Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01682083 · ClinicalTrials.gov registry record · Phase 3
Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).
A Phase 3 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 870
- Enrollment target
NCT01682083: Completed Phase 3 study, sponsored by Novartis Pharmaceuticals.
NCT01682083 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 870 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01682083, a Phase 3 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 870 participants
- Enrollment target
Study 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.
Primary Outcome
Relapse-Free Survival (RFS) was defined as the time from randomization to disease recurrence or death from any cause. RFS events included loco-regional recurrence, distant metastases, new primary melanoma, and death without prior documented recurrence; such deaths were counted as events and not censored. Patients without an event at the analysis cut-off (30-Jun-2017) were censored at the date of the last radiological or non-radiological efficacy assessment. Patients lost to follow-up before rec
Interventions
- DRUG Trametinib
- DRUG Placebos
- DRUG Dabrafenib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 870 participants |
| Start Date | 2013-01-08 |
| Est. Completion | 2023-07-31 |
| Phase | Phase 3 |
What the finished NCT01682083 record still lists
NCT01682083 is an interventional study that assigns participants to a tested intervention. The registered 870 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (13% higher).
The record links to 0 conditions, and to 3 interventions - of which Trametinib is the first listed.
NCT01682083 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01682083 about?
NCT01682083 is a clinical study titled "Dabrafenib With Trametinib in the Adjuvant Treatment of High-risk BRAF V600 Mutation-positive Melanoma (COMBI-AD).". 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 II...
What is the current status of trial NCT01682083?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 870 participants. The study started on 2013-01-08. Estimated completion is 2023-07-31.
What interventions are being tested in trial NCT01682083?
The interventions under investigation include: Trametinib (DRUG), Placebos (DRUG), Dabrafenib (DRUG).
Who is sponsoring clinical trial NCT01682083?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01682083's enrollment target sits among peer trials
870 373rd of 2000 higher than 1,627 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT04097145 · 870 participants · NA
Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial
- NCT06822790 · 869 participants · Phase 3
Long-Term Safety and Efficacy of Plozasiran in Adults With Hypertriglyceridemia
- NCT06077760 · 868 participants · Phase 3
A Study of Intismeran Autogene (V940) Plus Pembrolizumab (MK-3475) Versus Placebo Plus Pembrolizumab in Participants With Non-small Cell Lung Cancer (V940-002)
- NCT04933552 · 867 participants
Post-Authorization Safety Study for Assessment of Pregnancy Outcomes in Patients Treated With Mayzent
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI