To evaluate the efficacy of vemurafenib in combination with cobimetinib (GDC-0973), compared with vemurafenib and placebo, in previously untreated BRAF V600 mutation-positive patients with unresectable locally advanced or metastatic melanoma, as measured by progression-free survival (PFS), assessed by the study site investigator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
495
Placebo supplied as tablets
Vemurafenib supplied as tablets
Cobimetinib supplied as tablets
Progression-free Survival
Progression-free survival was defined as the time from randomization to the first occurrence of disease progression, as determined by the investigator using Response Evaluation Criteria in Solid Tumors v1.1, or death from any cause, whichever came first. Disease progression was defined as: (1) at least a 20% increase in the sum (the increase in the sum must be at least 5 mm) of diameters of target lesions, taking as reference the smallest sum during the study; (2) unequivocal progression of existing non-target lesions; or (3) the appearance of 1 or more new lesions.
Time frame: Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months)
Overall Survival
Overall survival was defined as the time from randomization until the date of death from any cause.
Time frame: Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months)
Percentage of Participants With an Objective Response
An objective response was defined as a complete response or a partial response determined on two consecutive occasions ≥ 4 weeks apart. Responses were determined by Response Evaluation Criteria in Solid Tumors v1.1. A complete response was defined as the disappearance of all target lesions or the disappearance of all non-target lesions and normalization of tumor marker level. A partial response was defined as at least a 30% decrease in the sum of the longest diameter of target lesions, taking as reference the baseline sum of the longest diameter of target lesions.
Time frame: Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months)
Duration of Response
Duration of response was defined as the time from first occurrence of a documented confirmed objective response until the time of disease progression, as determined by investigator review of tumor assessments using Response Evaluation Criteria in Solid Tumors v1.1 or death from any cause during the study. Disease progression was defined as: (1) at least a 20% increase in the sum (the increase in the sum must be at least 5 mm) of diameters of target lesions, taking as reference the smallest sum during the study; (2) unequivocal progression of existing non-target lesions; or (3) the appearance of 1 or more new lesions.
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University of Alabama at Birmingham
Birmingham, Alabama, United States
The Angeles Clinic and Research Institute - W LA Office
Los Angeles, California, United States
University of California Davis Health System
Sacramento, California, United States
Sutter Pacific Medical Foundation
Santa Rosa, California, United States
University Of Colorado
Aurora, Colorado, United States
Florida Cancer Specialists - Broadway
Fort Myers, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Orlando Health Inc.
Orlando, Florida, United States
Northwestern Center For Clinical Research
Chicago, Illinois, United States
Uni of Kansas Medical Center; Dept of Neurology
Kansas City, Kansas, United States
...and 146 more locations
Time frame: Baseline to the 21 July 2019 data cut-off (up to 7 years, 6 months)