An Observational Chart Review Study to Describe the Real-world Outcomes and Use of Avelumab in Combination With Axitinib for Treatment of Patients With Advanced Renal Cell Carcinoma in the United Kingdom.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 130
- 试验地点
- 1
- 主要终点
- Objective response (OR)
研究概览
简要总结
An observational chart review study to describe the real-world outcomes and use of avelumab in combination with axitinib for treatment of patients with advanced renal cell carcinoma in the United Kingdom.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
patients with advanced renal cell carcinoma
干预措施: avelumab (Drug)
patients with advanced renal cell carcinoma
干预措施: axitinib (Drug)
结局指标
主要结局
Objective response (OR)
时间窗: August 2019 through July 2023
"Percentage of participants with objective response based assessment of complete response (CR) or partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST). CR was defined as complete disappearance of all target lesions and non-target disease, with the exception of nodal disease. All nodes, both target and non-target, must decrease to normal (short axis \<10 mm). No new lesions. PR was defined as \>=30% decrease under baseline of the sum of diameters of all target lesions. The short aixs was used in the sum for target nodes, while the longest diameter was used in the sum for all other target lesions. No unequivocal progression of non-target disease. No new lesions. "
Overall Survival (OS)
时间窗: August 2019 through July 2023
Time in weeks or months from randomization (or the start of study treatment for non-randomized studies) to date of death due to any cause. OS was calculated as (the death date or last known alive date (if death date unavailable) minus the date of randomization (or first dose of study medication for non-randomized studies) plus 1) divided by 7 or 30.44 if in months.
Progression Free Survival (PFS)
时间窗: August 2019 through July 2023
Median time from the first dose of study treatment to the first documentation of objective tumor progression or to death due to any cause, whichever occurs first. PFS calculated as (Weeks) = (first event date minus first dose date plus 1) divided by 7
Duration of Response (DoR)
时间窗: August 2019 through July 2023
Median duration (50%) of tumor response for a subgroup of participants with objective disease response: who have not progressed or died due to any cause; with a response and subsequent progression or death due to any cause for DR. DR defined as time from start of first documented objective tumor response \[Complete Response (CR) or Partial Response (PR)\] to first documented objective tumor progression or death due to any cause, whichever occurs first. DR calculated as (Weeks) = (the end date for DR minus first subsequent confirmed CR or PR plus 1) divided by 7.
Duration of Treatment (DoT)
时间窗: August 2019 through July 2023
次要结局
未报告次要终点