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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.
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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dabrafenib in combination with trametinib as adjuvant treatment | Patients will be treated according to the China package insert for dabrafenib and trametinib. The approved starting doses of dabrafenib (150 mg twice daily) and trametinib (2 mg once daily) will be used. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| dabrafenib | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Relapse-free survival (RFS) | Relapse-free survival (RFS), defined as the time from start of treatment to disease recurrence or death due to any cause. | Up to 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Overall survival (OS) | Overall survival (OS) defined as the time from start of treatment to death due to any cause | Up to 36 months |
| Safety of dabrafenib in combination with trametinib | Adverse events (AEs) and serious adverse events (SAEs) will be measured |
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Inclusion Criteria:
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:
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 Criteria:
Patient will be excluded from this study if he/she meets any of the following criteria:
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This study will include Chinese patients with stage III BRAF V600 mutation positive melanoma treated with dabrafenib in combination with trametinib in a commercial setting.
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| Name | Affiliation | Role |
|---|---|---|
| Novartis Pharmaceuticals | Novartis Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Fuzhou | Fujian | 350014 | China | ||
| Novartis Investigative Site |
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| trametinib | Drug | 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. |
|
| Up to 36 months |
| Zhengzhou |
| Henan |
| 410100 |
| China |
| Novartis Investigative Site | Wuhan | Hubei | 430022 | China |
| Novartis Investigative Site | Changsha | Hunan | 410013 | China |
| Novartis Investigative Site | Nanjing | Jiangsu | 210008 | China |
| Novartis Investigative Site | Kunming | Yunnan | 650106 | China |
| Novartis Investigative Site | Hangzhou | Zhejiang | 310022 | China |
| Novartis Investigative Site | Beijing | 100036 | China |
| ID | Term |
|---|---|
| D008545 | Melanoma |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009380 | Neoplasms, Nerve Tissue |
| D018326 | Nevi and Melanomas |
| D012878 | Skin Neoplasms |
| D009371 | Neoplasms by Site |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C561627 | dabrafenib |
| C560077 | trametinib |
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