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

Not Recruiting

Trial ID: NCT01667419


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.

Official Title

A Phase III, Randomized, Double-Blind, Placebo-Controlled Study of Vemurafenib (RO5185426) Adjuvant Therapy in Patients With Surgically Resected, Cutaneous BRAF-Mutant Melanoma at High Risk for Recurrence

Stanford Investigator(s)

Sunil Arani Reddy
Sunil Arani Reddy

Clinical Associate Professor, Medicine - Oncology

Susan M. Swetter, MD
Susan M. Swetter, MD

Professor of Dermatology


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


drug: Placebo

drug: vemurafenib

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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