2023-509449-10-00招募中2 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
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 13
- 主要终点
- 1. Confirmed objective response rate
研究概览
简要总结
To evaluate the efficacy of atezolizumab plus tiragolumab and atezolizumab plus placebo on the basis of confirmed objective response rate
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double (Analyst, Carer, Subject, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
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
结局指标
主要结局
1. Confirmed objective response rate
1. Confirmed objective response rate
次要结局
- 1. Duration of Response
- 2. Progression free survival
- 3. Overall survival
- 4. Progression free survival rate at 6 months
- 5. Overall survival rate at 6 months and 12 months
- 6.Time to confirmed deterioration in patient-reported physical functioning
- 7. Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0
- 8. Serum concentration of atezolizumab and tiragolumab at specified timepoints
- 9. Prevalence of anti-drug antibodies (ADAs) to atezolizumab at baseline and during the study
- 10.Prevalence of ADAs to tiragolumab at baseline and during the study
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (13)
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