At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 495 enrolled
Drug / intervention
Placebo +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase III, Double-Blind, Placebo-Controlled Study of Vemurafenib Versus Vemurafenib Plus GDC-0973 in Previously Untreated BRAF^600-Mutation Positive Patients With Unresectable Locally Advanced or Metastatic Melanoma
In Brief
A Phase 3 clinical trial evaluating Placebo, Vemurafenib, and 1 other intervention for Malignant Melanoma. Completed, enrolled 495 participants across 156 sites in 19 countries.
Detailed Summary
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 Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Melanoma
CountriesAustralia, Austria, Belgium, Canada, Czechia, France, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Norway, Russia, Spain, Sweden, Switzerland, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 2012
Enrollment StartJan 2013
Primary CompletionMay 2014
Study CompletionJul 2019
TodayJul 2026
First PostedSep 21, 2012
Enrollment StartJan 8, 2013
Primary CompletionMay 9, 2014
Study CompletionJul 21, 2019
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 13.8 years ago
Interventions
Placebodrug
Placebo supplied as tablets
Vemurafenibdrug
Vemurafenib supplied as tablets
Cobimetinibdrug
Cobimetinib supplied as tablets