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.
4 tablets of vemurafenib 240 mg each (total 960 mg) were administered orally as per the schedule specified in the respective arm.
Placebo matching to vemurafenib were administered orally as per the schedule specified in the respective arm.
Buenos Aires, Argentina
Ciudad Autonoma Buenos Aires, Argentina
Ciudad Autonoma Buenos Aires, Argentina
Derqui-Pilar, Argentina
Pergamino, Argentina
Rosario, Argentina
Santa Fe, Argentina