Phase II Multi-Center Study of PARP Inhibitor Rucaparib in Combination With Anti-PD-1 Antibody Nivolumab in Patients With Advanced or Metastatic Biliary Tract Cancer Following Platinum Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 3
- 主要终点
- Proportion of Patients Alive and Without Radiological or Clinical Progression at 4 Months
研究概览
简要总结
Investigators hypothesize that following first-line platinum based chemotherapy, rucaparib in combination with nivolumab, will improve progression-free survival and overall survival in BTC patients.
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
Rucaparib and Nivolumab
Rucaparib 600 mg PO BID days 1-28 Nivolumab 240 mg IV days 1 and 15
干预措施: Rucaparib (Drug)
Rucaparib and Nivolumab
Rucaparib 600 mg PO BID days 1-28 Nivolumab 240 mg IV days 1 and 15
干预措施: Nivolumab (Drug)
结局指标
主要结局
Proportion of Patients Alive and Without Radiological or Clinical Progression at 4 Months
时间窗: 4 months
Progressive disease is defined as at least a 20% increase in the sum of the longest diameter (LD) of target lesions (with a minimum absolute increase of 5 mm), taking as reference the smallest sum LD recorded since the treatment started, or the appearance of one or more new lesions. A clinical decision of progression by the site investigator will be based on the subject's overall clinical condition, including performance status, clinical symptoms, and laboratory data.
次要结局
- The Proportion of Patients That Respond to Treatment(up 2 years after starting treatment, average of 4 months)
- Progression Free Survival (PFS) Time as Measured From Treatment Start(Up to 2 years)
- Progression Free Survival (PFS) Time as Measured From Start of 1st Line Platinum Therapy(Up to two years post treatment discontinuation)
- Overall Survival (OS) Time as Measured From Treatment Start(Up to two years post treatment discontinuation)
- Overall Survival (OS) Time as Measured From Start of 1st Line Platinum Therapy(Up to two years post treatment discontinuation)