A phase 3, randomised, multi-center, open label trial to evaluate the safety and efficacy of intravesical nadofaragene firadenovec alone or in combination with chemotherapy (gemcitabine and docetaxel) or immunotherapy (pembrolizumab) in subjects with high-grade Bacillus Calmette-Guerin therapy (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512177-27-01

Acronym

000434

Enrollment

143

Registered

2025-09-01

Start date

2025-09-29

Completion date

Unknown

Last updated

2026-01-26

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

Conditions

High-risk Bacillus Calmette-Guerin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ(CIS) with or without papillary tumours

Brief summary

Complete response ([CR] at any time from first treatment defined as absence of high-grade (HG) recurrence)

Interventions

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

DRUGADSTILADRIN

DRUGGEMCITABINE

DRUGDOCETAXEL

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Complete response ([CR] at any time from first treatment defined as absence of high-grade (HG) recurrence)	—

Countries

Czechia, Denmark, France, Poland, Spain

Outcome results

None listed

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