A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma
Status:
Completed
Trial end date:
2018-07-13
Target enrollment:
Participant gender:
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.