NCT06510374

Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer

A Phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 454 (estimated)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Intermediate Risk Non-Muscle Invasive Bladder Cancer

Interventions

Type	Name	Description
DRUG	Nadofaragene Firadenovec	Vector-based gene therapy for NMIBC treatment to potentiate durable therapeutic responses by interferon (IFN) alfa-2b (IFN-α2b) amplification.

Timeline

• Start date: 2024-10-01
• Primary completion: 2028-06-30
• Completion: 2031-06-30
• First posted: 2024-07-19
• Last updated: 2026-03-30

Locations

79 sites across 6 countries: United States, Canada, France, Japan, South Korea, Spain

Regulatory

• FDA-regulated drug study