EUCTR2016-003881-14-FI进行中（未招募）1 期
A Phase 3, Open-label, Randomized Study of Nivolumab Combined with Ipilimumab, or with Standard of Care Chemotherapy, versus Standard of Care Chemotherapy in Participants with Previously Untreated Unresectable or Metastatic Urothelial Cancer - CheckMate 901: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 901
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,375
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
- •- Metastatic or inoperable urothelial cancer
- •- Must have at least 1 lesion with measurable disease
- •- Must have full activity or, if limited, must be able to walk and carry out light activities such as light house work or office work
- •- No prior systemic chemotherapy treatment in the metastatic setting
- •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 206
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1169
排除标准
- •- Patients with ECOG PS >= 2
- •- Patients with disease that is suitable for local therapy administered with curative intent
- •- Patients with active brain metastases or leptomeningeal metastases
- •- Patients with active, known or suspected autoimmune disease
- •- Prior treatment with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways.
- •- Participants may not have received live/attenuated vaccines within 30
- •days prior to first study treatment
研究者
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