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
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 78
- 试验地点
- 8
- 主要终点
- Relapse-free survival (RFS)
研究概览
简要总结
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.
详细描述
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)
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: dabrafenib (Drug)
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.
干预措施: trametinib (Drug)
结局指标
主要结局
Relapse-free survival (RFS)
时间窗: 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.
次要结局
- Overall survival (OS)(Up to 36 months)
- Safety of dabrafenib in combination with trametinib(Up to 36 months)