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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 | Clinical Trials | Clareo Health

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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•Novartis Pharmaceuticals

View on ClinicalTrials.gov

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

Age

18 - 100 years

Sex

ALL

Healthy Volunteers

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)
+1 more criteria

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.

Locations (8)

Novartis Investigative Site

Fuzhou, Fujian, China

Novartis Investigative Site

Zhengzhou, Henan, China

Novartis Investigative Site

Wuhan, Hubei, China

Novartis Investigative Site

Changsha, Hunan, China

Novartis Investigative Site

Nanjing, Jiangsu, China

Novartis Investigative Site

Kunming, Yunnan, China

Novartis Investigative Site

Hangzhou, Zhejiang, China

Novartis Investigative Site

Beijing, China

Key Dates

Start Date

December 31, 2020

Primary Completion Date

February 4, 2028

Completion Date

February 4, 2028

Last Updated

February 19, 2026

Enrollment

ACTUAL participants

Conditions

Melanoma

Interventions

dabrafenib

DRUG

trametinib

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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