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

NCT06510374 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 454

Last updated 2026-05-22

No results posted yet for this study

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

DRUG

Nadofaragene Firadenovec

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

Sponsors & Collaborators

  • Ferring Pharmaceuticals

    lead INDUSTRY

Principal Investigators

  • Global Clinical Compliance · Ferring Pharmaceutical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-01
Primary Completion
2028-06-30
Completion
2031-06-30
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Czechia
  • France
  • Japan
  • Poland
  • South Korea
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06510374 on ClinicalTrials.gov