CTIS2023-509449-10-00招募中1 期
A Phase II, Randomized, Double-Blind Study of Atezolizumab Plus Tiragolumab and Atezolizumab Plus Placebo as First-Line Treatment in Patients with Recurrent/Metastatic PD-L1-Positive Squamous Cell Carcinoma of the Head and Neck - BO42533
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 115
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Known results from human papillomavirus status test for histologically or cytologically confirmed recurrent/metastatic SCCHN involving the oropharynx, oral cavity, larynx, or hypopharynx, that is considered incurable by local therapies. Known results from human papillomavirus status test are required for oropharyngeal carcinoma, No prior systemic therapy for metastatic and/or recurrent SCCHN, Measurable disease per Response Evaluation Criteria in Solid Tumors version 1.1, Tumor PD-L1 expression as determined by PD-L1 IHC assay in either a previously obtained archival tumor tissue or tissue obtained from a biopsy at prescreening/screening, Eastern Cooperative Oncology Group Performance Status of 0 or 1, Adequate hematologic and end-organ function
排除标准
- •Progressive or recurrent disease within 6 months of the last dose of curative intent systemic treatment for locally advanced SCCHN, Rapidly progressing disease in the opinion of the treating investigator, Grade >= 2 unresolved toxicity related to surgery or other prior therapies, Symptomatic, untreated, or actively progressing central nervous system metastases, History of leptomeningeal disease, Active or history of autoimmune disease or immune deficiency
研究者
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