A 2-part Phase III Randomized, Open Label, Multicenter Study of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
A 2-part Phase III Randomized, Open Label, Multicenter Study of LGX818 Plus MEK162 Versus Vemurafenib and LGX818 Monotherapy in Patients With Unresectable or Metastatic BRAF V600 Mutant Melanoma
This is 2-part, randomized, open label, multi-center, parallel group, phase III study comparing the efficacy and safety of LGX818 plus MEK162 to vemurafenib and LGX818 monotherapy in patients with locally advanced unresectable or metastatic melanoma with BRAF V600 mutation. A total of approximately 900 patients will be randomized.
Part 1:
Patients will be randomized in a 1:1:1 ratio to one of 3 treatment arms:
Part 2:
Patients will be randomized in a 3:1 ratio to one of the 2 treatment arms:
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Chicago, Illinois 60612, United States
Grand Rapids, Michigan 49503, United States
Rochester, New York 14642, United States
CABA, Buenos Aires C1125ABD, Argentina
Buenos Aires, Ciudad Autónoma de Buenosaires C1426ANZ, Argentina
Nuremberg, Bavaria 90419, Germany
Minden, North Rhine-Westphalia 32429, Germany
Mainz, Rhineland-Palatinate 55131, Germany
Erfurt, 99089, Germany
Torrette Site, Ancona 60126, Italy
Bologna, Emilia-Romagna 40138, Italy
Brescia, Lombardy 25123, Italy
Milan, Lombardy 20162, Italy
Udine, 33100, Italy
Chuo-ku, Tokyo 104-0045, Japan
México, 14050, Mexico
Ariënsplein Enschede, 7513 JX, Netherlands
Warsaw, Masovian Voivodeship 02-781, Poland
Lisbon, Lisbon District 1099-023, Portugal
Gangnam-gu, Seoul Teugbyeolsi 06351, South Korea
Zurich Flughafen, 8058, Switzerland