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A Phase 3 Study of Erdafitinib Compared with Vinflunine or Docetaxel or Pembrolizumab in Subjects with Advanced Urothelial Cancer and Selected FGFR Gene Aberrations

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-510296-56-00
Acronym
42756493BLC3001
Enrollment
179
Registered
2024-04-08
Start date
2018-03-26
Completion date
Unknown
Last updated
2025-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Advanced Urothelial Cancer

Brief summary

The primary endpoint is overall survival (OS). Overall survival is measured from the date of randomization to the date of the subject's death. If the subject is alive or the vital status is unknown, the subject will be censored at the date the subject was last known to be alive

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion
DRUGDocetaxel-ratiopharm 20mg/ml Konzentrat zur Herstellung einer Infusionslösung

Sponsors

Janssen Cilag International
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint is overall survival (OS). Overall survival is measured from the date of randomization to the date of the subject's death. If the subject is alive or the vital status is unknown, the subject will be censored at the date the subject was last known to be alive

Countries

Belgium, France, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026