A Multicenter, Phase 1/2 Study of Ramucirumab Plus Nivolumab as Second-line Therapy in Participants With Gastric or GEJ Cancer
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Number of participants with dose limiting toxicities (DLTs)
研究概览
简要总结
The main purpose of this study is to evaluate the safety and efficacy of the combination therapy of ramucirumab and nivolumab in participants with advanced or recurrent unresectable gastric or GEJ cancer.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Advanced or recurrent unresectable gastric or GEJ cancer
- •Histologically confirmed adenocarcinoma (papillary adenocarcinoma, tubular adenocarcinoma or poorly differentiated adenocarcinoma), signet-ring cell carcinoma, mucinous adenocarcinoma or hepatoid adnocarcinoma
- •Patients with normal oral intake
- •Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- •Patients who have measurable target lesion
- •Patients has a refractory or intolerant pretreatment by pyrimidine fluoride anticancer agent and platinum-based anticancer agent
- •Patients with adequate organ function
- •Patients with no pretreatment history including ramucirumab, nivolumab or other therapies targeting control of T cells
- •Patients with written informed consent
排除标准
- •Patients have double cancer
- •Patients have infection required systemic therapy
- •Known central vervous system (CNS) metastasis
- •Patients with history of pneumonitis or pulmonary fibrosis
- •Patients with history of serious anaphylaxis induced by antibody preparation
- •Patients who have known active autoimmune disease or history of chronic recurrent autoimmune disease
- •Female who is pregnant, lactating or suspected pregnancy
- •Patients with psychosis or dementia to interfere to obtain informed consent appropriately
研究组 & 干预措施
Phase 1
Ramucirumab: 8 mg/kg, every two week Nivolumab: 3.0 mg/kg or 1.0 mg/kg (optional), every two weeks
干预措施: Nivolumab (Biological)
Phase 2
Ramucirumab: 8 mg/kg, every two week Nivolumab: recommended dose established in the phase 1, every two weeks
干预措施: Ramucirumab (Biological)
Phase 1
Ramucirumab: 8 mg/kg, every two week Nivolumab: 3.0 mg/kg or 1.0 mg/kg (optional), every two weeks
干预措施: Ramucirumab (Biological)
Phase 2
Ramucirumab: 8 mg/kg, every two week Nivolumab: recommended dose established in the phase 1, every two weeks
干预措施: Nivolumab (Biological)
结局指标
主要结局
Number of participants with dose limiting toxicities (DLTs)
时间窗: Phase 1, course 1 (up to 28 days)
Number of participants with dose limiting toxicities (DLTs)
Progression free survival rate after 6 months
时间窗: from baseline to 6 months
Progression free survival rate after 6 months
次要结局
- Objective response rate (ORR)(from baseline to date of disease progression, approximately 24 months)
- Number of participants with adverse events(from baseline to date of treatment cessation, approximately 24 months)
- Overall survival (OS)(from baseline to date of death, approximately 24 months)
- Progression free survival (PFS)(from baseline to date of disease progression or death, approximately 24 months)
- Disease control rate (DCR)(from baseline to date of disease progression, approximately 24 months)
研究者
Ken Kato
Head Physician
National Cancer Center, Japan