A Study to Compare Chemotherapy Alone Versus Chemotherapy Plus Nivolumab or Nivolumab and BMS-986205, Followed by Continued Therapy After Surgery With Nivolumab or Nivolumab and BMS-986205 in Participants With Muscle Invasive Bladder Cancer
← catalyst calendarSponsored by Bristol-Myers Squibb (industry) · BMY — their whole pipeline →. With Ono Pharmaceutical Co., Ltd..
Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
855actual
Sites
172
Countries
Argentina, Australia, Austria +25
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 | 2018-11-06 | actual | When the study began enrolling |
| Primary completion | 2026-02-16 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-12-30 | estimated | The whole study's end, after follow-up |
| First posted | 2018-09-07 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-04-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Urinary Bladder Neoplasms
- Muscle-Invasive Bladder Cancer
Interventions
- Biological: Nivolumab — also filed as Opdivo, BMS-936558
- Drug: Gemcitabine — also filed as Chemotherapy
- Drug: Cisplatin — also filed as Chemotherapy
Primary outcomes
what the primary-completion date above is the date OFPathological Complete Response (pCR) rate, in all randomized participants
measured Approximately 43 months
Event-Free Survival (EFS), in all randomized participants
measured Approximately 36 months
Publications
- PMID 38155060 — linked by the registry
- PMID 31823654 — 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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