A phase 3, randomised, multi-center, open label trial to evaluate the safety and efficacy of intravesical nadofaragene firadenovec alone or in combination with chemotherapy (gemcitabine and docetaxel) or immunotherapy (pembrolizumab) in subjects with high-grade Bacillus Calmette-Guerin therapy (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC)
High-risk Bacillus Calmette-Guerin (BCG)-unresponsive non-muscle-invasive bladder cancer (NMIBC) with carcinoma in situ(CIS) with or without papillary tumours
Investigational medicinal product(s)
KEYTRUDA 25 mg/mL concentrate for solution for infusionADSTILADRINGEMCITABINEDOCETAXEL
Eligibility
Age group
65+ years, 18-64 years
Sex
Female, Male
Primary endpoint
Complete response ([CR] at any time from first treatment defined as absence of high-grade (HG) recurrence)
Official registry record
This page summarises publicly available CTIS data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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