A Multicenter Study to Explore the Mechanism of Acquired Immune Escape In Patients With Metastatic Cancer Progressing on Checkpoint Inhibitor Therapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 11
- 主要终点
- Number of Gene Alterations in at-Progression Biopsy of Patricipants with Acquired Immune Escape
研究概览
简要总结
The purpose of this study is to identify mechanisms associated with acquired immune escape by comparing baseline and at-progression tissue samples from participants who derive clinical benefit from CPI treatment of metastatic cancer or hematologic malignancies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •Response assessment of complete response (CR), partial response (PR), or long-term stable disease (SD) for >6 months with a cancer immunotherapy treatment for metastatic cancer or hematologic malignancies either through a marketed CPI or through participation in a Roche/Genentech CPI clinical trial.
- •Availability of tissue sample.
排除标准
- •Pregnant, lactating, or intending to become pregnant during the study.
- •Participants receiving CPI treatment as part of a non-Roche/Genentech clinical trial.
研究组 & 干预措施
Checkpoint Inhibitor Therapy
Pre-treatment (archival) and at progression biopsy for participants with a demonstrated clinical benefit on CPI therapy will be asked to participate in the study. In addition, retrospective enrollment of patients who progressed on CPI therapy after documented response and for whom an at-progression biopsy is available, is also possible.
干预措施: Biopsy (Procedure)
结局指标
主要结局
Number of Gene Alterations in at-Progression Biopsy of Patricipants with Acquired Immune Escape
时间窗: Day 1
Number of Gene Alterations Will Be Evaluated Using NGS Approaches by Comparing At-Progression Biopsy with Pre-Treatment Biopsy
次要结局
未报告次要终点