A Phase I Clinical Trial on Combined (Neo-)Adjuvant Intravenous Plus Intracranial Administration of Ipilimumab and Nivolumab in Recurrent Glioblastoma
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Determine the safety and feasibility of the proposed investigational (neo-)adjuvant treatment regimen in patients with resectable recurrent glioblastoma.
研究概览
简要总结
The goal of this phase I interventional study is to determine the safety and feasibility of the proposed investigational (neo-)adjuvant treatment regimen in patients with resectable reccurent glioblastoma.
Participants will:
- receive neo-adjuvant administration of intravenous immunotherapy
- followed by a maximal safe neurosurgical resection
- afterwards, immunotherapy will be injected into the brain tissue
- followed by insertion of an Ommaya reservoir
- postoperatively, administration of immunotherapy will be continued
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Experimental arm
干预措施: Neo-adjuvant nivolumab and ipililumab IV + adjuvant nivolumab and ipililumab IV (Drug)
Experimental arm
干预措施: Neurosurgery and intracavitary injection nivolumab and ipililumab (Procedure)
Experimental arm
干预措施: Adjuvant nivolumab IV + nivolumab and ipililumab intracavitary (Drug)
结局指标
主要结局
Determine the safety and feasibility of the proposed investigational (neo-)adjuvant treatment regimen in patients with resectable recurrent glioblastoma.
时间窗: 1 year
Incidence of treatment related adverse events (TRAE). TRAE will be collected on a continuous basis. Type, frequency and severity (graded according to the CTCAEv5) will be reported descriptively.
次要结局
- Estimate anti-tumor responses of the proposed investigational (neo-)adjuvant treatment regimen.(4 years)
研究者
Bart Neyns
prof. dr.
Universitair Ziekenhuis Brussel