EUCTR2022-002222-27-PL招募中1 期
A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants with Previously-Untreated Loally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 970
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •Participants with histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
- •At least one measurable target lesion per RECIST v1.1.
- •Adequate organ and marrow function
- •Able to provide an archival tumor sample that is representative of the cancer under investigation and suitable for central PD-L1 testing
- •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 436
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 534
排除标准
- •Underlying medical or psychiatric conditions that, in the investigator’s or sponsor’s opinion, will make the administration of study-specified therapy hazardous
- •Known HER-2-positive tumor.
- •Known untreated, symptomatic, or actively progressing central nervous system (CNS) (brain) metastases.
- •Received prior systemic treatment for locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.
- •Use of any live vaccines within 28 days prior to randomization.
研究者
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