NCT03036098

Study of Nivolumab in Combination With Ipilimumab or Standard of Care Chemotherapy Compared to the Standard of Care Chemotherapy Alone in Treatment of Participants With Untreated Inoperable or Metastatic Urothelial Cancer

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,314 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine whether an investigational immunotherapy nivolumab in combination with ipilimumab or in combination with standard of care chemotherapy is more effective than standard of care chemotherapy alone in treating participants with previously untreated inoperable or metastatic urothelial cancer.

Conditions

• Urothelial Cancer

Interventions

Type	Name	Description
BIOLOGICAL	Nivolumab	Specified Dose on Specified Days
BIOLOGICAL	Ipilimumab	Specified Dose on Specified Days
DRUG	Gemcitabine	Specified Dose on Specified Days
DRUG	Cisplatin	Specified Dose on Specified Days
DRUG	Carboplatin	Specified Dose on Specified Days

Timeline

• Start date: 2017-03-24
• Primary completion: 2024-08-30
• Completion: 2026-05-15
• First posted: 2017-01-30
• Last updated: 2026-03-06
• Results posted: 2025-09-18

Locations

174 sites across 30 countries: United States, Argentina, Australia, Brazil, Canada, Chile, China, Czechia, Denmark, Finland, France, Germany, Greece, Israel, Italy, Japan, Mexico, Netherlands, Norway, Peru, Poland, Romania, Russia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye)

Regulatory

• FDA-regulated drug study