EUCTR2016-002625-11-EE进行中（未招募）1 期
AN OPEN LABEL, SINGLE ARM, MULTICENTER, SAFETY STUDY OF ATEZOLIZUMAB IN LOCALLY ADVANCED OR METASTATIC UROTHELIAL OR NON-UROTHELIAL CARCINOMA OF THE URINARY TRACT
F. Hoffman-La Roche Ltd.0 个研究点目标入组 1,000 人开始时间: 2016年11月2日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Age >= 18 years
- •- Histologically documented locally advanced (tumor (T) 4b, any node (N); or any T, N 2-3) or metastatic (M1, Stage IV) urothelial or non-urothelial carcinoma of the urinary tract
- •- Patients with measurable and non-measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 are allowed
- •- Must have received one prior combination chemotherapy regimen (e.g., methotrexate, vinblastine, doxorubicin, and cisplatin [MVAC], gemcitabine and cisplatin [GC], etc.) for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract
- •- Representative formalin-fixed paraffin-embedded (FFPE) tumor specimen block available for submission at baseline
- •- Eastern cooperative oncology group (ECOG) performance status 0, 1 or 2
- •- Life expectancy >= 12 weeks
- •- Adequate hematologic and end-organ function, defined by the following laboratory results obtained within 2 weeks prior to the first study treatment
- •- Patients with treated, asymptomatic central nervous system (CNS) metastases are eligible (Note: Patients on stable doses of anticonvulsants or on prednisone doses [or dose equivalents] of <= 20 milligram/day are allowed)
- •- For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of < 1% per year during the treatment period and for at least 5 months after the last dose of atezolizumab
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 700
排除标准
- •- Treatment with more than three prior lines of systemic therapy for inoperable, locally advanced or metastatic urothelial or non-urothelial carcinoma of the urinary tract
- •- Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 4 weeks prior to study treatment initiation
- •- Treatment with chemotherapy within 2 weeks prior to study treatment initiation
- •- Treatment with radiotherapy ongoing at the time of study entry (for CNS-directed radiotherapy)
- •- Pregnant or lactating, or intending to become pregnant during the study
- •- Evidence of significant uncontrolled concomitant disease that could affect compliance with the protocol, including significant liver disease (such as cirrhosis, uncontrolled major seizure disorder, or superior vena cava syndrome)
- •- Significant cardiovascular disease, such as New York Heart Association cardiac disease >= Class III, myocardial infarction within 3 months, unstable arrhythmias, or unstable angina
- •- Significant renal disorder requiring dialysis or indication for renal transplant
- •- Signs or symptoms of severe infection within 2 weeks prior to initiation of study treatment, including but not limited to, hospitalization for complications of infection, bacteremia, or severe pneumonia
- •- Major surgical procedure within 4 weeks prior to study treatment initiation or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis
- •- History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •- Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the atezolizumab formulation
- •- History of autoimmune disease are allowed if controlled and on stable treatment (i.e., same treatment, same dose) for the last 12 weeks
- •- Prior allogeneic stem cell or solid organ transplantation
- •- History of idiopathic pulmonary fibrosis (including pneumonitis, drug-induced pneumonitis, organizing pneumonia (i.e. bronchiolitis obliterans, cryptogenic organizing pneumonia), or evidence of active pneumonitis on screening chest computed tomography (CT) scan
- •- Patients with active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C
- •- Active tuberculosis
- •- Administration of a live, attenuated vaccine within 4 weeks prior to study treatment initiation
- •- Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, including anti- cytotoxic T lymphocyte-associated (CTLA)-4, anti- programmed cell death protein 1 (PD-1), and anti- programmed death-ligand 1 (PD-L1) therapeutic antibodies
- •- Treatment with systemic immunostimulatory agents (including, but not limited to, interferons or interleukin-2) within 4 weeks or five half-lives of the drug, whichever is shorter, prior to initiation of study treatment
- •- Specifically for patients without autoimmune disease, treatment with systemic corticosteroids or other systemic immunosuppressive medications within 2 weeks prior to study treatment initiation or anticipated requirement for systemic immunosuppressive medications during the study treatment period. Note: For patients with autoimmune disease, immunosuppressive medications are permitted if the patient has controlled autoimmune disease and stable treatment (i.e., same tre
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