Status:
ACTIVE_NOT_RECRUITING
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
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Melanoma
Eligibility:
All Genders
18-100 years
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 mu...
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, u...
Eligibility Criteria
Inclusion
- Patient(s) must meet all of the following criteria to be eligible for inclusion:
- ≥18 years old of age at the time of informed consent and of Chinese descent
- Signed written informed consent
- Going to receive commercial dabrafenib and trametinib according to approved label
- 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
- Must be surgically rendered free of disease (defined as the date of the most recent surgery) no more than 12 weeks before enrollment
- Recovered from definitive surgery (e.g. no uncontrolled wound infections or indwelling drains)
- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
Exclusion
- Patient will be excluded from this study if he/she meets any of the following criteria:
- Known ocular melanoma
- Patient received other systemic neo-adjuvant and/or adjuvant therapy for melanoma (including dabrafenib in combination with trametinib started before ICF signature)
- Patient is not able to comply with the planned study procedures
- Taken an investigational drug within 28 days prior to enrolment
- 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.
Key Trial Info
Start Date :
December 31 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 4 2028
Estimated Enrollment :
78 Patients enrolled
Trial Details
Trial ID
NCT04666272
Start Date
December 31 2020
End Date
February 4 2028
Last Update
August 27 2025
Active Locations (9)
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1
Novartis Investigative Site
Fuzhou, Fujian, China, 350014
2
Novartis Investigative Site
Zhengzhou, Henan, China, 410100
3
Novartis Investigative Site
Wuhan, Hubei, China, 430022
4
Novartis Investigative Site
Changsha, Hunan, China, 410013