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
NCT ID: NCT06545955
Last Updated: 2025-11-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
250 participants
INTERVENTIONAL
2024-10-01
2030-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nadofaragene firadenovec
Nadofaragene firadenovec (intravesical)
Nadofaragene Firadenovec
vector-based gene therapy for NMIBC treatment to potentiate durable therapeutic responses by interferon (IFN) alfa-2b (IFN-α2b) amplification. It is a non-replicating recombinant adenovirus serotype 5 vector containing a transgene encoding the human IFN-α2b gene.
Nadofaragene firadenovec + gemcitabine & docetaxel
Nadofaragene firadenovec (intravesical), and sequential gemcitabine and docetaxel (intravesical)
Nadofaragene Firadenovec
vector-based gene therapy for NMIBC treatment to potentiate durable therapeutic responses by interferon (IFN) alfa-2b (IFN-α2b) amplification. It is a non-replicating recombinant adenovirus serotype 5 vector containing a transgene encoding the human IFN-α2b gene.
Gemcitabine
Intravesical Gemcitabine chemotherapy, used in combination with Docetaxel.
Docetaxel
Intravesical Docetaxel chemotherapy, used in combination with Gemcitabine.
Nadofaragene firadenovec + pembrolizumab
Nadofaragene firadenovec (intravesical), and pembrolizumab (IV infusion)
Nadofaragene Firadenovec
vector-based gene therapy for NMIBC treatment to potentiate durable therapeutic responses by interferon (IFN) alfa-2b (IFN-α2b) amplification. It is a non-replicating recombinant adenovirus serotype 5 vector containing a transgene encoding the human IFN-α2b gene.
Pembrolizumab
Pembrolizumab is an FDA approved immune checkpoint inhibitor which restores the anti-tumour immune response by blocking the programmed cell death protein 1 (PD-1). Pembrolizumab is administered via intravenous (IV) infusion.
Interventions
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Nadofaragene Firadenovec
vector-based gene therapy for NMIBC treatment to potentiate durable therapeutic responses by interferon (IFN) alfa-2b (IFN-α2b) amplification. It is a non-replicating recombinant adenovirus serotype 5 vector containing a transgene encoding the human IFN-α2b gene.
Gemcitabine
Intravesical Gemcitabine chemotherapy, used in combination with Docetaxel.
Docetaxel
Intravesical Docetaxel chemotherapy, used in combination with Gemcitabine.
Pembrolizumab
Pembrolizumab is an FDA approved immune checkpoint inhibitor which restores the anti-tumour immune response by blocking the programmed cell death protein 1 (PD-1). Pembrolizumab is administered via intravenous (IV) infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 use highly effective contraception and a condom during sexual contact regardless of partner's childbearing potential, until 3 months following the last trial drug administration.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Global Clinical Compliance
Role: STUDY_DIRECTOR
Ferring Pharmaceuticals
Locations
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American Institute of Research
Los Angeles, California, United States
USC Kenneth Norris Jr Cancer Hospital
Los Angeles, California, United States
University of California, Irvine
Orange, California, United States
Genesis Research, LLC - San Diego
San Diego, California, United States
Advent Health
Denver, Colorado, United States
Yale School of Medicine
New Haven, Connecticut, United States
Sarasota Memorial Healthcare System
Sarasota, Florida, United States
Emory University
Atlanta, Georgia, United States
Georgia Urology
Atlanta, Georgia, United States
Boise VA Medical Center
Boise, Idaho, United States
Indiana University
Indianapolis, Indiana, United States
Wichita Urology Group
Wichita, Kansas, United States
Chesapeake Urology Research Associates
Hanover, Maryland, United States
Michigan Institute of Urology
Troy, Michigan, United States
Atlantic Health
Morristown, New Jersey, United States
Roswell Park Cancer Institute
Buffalo, New York, United States
Great Lakes Physician PC d/b/a Western new York Urology Associates
Cheektowaga, New York, United States
Northwell Health -The Arthur Smith Institute for Urology
Lake Success, New York, United States
Premier Medical Group of the Hudson Valley
Poughkeepsie, New York, United States
James J. Peters VA Medical Center
The Bronx, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
MidLantic Urology
Bala-Cynwyd, Pennsylvania, United States
Keystone Urology Specialists
Lancaster, Pennsylvania, United States
University of Pennsylvania - Perelman Center for Advanced Medicine - Penn Urology
Philadelphia, Pennsylvania, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Houston Methodist Hospital (Houston)
Houston, Texas, United States
Fakultní Thomayerova Nemocnice
Prague, Prague, Czechia
Clinical Research Center Spółka z ograniczoną odpowiedzialnością Medic-R Sp.k.
Poznan, Wielkopolska, Poland
Medical Concierge Centrum Medyczne
Warsaw, Woj. Mazowieckie, Poland
Instituto de Investigacion Valdecilla (IDIVAL) / Hospital universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario Reina Sofia
Córdoba, Cordoba, Spain
Hospital Universitario de A Coruna
A Coruña, Galicia, Spain
Clinica Universidad de Navarra - Madrid
Madrid, Madrid, Spain
Hospital Universitario 12 De Octubre (Madrid)
Madrid, Madrid, Spain
Clinica Universidad de Navarra - Pamplona
Pamplona, Navarre, Spain
Countries
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Central Contacts
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Ferring Pharmaceuticals
Role: CONTACT
Phone: +1862-286-5200 (not US/Canada)
Email: [email protected]
Facility Contacts
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Role: primary
Other Identifiers
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U1111-1299-0176
Identifier Type: OTHER
Identifier Source: secondary_id
000434
Identifier Type: -
Identifier Source: org_study_id