EUCTR2018-001811-59-NL进行中（未招募）1 期
A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination with Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients with Muscle-Invasive Bladder Cancer - NIAGARA
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,050
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
- •Patient resectable muscle-invasive bladder cancer with clinical stage T2-T4aN0/1M0 with transitional and mixed transitional cell histology;
- •Patients must be planning to undergo a radical cystectomy;
- •Patients who have not received prior systemic chemotherapy or immunotherapy for treatment of MIBC;
- •ECOG performance status of 0 or 1 at enrollment.
- •Availability of tumor sample prior to study entry;
- •Must have a life expectancy of at least 12 weeks at randomization.
- •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 525
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 525
排除标准
- •Evidence of lymph node (N2-N3) involvement or metastatic (M1) disease at the time of screening.
- •Contra-indication to any of the study drugs
- •Requires immunosuppression medication for a concomitant condition
- •Active or prior documented autoimmune or inflammatory disorders
研究者
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