A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ATEZOLIZUMAB WITH OR WITHOUT TIRAGOLUMAB (ANTI-TIGIT ANTIBODY) IN PATIENTS WITH UNRESECTABLE LOCALLY ADVANCED ESOPHAGEAL SQUAMOUS CELL CARCINOMA.

F. Hoffmann-La Roche Ltd0 个研究点目标入组 750 人开始时间: 2020年9月14日最近更新: 2020年12月7日

适应症

试验速览

暂无简介。

•Age >=18 years
•Eastern Cooperative Oncology Group Performance Status of 0 or 1
•Histologically or cytologically confirmed diagnosis of squamous cell carcinoma of the esophagus
•Stage II-IVA per American Joint Committee on Cancer/Union for International Cancer Control, 8th edition, unresectable locally advanced disease
•Definitive concurrent chemoradiation treatment according to regional oncology guidelines for esophageal cancer
•Representative archival formalin-fixed, paraffin-embedded tumor specimens < 3 years old, collected prior to initiation of definitive chemoradiotherapy in paraffin blocks or >= 15 unstained slides containing freshly cut, serial sections
•Adequate hematologic and end-organ function
•For women of childbearing potential: agreement to remain abstinent or use contraception 5 months after the final dose of atezolizumab and for 90 days after the final dose of tiragolumab
•For men: agreement to remain abstinent or use a condom, and agreement to refrain from donating sperm, men must remain abstinent or use a condom during the treatment period and for 90 days after the final dose of tiragolumab to avoid exposing the embryo.
•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 285
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 465

•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 Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE) Grade >= 2 from the prior chemoradiation therapy
•Evidence of complete esophageal obstruction not amenable to treatment
•Histology consistent with small cell esophageal carcinoma, esophageal adenocarcinoma, or mixed carcinoma
•Grade >= 2 peripheral neuropathy as defined by NCI CTCAE v5.0 criteria
•High risk for developing esophageal fistula by clinical assessment or imaging, such as prior history or associated symptoms of esophageal fistula, or primary tumor invasion of the great vessels or trachea
•Prior esophagectomy
•Active or history of autoimmune disease or immune deficiency
•History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis on screening chest computed tomography scan
•History of malignancy 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 EGFR inhibitors, with therapeutic intent for esophageal cancer prior to randomization.

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