Survival in Adult Patients With BRAF V600 Mutation-Positive Advanced Melanoma: A Non-Interventional Ambispective Study of a Cohort of Patients Treated With Cobimetinib During the French Early Access Program (TAU)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 33
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This is a multicentre, ambispective (both retrospective and prospective), and non-interventional study conducted in France in adult participants with BRAF V600 mutation-positive unresectable or metastatic melanoma treated with cobimetinib in combination with vemurafenib (Zelboraf®).
详细描述
Concomitantly to the marketing authorization applications for cobimetinib and vemurafenib to European Medicines Agency (EMA) and United States Food and Drug Administration (USFDA) in 2014, a French TAU program was initiated in February 2015. This study will enroll participants under this program.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Participants included in the TAU from 26 February 2015
- •Participants with BRAF V600 mutation-positive unresectable or metastatic melanoma treated with cobimetinib in combination with vemurafenib
- •For alive participants: participants who have been informed verbally and in writing about this study who do not object to their data being electronically processed or subjected to data quality control
- •For participants who died before the inclusion period: participants who did not express their opposition when they were alive
排除标准
- •Alive participants unable to give informed consent
研究组 & 干预措施
Metastatic Melanoma
Participants with BRAF V600 mutation-positive unresectable or metastatic melanoma, having started treatment with cobimetinib in combination with vemurafenib as per local guidelines and/or routine clinical practice in context of TAU program, will be observed.
干预措施: Cobimetinib (Drug)
Metastatic Melanoma
Participants with BRAF V600 mutation-positive unresectable or metastatic melanoma, having started treatment with cobimetinib in combination with vemurafenib as per local guidelines and/or routine clinical practice in context of TAU program, will be observed.
干预措施: Vemurafenib (Drug)
结局指标
主要结局
Overall Survival (OS)
时间窗: From first intake of cobimetinib up to date of death due from any cause (assessed up to 18 months)
次要结局
- Percentage of Participants with Complete Response (CR) or Partial Response (PR) to Treatment According to RECIST as Assessed by Physician(From first intake of cobimetinib up to first disease progression or death from any cause (assessed up to 18 months))
- Percentage of Participants by Treatments After Disease Progression or Permanent Cobimetinib Treatment Discontinuation(From disease progression or permanent cobimetinib treatment discontinuation up to overall study completion (assessed up to 18 months))
- Retrospective Period: Percentage of Participants with Targeted Adverse Events (AEs)(From first intake of cobimetinib up to inclusion in the study (up to Day 1))
- Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors (RECIST)(From first intake of cobimetinib up to first disease progression or death from any cause (assessed up to 18 months))
- Prospective Period: Percentage of Participants with Adverse Events (AEs)(From first intake of cobimetinib up to overall study completion (assessed up to 18 months))
- Time to Cobimetinib Treatment Discontinuation(From first intake of cobimetinib up to cobimetinib treatment discontinuation (assessed up to 18 months))