EUCTR2014-003231-19-GB进行中（未招募）1 期
A PHASE III, OPEN-LABEL, MULTICENTER, RANDOMIZED STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF ATEZOLIZUMAB (ANTI-PD-L1 ANTIBODY) COMPARED WITH CHEMOTHERAPY IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC UROTHELIAL BLADDER CANCER AFTER FAILURE WITH PLATINUM-CONTAINING CHEMOTHERAPY
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 931
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
入选标准
- •Age >/= 18 years
- •Histologically or cytologically documented locally advanced or metastatic transitional cell carcinoma of the urothelium (including renal pelvis, ureters, urinary bladder, urethra)
- •Representative tumor specimens as specified by the protocol
- •Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- •Life expectancy >/= 12 weeks
- •Measurable disease, as defined by RECIST v1.1
- •Adequate hematologic and end organ function
- •Disease progression during or following treatment with at least one platinum-containing regimen (e.g., gemcitabine and cisplatin [GC], methotrexate, vinblastine, doxorubicin, and cisplatin [MVAC], CarboGem, etc.) for inoperable locally advanced or metastatic urothelial carcinoma or disease recurrence
- •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 740
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 191
排除标准
- •Any approved anti-cancer therapy within 3 weeks prior to initiation of study treatment
- •Treatment with any other investigational agent or participation in another clinical trial with therapeutic intent within 28 days prior to enrollment
- •Active or untreated central nervous system (CNS) metastases as determined by CT or MRI evaluation during screening and prior radiographic assessments
- •Leptomeningeal disease
- •Malignancies other than UBC within 5 years prior to Cycle 1, Day 1, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome or incidental prostate cancer
- •Pregnant and lactating women
- •History of autoimmune disease
- •History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan
- •Serum albumin < 2.5 g/dL
- •Positive test for HIV and/or active hepatitis B or hepatitis C or tuberculosis
- •Severe infections within 4 weeks prior to Cycle 1, Day 1
- •Significant cardiovascular disease
- •Major surgical procedure other than for diagnosis within 28 days prior to Cycle 1, Day 1
- •Prior allogeneic stem cell or solid organ transplant
- •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 interpretation of the results or render the patient at high risk from treatment complications
- •Prior treatment with CD137 agonists or immune checkpoint blockade
研究者
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