COMparative Prospective Assessment Through Clinically Integrated Randomized Trials Evaluating Intravesical Treatments: The COMPARE IT Trial
Memorial Sloan Kettering Cancer Center
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
- Age range
- 21+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 21 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…
Interventions
- DrugNadofaragene Firadenovec
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.
- DrugGemcitabine
gemcitabine instilled intravesically for 1 h, then drained completely out of the bladder
- DrugDocetaxel
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
Location
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, New York