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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 is a Phase 3 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 870 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01682083
The ClinicalTrials.gov registry entry for NCT01682083 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 870 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Trametinib is the first listed.
NCT01682083 reports 0 study locations.
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.
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