A Randomized, Multicenter, Open-Label, Phase 3 Study of Nivolumab Plus Ipilimumab or Nivolumab in Combination With Oxaliplatin Plus Fluoropyrimidine Versus Oxaliplatin Plus Fluoropyrimidine in Subjects With Previously Untreated Advanced or Metastatic Gastric or Gastroesophageal Junction Cancer
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,031
- 试验地点
- 179
- 主要终点
- Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5
研究概览
简要总结
The main purpose of this study is to compare how long patients with gastric or gastroesophageal junction cancer live after receiving nivolumab and ipilimumab or nivolumab and chemotherapy compared with patients receiving chemotherapy alone.
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
- •Male or Female at least 18 years of age
- •Must have gastric cancer or gastroesophageal junction cancer that cannot be operated on and that is advanced or has spread out
- •Did not receive neoadjuvant or adjuvant treatment (chemotherapy, radiotherapy, or both) for their disease within the last 6 months
- •Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
- •Must agree to provide tumor tissue sample, either from a previous surgery or biopsy within 6 months or fresh, prior to the start of treatment in this study
排除标准
- •Presence of tumor cells in the brain or spinal cord that have not been treated
- •Active known or suspected autoimmune disease
- •Any serious or uncontrolled medical disorder or active infection
- •Known history of positive test for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
- •Any positive test result for hepatitis B or C indicating acute or chronic infection
- •Other protocol-defined inclusion/exclusion criteria apply
研究组 & 干预措施
Nivolumab + Ipilimumab
Nivolumab + Ipilimumab for 4 doses, followed by Nivolumab monotherapy
Enrollment is closed for this arm
干预措施: Nivolumab (Drug)
Nivolumab + Ipilimumab
Nivolumab + Ipilimumab for 4 doses, followed by Nivolumab monotherapy
Enrollment is closed for this arm
干预措施: Ipilimumab (Drug)
XELOX (Oxaliplatin + Capecitabine)
干预措施: Oxaliplatin (Drug)
XELOX (Oxaliplatin + Capecitabine)
干预措施: Capecitabine (Drug)
FOLFOX (Oxaliplatin + Leucovorin + Fluorouracil)
干预措施: Oxaliplatin (Drug)
FOLFOX (Oxaliplatin + Leucovorin + Fluorouracil)
干预措施: Leucovorin (Drug)
FOLFOX (Oxaliplatin + Leucovorin + Fluorouracil)
干预措施: Fluorouracil (Drug)
Nivolumab + XELOX
干预措施: Nivolumab (Drug)
Nivolumab + FOLFOX
干预措施: Nivolumab (Drug)
Nivolumab + XELOX
干预措施: Oxaliplatin (Drug)
Nivolumab + XELOX
干预措施: Capecitabine (Drug)
Nivolumab + FOLFOX
干预措施: Oxaliplatin (Drug)
Nivolumab + FOLFOX
干预措施: Leucovorin (Drug)
Nivolumab + FOLFOX
干预措施: Fluorouracil (Drug)
结局指标
主要结局
Overall Survival (OS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5
时间窗: From the date of randomization up to the date of death, up to approximately 17 months
Overall survival (OS), defined as the time from randomization to the time of death, in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy with PD-L1 CPS (combined positive score) ≥ 5. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
Progression Free Survival (PFS) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy With PD-L1 CPS ≥ 5
时间窗: From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 10 months)
Progression Free Survival (PFS) is defined as the time from randomization to the date of the first documented PD or death due to any cause. PD is determined by blinded independent committee review (BICR) per RECIST1.1 criteria in participants treated with Nivolumab plus Chemotherapy vs Chemotherapy with PD-L1 CPS ≥ 5. Progressive disease (PD) is defined as at least a 20% increase in the sum of diameters of target lesions, taking in reference the smallest sum on study that also demonstrated an absolute increase of at least 5 mm. CPS is defined as the number of PD-L1 staining cells (tumor cells, lymphocytes, macrophages) divided by the total number of viable tumor cells, multiplied by 100.
次要结局
- OS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy(From the date of randomization up to the date of death, up to approximately 17 months)
- PFS in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy(From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 10 months))
- Objective Response Rate in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy(From randomization to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 43 months))
- Time to Symptom Deterioration (TTSD) in Participants Treated With Nivolumab Plus Chemotherapy vs Chemotherapy(From randomization until a clinically meaningful decline from baseline in GaCS score (approximately 10 months))
- OS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy(From the date of randomization up to the date of death, up to approximately 14 months)
- PFS in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy(From randomization to the date of the first documented progressive disease (PD) per BICR or death due to any cause (up to approximately 9 months))
- Objective Response Rate in Participants Treated With Nivolumab Plus Ipilimumab vs Chemotherapy(From randomization to the date of objectively documented progression or the date of subsequent anti-cancer therapy, whichever occurs first (up to approximately 43 months))