NCT03161613撤回不适用
Postmarketing Study to Assess the Safety of Nivolumab as a First- and Second-line Treatment in Patients With Metastatic Melanoma or as a Second-line Treatment for Metastatic Lung Cancer (Squamous and Nonsquamous), Metastatic Renal Cancer, Squamous Cell Carcinoma of the Head and Neck, and Chronic Hodgkin Lymphoma in Adult Patients in Mexico
Bristol-Myers Squibb1 个研究点 分布在 1 个国家开始时间: 2017年7月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Incidence of subjects who report on-study Adverse Events(AEs)
研究概览
简要总结
This is a post-marketing study of patients who started nivolumab as first- or second-line therapy for metastatic melanoma or as second-line therapy for metastatic squamous non-small cell lung cancer (SqNSCLC) , metastatic non-SqNSCLC, metastatic renal cell carcimona (RCC), or recurrent or metastatic squamous cell carcinoma of the head and neck cancer (SCCHN), or third-line therapy for classical Hodgkin lymphoma (cHL) in Mexico.
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
- •Male and female adult patients > 18 years of age who have a confirmed diagnosis of advanced or metastatic melanoma and is indicated for the treatment of advanced (unresectable or metastatic) melanoma; metastatic NSCLC; metastatic RCC; recurrent or metastatic SCCHN; or cHL in Mexico
- •Male and female adult patients > 18 years of age who completed the following lines of therapy: first-line platinum treatment for metastatic SqNSCLC or non-SqNSCLC; 1 first-line treatment for metastatic RCC; first-line platinum therapy for SCCHN; or bretuximab vedontin for the treatment of cHL
- •Patients who present with brain metastases are allowed, if asymptomatic, do not have edema, and are not receiving corticosteroids or radiation
- •Patients have received at least 1 dose of nivolumab
排除标准
- •The exclusion criteria are at the discretion of the physician. The physician should use his or her clinical judgement and international recommendations when determining eligibility. The patient will be excluded if he or she does not want to start or continue treatment.
结局指标
主要结局
Incidence of subjects who report on-study Adverse Events(AEs)
时间窗: approximately 24 months
incidence of subjects who report on-study Serious Adverse Events(SAEs)
时间窗: approximately 24 months
次要结局
- Distribution of on-study SAEs(approximately 24 months)
- Distribution of on-study AEs(approximately 24 months)
- Distribution of drug-related AEs(approximately 24 months)
- Distribution of AEs leading to discontinuation(approximately 24 months)
- Distribution of drug-related SAEs(approximately 24 months)
- Distribution of age in patients(At Baseline)
- Distribution of gender in patients(At Baseline)
- Distribution of SAEs leading to discontinuation(approximately 24 months)
- Distribution of tumor history in patients(At Baseline)
研究者
研究点 (1)
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