EUCTR2014-003625-17-ES进行中（未招募）不适用
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
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 306
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 153
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 153
排除标准
- •a) Subjects with active cancer that has spread to the central nervous system
- •b)Any serious or uncontrolled medical disorder, that in the opinion of the investigator, may increase the risk
- •associated with study participation or study drug administration, impair the ability of the subject to receive protocol therapy, or
- •interfere with the interpretation of study results.
- •c. Prior malignancy active within the previous 3 years except for locally curable cancers that have been apparently cured.
- •d. Subjects with active, known or suspected autoimmune disease. Subjects with vitiligo, type I diabetes mellitus, residual hypothyroidism, due to autoimmune condition only requiring hormone replacement, psoriasis not requiring systemic treatment, or conditions not expected to recur in the absence of an external trigger are permitted to enroll.
- •e. 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. Inhaled or topical steroids and adrenal replacement doses > 10 mg daily prednisone equivalents are permitted in the absence of active autoimmune disease.
- •f. Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways.
- •g.Treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 28 days of first administration of study treatment.
- •Exclusion laboratory criteria:
- •-Positive test for hepatitis B virus surface antigen (HBV sAg) or hepatitis C virus ribonucleic acid (RNA) or
- •hepatitis C antibody (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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