||Phase III (Cancer Control)
|Secondary Protocol No.
||A phase III, double-blind, placebo-controlled study of Vemurafenib vs. Vemurafenib plus GDC-0973 in previously untreated BRAF v600 mutation positive patients with unresectable locally advances or metastatic melanoma
||To evaluate the efficacy of vemurafenib in combination with GDC-0973, compared with vemurafenib and placebo, in previously untreated BRAFV6-- mutation positive patients with unresectable locally advanced or metastatic melanoma, as measured by prolongation of progression-free survival (PFS), as assessed by the study site investigator.
||Each treatment cycle will be 4 weeks (28 days) in length.
Vemurafenib-960 mg twice each day (4 tablets in the morning and 4 tablets in evening)
GDC-0973 (or placebo)-60 mg every day (3 tablets in the morning), on Days 1 to 21 of each treatment cycle.
||Patients with histologically confirmed melanoma, either unresectable stage IIIc or stage IV metastatic melanoma, as defined by AJCC 7th edition.
Patients must be naive to treatment for locally advanced unresectable or metastatic disease
Documentation of BRAF v600 mutation-positive status in melanoma tumor tissue
ECOG performance status of 0 or 1
Consent to provide archival tissue for biomarker analysis
Consent to undergo tumor biopsies of accessible lesions on Cycle 2 Day 15 and at progression for biomarker analyses
|Applicable Disease Sites
||Masonic Cancer Center