CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 870 enrolled
Drug / intervention
Dabrafenib +2 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.

Search/NCT01682083
NCT01682083Phase 3Completed
CompareCT.gov

COMBI-AD: A Phase III Randomized Double Blind Study of Dabrafenib (GSK2118436) in COMBInation With Trametinib (GSK1120212) Versus Two Placebos in the ADjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma After Surgical Resection

Novartis Pharmaceuticals·interventional·Posted Sep 10, 2012·Updated Apr 21, 2026

In Brief

A Phase 3 clinical trial evaluating Dabrafenib, Trametinib, and 1 other intervention for Melanoma. Completed, enrolled 870 participants across 168 sites in 25 countries.

Detailed Summary

This was a two-arm, randomized, double-blind Phase III study of dabrafenib in combination with trametinib versus 2 placebos in the adjuvant treatment of melanoma after surgical resection. Patients with completely resected, histologically confirmed, BRAF V600E/K mutation-positive, high-risk (Stage IIIa \[lymph node metastasis \>1 mm\], IIIb or IIIc) cutaneous melanoma were screened for eligibility. Approximately 852 patients were planned to be randomized in a 1:1 ratio, stratified by BRAF mutation status (V600E, V600K) and stage of disease (Stage IIIa, IIIb, IIIc). Patients received either dabrafenib (150 milligram (mg) twice daily \[BID\]) and trametinib (2 mg once daily \[QD\]) combination therapy or 2 matching placebos (one each for dabrafenib and trametinib) for 12 months or until disease recurrence, death, unacceptable toxicity, or withdrawal of consent. Patients were followed for disease recurrence and survival during and after the treatment period. The study did not permit crossover. Doses of study treatment could be modified and/or interrupted for management of toxicities associated with study treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMelanoma
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Czechia, Denmark, France, Germany, Greece, Israel, Italy, Japan, Netherlands, New Zealand, Norway, Poland, Russia, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedSep 10, 2012
Enrollment StartJan 8, 2013
Primary CompletionJun 30, 2017
Study CompletionJul 31, 2023
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 13.8 years ago

Interventions

Dabrafenibdrug

Each capsule contained 50 mg or 75 mg of free base (present as the mesylate salt)

Trametinibdrug

Each tablet contained 0.5 mg or 2.0 mg of trametinib parent (present as the DMSO solvate)

Placebosdrug

The placebo capsules and tablets contained the same inactive ingredients and film coatings as the dabrafenib and trametinib study treatment