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A Study Comparing Standard Treatments in People With Non-Muscle Invasive Bladder Cancer (NMIBC)
Sponsor: 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).
Official title: COMparative Prospective Assessment Through Clinically Integrated Randomized Trials Evaluating Intravesical Treatments: The COMPARE IT Trial
Key Details
Gender
All
Age Range
21 Years - Any
Study Type
INTERVENTIONAL
Enrollment
125
Start Date
2025-04-11
Completion Date
2028-04
Last Updated
2025-10-30
Healthy Volunteers
No
Conditions
Interventions
Nadofaragene 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.
Gemcitabine
gemcitabine instilled intravesically for 1 h, then drained completely out of the bladder
Docetaxel
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)
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States