At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 704 enrolled
Drug / intervention
Dabrafenib +2 moredrug
Likely dose
Dabrafenib 150 mgfrom 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, Randomised, Open-label Study Comparing the Combination of the BRAF Inhibitor, Dabrafenib and the MEK Inhibitor, Trametinib to the BRAF Inhibitor Vemurafenib in Subjects With Unresectable (Stage IIIc) or Metastatic (Stage IV) BRAF V600E/K Mutation Positive Cutaneous Melanoma
In Brief
A Phase 3 clinical trial evaluating Dabrafenib, Vemurafenib, and 1 other intervention for Melanoma. Completed, enrolled 704 participants across 205 sites in 28 countries.
Detailed Summary
This was a two-arm, open-label, randomized, Phase III study comparing dabrafenib (GSK2118436) and trametinib (GSK1120212) combination therapy with vemurafenib.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, Finland, France, Germany, Hungary, Ireland, Israel, Italy, Netherlands, New Zealand, Norway, Poland, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, Ukraine, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedMay 2012
Enrollment StartJun 2012
Primary CompletionApr 2014
Study CompletionApr 2019
TodayJul 2026
First PostedMay 14, 2012
Enrollment StartJun 4, 2012
Primary CompletionApr 17, 2014
Study CompletionApr 25, 2019
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 14.1 years ago
Interventions
Dabrafenibdrug
Dabrafenib 150 mg twice daily orally
Vemurafenibdrug
Vemurafenib 960 mg twice daily orally
Trametinibdrug
Trametinib 2 mg once daily orally