A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Subjects with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512029-10-00

Acronym

000423

Enrollment

253

Registered

2025-03-25

Start date

2025-12-05

Completion date

Unknown

Last updated

2026-01-16

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

Conditions

Intermediate risk, non-muscle invasive bladder cancer

Brief summary

The primary endpoint is recurrence-free survival (RFS), defined as the time from the date of randomization to first documented recurrence or progression (as defined in the below table), or death (due to any cause), whichever occurs first during the treatment period (24 months).

Interventions

DRUGADSTILADRIN

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The primary endpoint is recurrence-free survival (RFS), defined as the time from the date of randomization to first documented recurrence or progression (as defined in the below table), or death (due to any cause), whichever occurs first during the treatment period (24 months).	—

Countries

Denmark, France, Spain

Outcome results

None listed

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