Clinical Characteristics, Outcomes and Quality of Life in Patients With Squamous Cell Oesophageal Carcinoma Receiving Nivolumab After Prior Chemotherapy as Part of an Early Access to Medicines Scheme (EAMS) Program in the United Kingdom
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 87
- 试验地点
- 3
- 主要终点
- Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Disease history
研究概览
简要总结
This purpose of this observational study is to review medical chart and patient survey data collection within an early access to medicines scheme (EAMS) program. Participant who are eligible, provide consent and enroll into the squamous cell oesophageal cancer EAMS to receive Nivolumab will be included in this study.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult participant (≥18 years of age) enrolling into the squamous cell (including adenosquamous) oesophageal cancer early access to medicines scheme (EAMS) and plans to initiate treatment with nivolumab
- •Willing and able to comply with the study requirements and provide informed consent
排除标准
- •Does not receive at least one dose of nivolumab as part of the EAMS
- •Other protocol-defined inclusion/exclusion criteria apply
结局指标
主要结局
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Disease history
时间窗: At baseline
Distribution of disease progression to determine progression free survival (PFS) based on data collected as part of routine care
时间窗: Up to 12 months
Distribution of survival status to determine progression free survival (PFS) based on data collected as part of routine care
时间窗: Up to 12 months
Distribution of survival status to determine overall survival (OS) based on data collected as part of routine care
时间窗: Up to 12 months
Distribution of patient quality of life through EQ-5D-3L (EQ-5D) at baseline following patient enrolment into the EAMS
时间窗: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Age
时间窗: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Condition which the product is being used for
时间窗: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Number of organs with metastases
时间窗: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Concomitant medication
时间窗: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Weight
时间窗: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Gender
时间窗: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Prior surgery for oesophageal cancer
时间窗: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Treatment history
时间窗: At baseline
Distribution of disease progression to determine overall survival (OS) based on data collected as part of routine care
时间窗: Up to 12 months
Distribution of patient quality of life through EQ-5D-3L (EQ-5D) every two weeks for 24 weeks post-treatment initiation following patient enrolment into the EAMS
时间窗: Up to 24 weeks
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Sites of metastasis
时间窗: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Underlying comorbidities
时间窗: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Race
时间窗: At baseline
Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Eastern Cooperative Oncology Group Performance Status (ECOG PS)
时间窗: At baseline
Distribution of treatment patterns of nivolumab: Treatment duration
时间窗: Up to 12 months
次要结局
未报告次要终点