A Trial to Evaluate Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade BCG Unresponsive Non-muscle Invasive Bladder Cancer
Recruiting · Phase 3 · NCT06545955
Conditions: Non-muscle Invasive Bladder Cancer With Carcinoma in Situ
At a glance
- Research payments reported, 2025
- $444,055
- U.S. investigators named
- 15
- Sites paid
- 17
- Planned or actual enrollment
- 250
About the trial
- Sponsor
- Ferring Pharmaceuticals
- Tested
- Nadofaragene Firadenovec (drug), Gemcitabine (drug), Docetaxel (drug), Pembrolizumab (drug)
- Dates
- Started 2024-10-01; completion 2030-12-31
- Results posted
- Not yet
The pivotal phase 3 trial (rAd-IFN-CS 003) evaluating the efficacy of nadofaragene firadenovec showed that 55 (53.4%) of 103 subjects with CIS ± high-grade Ta/T1 achieved a complete response (CR) at 3 months. In this trial, the safety and efficacy of intravesical instillation of nadofaragene firadenovec alone or in combination with chemotherapy or immunotherapy will be evaluated in participants with NMIBC CIS (± high-grade Ta/T1).
From ClinicalTrials.gov, last updated 2026-10-30. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Ferring Pharmaceuticals As reported $444,055 in research payments for this study in 2025 (32 payments).
Products named: Adstiladrin
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Siamak Daneshmand, M.D. Urology · Los Angeles, CA
- John J. Kowalczyk, DO Urology · Los Angeles, CA
- William M. Schiff, M.D. Urology · Fresno, CA
- Edward M. Uchio, MD Urology · Orange, CA
- Matthew D. Truesdale, M.D. Urology · Largo, FL
- Vikram M. Narayan, MD Urology · Atlanta, GA
- Anjana L. Ganeshappa, M.D. Urology · Indianapolis, IN
- Philippe Nabbout, MD Urology · Wichita, KS
- Jason M. Hafron, MD Urology · West Bloomfield, MI
- Izak Faiena, MD Urology · Bronx, NY
- John M. Rutkowski, M.D. Urology · Sanborn, NY
- Manish A. Vira, MD Urology · New Hyde Park, NY
- Alberto Martini, MD Urology · Cincinnati, OH
- Laurence H. Belkoff, D.O. Urology · Bala Cynwyd, PA
- Fred E. Ghali, MD Dermatology · Grapevine, TX
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- The Feinstein Institutes for Medical Research $61,000
- Yale University $54,481
- Idaho Veterans Research and Education Foundation Inc $41,428
- University of Cincinnati $40,436
- Uci Health-Orange, CA $34,350
- The Research Foundation for The State University of New York $28,826
- Emory University Hospital, GA $22,418
- Centers for Advanced Urology LLC $22,322
- Wichita Urology Group PA $22,000
- Michigan Institute of Urology PC $21,772
- Advanced Urology Institute LLC $21,772
- Urology Associates of Central California Medical Group Inc $20,850
- University of Southern California $19,905
- Bronx Veterans Medical Research Foundation Inc $18,745
- Sabai LLC $7,250
- Clinical Biosafety Services LLC $4,500
- American Institute of Research $2,000
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.