Recruiting
Phase 3

Nadofaragene Firadenovec vs. Observation

Sponsor:

Ferring Pharmaceuticals

Code:

NCT06510374

Conditions

Intermediate Risk Non-Muscle Invasive Bladder Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nadofaragene Firadenovec

Study Details

Brief 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

Study ID

NCT06510374

Start date

Oct 1, 2024

Status verified date

May, 2026

Completion date

Jun 30, 2031

Anticipated

Primary completion date

Jun 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

454 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm 1 Nadofaragene Firadenovec

Participants in the nadofaragene firadenovec arm will receive quarterly instillations with nadofaragene firadenovec for 24 months. For these subjects, the disease evaluation visits will occur within 2 weeks prior to the investigation medicinal products instillation visits.

no intervention: Arm 2 - Observation

Subjects will be followed based on the surveillance schedule of the AUA/SUO guideline (quarterly) over the 24 months treatment period.

.

Interventions

Nadofaragene Firadenovec

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

Primary outcome measure

  • Recurrence Free survival [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Ferring Pharmaceuticals

833-548-1402disclosure@ferring.com

Locations

University of South Alabama (USA) Health System - USACM

Recruiting

Mobile, Alabama, United States, 36606

Urology Associates of Mobile

Recruiting

Mobile, Alabama, United States, 56608

Mayo Clinic Arizona

Recruiting

Phoenix, Arizona, United States, 85054

Center for Neurosciences

Recruiting

Tucson, Arizona, United States, 85718

Arkansas Urology, North Little Rock

Recruiting

Little Rock, Arkansas, United States, 72211

Michael G Oefelein, MD Clinical Trials

Recruiting

Bakersfield, California, United States, 93301

Urology Associates of Central California

Recruiting

Fresno, California, United States, 93720

American Institute of Research

Recruiting

Los Angeles, California, United States, 90017

Urology Center of Southern California

Recruiting

Murrieta, California, United States, 92563

University of California, Irvine

Recruiting

Orange, California, United States, 92868

Providence Saint John's Cancer Institute

Recruiting

Santa Monica, California, United States, 90404

Advent Health

Recruiting

Denver, Colorado, United States, 80210

Medstar Georgetown University Hospital

Recruiting

Washington D.C., District of Columbia, United States, 20007

Mayo Clinic

Recruiting

Jacksonville, Florida, United States, 32224

Advanced Urology institute - Pinellas

Recruiting

Largo, Florida, United States, 33771

Sarasota Memorial Healthcare System

Recruiting

Sarasota, Florida, United States, 34239

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

NextStage Clinical Research

Recruiting

Lisle, Illinois, United States, 60532

Blessing Health System

Recruiting

Quincy, Illinois, United States, 62301

First Urology Research (Jeffersonville)

Recruiting

Jeffersonville, Indiana, United States, 47130

Urology Center of Iowa Research

Recruiting

Clive, Iowa, United States, 50325

Wichita Urology Group

Recruiting

Wichita, Kansas, United States, 67226

University of Kentucky (UK) - Markey Cancer Center

Recruiting

Lexington, Kentucky, United States, 40536

Anne Arundel Urology, PA

Recruiting

Annapolis, Maryland, United States, 21401

Beth Israel Lahey Health-Beth Israel Deaconess Medical Center (BIDMC)

Recruiting

Boston, Massachusetts, United States, 02115

Mayo Clinic - Rochester Minnesota

Recruiting

Rochester, Minnesota, United States, 55905

Specialty Clinical Research of St. Louis

Recruiting

St Louis, Missouri, United States, 63141

Adult and Pediatric Urology P.C.

Recruiting

Omaha, Nebraska, United States, 68114

Atlantic Health

Recruiting

Morristown, New Jersey, United States, 07960

Albany Medical College

Recruiting

Albany, New York, United States, 10461

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

Recruiting

Cheektowaga, New York, United States, 14225

AccuMed Research Associates

Recruiting

Garden City, New York, United States, 11530

Northwell Health -The Arthur Smith Institute for Urology

Recruiting

Lake Success, New York, United States, 11042

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

Recruiting

New York, New York, United States, 10010

Integrated Medical Professionals, PLLC

Recruiting

New York, New York, United States, 10016

James J. Peters VA Medical Center

Recruiting

The Bronx, New York, United States, 10468

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45267

Oregon Health and Science University (Portland)

Recruiting

Portland, Oregon, United States, 97239

MidLantic Urology

Recruiting

Bala-Cynwyd, Pennsylvania, United States, 19004

Keystone Urology Specialists

Recruiting

Lancaster, Pennsylvania, United States, 17601

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

Recruiting

Philadelphia, Pennsylvania, United States, 19104

University of Pittsburgh Medical Center - Shadyside Medical Building

Recruiting

Pittsburgh, Pennsylvania, United States, 15232

Carolina Urologic Research Center

Recruiting

Myrtle Beach, South Carolina, United States, 29572

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

Recruiting

Germantown, Tennessee, United States, 38138

Urology Austin

Recruiting

Austin, Texas, United States, 78759

Urology Clinics of North Texas PLLC (Dallas)

Recruiting

Dallas, Texas, United States, 75231

Houston Metro Urology - Memorial City

Recruiting

Houston, Texas, United States, 77027

Houston Methodist Hospital (Houston)

Recruiting

Houston, Texas, United States, 77030

Urology of Virginia

Recruiting

Virginia Beach, Virginia, United States, 23462

Spokane Urology PLLC

Recruiting

Spokane, Washington, United States, 99202

Prostate Cancer Centre

Recruiting

Calgary, Alberta, Canada, T2V1P9

G kenneth Jansz Medicine Professional Corporation

Recruiting

Burlington, Ontario, Canada, L7N 3V2

University Health Network UHN - Princess Margaret Cancer Centre

Recruiting

Toronto, Ontario, Canada, M5G 1Z5

More Information

Sponsor

Ferring Pharmaceuticals

Last update posted

Sep 4, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Ferring Pharmaceuticals on 2026-09-04.