EUCTR2016-004441-82-ES进行中（未招募）1 期
Phase Ib /II Clinical Trial of Nivolumab Monotherapy and Nivolumab in Combination with Ipilimumab in Pediatric Subjects with High Grade Primary CNS Malignancies - CheckMate908
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1-Children and adolescents diagnosed with either:
- •_Diffuse Intrinsic Pontine Glioma (DIPG),
- •_High Grade Glioma (HGG),
- •_Medulloblastoma,
- •_Ependymoma, or
- •_Other high-grade tumors of the central nervous system.
- •2-Lansky play score (LPS) for =< 16 years of age or Karnofsky performance scale (KPS) for > 16 years of age assessed within two weeks of enrollment must be >= 60.
- •3-A tumor sample must be available for submission to central laboratory [not required for DIPG].
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 160
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 16
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1-Participants with active, known or suspected autoimmune disease.
- •2-Participants unable to taper steroids due to ongoing mass effect.
- •3-Participants with low-grade gliomas or tumors of unknown malignant potential.
- •4-Prior treatment with any drug that targets T cell co-stimulation pathways (such as checkpoint inhibitors).
研究者
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