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
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
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.
Inclusion Criteria:
Exclusion Criteria:
California City, California 90095, United States
Los Angeles, California 90095, United States
Los Angeles, California 90095, United States
Stanford, California 94305, United States
Indianapolis, Indiana 46202, United States
Louisville, Kentucky 40202, United States
St Louis, Missouri 63110, United States
New York, New York 10016, United States
Charleston, South Carolina 29425, United States
Ciudad Autonoma Buenos Aires, 1426, Argentina
Ciudad Autonoma Buenos Aires, C1284AEB, Argentina
Derqui-Pilar, B1629ODT, Argentina
Wodonga, New South Wales 3690, Australia
Passo Fundo, Rio Grande do Sul 99010-260, Brazil
Ijuí, Rondônia 98700-000, Brazil
Vancouver, British Columbia V5Z 4E6, Canada
Ste-Foy, Quebec G1V 4G2, Canada
Ostrava - Poruba, 708 52, Czechia
Kiel, 24105, Germany
Bergamo, Lombardy 24127, Italy
Moscovskaya Oblast, Moscow Oblast 143423, Russia
Observatory, 7925, South Africa
Dnipropetrovsk, 49102, Ukraine