RecruitingPhase 3NCT06510374
Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
A Phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
Sponsor
Ferring Pharmaceuticals
Enrollment
454 participants
Start Date
Oct 1, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
Eligibility
Min Age: 18 Years
Inclusion Criteria8
- 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
- Restage TURBT may be done at the discretion of the investigator
Exclusion Criteria13
- 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
Interventions
DRUGNadofaragene Firadenovec
Vector-based gene therapy for NMIBC treatment to potentiate durable therapeutic responses by interferon (IFN) alfa-2b (IFN-α2b) amplification.
Locations(77)
View Full Details on ClinicalTrials.gov
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NCT06510374