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Spots Global Cancer Trial Database for 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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Trial Identification

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

Conditions

Melanoma

Study Description

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)

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Novartis Pharmaceuticals

Affiliation: Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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