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Taking people in ItalyPhase 3

Tests nadofaragene firadenovec against observation in bladder cancer

Compares nadofaragene firadenovec with observation in adults with intermediate-risk bladder cancer.

Key facts

Who runs it
Ferring Pharmaceuticals
Where
Rome and Rozzano, ItalySee the 2 sitesAlso in 9 other countries, 117 sites
Trial code
Registry title
Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Status
Recruiting
Phase
Phase 3
People taking part
454 people, planned
Started
1 Oct 2024
Expected to end
30 Sept 2032
Type of study
Interventional, 2 groupsOne group gets no study treatment, for comparison.
Treatments tested
  • Nadofaragene Firadenovec
Record updated
12 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with intermediate risk non-muscle invasive bladder cancer who recently had the tumor removed. It compares nadofaragene firadenovec with observation.

Age
18 years or older
Sex
All sexes can join.
Disease stage
Intermediate risk non-muscle invasive bladder cancer (IR NMIBC), as defined by the AUA/SUO Guideline (2020). Examples: recurrence within 1 year of low-grade Ta, solitary low-grade Ta larger than 3 cm (1.2 in), multifocal low-grade Ta, solitary high-grade Ta of 3 cm (1.2 in) or less, or low-grade T1.
Earlier treatment
Must have had an adequate transurethral resection of bladder tumor (TURBT) within 60 days before randomization.

Main reasons for not taking part

  • Current or previous muscle invasive or metastatic disease
  • High risk NMIBC, such as high-grade T1, carcinoma in situ or any BCG failure in high-grade disease
  • Low risk NMIBC, such as a first low-grade solitary Ta of 3 cm (1.2 in) or less

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit; High risk NMIBC defined as:
  • Recurrence of low-grade solitary Ta ≤3 cm >12 months from previous occurrence
  • Any Bacillus Calmette-Guérin (BCG) failure in high-grade subject
  • Papillary urothelial neoplasm of low malignant potential
  • High-grade T1
  • Any recurrent, high-grade Ta
  • High-grade Ta >3 cm (or multifocal)
  • Any carcinoma in situ (CIS)
  • Any variant histology
  • Any prostatic urethral involvement; Low risk NMIBC defined as:
  • First occurrence of low-grade solitary Ta ≤3 cm

Where in Italy

Also in 9 other countries, 117 sites

  • I.F.O. Istituti Fisioterapici OspitalieriRome, ItalyTaking people
  • Humanitas Mirasole S.p.A.Rozzano, ItalyTaking people

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • Arm 1 Nadofaragene FiradenovecTreatment being tested

    Participants in the nadofaragene firadenovec arm will receive quarterly instillations with nadofaragene firadenovec for 24 months. For these subjects, the disease evaluation visits will occur within 2 weeks prior to the investigation medicinal products instillation visits.

    Treatment: Nadofaragene Firadenovec

  • Arm 2 - ObservationNo study treatment, for comparison

    Subjects will be followed based on the surveillance schedule of the AUA/SUO guideline (quarterly) over the 24 months treatment period. .

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
A Phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Plain-language title
Tests nadofaragene firadenovec against observation in bladder cancerGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
12 November 2026