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

Recruiting now · Phase 3

Conditions studied: Intermediate Risk Non-Muscle Invasive Bladder Cancer

In brief

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

Key facts

Study ID

NCT06510374

Run by

Ferring Pharmaceuticals

People needed

454

Starts

2024-10-01

Expected to finish

2031-06-30

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Urology Associates of Mobile — Mobile, Alabama, United States (enrolling)
• Mayo Clinic Arizona — Phoenix, Arizona, United States (enrolling)
• Center for Neurosciences — Tucson, Arizona, United States (enrolling)
• Arkansas Urology, North Little Rock — Little Rock, Arkansas, United States (enrolling)
• Michael G Oefelein, MD Clinical Trials — Bakersfield, California, United States (enrolling)
• Urology Associates of Central California — Fresno, California, United States (enrolling)
• American Institute of Research — Los Angeles, California, United States (enrolling)
• Urology Center of Southern California — Murrieta, California, United States (enrolling)
• University of California, Irvine — Orange, California, United States (enrolling)
• Providence Saint John's Cancer Institute — Santa Monica, California, United States (enrolling)
• Advent Health — Denver, Colorado, United States (enrolling)
• Medstar Georgetown University Hospital — Washington D.C., District of Columbia, United States (enrolling)
• Mayo Clinic — Jacksonville, Florida, United States (enrolling)
• Advanced Urology institute - Pinellas — Largo, Florida, United States (enrolling)
• Sarasota Memorial Healthcare System — Sarasota, Florida, United States (enrolling)
• Emory University — Atlanta, Georgia, United States (enrolling)
• NextStage Clinical Research — Lisle, Illinois, United States (enrolling)
• Blessing Health System — Quincy, Illinois, United States (enrolling)
• First Urology Research (Jeffersonville) — Jeffersonville, Indiana, United States (enrolling)
• Urology Center of Iowa Research — Clive, Iowa, United States (enrolling)
• Wichita Urology Group — Wichita, Kansas, United States (enrolling)
• University of Kentucky (UK) - Markey Cancer Center — Lexington, Kentucky, United States (enrolling)
• Anne Arundel Urology, PA — Annapolis, Maryland, United States (enrolling)
• Beth Israel Lahey Health-Beth Israel Deaconess Medical Center (BIDMC) — Boston, Massachusetts, United States (enrolling)
• University of South Alabama (USA) Health System - USACM — Mobile, Alabama, United States (enrolling)

Full record on ClinicalTrials.gov

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