Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer

Phase 3

Recruiting

• Conditions: Intermediate Risk Non-Muscle Invasive Bladder Cancer
• Interventions: Drug: Nadofaragene Firadenovec

• Registration Number: NCT06510374
• Lead Sponsor: Ferring Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-15
• Study First Submitted QC: 2024-07-15
• Study First Posted: 2024-07-19
• Status Verified: 2024-10
• Study Start: 2024-10-01
• Last Update Submitted: 2024-11-25
• Last Update Posted: 2024-11-26
• Primary Completion: 2028-08-01
• Study Completion: 2031-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 454

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 complete 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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 1 Nadofaragene Firadenovec	Nadofaragene Firadenovec	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.

Primary Outcome Measures

Name	Time	Method
Recurrence Free survival	24 months	Recurrence-free survival, defined as the time from the date of randomization to the date of first documented recurrence, progression or death (due to any cause), whichever occurs first during the treatment period.

Secondary Outcome Measures

Name	Time	Method
Adverse Events	up to 24 months	Frequency and intensity of adverse events will be recorded from the signed informed consent for participation in the trial up to month 24
Recurrence Free Survival at 12 Months	12 months	Recurrence free survival at 12 months defined as whether a subject is alive and is documented recurrence and progression-free for up to 12 months
Recurrence Free Survival at 24 Months	24 Months	Recurrence free survival at 24 months defined as whether a subject is alive and is documented recurrence and progression-free for up to 24 months

Trial Locations

Locations (1)

Ferring Investigational Site; 🇺🇸 Virginia Beach, Virginia, United States