A Randomized, Open-label, Phase II Clinical Trial of Relatlimab (Anti-LAG-3) and Nivolumab in Combination With Chemotherapy Versus Nivolumab in Combination With Chemotherapy as First-Line Treatment in Patients With Gastric or Gastroesophageal Junction Adenocarcinoma
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 274
- 试验地点
- 79
- 主要终点
- BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of investigational drug relatlimab plus nivolumab in combination with chemotherapy in participants with unresectable, untreated, locally advanced or metastatic gastric or GEJ 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
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- •Histologically- or cytologically-confirmed diagnosis of unresectable and either locally advanced, or metastatic gastric cancer or GEJ adenocarcinoma
- •No prior treatment with systemic treatment (including HER 2 inhibitors) given as primary therapy for unresectable and either locally advanced, or metastatic GC or GEJ adenocarcinoma
- •Tumor tissue must be provided for biomarker analyses
排除标准
- •Participants with HER2 positive status
- •Participants with known untreated central nervous system (CNS) metastases
- •Uncontrolled or significant cardiovascular disease
- •Other protocol defined inclusion/exclusion criteria could apply
研究组 & 干预措施
BMS-986213 + investigator's choice chemotherapy
BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX
干预措施: BMS-986213 (Biological)
BMS-986213 + investigator's choice chemotherapy
BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX
干预措施: Nivolumab (Biological)
BMS-986213 + investigator's choice chemotherapy
BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX
干预措施: XELOX (Drug)
BMS-986213 + investigator's choice chemotherapy
BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX
干预措施: FOLFOX (Drug)
BMS-986213 + investigator's choice chemotherapy
BMS-986213 + XELOX or BMS-986213 + FOLFOX or BMS-986213 + SOX
干预措施: SOX (Drug)
Nivolumab + investigator's choice chemotherapy
Nivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX
干预措施: Nivolumab (Biological)
Nivolumab + investigator's choice chemotherapy
Nivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX
干预措施: XELOX (Drug)
Nivolumab + investigator's choice chemotherapy
Nivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX
干预措施: FOLFOX (Drug)
Nivolumab + investigator's choice chemotherapy
Nivolumab + XELOX or Nivolumab + FOLFOX or Nivolumab + SOX
干预措施: SOX (Drug)
结局指标
主要结局
BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants
时间窗: Up to 25 months
The number of LAG-3 Positive (\>=1%) participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized LAG-3 positive (\>=1%) participants in each arm; recorded between randomization date and the date of objectively documented progression \[per RECISIT 1.1\], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first. CR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions
BICR-Assessed Objective Response Rate (ORR) in Randomized LAG-3 Positive (>=1 %) Participants - Extended Collection
时间窗: From randomization date to the date of objectively documented progression, death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months)
The number of LAG-3 Positive (\>=1%) participants with a Best Overall Response (BOR) of confirmed Complete Response (CR) or Partial Response (PR) divided by the number of randomized LAG-3 positive (\>=1%) participants in each arm; recorded between randomization date and the date of objectively documented progression \[per RECISIT 1.1\], death due to any cause, or date of subsequent anticancer therapy, whichever occurs first. CR= Disappearance of all target lesions PR= At least a 30% decrease in the sum of diameters of target lesions Progression=At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm.
次要结局
- Objective Response Rate (ORR)(From randomization date to the date of objectively documented progression, death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months))
- Duration of Response (DOR)(From the date of first dose to the date of the first disease progression or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months))
- Overall Survival (OS)(From the date of randomization to the date of death due to any cause (Up to 63 months))
- Progression-Free Survival (PFS)(From the date of randomization to the first date of documented progression, or death due to any cause, or date of subsequent anticancer therapy, whichever occurs first (Up to 63 months))
- Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)(From first dose to 30 days post last dose (Up to 60 months))
- Number of Participants Who Died(Up to 60 months)
- Number of Participants With Laboratory Abnormalities in Specific Liver Tests(From first dose to 30 days post last dose (Up to 60 months))
- Number of Participants With Laboratory Abnormalities in Specific Thyroid Tests(From first dose to 30 days post last dose (Up to 60 months))