellite lesions
  • History of or current clinical, radiographic, or pathologic evidence of recurrent lymph node involvement after resection of a primary melanoma with lymph node involvement at any time in the past
  • History of local and/or regional and/or distant melanoma recurrence
  • History or current radiographic or pathologic evidence of distant metastases
  • History of clinically significant cardiac or pulmonary dysfunction
  • Major surgical procedure or significant traumatic injury within 4 weeks prior to first dose of study treatment
  • Infection with human immunodeficiency virus (HIV), hepatitis B, or hepatitis C virus

Alabama

Birmingham
University of Alabama at Birmingham Cancer Center
Status: CLOSED_TO_ACCRUAL

California

Los Angeles
Translational Research In Oncology - US Inc (TRIO-US)
Status: ACTIVE
UCLA / Jonsson Comprehensive Cancer Center
Status: ADMINISTRATIVELY_COMPLETE
Palo Alto
Stanford Cancer Institute Palo Alto
Status: ADMINISTRATIVELY_COMPLETE
San Diego
University of California San Diego
Status: ADMINISTRATIVELY_COMPLETE

Colorado

Aurora
University of Colorado Hospital
Status: COMPLETED
Contact: Karl D. Lewis

Indiana

Indianapolis
Indiana University / Melvin and Bren Simon Cancer Center
Status: CLOSED_TO_ACCRUAL

Kansas

Kansas City
University of Kansas Cancer Center
Status: COMPLETED
Westwood
University of Kansas Hospital-Westwood Cancer Center
Status: COMPLETED

Michigan

Detroit
Wayne State University / Karmanos Cancer Institute
Status: ADMINISTRATIVELY_COMPLETE

Missouri

Saint Louis
Siteman Cancer Center at Washington University
Status: COMPLETED

New York

New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
Status: ADMINISTRATIVELY_COMPLETE
Memorial Sloan Kettering Cancer Center
Status: CLOSED_TO_ACCRUAL

North Carolina

Durham
Duke University Medical Center
Status: CLOSED_TO_ACCRUAL

Pennsylvania

Philadelphia
University of Pennsylvania / Abramson Cancer Center
Status: COMPLETED

South Carolina

Charleston
Medical University of South Carolina
Status: COMPLETED

Tennessee

Nashville
Vanderbilt University / Ingram Cancer Center
Status: ADMINISTRATIVELY_COMPLETE

Texas

Houston
M D Anderson Cancer Center
Status: COMPLETED

Trial Phase Phase III

Trial Type Treatment

Lead Organization
Hoffmann-La Roche

  • Primary ID GO27826
  • Secondary IDs NCI-2012-03085, 2011-004011-24, G027826, S12-02658
  • Clinicaltrials.gov ID NCT01667419