A Randomized, Open-label, Two-arm Phase II Trial Comparing the Efficacy of Sequential Ipilimumab Versus Best Supportive Care Following First-line Chemotherapy in Subjects With Unresectable Locally Advanced/Metastatic Gastric or Gastro-esophageal Junction Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 143
- 试验地点
- 36
- 主要终点
- Immune-related Progression Free Survival (irPFS) as Per Assessment of a Blinded Independent Review Committee (IRC) According to Immune Related Response Criteria (irRC) Guidelines
研究概览
简要总结
The purpose of the study is to compare the efficacy of Ipilimumab and standard of care as sequential or maintenance treatment immediately after first-line chemotherapy in the treatment of unresectable or metastatic gastric and gastro-esophageal 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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com.
- •Key Inclusion Criteria:
- •Histologically confirmed, unresectable locally advanced or metastatic adenocarcinoma of the gastric and gastro-esophageal junction
- •Received first-line chemotherapy using fluoropyrimidine and platinum combination without disease progression
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Measurable disease by modified WHO criteria (unless complete response from previous chemotherapy)
排除标准
- •Known Human Epidermal growth factor Receptor2 (HER2) positive status
- •Radiological evidence of brain metastases
- •History of severe autoimmune or immune mediated disease requiring prolonged immunosuppressive treatment
- •Inadequate hematologic, renal and hepatic function
研究组 & 干预措施
Arm B: Best Supportive care (BSC)
BSC may include the continuation of the Fluoropyrimidine that was used during the lead-in chemotherapy, but no other systemic anti cancer therapy
干预措施: Best Supportive care (BSC) (Other)
Arm A: Ipilimumab
Ipilimumab 10 mg/kg solution intravenously, 90 minute infusion, once every 3 weeks for 4 doses, then every 12 weeks until disease progression (for a maximum treatment period of 3 years from the first dose)
干预措施: Ipilimumab (Biological)
结局指标
主要结局
Immune-related Progression Free Survival (irPFS) as Per Assessment of a Blinded Independent Review Committee (IRC) According to Immune Related Response Criteria (irRC) Guidelines
时间窗: Randomization up to 91 irPFS events (Approximately 19 months )
irPFS is defined as the time between the randomization date and the time of disease progression per irRC or death, whichever occurs first. irRC criteria=Measurable new lesions: incorporated into the tumor burden (eg, added to the index lesions); do not define progression unless the total measurable tumor burden increases by the required amount (25%). New non-measurable lesions: not considered progression if the total measurable tumor burden is stable or shrinking. irPFS was measured in months.
次要结局
- Progression Free Survival (PFS) Per Modified World Health Organization (mWHO) Criteria(Randomization up to 91 irPFS events (Approximately 19 months ))
- Overall Survival (OS) at Primary Endpoint(Randomization up to 91 irPFS events (Approximately 19 months))
- Overall Survival (OS) at Study Completion(Randomization up to end of study, April 2015 (Approximately 28 months))
- Percentage of Participants With Immune-Related Best Overall Response (irBOR)(Randomization up to 91 irPFS events (Approximately 19 months))