A Phase 2 Study of Pembrolizumab, a Monoclonal Antibody Against PD-1, in Combination With Capecitabine and Oxaliplatin (CAPOX) in Subjects With Advanced Biliary Tract Carcinoma (BTC)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
Background:
Biliary tract cancers are rare but they are serious. Researchers want to see if a certain drug helps the immune system fight cancer cells. The drug is called pembrolizumab. It may work even better with two chemotherapy drugs that are widely used to treat gastrointestinal cancers.
Objective:
To study if pembrolizumab given with capecitabine and oxaliplatin (CAPOX) increases the time it takes for a person's biliary tract cancer to get worse.
Eligibility:
People age 18 and older with previously treated biliary tract cancer that has spread to other parts of the body
Design:
Participants will be screened with tests as part of their regular cancer care.
Each study cycle is 3 weeks.
For 6 cycles, participants will:
Get pembrolizumab and oxaliplatin on day 1 of each cycle. They will be given in an intravenous (IV) catheter.
Take capecitabine by mouth for 2 weeks then have 1 week without it.
Participants will complete a patient diary.
Starting with cycle 7, participants will get only pembrolizumab. They will get it once every 3 weeks.
On day 1 of every cycle, participants will have:
Physical exam
Review of symptoms and how well they do normal activities
Blood tests
Every 9 weeks, they will have a scan.
Participants may have tumor samples taken.
Participants will have a final visit about 1 month after they stop the study drug. After that, they will be contacted by phone or email yearly.
详细描述
Background:
- The most compelling argument in favor of testing immune-based strategies (and anti-Programmed cell death protein 1 (PD1) therapy in particular) in biliary tract cancers (BTC) is that chronic inflammation appears to be the most common etiologic factor in the development of biliary tract cancer.
- Single-agent activity has been shown for PD1-directed therapy in BTC. Given the potential for oxaliplatin-induced immunogenic cell death we would like to evaluate the combination of capecitabine and oxaliplatin (CAPOX) chemotherapy with pembrolizumab.
Objective:
To determine the 5-month progression free survival (PFS) of Pembrolizumab in combination with CAPOX in patients with advanced biliary tract carcinoma.
Eligibility:
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
1/Arm 1
Pembrolizumab plus Oxaliplatin plus Capecitabine
干预措施: Pembrolizumab (MK-3475) (Biological)
1/Arm 1
Pembrolizumab plus Oxaliplatin plus Capecitabine
干预措施: Capecitabine (Drug)
1/Arm 1
Pembrolizumab plus Oxaliplatin plus Capecitabine
干预措施: Oxaliplatin (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: 5 Months
Median amount of time subject survives without disease progression for 5 months after treatment. Disease progression was assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and is defined as at least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). The appearance of one or more new lesions is also considered progressions.
次要结局
- Number of Participants Obtaining a Complete Response (CR) and Partial Response (PR)(Every 9 Weeks, until disease progression or patient is taken off the trial, whichever comes first, approximately 36 weeks.)
- Number Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, Probably and Definitely Related to Pembrolizumab(30 Days After Enrollment)
- Number Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, Probably and Definitely Related to Oxaliplatin(30 Days After Enrollment)
- Overall Survival(Death, approximately 48 weeks after stopping therapy.)
- Number of Participants With Grade 1-4 Adverse Events Unrelated, Unlikely, Possibly, and Probably Related to Capecitabine(30 Days After Enrollment)
研究者
Tim Greten, M.D.
National Cancer Institute
National Cancer Institute (NCI)