NL-OMON45493已完成3 期
A PHASE III, MULTICENTER, RANDOMIZED,<br>PLACEBO-CONTROLLED STUDY OF ATEZOLIZUMAB<br>(ANTI*PD-L1 ANTIBODY) AS MONOTHERAPY AND IN<br>COMBINATION WITH PLATINUM-BASED CHEMOTHERAPY<br>IN PATIENTS WITH UNTREATED LOCALLY ADVANCED OR<br>METASTATIC UROTHELIAL CARCINOMA - WO30070/ IMVIGOR130
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
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 64（—）
入选标准
- •Inclusion Criteria
- •Signed Informed Consent Form
- •Age * 18 years
- •Eastern Cooperative Oncology Group (ECOG) performance status of * 2
- •Able to comply with the study protocol, in the investigator*s judgment
- •Histologically documented, locally advanced (T4b, any N; or any T, N 2*3) or metastatic urothelial carcinoma (mUC) (M1, Stage IV) (also termed Transitional cell carcinoma (TCC), also called urothelial cell carcinoma (UCC) of the urinary tract; including renal pelvis, ureters, urinary bladder, and urethra)
- •Representative formalin-fixed paraffin-embedded (FFPE) tumor specimens in paraffin blocks (blocks preferred) or at least 15 unstained slides, with an associated pathology report, for central testing and determined to be evaluable for tumor PD-L1 expression prior to study enrollment; patients who have fewer than 15 unstained slides available at baseline (but no fewer than 10) may be eligible following discussion with the Medical Monitor.
- •No prior chemotherapy for inoperable locally advanced or mUC
- •Patients eligible for platinum based therapy. To define a patient as ineligible (*unfit*) for cisplatin-based therapy the following criteria (based on Galsky et al. 2011) can be used:
- •Measurable disease, as defined by RECIST v1.1
- •Adequate hematologic and end-organ function, defined by the following laboratory results obtained within 28 days prior to the first study treatment:
- •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 6 months after the last dose of cisplatin, carboplatin or gemcitabine or for 5 months after the last dose of atezolizumab
- •For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm, as defined below:;The inclusion criteria are described more into detail in the protocol page 94-97.
排除标准
- •Exclusion Criteria
- •Patients who meet any of the following criteria will be excluded from study entry:
- •Cancer-Specific Exclusions
- •Any approved anti-cancer therapy, including chemotherapy or hormonal therapy, within 3 weeks prior to initiation of study treatment; the following exceptions are allowed:
- •Treatment with any other investigational agent or participation in another clinical study with therapeutic intent within 28 days prior to enrollment
- •Active or untreated CNS metastases as determined by computed tomography or magnetic resonance imaging evaluation during screening and prior radiographic assessments
- •Leptomeningeal disease
- •Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently)
- •Uncontrolled tumor-related pain
- •Uncontrolled hypercalcemia defined as any one or more of the following criteria:
- •Malignancies other than urothelial carcinoma within 5 years prior to Cycle 1, Day 1;General Medical Exclusions
- •Life expectancy of * 12 weeks
- •Pregnant or lactating, or intending to become pregnant during the study
- •Serum albumin * 2.5 g/dL ;Exclusion Criteria Related to Atezolizumab
- •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 including but not limited to myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener*s granulomatosis, Sjögren*s syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
- •Patients with 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
- •Significant cardiovascular disease, such as New York Heart Association cardiac disease (Class III or greater), myocardial infarction within 3 months prior to randomization, unstable arrhythmias, or unstable angina
- •Known left ventricular ejection fraction (LVEF) * 40%
- •Positive test for HIV
- •Active hepatitis B (defined as having a positive hepatitis B surface antigen [HBsAg] test at screening) or hepatitis C
- •Active tuberculosis
- •Severe infections within 4 weeks prior to randomization including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
- •Therapeutic oral or IV antibiotics within 2 weeks prior to randomization
- •Major surgical procedure within 4 weeks prior to randomization or anticipation of need for a major surgical procedure during the course of the study other than for diagnosis.
- •Administration of a live, attenuated vaccine within 4 weeks before Cycle 1, Day 1
- •Any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug or that may affect the interpreta
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