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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
2026-05-11
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 (9)
Johns Hopkins University (Data Collection Only)
Baltimore, Maryland, United States
Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, United States
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, United States
Memorial Sloan Kettering Suffolk - Commack (Consent Only)
Commack, New York, United States
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, United States
Columbia University (Data Collection Only)
New York, New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Memorial Sloan Kettering Nassau (Consent Only)
Uniondale, New York, United States