An Open-label Phase II Multicenter Study of Vemurafenib (Zelboraf®) Plus Cobimetinib (Cotellic®) After Radiosurgery in Patients With Active BRAF-V600-mutant Melanoma Brain Metastases
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 20
- 试验地点
- 3
- 主要终点
- Best overall response rate in the brain
研究概览
简要总结
This is a phase II, open label, non-randomised study of vemurafenib and cobimetinib after radiosurgery in adult patients with BRAFV600-mutant melanoma brain metastases. All patients will receive vemurafenib 960 mg twice a day on days 1 - 28 combined with cobimetinib 60 mg once a day on days 1 - 21 of each 28-day treatment cycle until disease progression, drug toxicity or death.
The primary objective of this study is to determine the best overall response rate (BORR) in the brain. The extracranial BORR, intra- and extracranial duration of response, progression-free survival and overall survival, adverse events, quality of life and radiomics features predicting long-term local control of brain metastases and treatment-related toxicity will also be examined.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Treatment
all patients will be treated with Vemurafenib + Cobimetinib
干预措施: Vemurafenib (Drug)
Treatment
all patients will be treated with Vemurafenib + Cobimetinib
干预措施: Cobimetinib (Drug)
结局指标
主要结局
Best overall response rate in the brain
时间窗: 2 years
rate of patients with complete response or partial response (intracranial)
次要结局
- Best overall response rate calculated for the whole body tumor sites(2 years)
- Intracranial duration of response(2 years)
- Extracranial duration of response(2 years)
- Radiomics for intracranial Treatment-related toxicity(every 6 weeks up to 2 years)
- Extracranial best overall response rate(2 years)
- Progression-free survival(2 years)
- Overall survival(2 years)
- Incidence of adverse events(2 years)
- Radiomics for long-term control of brain metastases(every 6 weeks up to 2 years)