EUCTR2014-003625-17-PL进行中（未招募）1 期
A phase II single arm clinical trial of nivolumab (BMS-936558) in subjects with metastatic or unresectable urothelial cancer who have progressed or recurred following treatment with a platinum agent
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 323
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
- •a. Evidence of metastatic or surgically unresectable transitional cell carcinoma of the urothelium involving the bladder, urethra, ureter, or renal pelvis.
- •b. Measurable disease by CT or MRI
- •c. Progression or recurrence after treatment
- •i) with at least 1 platinum-containing chemotherapy regimen for metastatic or surgically-unresectable locally advanced urothelial cancer, or
- •ii) within 12 months of peri-operative (neo-adjuvant or adjuvant) treatment with platinum agent in the setting of cystectomy for localized muscle-invasive urothelial cancer.
- •d)Subjects that have received more than 2 prior lines of chemotherapy must not have liver metastases.
- •e) tumor tissue (archived or new biopsy) must be provided for biomarker analysis
- •f) Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.
- •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 161
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 162
排除标准
- •a.Subjects with active cancer that has spread to the central nervous system.
- •b.Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
- •c.Subjects with active, known or suspected autoimmune disease.
- •d.Subjects with a condition requiring systemic treatment with either corticosteroids (> 10 mg daily prednisone equivalents) or other immunosuppressive medications within 14 days of study drug administration.
- •e.Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, anti-CD137, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
- •Exclusion laboratory criteria:
- •- Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection.
- •- Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
研究者
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