2023-504027-78-00招募中2 期
A Phase II, Randomized, Multicenter, Open-Label, Controlled Study of Tobemstomig Alone or in Combination With Tiragolumab Versus Atezolizumab in Patients With Previously Untreated Locally Advanced or Metastatic Urothelial Cancer Who Are Ineligible for Platinum-Containing Chemotherapy
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 31
- 主要终点
- 1. Incidence and severity of adverse events, with severity determined according to national cancer institute common terminology criteria for adverse events, version 5.0 (NCI CTCAE v5), with the exception of Cytokine Release Syndrome (CRS) event severity which will be determined according to the American Society for Transplantation and Cellular Therapy (ASTCT)
研究概览
简要总结
- To evaluate the safety of tobemstomig alone and in combination with tiragolumab, compared to atezolizumab
研究设计
- 分配方式
- Non-randomized
- 主要目的
- Phase II, open label, controlled study with Tobemstomig for Patients with urothelial cancer
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 2
- •Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma (TCC) of the urothelium. Patients with squamous, sarcomatoid, micropapillary, and glandular variant histologies are eligible for inclusion in the study, provided that a urothelial component is present in the tumor specimen. Patients with other variant histologies or pure variant histologies are not eligible for inclusion in the study
- •Considered to be ineligible ("unfit") to receive platinum-based chemotherapy defined by one of the following criteria: • ECOG Performance Status of 0 with baseline GFR ≥ 15 mL/min/1.73 m2 and ≤ 30 mL/min/1.73 m2 • ECOG Performance Status of 1 or 2 with baseline GFR ≥ 15 mL/min/1.73 m2 and ≤ 45 mL/min/1.73 m2 • ECOG Performance Status of 0-2 with Grade ≥ 2 neuropathy • Patients for whom chemotherapy is not deemed appropriate
- •No prior chemotherapy for inoperable locally advanced or metastatic or recurrent urothelial carcinoma (UC)
- •Measurable disease; at least one measurable lesion as defined by response evaluation criteria in solid tumors, version 1.1 (RECIST v1.1)
- •Availability of a representative leftover tumor specimen that meet the criteria outlined prior to study enrollment, and that is suitable for determination of programmed death-ligand 1 (PD-L1) status, and for stratification as assessed by a central laboratory
排除标准
- •Pregnancy or breastfeeding, or intention of becoming pregnant during study treatment or within 5 months after the final dose of atezolizumab, 4 months after the final dose of tobemstomig, or 90 days after the final dose of tiragolumab
- •Glomerular filtration rate (GFR) < 15 mL/min/1.73 m2 as calculated through use of the chronic kidney disease epidemiology collaboration (CKD-EPI) equation or receiving dialysis
- •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 and 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 (TB) or acute or chronic active Epstein-Barr virus (EBV)
结局指标
主要结局
1. Incidence and severity of adverse events, with severity determined according to national cancer institute common terminology criteria for adverse events, version 5.0 (NCI CTCAE v5), with the exception of Cytokine Release Syndrome (CRS) event severity which will be determined according to the American Society for Transplantation and Cellular Therapy (ASTCT)
1. Incidence and severity of adverse events, with severity determined according to national cancer institute common terminology criteria for adverse events, version 5.0 (NCI CTCAE v5), with the exception of Cytokine Release Syndrome (CRS) event severity which will be determined according to the American Society for Transplantation and Cellular Therapy (ASTCT)
次要结局
未报告次要终点
研究者
Trial Information System - TISL
Scientific
F. Hoffmann-La Roche AG
研究点 (31)
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