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
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
1,314actual
Sites
174
Countries
Argentina, Australia, Brazil +27
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2017-03-24 | actual | When the study began enrolling |
| Primary completion | 2024-08-30 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-05-15 | estimated | The whole study's end, after follow-up |
| First posted | 2017-01-30 | estimated | When this record first appeared on the registry |
| Results posted | 2025-09-18 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-03-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Urothelial Cancer
Interventions
- Biological: Nivolumab — also filed as BMS-936558, Opdivo
- Biological: Ipilimumab — also filed as BMS-734016, Yervoy
- Drug: Gemcitabine
- Drug: Cisplatin
- Drug: Carboplatin
Primary outcomes
what the primary-completion date above is the date OFOverall Survival (OS) in Cisplatin-ineligible Randomized Participants for Primary Study
measured From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months)
Overall Survival (OS) in Programmed Death-Ligand 1 (PD-L1) Positive (≥ 1%) Randomized Participants by Immunohistochemistry (IHC) for Primary Study
measured From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months)
Progression-Free Survival (PFS) by Blinded Independent Central Review (BICR) [Using Response Evaluation Criteria in Solid Tumors (RECIST) 1.1] in Cisplatin-eligible Participants for Sub-study
measured From the date of randomization to the date of first documented disease progression or death due to any cause, whichever occurs first (up to approximately 89 months)
Overall Survival (OS) in Cisplatin-eligible Participants for Sub-study
measured From the date of randomization to the date of death from any cause, or data cut-off date, whichever occurred first (up to approximately 89 months)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocol and Statistical Analysis Planposted 2023-04-27 · 1.8 MB · Prot_SAP_000.pdf
Publications
- PMID 41015742 — linked by the registry
- PMID 37870949 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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