Assessment of Efficacy and Safety of Durvalumab Plus BCG Compared to the Standard Therapy With BCG in Non-muscle Invasive Bladder Cancer
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
1,018actual
Sites
120
Countries
Australia, Austria, Belgium +9
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 | 2018-05-14 | actual | When the study began enrolling |
| Primary completion | 2025-04-03 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2028-10-03 | estimated | The whole study's end, after follow-up |
| First posted | 2018-05-18 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-07-07 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Non-muscle-invasive Bladder Cancer
Interventions
- Biological: Durvalumab (MEDI4736)
- Biological: Bacillus Calmette-Guerin (BCG)
Primary outcome
what the primary-completion date above is the date OFThe efficacy of Durvalumab + BCG (induction plus maintenance) combination therapy compared to SoC in terms of Disease free survival (DFS) in patients with NMIBC
measured Up to 4 years
Publications
- PMID 41115436 — 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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