A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ATEZOLIZUMAB WITH OR WITHOUT TIRAGOLUMAB (ANTI-TIGIT ANTIBODY) IN PATIENTS WITH UNRESECTABLE ESOPHAGEAL SQUAMOUS CELL CARCINOMA WHOSE CANCERS HAVE NOT PROGRESSED FOLLOWING DEFINITIVE CONCURRENT CHEMORADIOTHERAPY

Clinical trials information0 个研究点目标入组 750 人开始时间: 2020年10月20日最近更新: 2023年10月17日

适应症

试验速览

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•Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
•- Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the esophagus
•- Unresectable disease ineligible for curative surgery based on the documented opinion of the qualified medical, surgical or radiation oncologist and is not expected to undergo tumor resection during the course of the study
•- Definitive concurrent chemoradiation treatment according to regional oncology guidelines for esophageal cancer
•- Representative archival formalin-fixed, paraffin-embedded (FFPE) tumor specimens, collected prior to initiation of definitive concurrent chemoradiotherapy
•- Adequate hematologic and end-organ function

•- Prior treatment with CD137 agonists or immune checkpoint blockade therapies, including anti-CTLA-4, anti-PD-1, anti-PD-L1 and anti-TIGIT therapeutic antibodies
•- Any unresolved toxicity of National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Grade >_ 2 from the prior chemoradiation therapy with the exception of irreversible and manageable hearing loss
•- Prior allogeneic stem cell or solid organ transplantation
•- Active or history of autoimmune disease or immune deficiency
•- History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis
•- Malignancies other than esophageal cancer within 2 years prior to screening, with the exception of malignancies with a negligible risk of metastasis or death
•- Treatment with any other investigational agent, including epidermal growth factor receptor (EGFR) inhibitors, with therapeutic intent for esophageal cancer prior to randomization

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