NCT06545955From ClinicalTrials.govRecruiting

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

A Phase 3, Randomised, Multi-center, Open Label Trial to Evaluate the Safety and Efficacy of Intravesical Nadofaragene Firadenovec Alone or in Combination With Chemotherapy or Immunotherapy in Participants With High-grade Bacillus Calmette-Guerin Therapy (BCG) Unresponsive Non-muscle Invasive Bladder Cancer (NMIBC)

Non-muscle Invasive Bladder Cancer With Carcinoma in Situ

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Ferring Pharmaceuticals
Enrolment target: 250
Started: 1 October 2024
Main results due: 30 June 2028
Study sites: 80
Registry updated: 25 September 2026

Can you take part?

Aged 18 years and over.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

Inclusion Criteria:

* Diagnosed, as documented, with carcinoma in situ (CIS) ±Ta/T1 high-grade disease.

  * For T1 disease biopsies should contain muscle fibres.
* Unresponsive to ≥2 courses of Bacillus Calmette-Guerin (BCG) therapy within the last 12 months. BCG-unresponsive refers to participants with high-grade non-muscle invasive bladder cancer (NMIBC) who are unlikely to benefit from and who will not be receiving further intravesical BCG. The term "BCG-Unresponsive" includes participants who did not respond to BCG treatment and have a persistent high-grade recurrence within 12 months after BCG was initiated, and those who despite an initial complete response to BCG, relapse with CIS within 12 months of their last intravesical treatment with BCG or relapse with high-grade Ta/T1 NMIBC within 6 months of their last intravesical treatment with BCG. The following criteria define the participants who may be included in the trial:

  * Have received at least 2 courses of BCG within a 12 month period - defined as at least 5 of 6 induction BCG instillations and at least 2 of 3 instillations of maintenance BCG, or at least 2 of 6 instillations of a second induction course, where maintenance BCG is not given.

    o Exception: those who have T1 high-grade disease at 1st evaluation after induction BCG alone (at least 5 of 6 doses) may qualify in the absence of disease progression
  * At the time of tumour recurrence, participants with CIS alone or high-grade Ta/T1 with CIS should be within 12 months of last exposure to BCG
  * No maximum limit to the amount of BCG administered
  * All visible papillary tumours must be resected and those with persistent T1 disease on transurethral resection of bladder tumour (TURBT) should undergo an additional re-TURBT within 14 to 70 days prior to beginning trial treatment. Obvious areas of CIS should also be fulgurated
* Eastern Cooperative Oncology Group (ECOG) status ≤2
* Aged ≥18 years at the time of consent
* Available for the whole duration of the trial
* Life expectancy \>2 years, in the opinion of the investigator
* Absence of concomitant upper tract urothelial carcinoma or urothelial carcinoma within the prostatic urethra. Freedom from upper tract disease (if clinically indicated) as indicated by no evidence of upper tract tumour by either intravenous pyelogram, retrograde pyelogram, computed tomography (CT) scan with or without urogram, or magnetic resonance imaging (MRI) with or without urogram performed within 6 months of enrolment. Absence of locally advanced disease as assessed by CT scan or MRI
* Participants who elect not to undergo cystectomy
* Participants with prostate cancer on active surveillance at low risk for progression are permitted to be included into the trial at the discretion of the investigator
* Females of reproductive potential must have a negative highly sensitive urine or serum pregnancy test upon entry into this trial and be willing to use highly effective contraception during treatment with the investigational medicinal product and for 6 months following the last dose. Otherwise, female participants must be post-menopausal (no menstrual period for a minimum of 12 months, as confirmed by follicle-stimulating hormone levels) or surgically sterile
* Male subjects must be willing to use a male condom and effective contraception during sex throughout the treatment period and for 3 months following the last dose.

Exclusion Criteria:

* Current or previous evidence of muscle-invasive (muscularis propria) or metastatic disease presented at the screening visit. Examples of increased risk of muscle-invasive disease include but are not limited to:

  * Presence of lymphovascular invasion and / or micropapillary, sarcomatoid, plasmacytoid and / or neuroendocrine disease as shown in the histology of the biopsy sample
  * Participants with CIS+T1 disease accompanied by the presence of hydronephrosis secondary to the primary tumour
* Current systemic therapy for bladder cancer other than investigational medicinal products used in randomisation arm
* Current or prior investigational treatment for BCG-unresponsive NMIBC or any other investigational drug (drug used in a clinical trial, i.e drug used in a Ferring sponsored non interventional study does not apply) within 1 month prior to screening
* Current or prior pelvic external beam radiotherapy within 2 years of screening
* Prior treatment with nadofaragene firadenovec at any time
* Prior systemic therapy for bladder cancer at any time
* Prior intravesical chemotherapy for the treatment of BCG-unresponsive NMIBC

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(80)

