A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
1,068actual
Sites
194
Countries
Australia, Belgium, Canada +11
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 | 2019-12-30 | actual | When the study began enrolling |
| Primary completion | 2024-12-02 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-12-02 | estimated | The whole study's end, after follow-up |
| First posted | 2019-11-15 | actual | When this record first appeared on the registry |
| Results posted | 2026-01-22 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-01-22 | 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
- Drug: PF-06801591 — also filed as Sasanlimab
- Drug: Bacillus Calmette-Guerin — also filed as BCG
Primary outcome
what the primary-completion date above is the date OFCohort A: Event Free Survival (EFS) as Assessed by the Investigator: Arm A Versus Arm C
measured From randomization (Day 1) to first documentation of high-grade disease, progression of disease, persistence of CIS or death due to any cause, whichever occurred first (maximum follow up duration was up to 257.1 weeks)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-06-17 · 2.0 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-12-10 · 1011 KB · SAP_001.pdf
Publications
- PMID 42177753 — linked by the registry
- PMID 40450141 — linked by the registry
- PMID 38189180 — 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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