NCT03704077撤回2 期
A Randomized, Active-Controlled, Open-Label, Phase 2 Clinical Trial of BMS-986213, in Combination With Various Standard-of-Care Therapeutic Regimens, in Participants With Recurrent, Locally Advanced, or Metastatic Gastric Cancer (GC) or Gastroesophageal Junction (GEJ) Adenocarcinoma
Bristol-Myers Squibb1 个研究点 分布在 1 个国家开始时间: 2019年10月31日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
The purpose of this study is to determine the effectiveness of relatlimab plus nivolumab, alone or in combination with various standard-of-care treatments in participants with gastric cancer (GC) or gastroesophageal junction (GEJ) adenocarcinoma that has come back or spread to other places in the body after prior therapy.
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
- •Histologically or cytologically confirmed locally advanced or recurrent or metastatic GC or GEJ adenocarcinoma that is considered incurable by local therapies such as radiation or surgery
- •Evidence of progressive disease (PD) on at least one prior platinum- and fluoropyrimidine-containing chemotherapy regimen
- •Available tumor tissue for biomarker analysis
排除标准
- •Must not have squamous cell or undifferentiated GC or GEJ
- •Untreated known 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
Cohort A: relatlimab + nivolumab + paclitaxel
Experimental
干预措施: Relatlimab + Nivolumab (Biological)
Cohort A: relatlimab + nivolumab + paclitaxel
Experimental
干预措施: Nivolumab (Biological)
Cohort A: relatlimab + nivolumab + paclitaxel
Experimental
干预措施: Paclitaxel (Drug)
Cohort A: nivolumab + paclitaxel
Experimental
干预措施: Nivolumab (Biological)
Cohort A: nivolumab + paclitaxel
Experimental
干预措施: Paclitaxel (Drug)
Cohort A: ramucirumab + paclitaxel
Active Comparator
Standard-of-care
干预措施: Paclitaxel (Drug)
Cohort A: ramucirumab + paclitaxel
Active Comparator
Standard-of-care
干预措施: Ramucirumab (Drug)
Cohort B: relatlimab + nivolumab
Experimental
干预措施: Relatlimab + Nivolumab (Biological)
Cohort B: relatlimab + nivolumab
Experimental
干预措施: Nivolumab (Biological)
Cohort B: nivolumab
Active Comparator
Standard-of-care
干预措施: Nivolumab (Biological)
Cohort C: relatlimab + nivolumab
Experimental
干预措施: Relatlimab + Nivolumab (Biological)
Cohort C: relatlimab + nivolumab
Experimental
干预措施: Nivolumab (Biological)
结局指标
主要结局
Overall response rate (ORR)
时间窗: Approximately 31 months
次要结局
- Incidence of AEs leading to discontinuation(Approximately 5 years)
- Incidence of laboratory abnormalities(Approximately 5 years)
- Progression free survival (PFS)(Approximately 5 years)
- ORR(Approximately 5 years)
- Duration of response (DOR)(Approximately 5 years)
- Overall survival (OS)(Approximately 5 years)
- Incidence of serious adverse events (SAEs)(Approximately 5 years)
- Incidence of adverse events (AEs)(Approximately 5 years)
- Incidence of deaths(Approximately 5 years)
研究者
研究点 (1)
Loading locations...
相似试验
终止
3 期
A Study of Nivolumab-relatlimab Fixed-dose Combination Versus Regorafenib or TAS-102 in Participants With Later-lines of Metastatic Colorectal CancerColorectal NeoplasmsNCT05328908Bristol-Myers Squibb769
进行中（未招募）
2 期
A Study of Relatlimab Plus Nivolumab Versus Nivolumab Alone in Participants With Advanced MelanomaMelanomaNCT03470922Bristol-Myers Squibb714
终止
2 期
Nivolumab Ipilimumab in Patients With hyperMutated Cancers Detected in Blood (NIMBLe)Advanced Solid TumorsNCT03461952Canadian Cancer Trials Group4
已完成
2 期
A Study of Relatlimab Plus Nivolumab in Combination With Chemotherapy vs. Nivolumab in Combination With Chemotherapy as First Line Treatment for Participants With Stage IV or Recurrent Non-small Cell Lung Cancer (NSCLC)Recurrent Non-small Cell Lung CancerMetastatic Non-small Cell Lung CancerNon-small Cell Lung CancerNCT04623775Bristol-Myers Squibb468
已完成
2 期
A Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Liver Cancer Who Have Never Been Treated With Immuno-oncology Therapy After Prior Treatment With Tyrosine Kinase InhibitorsHepatomaHepatocellular CarcinomaLiver Cancer, AdultLiver Cell CarcinomaLiver Cell Carcinoma, AdultNCT04567615Bristol-Myers Squibb266