RecruitingInterventionalPhase 3

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

NCT ID: NCT06510374Sponsor: Ferring PharmaceuticalsLast updated: 2026-06-17

Summary

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

Arms & interventions

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

Outcome measures

Primary

Recurrence Free survival
Recurrence-free survival, defined as the time from the date of randomization to the date of first documented recurrence, progression or death (due to any cause), whichever occurs first during the treatment period.
Time frame: 24 months

Secondary

Adverse Events
Time frame: up to 24 months
Recurrence Free Survival at 12 Months
Time frame: 12 months
Recurrence Free Survival at 24 Months
Time frame: 24 Months

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No

Inclusion Criteria: * Diagnosed with intermediate risk non-muscle invasive bladder cancer (IR NMIBC) as defined by American Urological Association (AUA)/Society of Urologic Oncology \[SUO\] Guideline (2020) * Has undergone adequate transurethral resection of bladder tumor (TURBT; with or without peri-operative chemotherapy) within 60 days prior to randomization: * Recurrence within 1 year, low-grade Ta * Solitary low-grade Ta \>3 cm * Low-grade Ta, multifocal * Solitary high-grade Ta, ≤3 cm * Low-grade T1 * Patients with T1 disease should undergo resection at the base of the lesion and biopsies should contain muscle fibres. * Restage TURBT may be done at the discretion of the investigator Exclusion Criteria: * Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit High risk NMIBC defined as: * High-grade T1 * Any recurrent, high-grade Ta * High-grade Ta \>3 cm (or multifocal) * Any carcinoma in situ (CIS) * Any Bacillus Calmette-Guérin (BCG) failure in high-grade subject * Any variant histology * Any prostatic urethral involvement Low risk NMIBC defined as: * First occurrence of low-grade solitary Ta ≤3 cm * Recurrence of low-grade solitary Ta ≤3 cm \>12 months from previous occurrence * Papillary urothelial neoplasm of low malignant potential

Study locations (50)

University of South Alabama (USA) Health System - USACM

Mobile, Alabama, 36606

Recruiting

Urology Associates of Mobile

Mobile, Alabama, 56608

Recruiting

Mayo Clinic Arizona

Phoenix, Arizona, 85054

Recruiting

Center for Neurosciences

Tucson, Arizona, 85718

Recruiting

Arkansas Urology, North Little Rock

Little Rock, Arkansas, 72211

Recruiting

Michael G Oefelein, MD Clinical Trials

Bakersfield, California, 93301

Recruiting

Urology Associates of Central California

Fresno, California, 93720

Recruiting

American Institute of Research

Los Angeles, California, 90017

Recruiting

Urology Center of Southern California

Murrieta, California, 92563

Recruiting

University of California, Irvine

Orange, California, 92868

Recruiting

Providence Saint John's Cancer Institute

Santa Monica, California, 90404

Recruiting

Advent Health

Denver, Colorado, 80210

Recruiting

Medstar Georgetown University Hospital

Washington D.C., District of Columbia, 20007

Recruiting

Mayo Clinic

Jacksonville, Florida, 32224

Recruiting

Advanced Urology institute - Pinellas

Largo, Florida, 33771

Recruiting

Sarasota Memorial Healthcare System

Sarasota, Florida, 34239

Recruiting

Emory University

Atlanta, Georgia, 30322

Recruiting

NextStage Clinical Research

Lisle, Illinois, 60532

Recruiting

Blessing Health System

Quincy, Illinois, 62301

Recruiting

First Urology Research (Jeffersonville)

Jeffersonville, Indiana, 47130

Recruiting

Urology Center of Iowa Research

Clive, Iowa, 50325

Recruiting

Wichita Urology Group

Wichita, Kansas, 67226

Recruiting

University of Kentucky (UK) - Markey Cancer Center

Lexington, Kentucky, 40536

Recruiting

Anne Arundel Urology, PA

Annapolis, Maryland, 21401

Recruiting

Mayo Clinic - Rochester Minnesota

Rochester, Minnesota, 55905

Recruiting

Mercy Clinic Oncology and Hematology - David C. Pratt Cancer Center

Creve Coeur, Missouri, 63141

Terminated

Specialty Clinical Research of St. Louis

St Louis, Missouri, 63141

Recruiting

Adult and Pediatric Urology P.C.

Omaha, Nebraska, 68114

Recruiting

Atlantic Health

Morristown, New Jersey, 07960

Recruiting

Albany Medical College

Albany, New York, 10461

Recruiting

Great Lakes Physician PC d/b/a Western New York Urology Associates

Cheektowaga, New York, 14225

Recruiting

AccuMed Research Associates

Garden City, New York, 11530

Recruiting

Northwell Health -The Arthur Smith Institute for Urology

Lake Success, New York, 11042

Recruiting

Veterans Affairs New York Harbor Healthcare System - Manhattan VA Medical Center

New York, New York, 10010

Recruiting

Integrated Medical Professionals, PLLC

New York, New York, 10016

Recruiting

Premier Medical Group of the Hudson Valley

Poughkeepsie, New York, 12603

Terminated

James J. Peters VA Medical Center

The Bronx, New York, 10468

Recruiting

University of Cincinnati

Cincinnati, Ohio, 45267

Recruiting

Oregon Health and Science University (Portland)

Portland, Oregon, 97239

Recruiting

MidLantic Urology

Bala-Cynwyd, Pennsylvania, 19004

Recruiting

Keystone Urology Specialists

Lancaster, Pennsylvania, 17601

Recruiting

University of Pennsylvania - Perelman Center for Advanced Medicine - Penn Urology

Philadelphia, Pennsylvania, 19104

Recruiting

University of Pittsburgh Medical Center - Shadyside Medical Building

Pittsburgh, Pennsylvania, 15232

Recruiting

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572

Recruiting

The Conrad Pearson Clinic - Wolf River Office (Urology Center of the South)

Germantown, Tennessee, 38138

Recruiting

Urology Austin

Austin, Texas, 78759

Recruiting

Urology Clinics of North Texas PLLC (Dallas)

Dallas, Texas, 75231

Recruiting

Houston Metro Urology - Memorial City

Houston, Texas, 77027

Recruiting

Houston Methodist Hospital (Houston)

Houston, Texas, 77030

Recruiting

Urology of Virginia

Virginia Beach, Virginia, 23462

Recruiting