Center for Neurosciences
Tucson, Arizona, United States
Recruiting
Arkansas Urology, North Little Rock
Little Rock, Arkansas, United States
Recruiting
American Institute of Research
Los Angeles, California, United States
Recruiting
USC Kenneth Norris Jr Cancer Hospital
Los Angeles, California, United States
Recruiting
University of California, Irvine
Orange, California, United States
Recruiting
Genesis Research, LLC - San Diego
San Diego, California, United States
Recruiting
Advent Health
Denver, Colorado, United States
Recruiting
Colorado Urology - St. Anthony Hospital Campus
Lakewood, Colorado, United States
Recruiting
Yale School of Medicine
New Haven, Connecticut, United States
Recruiting
Medstar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Recruiting
Sarasota Memorial Healthcare System
Sarasota, Florida, United States
Recruiting
Emory University
Atlanta, Georgia, United States
Recruiting
Georgia Urology
Atlanta, Georgia, United States
Recruiting
Boise VA Medical Center
Boise, Idaho, United States
Recruiting
NextStage Clinical Research
Lisle, Illinois, United States
Recruiting
Indiana University
Indianapolis, Indiana, United States
Recruiting
Wichita Urology Group
Wichita, Kansas, United States
Recruiting
Anne Arundel Urology, PA
Annapolis, Maryland, United States
Recruiting
Chesapeake Urology Research Associates
Hanover, Maryland, United States
Recruiting
The Urology Group P.C.
Southhaven, Mississippi, United States
Recruiting
Atlantic Health
Morristown, New Jersey, United States
Recruiting
Roswell Park Cancer Institute
Buffalo, New York, United States
Recruiting
Great Lakes Physician PC d/b/a Western new York Urology Associates
Cheektowaga, New York, United States
Recruiting
Northwell Health -The Arthur Smith Institute for Urology
Lake Success, New York, United States
Recruiting
Veterans Affairs New York Harbor Healthcare System - Manhattan VA Medical Center
New York, New York, United States
Recruiting
James J. Peters VA Medical Center
The Bronx, New York, United States
Recruiting
University of Cincinnati
Cincinnati, Ohio, United States
Recruiting
OSU Arthur James Cancer Hospital
Columbus, Ohio, United States
Recruiting
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
Recruiting
Keystone Urology Specialists
Lancaster, Pennsylvania, United States
Recruiting
University of Pennsylvania - Perelman Center for Advanced Medicine - Penn Urology
Philadelphia, Pennsylvania, United States
Recruiting
University of Pittsburgh Medical Center - Shadyside Medical Building
Pittsburgh, Pennsylvania, United States
Recruiting
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Recruiting
The Conrad Pearson Clinic - Wolf River Office (Urology Center of the South)
Germantown, Tennessee, United States
Recruiting
Urology Associates, P.C.
Nashville, Tennessee, United States
Recruiting
Urology Austin
Austin, Texas, United States
Recruiting
Urology Clinics of North Texas PLLC (Dallas)
Dallas, Texas, United States
Recruiting
University of Texas Southwestern Medical Center - Urology Clinic
Dallas, Texas, United States
Recruiting
Houston Methodist Hospital (Houston)
Houston, Texas, United States
Recruiting
Virginia Mason Medical Center
Seattle, Washington, United States
Recruiting
Prostate Cancer Centre
Calgary, Alberta, Canada
Recruiting
Research St. Joseph's- Hamilton/St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada
Recruiting
University Health Network UHN - Princess Margaret Cancer Centre
Toronto, Ontario, Canada
Recruiting
Centre Hospitalier de L'Universite de Montreal
Montreal, Quebec, Canada
Recruiting
Krajska Nemocnice Liberec
Liberec, Liberec Region, Czechia
Recruiting
Fakultní Thomayerova Nemocnice
Prague, Prague, Czechia
Recruiting
Fakultni nemocnice v Motole
Prague, Prague, Czechia
Recruiting
Androgeos, spol. s r.o.
Prague, Prague, Czechia
Recruiting
Kromerizska Nemocnice A S
Kroměříž, Zlín, Czechia
Recruiting
Aarhus University Hospital
Aarhus, Central Jutland, Denmark
Recruiting
CHU Clermont Ferrand - Hopital Gabriel Montpied
Clermont-Ferrand, Auvergne-Rhône-Alpes, France
Recruiting
Hospices Civils de Lyon - Edouard Herriot Hosp.
Lyon, Auvergne-Rhône-Alpes, France
Recruiting
CHU Toulouse - Hopital Rangueil
Toulouse, Huate-Garonne, France
Recruiting
CHU Nantes - Hotel Dieu
Nantes, Nantes, France
Recruiting
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, New Aquitaine, France
Recruiting
Centre Hospitalier Universitaire De Nimes (Nîmes)
Nîmes, Occitanie, France
Recruiting
Centre Hospitaliser Universitaire de Lyon Sud
Lyon, Rhone.Alpe, France
Recruiting
Hopital La Pitie Salpetriere
Paris, France
Recruiting
APHP - Hopital Bichat
Paris, Île-de-France Region, France
Recruiting
IN-VIVO Bydgoszcz
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Recruiting

Showing 60 of 80 sites — filter to narrow it down. 80 of the 80 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06545955. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

Not the right study?

Answer three questions and see the studies recruiting near you, in plain language.

Find a study for me