A Safety and Efficacy Study of Combined Fianlimab + Cemiplimab in Children and Young Adults With Recurrent or Progressive High-Grade Glioma or Posterior Fossa-A Ependymoma
2026年4月28日 更新者：Regeneron Pharmaceuticals
A Phase 1/2 Open-Label, Safety and Efficacy Study of Neoadjuvant Fianlimab (Anti-LAG-3 Antibody) in Combination With Cemiplimab (Anti-PD-1 Antibody) and Cemiplimab Alone Followed by Adjuvant Fianlimab in Combination With Cemiplimab in Pediatric and Young Adult Participants With Recurrent or Progressive High-Grade Glioma or Pediatric and Adult Participants With Recurrent or Progressive Posterior Fossa-A Ependymoma
This study is researching an experimental drug called cemiplimab (called "study drug") and the combination of experimental drugs of fianlimab and cemiplimab (called "study drugs"). The study is focused on children and young adults with recurrent or progressive High-Grade Glioma (HGG) or ependymoma. "Recurrent" means that the cancer came back after treatment. "Progressive" means that the tumor has grown or spread.
The aim of the study is to see how safe, tolerable, and effective cemiplimab and the combination of fianlimab and cemiplimab are.
The study is looking at several other research questions, including:
- What side effects may happen from receiving the study drug(s)
- Do the study drug(s) help study participants live longer without their tumors growing or spreading
- How much of the study drug(s) is in the blood at different times
- Whether the body makes antibodies against the study drug(s) (which could make the study drug[s] less effective or lead to side effects)
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
120
阶段
- 阶段2
- 阶段1
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Clinical Trials Administrator
- 电话号码：844-734-6643
- 邮箱：clinicaltrials@regeneron.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
接受健康志愿者
不
描述
Key Inclusion Criteria:
- Participant must be diagnosed with recurrent/progressive HGG or PF-A ependymoma with unequivocal progression on Magnetic Resonance Imaging (MRI) as described in the protocol
- Participant must have histologically confirmed (at initial diagnosis or relapse) HGG or PF-A ependymoma
- Participant must be an adequate medical candidate for surgical resection as described in the protocol
- Karnofsky Performance Status (KPS) score ≥50 (in participants ≥16 years) or Lansky Performance Status (LPS) score ≥50 (in participants <16 years) as described in the protocol
- Adequate organ function as described in the protocol
Key Exclusion Criteria:
- Active autoimmune disease requiring systemic immunosuppressive therapy in the past 2 years
- Active, serious medical illness, infection or other systemic illness which would limit participation in the trial
- Has not yet recovered from any acute toxicities resulting from prior therapy
- History of myocarditis
- Prior treatment with antibodies to Programmed Cell Death Protein -1 (PD-1), Programmed Cell Death Protein Ligand -1 (PD-L1), Lymphocyte Activation Gene 3 (LAG3), or Cytotoxic T-Lymphocyte Associated protein 4 (CTLA-4)
- Treatment with high dose systemic corticosteroids as described in the protocol
- History of interstitial lung disease (eg, idiopathic pulmonary fibrosis, organizing pneumonia) or active, noninfectious pneumonitis that required immune-suppressive doses of glucocorticoids to assist with management
Note: Other protocol defined Inclusion/ Exclusion Criteria apply
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Phase 1 Arm A
Neoadjuvant Period: cemiplimab Adjuvant Period: fianlimab+cemiplimab
|
根据协议进行管理
其他名称：
Administered per the protocol
其他名称：
|
|
实验性的：Phase 1 Arm B
Neoadjuvant Period: fianlimab+cemiplimab Adjuvant Period: fianlimab+cemiplimab
|
Administered per the protocol
其他名称：
|
|
实验性的：Phase 2
Neoadjuvant Period: fianlimab+cemiplimab Adjuvant Period: fianlimab+cemiplimab
|
Administered per the protocol
其他名称：
|
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
总生存期（OS）
大体时间：12个月
|
12个月
|
|
无进展生存期 (PFS)
大体时间：12个月
|
12个月
|
|
Occurrence of Treatment Emergent Adverse Events (TEAEs)
大体时间：Up to 26 months
|
Up to 26 months
|
|
Severity of TEAEs
大体时间：Up to 26 months
|
Up to 26 months
|
次要结果测量
结果测量 |
大体时间 |
|---|---|
|
总生存期
大体时间：长达 5 年
|
长达 5 年
|
|
无进展生存期 (PFS)
大体时间：长达 5 年
|
长达 5 年
|
|
茶的严重程度
大体时间：长达5年
|
长达5年
|
|
Concentrations of fianlimab in serum
大体时间：Up to 5 years
|
Up to 5 years
|
|
Concentrations of cemiplimab in serum
大体时间：Up to 5 years
|
Up to 5 years
|
|
Occurrence of Anti-Drug Antibody (ADA) to fianlimab
大体时间：Up to 5 years
|
Up to 5 years
|
|
Occurrence of ADA to cemiplimab
大体时间：Up to 5 years
|
Up to 5 years
|
|
Magnitude of ADA to fianlimab
大体时间：Up to 5 years
|
Up to 5 years
|
|
Magnitude of ADA to cemiplimab
大体时间：Up to 5 years
|
Up to 5 years
|
|
Death due to any cause
大体时间：Up to 5 years
|
Up to 5 years
|
|
Occurrence of TEAEs
大体时间：Up to 5 years
|
Up to 5 years
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Clinical Trial Management、Regeneron Pharmaceuticals
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年8月31日
初级完成 (估计的)
2032年8月27日
研究完成 (估计的)
2034年8月17日
研究注册日期
首次提交
2026年4月28日
首先提交符合 QC 标准的
2026年4月28日
首次发布 (实际的)
2026年5月5日
研究记录更新
最后更新发布 (实际的)
2026年5月5日
上次提交的符合 QC 标准的更新
2026年4月28日
最后验证
2026年4月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- R3767-ONC-2320
- 2025-521485-96-00 (克蒂斯)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
IPD 共享时间框架
When Regeneron has:
- received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
- made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
- the legal authority to share the data, and
- ensured the ability to protect participant privacy
IPD 共享访问标准
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli.
Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 分析代码
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
是的
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.