EUCTR2016-003881-14-NO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+ Protocol Amendment 07 specific to Norway dated 15-Dec-2017 - CheckMate 901: CHECKpoint pathway and nivoluMAb clinical Trial Evaluation 901
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
- 1,792
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
- •-Histological or cytological evidence of metastatic or surgically inoperable transitional cell cancer (TCC) of the urothelium involving the renal pelvis, ureter, bladder or urethra
- •-No prior systemic chemotherapy for metastatic or surgically inoperable urothelial cancer (UC)
- •-Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1
- •-Women and men must agree to follow specific methods of contraception, if applicable
- •Other protocol-defined inclusion criteria apply
- •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 269
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1523
排除标准
- •-Disease that is suitable for local therapy administered with curative intent
- •-Any serious or uncontrolled medical disorder in the opinion of the investigator that may increase the risk associated with study participation or study drug administration or interfere with the interpretation of study results
- •-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 costimulation or checkpoint pathways
- •Other protocol-defined exclusion criteria apply
研究者
相似试验
进行中（未招募）
1 期
Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care Chemotherapy in Treatment of Patients with Untreated Inoperable or Metastatic Urothelial CancerEUCTR2016-003881-14-ESBristol-Myers Squibb International Corporation1,045
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 CancerEUCTR2016-003881-14-FIBristol-Myers Squibb International Corporation1,375
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: 100000004864EUCTR2016-003881-14-DKBristol-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 CancerEUCTR2016-003881-14-SEBristol-Myers Squibb International Corporation1,792