a study of vemurafenib adjuvant therapy in participants with surgically resected cutaneous braf-mutant melanoma

Conditions: Melanoma

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 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.


Eligibility criteria:
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