NIPH Clinical Trials Search

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

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Intermediate Risk Non-muscle invasive bladder cancer
Date of first enrollment	28/04/2025
Target sample size	36
Countries of recruitment	United States,Japan,Canada,Japan
Study type	Interventional
Intervention(s)	75mL intravesical instillation of FE999326 at a dose of 3 x 10^11 vp/mL given in a single time, and should remain in the bladder for one hour before being voided. Up to 8 doses of intravesical nadofaragene firadenovec will be instilled quarterly over the 24 months treatment period in the absence of disease recurrence or progression.

Outcome(s)

Primary Outcome	Recurrence-free survival (RFS), defined as the time from the date of randomization to first documented recurrence or progression (as defined in the below table), or death (due to any cause), whichever occurs first during the treatment period (24 months).
Secondary Outcome	Frequency and intensity of adverse events RFS at 12 and 24 months, defined as whether a subject is alive and is documented recurrence and progression-free (as defined for the primary endpoint) at month 12 and 24, respectively

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender
Include criteria	Newly diagnosed or recurrent intermediate risk (IR) non-muscle invasive bladder cancer (NMIBC) at screening 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 intravesical chemotherapy) within 60 days prior to randomization, with 1 of the following confirmed by a diagnostic pathology report (which should indicate whether lamina propria and muscularis propria are present as well as the degree of involvement, if present): 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
Exclude 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-Guerin (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