A Phase I Open Label Study to Assess Safety, Feasibility, Efficacy, and Biological Activity of Single Administration of Neoadjuvant Treatments Ezabenlimab in Combination With BI 765063 and Pembrolizumab in Combination With BI 765063 in Patients With Newly Diagnosed Surgically-resectable, Locoregional Colorectal Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Composite Endpoint: Proportion of Patients With at Least One Occurrence of a Safety or Feasibility Event
研究概览
简要总结
This study is open to people with newly diagnosed colorectal cancer. People who are scheduled for surgery can participate. People either get a medicine called BI 765063 combined with ezabenlimab or combined with pembrolizumab in preparation of the upcoming surgery. The tested medicines in this study are antibodies that may help the immune system fight cancer.
The purpose of this study is to find out how well people with early colorectal cancer can tolerate treatment with these medicines. The study also looks at whether the tumor changes.
Participants are put into 2 groups. One group gets ezabenlimab and BI 765063. The other group gets pembrolizumab and BI 765063. All participants receive the study medicines as 2 subsequent infusions into a vein on a single day.
Participants are in the study for about 4 months. During this time, they visit the study site about 5 times. The doctors check the health of the participants and note any health problems that could have been caused by ezabenlimab, pembrolizumab, or BI 765063. The doctors also check whether these health problems lead to a delay of the planned surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
Cohort A: Ezabenlimab + BI 765063
干预措施: Ezabenlimab (Drug)
Cohort A: Ezabenlimab + BI 765063
干预措施: BI 765063 (Drug)
Cohort B: Pembrolizumab + BI 765063
干预措施: BI 765063 (Drug)
Cohort B: Pembrolizumab + BI 765063
干预措施: Pembrolizumab (Drug)
结局指标
主要结局
Composite Endpoint: Proportion of Patients With at Least One Occurrence of a Safety or Feasibility Event
时间窗: Up to 91 days after drug administration.
Safety: A safety event was defined as any grade 3 or higher adverse events (AEs; according to National Cancer Institute's Common Terminology Criteria for Adverse Events \[CTCAE\] version 5.0) related to study treatments at any point within the follow-up period following the administration of study treatments. Feasibility (delay in surgery): A feasibility event or delay in surgery was defined as any treatment related AE leading to delay in surgery, which was scheduled to take place between 2 weeks and up to 6 weeks following the study treatment administration will be considered as a relevant AE for this endpoint.
次要结局
- Pathologic Response (PR)(Up to 91 days after drug administration.)
- Time From Administration of Trial Treatment to Surgery(Up to 91 days after drug administration.)
- Radiographic Response Rate(Up to 91 days after drug administration.)