UPCC 05825 A Phase 3b, Randomised, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Subjects with Intermediate Risk (IR) Non-Muscle Invasive Bladder Cancer (NMIBC) (ABLE-32)

Investigational Treatment for Intermediate Risk Bladder Cancer

Enrolling By Invitation
18 years or above
All
Phase 3
454 participants needed
1 Location

Brief description of study

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

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Intermediate Risk Non-Muscle Invasive Bladder Cancer
  • Age: 18 years or above
  • Gender: All

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit

High risk NMIBC defined as:

  • High-grade T1
  • Any recurrent, high-grade Ta
  • High-grade Ta >3 cm (or multifocal)
  • Any carcinoma in situ (CIS)
  • Any Bacillus Calmette-Guérin (BCG) failure in high-grade subject
  • Any variant histology
  • Any prostatic urethral involvement

Low risk NMIBC defined as:

  • First occurrence of low-grade solitary Ta ≤3 cm
  • Recurrence of low-grade solitary Ta ≤3 cm >12 months from previous occurrence
  • Papillary urothelial neoplasm of low malignant potential

This study investigates the effects of an investigational medication compared to observation in patients with intermediate risk non-muscle invasive bladder cancer (NMIBC). The study aims to understand how the investigational treatment affects the condition in comparison to standard observation.

Participants in the study will either receive the investigational medication or be placed under observation without any active treatment. The study includes procedures such as regular medical assessments and monitoring to evaluate the condition of the bladder cancer.

  • Who can participate: People with intermediate risk bladder cancer who had a bladder tumor removed in the last 60 days can join.
  • Study details: Participants will undergo regular assessments to monitor their condition.
Updated on 10 Jul 2026. Study ID: 25-0086
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Study is selecting its participants from a population, or group of people, decided on by the researchers in advance.

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