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A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma
Not Recruiting
Trial ID: NCT01667419
Purpose
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
Clinical Associate Professor, Medicine - Oncology
Susan M. Swetter, MD
Professor of Dermatology
Eligibility
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
Intervention(s):
drug: Placebo
drug: vemurafenib
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061