A Study Comparing Standard Treatments in People With Non-Muscle Invasive Bladder Cancer (NMIBC)
COMparative Prospective Assessment Through Clinically Integrated Randomized Trials Evaluating Intravesical Treatments: The COMPARE IT Trial
Memorial Sloan Kettering Cancer Center
125 participants
Apr 11, 2025
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria7
- years of age or older
- Being treated for high-grade NMIBC (Tis, Ta, or T1) with one of the participating treating urologists at MSK
- One or more prior induction course of BCG at any point in time and judgment by the treating urologist that BCG has failed
- °Any amount of maintenance BCG is allowed
- 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
- °An intravesical agent can include BCG or any other NMIBC treatment
- In the opinion of the treating urologist, there is no contraindication to treatment with nadofaragene firadenovec (i.e. hypersensitivity to IFNa, severe immunosuppression) and there is uncertainty over whether nadofaragene is better than "best usual care"
Exclusion Criteria3
- Opting for treatment with radical cystectomy
- Currently enrolled in a clinical trial of an experimental therapy for NMIBC
- Prior exposure to nadofaragene firadenovec
Interventions
For 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 instilled intravesically for 1 h, then drained completely out of the bladder
followed 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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06929286