2026-526036-38-00招募中2 期
Giving Upfront Anti-p40 to Reduce toxicity from Dual Immune Checkpoint Inhibition in MESOthelioma
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2026年8月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- The primary endpoint of the study is the incidence of severe (grade ≥3) irAEs occurring within 24 weeks after initiation of dual ICB, graded according to CTCAE version 5.0
研究概览
简要总结
To evaluate whether co-administration of an anti-p40 antibody reduces the incidence of severe (grade ≥3) irAEs in patients receiving dual ICB with anti–PD-1 and anti–CTLA-4 antibodies.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of pathologically confirmed irresectable pleural mesothelioma (confirmed by histology or cytology)
- •Age 18 years or older
- •ECOG performance status of 0 or 1, or a Karnofsky Performance Scale of 70 or higher
- •Eligible for dual ICB treatment
排除标准
- •Current use of immunomodulatory drugs within 14 days prior to initiation of ICB
- •Known hypersensitivity to ustekinumab
- •Active (mycobacterial) infection
- •Chronic, recurring infections
结局指标
主要结局
The primary endpoint of the study is the incidence of severe (grade ≥3) irAEs occurring within 24 weeks after initiation of dual ICB, graded according to CTCAE version 5.0
The primary endpoint of the study is the incidence of severe (grade ≥3) irAEs occurring within 24 weeks after initiation of dual ICB, graded according to CTCAE version 5.0
次要结局
- The incidence of grade ≥2 irAEs within 24 weeks after initiation of dual ICB therapy, graded according to CTCAE version 5.0.
- Time from initiation of dual ICB to first occurrence of grade ≥3 irAE.
- Objective response rate on chest CT scan assessed by mRECIST v1.1.
- Duration of response from initiation of dual ICB until progression or death whichever occurs first.
- Median progression free survival (PFS) from initiation of dual ICB until progression or death whichever occurs first
- The incidence of severe (grade ≥3) irAEs from 24 and 48 weeks after initiation of dual ICB therapy, graded according to CTCAE version 5.
- T-cell population dynamics after initiation of dual ICB
- Serum proteome level dynamics after initiation of dual ICB
- cfDNA level dynamics after initiation of dual ICB and at time of irAE occurrence
研究者
Maria Cinta Iriondo Martinez
Scientific
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)
研究点 (1)
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