Effectiveness and Safety of Dabrafenib in Combination With Trametinib as Adjuvant Treatment for Chinese Patients With Stage III BRAF V600 Mutation-positive Melanoma After Complete Resection
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- STATUS
- Recruiting
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- End date
- Dec 31, 2026
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- participants needed
- 150
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- sponsor
- Novartis Pharmaceuticals
Summary
This is a prospective, open label, single-arm, multicenter, non-interventional study of dabrafenib in combination with trametinib as adjuvant treatment for Chinese patients with stage III BRAF V600 mutation positive melanoma after complete resection.
Description
The study will consist of a treatment phase and follow-up phase. The treatment period is 12 months. Discontinuation of study treatment may occur earlier than 12 months for disease recurrence, death, unacceptable toxicity or withdrawal of consent. Patients will be followed for disease recurrence every 6 months and up to 24 months after the end of treatment (EOT)
Details
| Condition | Melanoma |
|---|---|
| Treatment | Dabrafenib, Trametinib |
| Clinical Study Identifier | NCT04666272 |
| Sponsor | Novartis Pharmaceuticals |
| Last Modified on | 23 October 2022 |
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