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.

F. Hoffmann-La Roche Ltd0 个研究点目标入组 750 人开始时间: 2020年9月16日最近更新: 2024年7月29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
•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 (dCRT) according to regional oncology guidelines for esophageal cancer
•Representative archival formalin-fixed, paraffin-embedded tumor specimens, collected prior to initiation of dCRT
•Adequate hematologic and end-organ function
•Women of childbearing potential must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period, for 5 months after the final dose of atezolizumab/placebo, and for 90 days after the final dose of tiragolumab/placebo, whichever is later
•Men must agree to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for 90 days after the final dose of
•tiragolumab/placebo 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 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
•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
•Severe infection within 4 weeks prior to randomization, including, but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia, or any active infection that, in the opinion of the
•investigator, could impact patient safety.

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