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Study of Nadofaragene Firadenovec for Bladder Cancer

This study is for people with high-grade non-muscle invasive bladder cancer (NMIBC) that has not responded to previous BCG therapy. It is looking at a gene therapy called Nadofaragene Firadenovec, either by itself or combined with chemotherapy (Gemcitabine and Docetaxel) or immunotherapy (Pembrolizumab). The main goal is to see if these treatments can lead to a complete response (meaning the cancer is no longer detectable) within 6 months. You might be able to join if you are 18 or older and have carcinoma in situ (CIS) with or without high-grade Ta/T1 disease, and your cancer has not responded to at least two courses of BCG treatment in the last year. This study aims to enroll about 250 participants.

Study design
This is an interventional study, meaning participants will receive specific treatments. The study aims to enroll 250 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint for measuring complete response is up to 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06545955

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
PHASE3Ages 18+InterventionalTreatment
Ferring Pharmaceuticals
~250 participants
Updated 2026-08-06 on ClinicalTrials.gov
What's tested:Nadofaragene FiradenovecGemcitabineDocetaxelPembrolizumab

At a glance

Recruiting sites
76 of 76 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Complete response
Measured over up to 6 months

Conditions

Non-muscle Invasive Bladder Cancer With Carcinoma in Situ

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Bladder Carcinoma

NCT06545955

Where you'd take part

This study runs at 76 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Advent Health

    Denver, Coloradono site contact published

    Recruiting

  • American Institute of Research

    Los Angeles, Californiano site contact published

    Recruiting

  • Androgeos, spol. s r.o.

    Prague, Prague, Czechiano site contact published

    Recruiting

  • Anne Arundel Urology, PA

    Annapolis, Marylandno site contact published

    Recruiting

  • APHP - Hopital Bichat

    Paris, Île-de-France Region, Franceno site contact published

    Recruiting

  • Arkansas Urology, North Little Rock

    Little Rock, Arkansasno site contact published

    Recruiting

  • Atlantic Health

    Morristown, New Jerseyno site contact published

    Recruiting

  • Boise VA Medical Center

    Boise, Idahono site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Global Clinical Compliance · STUDY_DIRECTOR · Ferring Pharmaceuticals

Who to contact

Ferring Pharmaceuticals
[email protected]
833-548-1402 (US/Canada)
Email the study team

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Eligibility criteria

Inclusion

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.
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

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 trial measures

  • Complete responseup to 6 months

    Complete response (CR) at any time from first treatment (defined as absence of high-grade (HG) recurrence).