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Active, not recruiting Observational

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

NCT04666272 · tracked via the Priya Life Science China tracker
Phase
Observational
Started
2020-12-31
Last updated
2026-02-19

Condition(s) studied

Melanoma

Investigational drug(s) / intervention(s)

dabrafenib →trametinib →

dabrafenib: 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.

trametinib: 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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: Patient(s) must meet all of the following criteria to be eligible for inclusion: 1. ≥18 years old of age at the time of informed consent and of Chinese descent 2. Signed written informed consent 3. Going to receive commercial dabrafenib and trametinib according to approved label 4. Completely resected histologically confirmed Stage III BRAF V600 mutation positive cutaneous or mucosal melanoma as defined by the following staging systems: * for stage III cutaneous melanoma: as per American Joint Committee on Cancer (AJCC) 8th edition for melanoma * for stage III mucosal melanoma of the head and neck origin: as per AJCC 8th edition for mucosal melanoma of the head and neck * for stage III mucosal melanoma of anal canal, rectum and genital track origin: as per Chinese guidelines on the diagnosis and treatment of melanoma 2019 edition 5. Must be surgically rendered free of disease (defined as the date of the most recent surgery) no more than 12 weeks before enrollment 6. Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains) 7. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 Exclusion Criteria: Patient will be excluded from this study if he/she meets any of the following criteria: 1. Known ocular melanoma 2. Patient received other systemic neo-adjuvant and/or adjuvant therapy for melanoma (including dabrafenib in combination with trametinib started before ICF signature) 3. Patient is not able to comply with the planned study procedures 4. Taken an investigational drug within 28 days prior to enrolment 5. History of another malignancy (including melanoma) or a concurrent malignancy, except malignancies that were treated curatively and have not recurred within 2 years prior to treatment.

Primary outcome measure(s)

  • Relapse-free survival (RFS) — Up to 36 months
    Relapse-free survival (RFS), defined as the time from start of treatment to disease recurrence or death due to any cause.

Trial sites (8)

FacilityCityRegionStatus
Novartis Investigative Site Fuzhou Fujian
Novartis Investigative Site Zhengzhou Henan
Novartis Investigative Site Wuhan Hubei
Novartis Investigative Site Changsha Hunan
Novartis Investigative Site Nanjing Jiangsu
Novartis Investigative Site Kunming Yunnan
Novartis Investigative Site Hangzhou Zhejiang
Novartis Investigative Site Beijing China
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04666272 on ClinicalTrials.gov ↗ ← All trials in China