NCT04845139Unknown不适用
A Case Study of Nivolumab for Relapsed/Refractory Primary Central Nervous System Lymphoma
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2022年7月2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
- 发起方
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
The purpose of this study is to determine whether Nivolumab given intrathecally is effective in the treatment of Relapsed/Refractory Primary Central Nervous System Lymphoma (PCNSL)
详细描述
This is a case study aiming to recruit 1 patient. This study is indicated for relapsed/refractory primary central nervous system lymphoma. Primary objective is to explore the safety.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with ECOG 0,1,2,3
- •Subjects with pathologically confirmed PCNSL with lesion in brain who progressed after or did not respond to at least 1 line of systemic therapy. PCNSL prior therapy may include HD-MTX, HD-MTX-based regimen, high-dose cytarabine, radiation therapy alone as treatment or as part of consolidation therapy, high-dose therapy with autologous stem cell transplant as part of consolidation therapy, and/or intraocular MTX alone or as part of consolidation therapy
- •Subject with sufficient function of liver, kidney, heart, lung and hematopoiesis
- •Subjects with relapsed PCNSL and are able to receive biopsy
排除标准
- •Subjects that are not DLBCL type pathologically
- •Intraocular PCNSL without evidence of brain disease
- •Subjects who cannot undergo MRI assessments
- •Relapsed PCNSL patients who cannot undergo biopsy
- •Biopsy suggests no significant tumor-infiltration T cell or poor PD-1 expression
- •Subjects with other malignancy
- •Subjects with history of any inflammatory CNS diseases
- •Subjects with an active, known, or suspected autoimmune disease
- •Subjects with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications within 14 days of start of study treatment
- •Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
Nivolumab administration
Experimental
Nivolumab administration Q2W by intraventricular injection through Ommaya reservoir
干预措施: Nivolumab (Drug)
结局指标
主要结局
Adverse events
时间窗: On a continuous basis up to 1 month after the first dose of study drug
Adverse events Adverse events assessed according to NCI-CTCAE v5.0 criteria
次要结局
- Best overall response(BOR)(up to 3 months after the first dose of study drug)
研究者
研究点 (1)
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