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临床试验/EUCTR2017-004896-30-GR
EUCTR2017-004896-30-GR进行中(未招募)1 期

A Randomized, Active-Controlled, Blinded, Phase III Clinical Trial of BMS- 986213 (Fixed Dose Combination of Relatlimab [anti-LAG-3] and Nivolumab) in Combination with Chemotherapy versus Placebo in Combination with Chemotherapy as First-Line Treatment in Participants with Unresectable, Locally Advanced or Metastatic LAG-3 Positive Gastric or Gastroesophageal Junction Adenocarcinoma

Bristol-Myers Squibb International Corporation0 个研究点目标入组 2,420 人开始时间: 2018年7月4日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
2,420

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • - Participants must have histologically- or cytologically-confirmed diagnosis of unresectable, locally advanced, or metastatic gastric or GEJ adenocarcinoma
  • - Available tumor tissue for biomarker analysis; participants must have LAG-3 positive expression
  • - Participants must have at least one measurable lesion or evaluable disease by CT or MRI per RECIST 1.1 criteria
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 1694
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 726

排除标准

  • - Participants known HER2 positive status
  • - Participants with untreated known CNS metastases
  • - Participants with ascites which cannot be controlled with appropriate interventions

研究者

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