NCT03114163已完成不适用
A National, Prospective, Non-Interventional Study (NIS) of Nivolumab (BMS-936558) in Patients With Squamous Cell Carcinoma of the Head and Neck (SCCHN) Progressing on or After Platinum-Based Therapy
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 485 人开始时间: 2017年5月12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
- 485
- 试验地点
- 1
- 主要终点
- Overall Survival
研究概览
简要总结
This is a German, observational study in adult participants diagnosed with squamous cell carcinoma of the head and neck (SCCHN) progressing on or after platinum-based therapy, who start a new systemic therapy with nivolumab in 1st line (cohort 2) or ≥2nd line (cohort 1) for the first time, and are treated within the market authorization approval. Participants are to be enrolled into the study no earlier than the decision to initiate treatment with nivolumab and no later than the first dose of nivolumab treatment.
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 Squamous cell carcinoma of the head and neck (SCCHN) and participants are progressing on or after platinum-based therapy, administered for locally advanced, metastatic or recurrent disease (Cohort 2: prior platinum-based therapy was administered for locally advanced disease in the adjuvant or primary setting, e.g. radiotherapy)
- •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 Germany) has already been taken
排除标准
- •Current primary diagnosis of a cancer other than SCCHN, ie, a cancer other than SCCHN or cancer of unknown primary (CUP-syndrome) that requires systemic or other treatment, or has not been treated curatively (as per discretion of the investigator)
- •Previously treated with nivolumab and/or ipilimumab, an anti-PD-1, anti-programmed death ligand 1 (anti-PD-L1), anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways (applicable for any indication)
- •Currently included in an interventional clinical trial for their SCCHN. 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 Overall survival (OS) can be enrolled
结局指标
主要结局
Overall Survival
时间窗: Up to 5 years
次要结局
- Progression-Free Survival (PFS)(Up to 5 years)
- Best overall response (BOR)(Up to 5 years)
- Overall Survival(Up to 5 years)
- Tumor response (Investigator assessed)(Up to 5 years)
- Description of management of participants with treatment-related adverse events (AEs)(Up to 5 years)
- Description of Severity of AEs(Up to 5 years)
- Description of management of AEs(Up to 5 years)
- Time to progression(Up to 5 years)
- Time to response (TTR)(Up to 5 years)
- Description of socio-demographic characteristics of participants(Up to 5 years)
- Description of participant-reported outcomes (PROs) and health-related quality-of-life (QoL) of participants using the Functional Assessment of Cancer Therapy - Head & Neck (FACT-H&N) questionnaires(Up to 5 years)
- Description of participant-reported outcomes (PROs) and health-related quality-of-life (QoL) of participants using European Quality of Life-5 Dimensions (EQ-5D) questionnaires(Up to 5 years)
- Overall Response Rate (ORR)(Up to 5 years)
- Best overall response rate (BORR)(Up to 5 years)
- Duration of response (DOR)(Up to 5 years)
- Description of clinical characteristics of participants(Up to 5 years)
- Description of incidence of AEs(Up to 5 years)
研究者
研究点 (1)
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