NCT05144854进行中（未招募）3 期
A Randomized, Multicenter, Open-label, Phase III Study to Compare the Efficacy and Safety of ONO-4538 in Combination With Ipilimumab, Fluoropyrimidine-based and Platinum-based Chemotherapy (Hereinafter Referred to as "Chemotherapy") Versus Chemotherapy in Chemotherapy-naïve Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Negative Unresectable Advanced or Recurrent Gastric Cancer (Including Esophagogastric Junction Cancer)
Ono Pharmaceutical Co., Ltd.91 个研究点 分布在 3 个国家目标入组 626 人开始时间: 2021年11月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 626
- 试验地点
- 91
- 主要终点
- Overall survival (OS)
研究概览
简要总结
This study is to compare and evaluate the efficacy and safety of ONO-4538 in combination with ipilimumab and chemotherapy versus chemotherapy in chemotherapy-naïve participants with HER2-negative unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer).
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Participants with unresectable advanced or recurrent gastric cancer (including esophagogastric junction cancer) that has been histologically confirmed to be predominant adenocarcinoma
- •Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score 0 or 1
- •Participants who have a life expectancy of at least 3 months
排除标准
- •Participants with a history or complications of multiple cancers
- •Participants with a complication or history of severe hypersensitivity to any other antibody products
- •Participants with concurrent autoimmune disease or a history of chronic or recurrent autoimmune disease.
研究组 & 干预措施
ONO-4538 + ipilimumab + chemotherapy
Experimental
干预措施: ONO-4538 (Drug)
ONO-4538 + ipilimumab + chemotherapy
Experimental
干预措施: Oxaliplatin (Drug)
ONO-4538 + ipilimumab + chemotherapy
Experimental
干预措施: S-1 (Drug)
Chemotherapy
Active Comparator
干预措施: Oxaliplatin (Drug)
Chemotherapy
Active Comparator
干预措施: Capecitabine (Drug)
ONO-4538 + ipilimumab + chemotherapy
Experimental
干预措施: Ipilimumab (Drug)
ONO-4538 + ipilimumab + chemotherapy
Experimental
干预措施: Capecitabine (Drug)
Chemotherapy
Active Comparator
干预措施: S-1 (Drug)
结局指标
主要结局
Overall survival (OS)
时间窗: up to 3 years
(N/A)
次要结局
- Objective response rate (ORR) (site investigator assessment)(up to 3 years)
- Best overall response (BOR) (site investigator assessment)(up to 3 years)
- Progression-free survival (PFS) (site investigator assessment)(up to 3 years)
- Duration of response (DOR) (site investigator assessment)(up to 3 years)
- Disease control rate (DCR) (site investigator assessment)(up to 3 years)
- Time to response (TTR) (site investigator assessment)(up to 3 years)
- Maximum percent change in the sum diameters of the target lesions (site investigator assessment)(up to 3 years)
- Progression-free survival after the next line of therapy (PFS2) (site investigator assessment)(up to 3 years)
- Adverse event(Up to 30 days after the last dose)
研究者
研究点 (91)
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