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
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 701
- 试验地点
- 39
- 主要终点
- Primary endpoint of OS in cisplatin-ineligible randomized participants
研究概览
简要总结
Main Study: -To compare Overall Survival (OS) of nivolumab combined with ipilimumab versus standard of care (SOC) chemotherapy in cisplatin-ineligible participants with previously untreated, unresectable or metastatic urothelial carcinoma (UC). -To compare OS of nivolumab combined with ipilimumab versus standard of care (SOC) chemotherapy in PD-L1 positive (>= 1%) participants with previously untreated, unresectable or metastatic UC.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
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
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.
结局指标
主要结局
Primary endpoint of OS in cisplatin-ineligible randomized participants
Primary endpoint of OS in cisplatin-ineligible randomized participants
Primary endpoint of OS in PD-L1 positive (>= 1%) randomized participants by immunohistochemistry (IHC)
Primary endpoint of OS in PD-L1 positive (>= 1%) randomized participants by immunohistochemistry (IHC)
次要结局
- OS in all randomized participants
- PFS by blinded independent central review (BICR) (using RECIST 1.1) in cisplatin-ineligible randomized participants, in PD-L1 positive (>=1%) randomized participants and in all randomized participants
- European Organisation for Research and Treatment of Care (EORTC) QLQ-C30 Global Health Status score in all randomized participants
研究者
GSM-CT
Scientific
Bristol Myers Squibb International Corporation