A Multicenter Phase 2 Study of Oncolytic Polio/Rhinovirus Recombinant (Lerapolturev) in Recurrent WHO Grade IV Malignant Glioma Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 6
- 主要终点
- Number of Participants With Objective Radiographic Response
研究概览
简要总结
This is a phase 2 study of lerapolturev, an oncolytic polio/rhinovirus recombinant, in adult patients with recurrent World Health Organization (WHO) grade IV malignant glioma.
详细描述
This is a Phase 2 study of lerapolturev, an oncolytic polio/rhinovirus recombinant, in adult patients with recurrent World Health Organization (WHO) grade IV malignant glioma. The objective of this study is to investigate the safety and efficacy (anti-tumor response and survival) of lerapolturev in recurrent WHO grade IV malignant glioma.
Patients will be administered lerapolturev intratumorally via convection-enhanced delivery (CED) using an intracerebral catheter placed within the enhancing portion of the tumor. Retreatment with lerapolturev is allowed, provided retreatment eligibility criteria are met.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
lerapolturev
lerapolturev administered once intratumorally by convection-enhanced delivery
干预措施: lerapolturev (Biological)
lerapolturev + lomustine
lerapolturev administered once intratumorally by convection-enhanced delivery plus one dose of lomustine at 8 weeks post-lerapolturev dosing
干预措施: lerapolturev (Biological)
lerapolturev + lomustine
lerapolturev administered once intratumorally by convection-enhanced delivery plus one dose of lomustine at 8 weeks post-lerapolturev dosing
干预措施: Lomustine (Drug)
结局指标
主要结局
Number of Participants With Objective Radiographic Response
时间窗: up to 5 years
Assess objective anti-tumor response based on iRANO criteria.
Duration of Objective Radiographic Response
时间窗: up to 5 years
Assess time of confirmed response to confirmed disease progression or death
次要结局
- Median Overall Survival(up to 5 years)
- Landmark Survival(at 24 and 36 months post-lerapolturev infusion)
- Disease Control Rate(up to 5 years)
- Safety of Lerapolturev(up to 52 weeks)