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Back|NCT06510374Recruiting
Official Title

A Phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer

Phase
Phase 3
Sponsor
Ferring Pharmaceuticals
Enrollment
454
Timeline
Oct 2024 → Jun 2031
About This 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 Criteria

Inclusion Criteria

  • 1Diagnosed with intermediate risk non-muscle invasive bladder cancer (IR NMIBC) as defined by American Urological Association (AUA)/Society of Urologic Oncology \[SUO\] Guideline (2020)
  • 2Has undergone adequate transurethral resection of bladder tumor (TURBT; with or without peri-operative chemotherapy) within 60 days prior to randomization:
  • 3Recurrence within 1 year, low-grade Ta
  • 4Solitary low-grade Ta \>3 cm
  • 5Low-grade Ta, multifocal
  • 6Solitary high-grade Ta, ≤3 cm
  • 7Low-grade T1
  • 8Restage TURBT may be done at the discretion of the investigator

Exclusion Criteria

  • 1Current or previous evidence of muscle invasive (muscularis propria) or metastatic disease presented at the screening visit
  • 2High risk NMIBC defined as:
  • 3High-grade T1
  • 4Any recurrent, high-grade Ta
  • 5High-grade Ta \>3 cm (or multifocal)
  • 6Any carcinoma in situ (CIS)
  • 7Any Bacillus Calmette-Guérin (BCG) failure in high-grade subject
  • 8Any variant histology
  • 9Any prostatic urethral involvement
  • 10Low risk NMIBC defined as:
  • 11First occurrence of low-grade solitary Ta ≤3 cm
  • 12Recurrence of low-grade solitary Ta ≤3 cm \>12 months from previous occurrence
  • 13Papillary urothelial neoplasm of low malignant potential

Locations

52 sites participating in this study

Emory University

Atlanta, Georgia 30322

Recruiting

University of South Alabama (USA) Health System - USACM

Mobile, Alabama 36606

Recruiting

Urology Associates of Mobile

Mobile, Alabama 56608

Recruiting
Data sourced from ClinicalTrials.govView on ClinicalTrials.gov →