The purpose of this study is to compare the effectiveness of different FDA-approved/NCCN-recommended drug treatments for NMIBC. In particular, the FDA-approved drug nadofaragene firadenovec will be compared to usual care with other NCCN-recommended standard treatments for NMIBC (gemcitabine with or without docetaxel, mitomycin, re-treatment with BCG, or pembrolizumab).
21 years of age or older
Being treated for high-grade NMIBC (Tis, Ta, or T1) under the care of the participating treating urologists
One or more prior induction course of BCG at any point in time and judgment by the treating urologist that BCG has failed
In the previous 12 months, receipt of at least one instillation of any intravesical agent (induction or maintenance) or one administration of systemic therapy for NMIBC treatment
Opting for treatment with radical cystectomy
Currently receiving treatment on a clinical trial of an experimental therapy for NMIBC
Prior exposure to nadofaragene firadenovec
Parallel
Nadofaragene Firadenovec
DrugFor patients randomized to receive nadofaragene firadenovec, the patient will receive nadofaragene firadenovec as of normal saline instilled intravesically every 3 months for up to 12 months.
Gemcitabine
Druggemcitabine instilled intravesically for 1 h, then drained completely out of the bladder
Docetaxel
Drugfollowed by docetaxel instilled intravesically for 1 h. This is given once weekly for 6 weeks for induction. Those who have a complete response typically proceed with once-monthly instillations of GemDoce for up to 24 months as maintenance therapy
high-grade recurrence-free survival
The time from the initiation of treatment to the detection of recurrence of high-grade bladder cancer (biopsy-proven intravesical recurrence or distant metastasis). Biopsy proven high grade intravesical recurrence will be based on the MSK pathology review of the bladder tissue samples.
Progression-free survival
Disease progression is defined as the development of muscle-invasive disease (stage ≥T2), lymph node or distant metastasis, or death without documented disease progression.
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