Melanoma
Conditions
Keywords
BRAF V600 mutation-positive melanoma, cutaneous or mucosal melanoma, China, dabrafenib, trametinib
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)
Interventions
DRUGdabrafenib
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.
DRUGtrametinib
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.
Sponsors
Novartis Pharmaceuticals
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival (OS) | Up to 36 months | Overall survival (OS) defined as the time from start of treatment to death due to any cause |
| Safety of dabrafenib in combination with trametinib | Up to 36 months | Adverse events (AEs) and serious adverse events (SAEs) will be measured |
Countries
China
Contacts
STUDY_DIRECTORNovartis Pharmaceuticals
Novartis Pharmaceuticals
Outcome results
None listed