In this phase 4 trial (000439), subjects with NMIBC CIS (± high-grade Ta/T1) who have not responded to their first dose of nadofaragene firadenovec (commercial ADSTILADRIN received before trial entry) will be offered reinduction when entering the trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
The investigational medicinal product dose, concentration, and assessments are aligned with nadofaragene firadenovec US prescribing information.
Ferring Investigational Site
Little Rock, Arkansas, United States
Ferring Investigational Site
Atlanta, Georgia, United States
Complete response (CR) achieved at month 3 after nadofaragene firadenovec retreatment
Time frame: at month 3
Maintenance of CR at months 6 after nadofaragene firadenovec retreatment
Time frame: at 6 months after nadofaragene firadenovec retreatment
Maintenance of CR at months 9 after nadofaragene firadenovec retreatment
Time frame: at 9 months after nadofaragene firadenovec retreatment
Maintenance of CR at months 12 after nadofaragene firadenovec retreatment
Time frame: at 12 months after nadofaragene firadenovec retreatment
Durability of CR at months 6 after nadofaragene firadenovec retreatment
No evidence of CIS and/or high-grade Ta/T1
Time frame: at 6 months after nadofaragene firadenovec retreatment
Durability of CR at months 9 after nadofaragene firadenovec retreatment
No evidence of CIS and/or high-grade Ta/T1
Time frame: at 9 months after nadofaragene firadenovec retreatment
Durability of CR at months 12 after nadofaragene firadenovec retreatment
No evidence of CIS and/or high-grade Ta/T1
Time frame: at 12 months after nadofaragene firadenovec retreatment
Muscle-invasive progression of disease up to month 12 after nadofaragene firadenovec retreatment
Time frame: Up to12 months after nadofaragene firadenovec retreatment
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Incidence of cystectomy
Time frame: Up to 12 months after nadofaragene firadenovec retreatment
Time to cystectomy
Time frame: Up to 12 months after nadofaragene firadenovec retreatment
Pathological staging at cystectomy
Time frame: Up to 12 months after nadofaragene firadenovec retreatment