A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects Who Previously Received Talimogene Laherparepvec in Amgen or BioVEX-Sponsored Clinical Trials
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 185
- 试验地点
- 59
- 主要终点
- Talimogene Laherparepvec Related Adverse Events
研究概览
简要总结
A Registry Study to Evaluate the Survival and Long-Term Safety of Subjects Who Previously Received Talimogene Laherparepvec in Amgen or BioVEX-Sponsored Clinical Trials
详细描述
A registry study is to evaluate the overall survival, use of subsequent anti-cancer therapy, and the long-term safety of subjects who have received at least one dose of talimogene laherparepvec on an Amgen or BioVEX-sponsored clinical trial for any tumor type. Follow-Up will occur every 3 months.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All subjects must provide informed consent prior to initiation of any study activities.
- •All subjects must have received at least one dose of talimogene laherparepvec on an Amgen or BioVEX-sponsored clinical trial for any tumor type and must have discontinued treatment and participation, including long-term follow-up (if applicable) in that trial.
排除标准
- •Subjects currently receiving talimogene laherparepvec in Amgen or BioVEX-sponsored clinical trial.
- •Subject currently participating, including for long-term follow-up (if applicable), in other Amgen-sponsored talimogene laherparepvec clinical trial.
结局指标
主要结局
Talimogene Laherparepvec Related Adverse Events
时间窗: 7 years
Long-term safety of talimogene laherparepvec will be assessed by reporting of related adverse events every 3 months. Related serious adverse events will be reported within 24 hours following investigator's knowledge of the event.
Subject overall survival
时间窗: 7 years
Overall survival status will be reported every 3 months
Use of subsequent anti-cancer therapy
时间窗: 7 years
The use of subsequent anti-cancer therapy, for the tumor indication in the prior Amgen or BioVEX-sponsored clinical trial, including retreatment with marketed talimogene laherparepvec for approved indication in subjects previously enrolled in Amgen or BioVEX-sponsored talimogene laherparepvec clinical trials, will be monitored
次要结局
未报告次要终点