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Brief Title: 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
Official Title: 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
Study ID: NCT04666272
Brief 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.
Detailed 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)
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Novartis Investigative Site, Fuzhou, Fujian, China
Novartis Investigative Site, Zhengzhou, Henan, China
Novartis Investigative Site, Changsha, Hunan, China
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
Novartis Investigative Site, Wuhan, , China
Name: Novartis Pharmaceuticals
Affiliation: Novartis Pharmaceuticals
Role: STUDY_DIRECTOR