COMparative Prospective Assessment Through Clinically Integrated Randomized Trials Evaluating Intravesical Treatments: The COMPARE IT Trial
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 21
Healthy Volunteers: f
View:
• 21 years of age or older
• Being treated for high-grade NMIBC (Tis, Ta, or T1) with one 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
• °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
Locations
United States
Maryland
Johns Hopkins University (Data Collection Only)
NOT_YET_RECRUITING
Baltimore
New Jersey
Memorial Sloan Kettering Basking Ridge (Consent Only)
RECRUITING
Basking Ridge
Memorial Sloan Kettering Monmouth (Consent Only)
RECRUITING
Middletown
Memorial Sloan Kettering Bergen (Consent Only)
RECRUITING
Montvale
New York
Memorial Sloan Kettering Suffolk - Commack (Consent Only)
RECRUITING
Commack
Memorial Sloan Kettering Westchester (Consent Only)
RECRUITING
Harrison
Columbia University (Data Collection Only)
NOT_YET_RECRUITING
New York
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
RECRUITING
New York
Memorial Sloan Kettering Nassau (Consent Only)
RECRUITING
Uniondale
Contact Information
Primary
Eugene Pietzak, MD
pietzake@mskcc.org
646-422-4781
Backup
Bernard Bochner, MD
646-422-4387
Time Frame
Start Date:2025-04-11
Estimated Completion Date:2028-04
Participants
Target number of participants:125
Treatments
Experimental: Nadofaragene firadenovec
The patient will receive nadofaragene firadenovec.
Active_comparator: Best usual care
For patients randomized to receive best usual care, the combination of intravesical GemDoce is the current standard of care at MSK for most patients with BCG failure.