A Randomized, Open-Label, Multicenter Phase 3 Trial of Domvanalimab, Zimberelimab, and Chemotherapy Versus Nivolumab and Chemotherapy in Participants with Previously Untreated Locally Advanced Unresectable or Metastatic Gastric, Gastroesophageal Junction, and Esophageal Adenocarcinoma (STAR-221)

Taiho Pharmaceutical Co., Ltd.0 个研究点目标入组 970 人开始时间: 2023年6月20日最近更新: 2024年8月20日

试验速览

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•Age >= 18 years at the time of signing the informed consent.
•Capable of giving signed informed consent which is in compliance with the requirements and restrictions listed in the informed consent form (ICF) and in protocol.
•Histologically confirmed diagnosis of locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.
•Eastern Cooperative Oncology Group (ECOG) Performance Score of 0-
•At least one measurable target lesion per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.

•Underlying medical or psychiatric conditions that, in the investigator's or sponsor's opinion, will make the administration of study-specified therapy hazardous, including but not limited to:
•Interstitial lung disease, including history of interstitial lung disease or non-infectious pneumonitis. Active viral, bacterial, or fungal infections requiring parenteral treatment within 14 days of randomization.
•Clinically significant cardiovascular disease, such as New York Heart Association Class II or greater cardiac disease or cerebrovascular accident within 3 months prior to randomization, unstable angina, or new onset angina within 3 months prior to randomization, myocardial infarction within 6 months prior to randomization, or unstable arrhythmia within 3 months prior to randomization.
•History of prior solid-organ transplantation, including allogenic bone marrow transplantation.
•Dementia, psychiatric, or substance abuse disorders that would interfere with satisfying the requirements of the trial.
•Known human epidermal growth factor receptor 2 (HER-2) positive tumor.
•Known untreated, symptomatic, or actively progressing central nervous system (CNS) (brain) metastases. Participants with leptomeningeal metastases are excluded from enrollment.
•Received prior systemic treatment for locally advanced unresectable or metastatic gastric, GEJ, or esophageal adenocarcinoma.
•Disease progression within 6 months of neoadjuvant or adjuvant chemotherapy.

Overall survival [ Time Frame: From randomization until death from any cause ]

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