NCT02940639已完成不适用
A National, Prospective, Non-Interventional Study (NIS) in Patients With Advanced/Metastatic Renal Cell Carcinoma Starting 1st Line Nivolumab and Ipilimumab Combination Therapy or Nivolumab Monotherapy After Prior Therapy
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 499 人开始时间: 2016年10月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 499
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this study is to estimate overall survival over a 5-year follow-up period among adult participants with advanced/metastatic kidney cancer, starting 1st line nivolumab and ipilimumab combination therapy or nivolumab monotherapy after prior therapy, in real-life conditions in Germany
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 participants, at least 18 years of age at time of treatment decision
- •Diagnosis of advanced/metastatic renal cell carcinoma (RCC) (confirmed by histology or cytology)
- •Treatment decision to initiate a treatment with nivolumab and ipilimumab or nivolumab for the first time for the treatment of advanced/metastatic RCC (according to the label approved in Germany) has already been taken
- •Signed informed consent
排除标准
- •Participants with a diagnosis of a cancer other than advanced/metastatic advanced RCC within the past five years, ie, a cancer other than advanced/metastatic RCC that requires systemic or other treatment. Participants that have been treated curatively more than five years ago with no evidence of recurrence and prostate cancer patients in active surveillance can be included.
- •Participants previously treated with nivolumab and/or ipilimumab
- •Participants currently included in an interventional clinical trial for their locally advanced or metastatic RCC. Participants who have completed their participation in an interventional trial; or who are not receiving study drug anymore and who are only followed-up for OS can be enrolled.
结局指标
主要结局
Overall Survival (OS)
时间窗: Approximately 5 years
In participants with nivolumab and ipilimumab or nivolumab therapy
次要结局
- Distribution of severity of Adverse Events (AEs)(Approximately 5 years)
- Distribution of Adverse Events (AE) characteristics(Approximately 5 years)
- Progression-Free Survival (PFS)(Approximately 5 years)
- Overall response rate (ORR)(Approximately 5 years)
- Best Overall Response Rate (BORR)(Approximately 5 years)
- Distribution of socio-demographic characteristics(Approximately 5 years)
- Distribution of clinical characteristics(Approximately 5 years)
- Incidence rate of Adverse Events (AEs), treatment-related AEs, select AEs and other immune-related AEs(Approximately 5 years)
- Distribution of management of Adverse Events (AEs)(Approximately 5 years)
- Quality of Life as assessed by Functional Assessment of Cancer Therapy - Kidney Symptom Index (FKSI-19) Questionnaire(Approximately 5 years)
- Overall Survival (OS)(Approximately 5 years)
- Distribution of Renal Cell Carcinoma (RCC) Treatment History(At Baseline)
- Best Overall Response (BOR)(Approximately 5 years)
- Distribution of Nivolumab Treatment Characteristics(At initiation - index date, baseline)
- Distribution of Treatment Patterns(Approximately 5 years)
- Utility as assessed by European Quality of Life-5 Dimensions (EQ-5D) Questionnaire(Approximately 5 years)
- Duration of Response(Approximately 5 years)
研究者
研究点 (1)
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