2025-524160-38-00招募中3 期
A Multicenter, Open-label, Phase 3 Extension Study to Evaluate the Long‑term Efficacy and Safety in Participants Who Are Currently on Treatment in a Belzutifan Study (LITESPARK-043)
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 20
- 主要终点
- Overall survival (OS)
研究概览
简要总结
To assess OS in Cohort A and Cohort B
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participants with advanced solid tumors or von Hippel-Lindau-related neoplasms who are participating in belzutifan-containing studies and on active treatment in a belzutifan parent study
排除标准
- •Has an on-going serious adverse event in the parent study, unless no longer hospitalized and considered clinically stable
- •Is currently on a dose interruption due to an Adverse Event (AE) in the parent study; once treatment has been resumed in the parent study, the participant is eligible to enroll
研究组 & 干预措施
Lenvatinib, Lenvatinib
Test
干预措施: Lenvatinib (Drug)
Belzutifan
Test
干预措施: Belzutifan (Drug)
结局指标
主要结局
Overall survival (OS)
Overall survival (OS)
次要结局
- Number of Participants Who Experience One or More Adverse Events (AEs)
- Number of Participants Who Discontinue Study Treatment Due to AEs
研究者
Karla Rodriguez-Lopez
Scientific
Merck Sharp & Dohme LLC
研究点 (20)
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