A Randomized, Multicenter, Double Blind, Phase III Study of Adjuvant Nivolumab or Placebo in Subjects With Resected Esophageal, or Gastroesophageal Junction Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 794
- 试验地点
- 204
- 主要终点
- Disease-free Survival (DFS)
研究概览
简要总结
The primary purpose of this study is to determine whether Nivolumab will improve disease-free survival compared with placebo.
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
- Double (Participant, Investigator)
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
- •Diagnosed with Stage II/III carcinoma of the esophagus or gastroesophageal junction
- •Completed pre-operative chemo radiotherapy followed by surgery
- •Diagnosed with residual pathologic disease after being surgically rendered free of disease with negative margins following complete resection
排除标准
- •Diagnosed with cervical esophageal carcinoma
- •Diagnosed with Stage IV resectable disease
- •Did not receive concurrent chemoradiotherapy prior to surgery
- •Participants who have received a live/attenuated vaccine within 30 days of the first treatment
- •Other protocol defined Inclusion/exclusion criteria could apply
研究组 & 干预措施
Nivolumab
干预措施: Nivolumab (Drug)
Placebo
干预措施: Placebo (Other)
结局指标
主要结局
Disease-free Survival (DFS)
时间窗: From randomization to the date of recurrence or death (up to approximately 46 months)
Disease-free survival is defined as the time between randomization date and first date of recurrence or death, whichever occurs first. Recurrence is defined as the appearance of one or more new lesions, which can be local, regional, or distant in location from the primary resected site ( assessed by imaging or pathology). All deaths without prior recurrence are considered as DFS events. For participants who remained alive and without recurrence, DFS was censured on the date of last evaluable disease assessment
次要结局
- Overall Survival (OS)(From randomization to the date of death (up to approximately 60 months))
- Overall Survival Rates at 12-, 24-, and 36-months(At 12-, 24- and 36-months post first dose.)