At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 552 enrolled
Drug / intervention
Dabrafenib +1 moredrug
Likely dose
Dabrafenib 50 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.
COMBI-APlus: Open-label, Phase IIIb Study of Dabrafenib in COMBInation With Trametinib in the Adjuvant Treatment of Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection to Evaluate the Impact on Pyrexia Related Outcomes of an Adapted Pyrexia AE-management Algorithm (Plus)
In Brief
A Phase 3 clinical trial evaluating Dabrafenib and Trametinib for Malignant Melanoma. Completed, enrolled 552 participants across 100 sites in 23 countries.
Detailed Summary
The main purpose of this study was to evaluate the impact on pyrexia-related outcomes of an adapted pyrexia adverse event (AE)-management algorithm, as well as safety, efficacy and health-related outcomes.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMalignant Melanoma
CountriesArgentina, Australia, Brazil, Canada, Czechia, Finland, France, Greece, Hungary, Israel, Italy, Japan, Latvia, Lithuania, Norway, Poland, Portugal, Russia, Slovakia, Slovenia, Sweden, Turkey (Türkiye), United Kingdom
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJun 2018
Enrollment StartAug 2018
Primary CompletionOct 2020
Study CompletionSep 2021
TodayJul 2026
First PostedJun 11, 2018
Enrollment StartAug 29, 2018
Primary CompletionOct 5, 2020
Study CompletionSep 16, 2021
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 8.1 years ago
Interventions
Dabrafenibdrug
Supplied as dabrafenib 50 mg and 75 mg capsules for oral administration
Trametinibdrug
Supplied as trametinib 0.5mg, and 2.0mg tablets for oral administration