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.
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)
Study Type
OBSERVATIONAL
Enrollment
78
There is no treatment allocation. Patients administered dabrafenib alone by prescription that have started before inclusion of the patient into the study could be enrolled.
There is no treatment allocation. Patients administered trametinib alone by prescription that have started before inclusion of the patient into the study could be enrolled.
Novartis Investigative Site
Fuzhou, Fujian, China
Novartis Investigative Site
Zhengzhou, Henan, China
Novartis Investigative Site
Wuhan, Hubei, China
Novartis Investigative Site
Changsha, Hunan, China
Relapse-free survival (RFS)
Relapse-free survival (RFS), defined as the time from start of treatment to disease recurrence or death due to any cause.
Time frame: Up to 36 months
Overall survival (OS)
Overall survival (OS) defined as the time from start of treatment to death due to any cause
Time frame: Up to 36 months
Safety of dabrafenib in combination with trametinib
Adverse events (AEs) and serious adverse events (SAEs) will be measured
Time frame: Up to 36 months
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Novartis Investigative Site
Nanjing, Jiangsu, China
Novartis Investigative Site
Changchun, Jilin, China
Novartis Investigative Site
Kunming, Yunnan, China
Novartis Investigative Site
Hangzhou, Zhejiang, China
Novartis Investigative Site
Beijing, China