NCT06390111

A Trial to Evaluate Efficacy of Reinduction With Nadofaragene Firadenovec in Subjects With CIS ± High-grade Ta/T1 and no Complete Response to First Nadofaragene Firadenovec Dose.

A Phase 4, Multi-center, Open Label Trial to Evaluate Efficacy of Reinduction With Nadofaragene Firadenovec in Subjects With CIS ± High-grade Ta/T1 and no Complete Response to First Nadofaragene Firadenovec Dose.

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

In this phase 4 trial (000439), subjects with NMIBC CIS (± high-grade Ta/T1) who have not responded to their first dose of nadofaragene firadenovec (commercial ADSTILADRIN received before trial entry) will be offered reinduction when entering the trial.

Conditions

• Bladder Cancer
• Ta/T1
• CIS

Interventions

Type	Name	Description
DRUG	nadofaragene firadenovec	The investigational medicinal product dose, concentration, and assessments are aligned with nadofaragene firadenovec US prescribing information.

Timeline

• Start date: 2024-06-17
• Primary completion: 2026-07-31
• Completion: 2026-07-31
• First posted: 2024-04-30
• Last updated: 2024-11-22

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study