跳至主要内容
临床试验/EUCTR2016-003881-14-IT
EUCTR2016-003881-14-IT进行中(未招募)1 期

A Phase 3, Open-label, Randomized Study of Nivolumab Combined withIpilimumab, or with Standard of Care Chemotherapy, versus Standard ofCare Chemotherapy in Participants with Previously Untreated Unresectableor Metastatic Urothelial Cancer - CheckMate 901: CHECKpoint pathway and nivoluMAb clinical Trial

BRISTOL-MYERS SQUIBB INTERNATIONAL CORPORATIO0 个研究点目标入组 1,360 人开始时间: 2021年6月17日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
入组人数
1,360

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

  • - 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 204
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 1156

排除标准

  • - 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.

研究者

相似试验

进行中(未招募)
1 期
Study of Nivolumab in Combination With Ipilimumab or with Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy in Treatment of Patients with Untreated Inoperable or Metastatic Urothelial Cancer
EUCTR2016-003881-14-DEBristol-Myers Squibb International Corporation1,792
已完成
3 期
A Phase 3 Study of ONO-4538(ONO-4538-56/CA209901)
JPRN-jRCT2080223696ONO PHARMACEUTICAL CO.,LTD.1,290
进行中(未招募)
1 期
Study of Nivolumab in Combination With Ipilimumab or with Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy in Treatment of Patients with Untreated Inoperable or Metastatic Urothelial Cancer
EUCTR2016-003881-14-GRBristol-Myers Squibb International Corporation1,792
进行中(未招募)
1 期
Study of Nivolumab in Combination With Ipilimumab or with Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy in Treatment of Patients with Untreated Inoperable or Metastatic Urothelial Cancerntreated Unresectable or Metastatic Urothelial CancerMedDRA version: 20.0Level: LLTClassification code 10064467Term: Urothelial carcinomaSystem Organ Class: 100000004864
EUCTR2016-003881-14-NOBristol-Myers Squibb International Corporation1,792
招募中
3 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 CancerUrothelial Carcinoma10004994Bladder Cancer
NL-OMON56458Bristol-Myers Squibb70