A Phase 1b/2 Multicenter Study to Investigate the Safety, Efficacy and Proof of Concept (POC) of Nivolumab Monotherapy as a Sequential Therapy Following Preoperative Chemoradiotherapy Patients With Locally Advanced Resectable Rectal Cancer
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 90
- 试验地点
- 3
- 主要终点
- Pathological complete response
研究概览
简要总结
This is a phase Ib/II, open-label, single-arm, multicenter study to investigate the safety, efficacy, and proof of concept (POC) of monotherapy with nivolumab, an anti-PD-1 antibody drug, as a sequential therapy following chemoradiotherapy (CRT) with capecitabine and subsequent surgical therapy in patients with locally advanced resectable rectal cancer.
详细描述
[Phase Ib]
After preoperative CRT, to sequentially administer nivolumab in combination for patients with locally advanced resectable rectal cancer. To evaluate the safety of nivolumab in sequential combination therapy, the onset of dose-limiting toxicity (DLT) and the safety of subsequent surgical therapy, and to decide on a recommended dose (RD) for the phase II part.
[Phase II] PhaseⅡ is composed of 4 cohorts.
Cohort A: First-onset rectal cancer cohort (42 cases) To evaluate the efficacy and safety of nivolumab (at the RD determined in Phase Ib) in sequential combination with surgery, administered following preoperative CRT.
And to search for biomarkers related to therapeutic effects in first-onset cases. Evaluate the safety of surgical treatment.
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
- 20 Years 至 80 Years（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
Nivolumab & Ipilimumab(Only Cohort D)
chemoradiotherapy with capecitabine+ Nivolumab + Ipilimumab(Only Cohort D) + surgical therapy
干预措施: Nivolumab (Drug)
Nivolumab & Ipilimumab(Only Cohort D)
chemoradiotherapy with capecitabine+ Nivolumab + Ipilimumab(Only Cohort D) + surgical therapy
干预措施: Ipilimumab (Drug)
结局指标
主要结局
Pathological complete response
时间窗: 1 year
Pathological complete response will be evaluated with American Joint Committee on Cancer (AJCC) Cancer Staging
次要结局
- Rate of radical resection(1 year)
- Recurrence pattern (local or distant)(1 year)
- Disease-free survival (DFS)(5years)
- Overall survival (OS)(5years)
- Incidence of adverse events (AEs)(1 year)
- Objective response rate(1 year)
- Rate of completing the protocol therapy(1 year)
- Safety evaluation(5years)
- macroscopic evaluation of (rectal cancer) resected specimen(1 year)
研究者
Takayuki Yoshino
Director of Gastrointestinal Oncology Division
National Cancer Center Hospital East