Durvalumab+ Gemcitabine/Cisplatin (Neoadjuvant Treatment) and Durvalumab (Adjuvant Treatment) in Patients With MIBC
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
1,063actual
Sites
188
Countries
Australia, Belgium, Brazil +19
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 | 2018-11-16 | actual | When the study began enrolling |
| Primary completion | 2024-04-29 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2027-11-08 | estimated | The whole study's end, after follow-up |
| First posted | 2018-11-06 | actual | When this record first appeared on the registry |
| Results posted | 2025-07-03 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-07-17 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Muscle Invasive Bladder Cancer
Interventions
- Drug: Durvalumab
- Drug: Cisplatin
- Drug: Gemcitabine
Primary outcomes
what the primary-completion date above is the date OFPathologic Complete Response (pCR) Rates at Time of Cystectomy
measured Up to 6 months
Event-free Survival (EFS) Per Central Review Defined as Time From Randomization to Event
measured Up to 48 months
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-01-29 · 4.7 MB · Prot_002.pdf
Statistical Analysis Planposted 2024-03-22 · 1.4 MB · SAP_003.pdf
Publications
- PMID 39282910 — 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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