NCT01996202已完成1 期
A Pilot Study of Ipilumimab and Radiation in Poor Prognosis Melanoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Incidence of immune related adverse events associated with ipilimumab
研究概览
简要总结
This is a pilot study assessing the safety of the combination of ipilimumab administered concurrently with radiotherapy for patients with locally advanced or unresectable melanoma and patients at high risk for recurrence after resection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Resected Melanoma
Other
Subjects with resected melanoma.
干预措施: Ipilumimab (Drug)
Resected Melanoma
Other
Subjects with resected melanoma.
干预措施: Radiation (Radiation)
Unresected Melanoma
Other
Subjects with unresected melanoma.
干预措施: Ipilumimab (Drug)
Unresected Melanoma
Other
Subjects with unresected melanoma.
干预措施: Radiation (Radiation)
结局指标
主要结局
Incidence of immune related adverse events associated with ipilimumab
时间窗: 2 years
Incidence of acute and late radiation toxicities
时间窗: 2 years
次要结局
- Overall response rate (ORR)(2 years)
- 6 month progression free survival (PFS)(6 months)
- 12 month progression free survival (PFS)(12 months)
- Overall survival(2 years)
- CD4+ and CD8+ reactivity to melanoma tumor antigens(2 years)
- Cytokines associated with anti-tumor response(2 years)
研究者
研究点 (1)
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