Multicenter Non-interventional Retro- and Prospective Safety and Efficacy Study of Prolgolimab (Forteca - Anti-PD1) in Patients With Advanced Melanoma (FOrteca Real Practice Assessment)
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
Describe the safety, tolerability, efficacy and approaches to prescribing prolgolimab in the standard dosing regimen of 1 mg / kg every 2 weeks in patients with advanced melanoma in routine practice.
Prolgolimab (Forteca, formerly BCD 100) is an IgG1 anti-PD-1 (programmed cell death protein 1) monoclonal antibody containing the Fc-silencing 'LALA' mutation.
详细描述
Describe the safety and tolerability of using Prolgolimab at a standard dosage regimen of 1 mg / kg every 2 weeks.
Describe the efficacy of prolgolimab 1 mg / kg every 2 weeks in patients with metastatic or inoperable melanoma in routine practice, based on the following indicators: Progression-free survival (time from first dose of prolgolimab to disease progression or death for any reason); Overall survival (time from receiving the first dose of prolgolimab to death for any reason); Objective response rate (proportion of patients with a complete or partial response to prolgolimab therapy).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Histological confirmed melanoma Advanced stage (unresectable III or metastatic IV) Treated by at least one therapy line including prolgolimab in routine practice -
排除标准
- •Patient participation in any interventional clinical study.
结局指标
主要结局
Objective response rate
时间窗: 3 years
The response rate during prolgolimab therapy in patients with unresectable advanced melanoma
The incidence of adverse events during prolgolimab therapy
时间窗: 2 years
The rate of all grade and grade 3-5 adverse events and the rate of discontinuation of study drug(s) due to adverse events.
次要结局
- Progression free survival (PFS)(3 years)
- Overall survival (OS)(3 years)