Cabozantinib in Patients With Locally Advanced or Metastatic Urothelial Cell Carcinoma Who Have Progressed After Cisplatin-based Chemotherapy and Anti-PD-1/PD-L1 Therapy or After Anti-PD-1/PD-L1 Therapy Only.
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- Objective response rate after 6 months of cabozantinib treatment
研究概览
简要总结
In this Phase II study we investigate the benefit of cabozantinib treatment for patients with locally advanced or metastasized urothelial cell carcinoma who have been pre-treated with checkpoint inhibitors only (cohort 1) or who have been pre-treated with cisplatin-based chemotherapy and checkpoint inhibitors (cohort 2). We are lacking adequate response and outcome data in patients after immunotherapy and consider that this study will improve future treatment modalities for this important patient cohort.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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
Experimental (cohorts 1 and 2)
Cohort 1 will consist of patients who have been pre-treated with checkpoint inhibitors only (2nd line setting for cabozantinib). Cohort 2 will consist of patients who have been pre-treated with cisplatin-based chemotherapy and checkpoint inhibitors (3rd line setting for cabozantinib). Both cohorts receive the same treatment.
干预措施: Cabozantinib (Drug)
结局指标
主要结局
Objective response rate after 6 months of cabozantinib treatment
时间窗: 6 months
The response rate is defined as the percentage of subjects with a confirmed reduction in tumor size compared to baseline as well as fulfilling the criteria for complete or partial response according to RECIST 1.1. The response to treatment is measured by computer tomography (CT) every 12 weeks starting from the first day of cabozantinib treatment.
次要结局
- Progression-free survival (PFS)(Through study completion, up to approximately 2 years)
- Response duration(Through study completion, up to approximately 2 years)
- Overall survival(Through study completion, up to approximately 2 years)
- 1-year survival(1 year)
- Number of Participants Who Discontinue Study Treatment Due to Adverse Events (AEs)(Through study completion, up to approximately 2 years)
- Clinical benefit rate(Through study completion, up to approximately 2 years)
- Number of Participants with Adverse Events (AEs)(Through study completion, up to approximately 2 years)
研究者
Georg Bartsch
Assistant Medical Director of Department of Urology and Pediatric Urology
Johannes Gutenberg University Mainz