NCT04321330已完成2 期
An Open-Label, Single Arm, Multicenter Study to Investigate the Efficacy and Safety of Atezolizumab (Tecentriq) in Previously-Treated Patients With Advanced Thymic Carcinoma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 10
- 主要终点
- Objective response rate (ORR)
研究概览
简要总结
This is a phase II, open-label, single-arm, multicenter study of the efficacy and safety of atezolizumab treatment in participants with advanced thymic carcinoma who failed prior systemic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histological confirmation of thymic carcinoma by the central pathology laboratory
- •Advanced disease not amenable to curative treatment
- •At least 1 prior line of chemotherapy
- •Progression of disease must be documented prior to study entry
- •Measurable disease, as defined by Response Evaluation Criteria for Solid Tumors, Version 1.1 (RECIST v1.1)
- •Availability of a representative tumor specimen that is suitable for biomarkers research via central testing
- •ECOG performance status 0 or1
- •Life expectancy > 3 months
- •Adequate hematologic and end-organ function within 14 days prior to the first study treatment
- •For patients receiving therapeutic anticoagulation: stable anticoagulant regimen
- •For women of childbearing potential: agreement to remain abstinent or use contraception
排除标准
- •Disease which is amenable to radical treatment with surgery or radiation or a combination of treatments.
- •Symptomatic, untreated, or actively progressing central nervous system (CNS) metastases
- •History of leptomeningeal disease
- •Uncontrolled tumor-related pain
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
- •Uncontrolled or symptomatic hypercalcemia
- •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 (CT) scan
- •Active tuberculosis
- •Significant cardiovascular disease within 3 months prior to initiation of study treatment unstable arrhythmia, or unstable angina.
- •Prior treatment with chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered from adverse events due to a previously administered agent.
- •Additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.
研究组 & 干预措施
Atezolizumab
Experimental
Participants will receive atezolizumab at a fixed dose of 1200 milligrams (mg) by intravenous (IV) infusion on Day 1 of each 21-day cycle until unacceptable toxicity or loss of clinical benefit.
干预措施: Atezolizumab (Drug)
结局指标
主要结局
Objective response rate (ORR)
时间窗: Baseline up to approximately 3.5 years
ORR is defined as the proportion of patients with a complete response (CR) or partial response (PR) on two consecutive occasions 4 weeks apart, as determined by the Investigator according to Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1).
次要结局
- Disease Control Rate (DCR)(Baseline up to approximately 3.5 years)
- Duration of Objective Response (DOR)(Baseline up to approximately 3.5 years)
- Progression-Free Survival (PFS)(Baseline up to approximately 3.5 years)
- Distribution of PD-L1 Expression(Baseline up to approximately 3.5 years)
- Percentage of Participants With Adverse Events(Baseline up to approximately 3.5 years)
- Percentage of Participants With Immune-Related Adverse Events(Baseline up to approximately 3.5 years)
- Distribution of TMB Expression(Baseline up to approximately 3.5 years)
- Overall Survival (OS)(Baseline up to approximately 3.5 years)
研究者
研究点 (10)
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