NCT04050761已完成不适用
A French Prospective, Non-interventional Research ( NIR) of Nivolumab in Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN) Progressing on or After a Platinum-based Therapy
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 502 人开始时间: 2019年6月26日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 502
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
A prospective real world evidence study of Nivolumab use in France in patient with recurrent or metastatic squamous cell carcinoma of the Head and Neck progressing on or after a platinum based therapy
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
- •Diagnosis of Squamous Cell Carcinoma Head and Neck (SCCHN) patients progressing on or after platinum-based therapy.
- •Diagnosis of SCCHN has been confirmed by histology or cytology (either at initial diagnosis or any time later during the course of the disease)
- •Treatment decision to initiate a treatment with nivolumab for the first time for the treatment of SCCHN (according to the label approved in France) has already been taken
排除标准
- •Patients previously treated with Nivolumab, Ipilimumab, or any other antibody or drug specifically targeting T-Cell Co stimulation or immune Checkpoint pathway.
- •Patients currently included in an interventional clinical trial for their SCCHN.
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Monotherapy
Participants diagnosed with recurrent or metastatic squamous cell carcinoma of the Head and Neck and whose physician has decided to initiate a treatment with Nivolumab for the first time for the treatment of SCCHN.
干预措施: Nivolumab (Biological)
结局指标
主要结局
Overall Survival
时间窗: 3 Years
次要结局
- Best overall response rate (BORR)(3 years)
- Overall Survival within Sub groups(3 year)
- Overall response rate (ORR)(3 years)
- Progression-free survival (PFS)(3 Years)
- Duration of response (DOR)(3 years)
- Incidents of immune-related Adverse Events(3 years)
- Number of treatment characteristics in adult patients with SCCHN(3 Years)
- Time to response (TTR)(3 years)
- Incidents of Adverse Events (AEs)(3 years)
- Number of clinical characteristics in adult patients with SCCHN(3 Years)
- Number of socio-demographic characteristics in adult patients with SCCHN(3 years)
- Quality of life of caregiver (CarGoQoL ) Score(3 Years)
- Supportive Care Needs Survey for Partners and Caregivers (SCNS-P&C) Assessment score(3 Years)
- Incident of treatment-related Adverse Events(3 years)
- European Quality of Life-5 Dimensions (EQ-5D) score(3 Years)
- Functional Assessment of Cancer Therapy - Head & Neck (FACT-H&N) Score(3 Years)
研究者
研究点 (1)
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