Actively Recruiting
COMparative Prospective Assessment Through Clinically Integrated Randomized Trials Evaluating Intravesical Treatments: The COMPARE IT Trial
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-11
125
Participants Needed
9
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are comparing the effectiveness of FDA-approved and NCCN-recommended drug treatments for people with high-grade Non-Muscle Invasive Bladder Cancer (NMIBC). The study focuses on evaluating nadofaragene firadenovec against usual care options, which include gemcitabine with or without docetaxel, mitomycin, re-treatment with BCG, or pembrolizumab. This Phase 3 trial aims to determine which treatment may better prevent cancer recurrence and progression. Participants are randomly assigned to receive either nadofaragene firadenovec or the current standard of care at the study center. Those receiving nadofaragene firadenovec will have it instilled into the bladder every three months for up to 12 months. Patients receiving usual care may get a combination of gemcitabine and docetaxel given intravesically, with an induction phase of weekly treatments for six weeks followed by monthly maintenance for up to 24 months if a complete response is observed. Throughout the study, participants will be monitored for up to 24 months to measure high-grade recurrence-free survival and progression-free survival. Regular assessments will track how well the treatments control cancer and any changes in health. The study's design allows researchers to gather detailed information on treatment outcomes to better understand the benefits and risks of these therapies for NMIBC.
CONDITIONS
Brief Title
A Study Comparing Standard Treatments in People With Non-Muscle Invasive Bladder Cancer (NMIBC)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- In the opinion of the treating urologist, there is no contraindication to treatment with nadofaragene firadenovec and uncertainty over whether nadofaragene is better than best usual care
You will not qualify if you...
- Opting for treatment with radical cystectomy
- Currently enrolled in a clinical trial of an experimental therapy for NMIBC
- Prior exposure to nadofaragene firadenovec
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 24 months
Participants receive either nadofaragene firadenovec instilled into the bladder every 3 months for up to 12 months or a combination of gemcitabine and docetaxel instilled into the bladder once weekly for 6 weeks for induction, followed by monthly instillations for up to 24 months if they respond.
1 visit every 3 months for nadofaragene firadenovec or weekly visits for 6 weeks followed by monthly visits for gemcitabine plus docetaxel
Trial Site Locations
Total: 9 locations
1
Johns Hopkins University (Data Collection Only)
Baltimore, Maryland, United States, 21287
Not Yet Recruiting
2
Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
3
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, New Jersey, United States, 07748
Actively Recruiting
4
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, New Jersey, United States, 07645
Actively Recruiting
5
Memorial Sloan Kettering Suffolk - Commack (Consent Only)
Commack, New York, United States, 11725
Actively Recruiting
6
Memorial Sloan Kettering Westchester (Consent Only)
Harrison, New York, United States, 10604
Actively Recruiting
7
Columbia University (Data Collection Only)
New York, New York, United States, 10032
Not Yet Recruiting
8
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065
Actively Recruiting
9
Memorial Sloan Kettering Nassau (Consent Only)
Uniondale, New York, United States, 11553
Actively Recruiting
Research Team
E
Eugene Pietzak, MD
B
Bernard Bochner, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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