Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).
Public ClinicalTrials.gov record NCT01682083. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT01682083
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 870 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 7, 2013
- Primary completion
- Jun 29, 2017
- Completion
- Jul 30, 2023
- Last update posted
- Apr 20, 2026
2013 – 2023
United States locations
- U.S. sites
- 20
- U.S. states
- 15
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | Birmingham | Alabama | 35243 | — |
| Novartis Investigative Site | Tucson | Arizona | 85724 | — |
| Novartis Investigative Site | San Francisco | California | 94115 | — |
| Novartis Investigative Site | San Francisco | California | 94143 | — |
| Novartis Investigative Site | Aurora | Colorado | 80045 | — |
| Novartis Investigative Site | Lake Worth | Florida | 33461 | — |
| Novartis Investigative Site | Orlando | Florida | 32806 | — |
| Novartis Investigative Site | Tampa | Florida | 33612 | — |
| Novartis Investigative Site | Atlanta | Georgia | 30322 | — |
| Novartis Investigative Site | Atlanta | Georgia | 30341 | — |
| Novartis Investigative Site | Lutherville-Timonium | Maryland | 21093 | — |
| Novartis Investigative Site | Boston | Massachusetts | 02114 | — |
| Novartis Investigative Site | Boston | Massachusetts | 02115 | — |
| Novartis Investigative Site | Ann Arbor | Michigan | 48019 | — |
| Novartis Investigative Site | Winston-Salem | North Carolina | 27157 | — |
| Novartis Investigative Site | Columbus | Ohio | 43210 | — |
| Novartis Investigative Site | Portland | Oregon | 97123 | — |
| Novartis Investigative Site | Pittsburgh | Pennsylvania | 15232 | — |
| Novartis Investigative Site | Nashville | Tennessee | 37203 | — |
| Novartis Investigative Site | Dallas | Texas | 75390 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 148 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01682083, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 20, 2026 · Synced Sep 18, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01682083 live on ClinicalTrials.gov.