NCT04196452进行中（未招募）不适用
Long-term Follow-up of Ipilimumab-treated Pediatric Patients Enrolled in the Dutch Melanoma Treatment Registry (DMTR)
Bristol-Myers Squibb0 个研究点目标入组 10 人开始时间: 2019年8月12日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 10
- 主要终点
- Frequency of Adverse Events (AEs) Grades 3-4
研究概览
简要总结
This is an observational, national, retrospective study consisting of pediatric patients with advanced (spread or unremoveable) melanoma identified in the DMTR in the Netherlands
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Less than 18 years of age at first dose of monotherapy Ipilimumab used for treatment of advanced melanoma
- •Histological or cytological confirmation of advanced (unresectable or metastatic) melanoma
排除标准
- •Participation in a clinical trial within the past 4 weeks prior to first dose with ipilimumab or concurrently
- •Other inclusion/exclusion criteria apply
研究组 & 干预措施
Arm A: participants 12 to under 18
干预措施: Ipilimumab (Drug)
Arm B: participants under 12
干预措施: Ipilimumab (Drug)
结局指标
主要结局
Frequency of Adverse Events (AEs) Grades 3-4
时间窗: up to 10 years
次要结局
- Assessment of ipilimumab number of infusions(up to 10 years)
- Assessment of Ipilimumab dose frequency(up to 10 years)
- Baseline assessment of population demographics(up to 10 years)
- Baseline assessment of disease characteristics(up to 10 years)
- Overall Survival (OS)(up to 10 years)
- Assessment of physical growth and development(up to 10 years)
- Assessment of changes in ipilumamb treatment: dose interruptions/discontinuations(up to 10 years)
- Baseline assessment of comorbidities(up to 10 years)
- Assessment of ipilimumab dose exposure(up to 10 years)
- Assessment of ipilimumab treatment duration(up to 10 years)
- Time to progression (TTP)(up to 10 years)
- Baseline assessment of treatment history(up to 10 years)
研究者
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