A Multi-National, Prospective, Observational Study in Patients With Unresectable or Metastatic Melanoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,411
- 试验地点
- 4
- 主要终点
- Frequency at which immunosuppressive therapy was administered to patients to manage treatment-related adverse events associated with Ipilimumab
研究概览
简要总结
The purpose of this study is to examine the safety of Ipilimumab and patterns of use in the treatment of unresectable or metastatic melanoma in the post-approval setting
详细描述
Time Perspective: this study does have a retrospective component involving a subset of patients
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 unresectable or metastatic melanoma
- •Age of 18 years or older at time of entry into the study
- •Patients who have initiated treatment for unresectable or metastatic melanoma at medical practice (e.g. community-based, office-based, hospital-based, academic setting)within 21 days before informed consent for this study OR in the case where treatment has not yet been initiated, documentation that the treatment strategy was determined before informed consent for this study, and treatment must be initiated within 28 days after informed consent
- •Ipilimumab-treated patients must be receiving treatment for the indication(s) approved in their country of residence or where they are receiving treatment
排除标准
- •Current or pending participation in a clinical trial examining therapy for the treatment of any cancer (including unresectable or metastatic melanoma)
- •Current use of therapy to treat a primary cancer other than melanoma
结局指标
主要结局
Frequency at which immunosuppressive therapy was administered to patients to manage treatment-related adverse events associated with Ipilimumab
时间窗: Every 12 months up to 5 years
Patterns of disease monitoring as observed in a real-world setting
时间窗: Every 12 months up to 5 years
To evaluate patterns of care, descriptive statistics will describe treatment, dosing, regimen, indication, treatment rationales, management of treatment-related adverse events, reasons for treatment termination
Incidence and severity of adverse reactions in patients treated with Ipilimumab in the post-approval setting
时间窗: Every 12 months up to 5 years
Incidence rate with person-year-exposure and frequency estimate of adverse events/serious adverse events
时间窗: Every 12 months up to 5 years
次要结局
- Quality of life (QoL), impact on work productivity, and overall satisfaction among patients receiving any therapy for unresectable or metastatic melanoma(Every 12 months up to 5 years)
- Resource utilization associated with advanced melanoma treatment(Every 12 months up to 5 years)
- Overall survival (OS) in patients receiving Ipilimumab or other therapies for unresectable or metastatic melanoma(Every 12 months up to 5 years)