NCT04825873已完成不适用
The Observational Safety Study for Nivolumab in China Routine Oncology Practice
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 3,102 人开始时间: 2021年5月28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
- 3,102
- 试验地点
- 1
- 主要终点
- Severity of TRAEs
研究概览
简要总结
The purpose of this study is to assess the safety of nivolumab in routine cancer practice in China. Part one of the study will investigate nivolumab for non-small cell lung cancer previously treated with platinum-based chemotherapy that has locally advanced or has spread. Part two will investigate nivolumab for post-platinum squamous cell carcinoma of head and neck that is recurrent or has spread. Part three will investigate nivolumab for locally advanced or metastatic non-small cell lung cancer. Part four will investigate nivolumab for recurrent or metastatic squamous cell carcinoma of head and neck.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Histologically or cytologically confirmed diagnosis of locally advanced/metastatic non-small cell lung cancer (NSCLC) participants
- •Treatment with nivolumab per physician's prescription
- •Histologically or cytologically confirmed diagnosis of recurrent/metastatic squamous cell carcinoma of head and neck (SCCHN)
- •Treatment with nivolumab for recurrent or metastatic SCCHN
- •Histologically or cytologically confirmed diagnosis of locally advanced/metastatic NSCLC
- •Participants with at least one dose of nivolumab administered since June 2018
- •Histologically or cytologically confirmed diagnosis of recurrent/metastatic SCCHN
- •Participants with at least one dose of nivolumab administered since September 2019
排除标准
- •Prior participation in a clinical trial within the past 4 weeks
- •Current or pending participation in a clinical trial
- •Current or pending systemic treatment for cancer other than NSCLC for part 1 and SCCHN for part 2
- •Previously treated with immune checkpoint inhibitors for part 3 and part 4
- •Participants must not have any other concurrent primary tumor(s) for part 3 and part 4
- •Other protocol-defined inclusion/exclusion criteria apply
结局指标
主要结局
Severity of TRAEs
时间窗: Up to approximately 48 months
Part 3 and Part 4
Management of irAEs
时间窗: Up to approximately 48 months
Part 3 and Part 4
Severity of nivolumab-related irAEs
时间窗: Up to approximately 48 months
Severity of nivolumab-related AEs
时间窗: Up to approximately 48 months
Incidence rate of nivolumab-related immune-related adverse events (irAEs)
时间窗: Up to approximately 48 months
Incidence rate of nivolumab-related adverse events (AEs)
时间窗: Up to approximately 48 months
Incidence rate of nivolumab-related serious adverse events (SAEs)
时间窗: Up to approximately 48 months
Incidence rate of treatment-related adverse events TRAEs
时间窗: Up to approximately 48 months
Part 3 and Part 4
Distribution of outcomes of irAEs
时间窗: Up to approximately 48 months
Part 3 and Part 4
Severity of nivolumab-related SAEs
时间窗: Up to approximately 48 months
次要结局
- Management of Common Terminology Criteria for Adverse Event (CTCAE) Grades 2-5 nivolumab-related irAEs(Up to approximately 48 months)
- Distribution of outcomes of CTCAE Grades 2-5 irAEs associated with nivolumab when managed according to the risk management algorithms described in the nivolumab label(Up to approximately 48 months)
- Distribution of treatment patterns of nivolumab in routine oncology practice: Treatment duration(Up to approximately 48 months)
- Distribution of treatment patterns of nivolumab in routine oncology practice: Reasons for nivolumab discontinuation(Up to approximately 48 months)
- Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Height(Up to approximately 48 months)
- Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: BMI(Up to approximately 48 months)
- Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Eastern Cooperative Oncology Group (ECOG) performance status(Up to approximately 48 months)
- Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Disease history(Up to approximately 48 months)
- Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Height(Up to approximately 48 months)
- Distribution of treatment patterns of nivolumab in routine oncology practice: Treatment sequencing(Up to approximately 48 months)
- Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Sex(Up to approximately 48 months)
- Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Weight(Up to approximately 48 months)
- Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Smoking status(Up to approximately 48 months)
- Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Comorbidities(Up to approximately 48 months)
- Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Disease history(Up to approximately 48 months)
- Distribution of clinical characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Treatment history(Up to approximately 48 months)
- Distribution of treatment outcomes of NSCLC participants treated with nivolumab from start of nivolumab treatment: overall survival (OS)(Up to approximately 48 months)
- Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Age(Up to approximately 48 months)
- Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Weight(Up to approximately 48 months)
- Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Treatment history(Up to approximately 48 months)
- Management of CTCAE Grades 2-5 nivolumab-related SAEs(Up to approximately 48 months)
- Distribution of outcomes of CTCAE Grades 2-5 AEs associated with nivolumab when managed according to the risk management algorithms described in the nivolumab label(Up to approximately 48 months)
- Distribution of outcomes of CTCAE Grades 2-5 SAEs associated with nivolumab when managed according to the risk management algorithms described in the nivolumab label(Up to approximately 48 months)
- Management of CTCAE Grades 2-5 nivolumab-related AEs(Up to approximately 48 months)
- Distribution of demographic characteristics of NSCLC participants treated with nivolumab at initiation of nivolumab treatment: Age(Up to approximately 48 months)
- Distribution of treatment outcomes of NSCLC participants treated with nivolumab from start of nivolumab treatment: real-world progression free survival (rwPFS)(Up to approximately 48 months)
- Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Alcohol consumption(Up to approximately 48 months)
- Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Human papillomavirus (HPV) status(Up to approximately 48 months)
- Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Eastern Cooperative Oncology Group (ECOG) performance status(Up to approximately 48 months)
- Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Comorbidities(Up to approximately 48 months)
- Distribution of treatment patterns of nivolumab for metastatic SCCHN(Up to approximately 48 months)
- Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Sex(Up to approximately 48 months)
- Distribution of treatment patterns of nivolumab for recurrent squamous cell carcinoma of head and neck (SCCHN)(Up to approximately 48 months)
- Distribution of demographic characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: BMI(Up to approximately 48 months)
- Distribution of treatment effectiveness of SCCHN participants treated with nivolumab from the start of nivolumab treatment: rwPFS(Up to approximately 48 months)
- Distribution of clinical characteristics of SCCHN participants treated with nivolumab at initiation of nivolumab treatment: Smoking status(Up to approximately 48 months)
- Distribution of treatment effectiveness of SCCHN participants treated with nivolumab from the start of nivolumab treatment: OS(Up to approximately 48 months)
研究者
研究点 (1)
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