Comparing Treatments for Early Bladder Cancer That Has Not Spread Into the Muscle
Compares nadofaragene firadenovec with other standard bladder treatments in adults with bladder cancer.
Plain-language title generated from the registry record
Registry title: A Study Comparing Standard Treatments in People With Non-Muscle Invasive Bladder Cancer (NMIBC)
Key facts
- Where
- Baltimore, Basking Ridge, Commack, East White Plains, Middletown, Montvale, New York, and Uniondale, United StatesSee the 9 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 21 or older with high-grade non-muscle invasive bladder cancer whose earlier BCG treatment has failed.
- Age
- 21 years or older
- Sex
- All sexes can join.
- Disease stage
- High-grade non-muscle invasive bladder cancer (Tis, Ta, or T1), treated by a participating urologist.
- Earlier treatment
- At least one earlier induction course of BCG, which the urologist judges has failed. Any amount of maintenance BCG is allowed. In the past 12 months, at least one bladder instillation of any agent or one systemic treatment for this cancer.
Main reasons for not taking part
- Choosing to have the bladder removed (radical cystectomy)
- Currently in a trial of an experimental treatment for this cancer
- Already treated with nadofaragene firadenovec
- Urologist sees a reason not to use nadofaragene firadenovec, such as hypersensitivity to IFNa or severe immunosuppression
Read by machine on 9 November 2026.
Where in United States
- Johns Hopkins University (Data Collection Only)Baltimore, United StatesNot yet recruiting
- Memorial Sloan Kettering Basking Ridge (Consent Only)Basking Ridge, United StatesTaking people
- Memorial Sloan Kettering Suffolk - Commack (Consent Only)Commack, United StatesTaking people
- Memorial Sloan Kettering Westchester (Consent Only)East White Plains, United StatesTaking people
- Memorial Sloan Kettering Monmouth (Consent Only)Middletown, United StatesTaking people
- Memorial Sloan Kettering Bergen (Consent Only)Montvale, United StatesTaking people
- Columbia University (Data Collection Only)New York, United StatesNot yet recruiting
- Memorial Sloan Kettering Cancer Center (All Protocol Activities)New York, United StatesTaking people
- Memorial Sloan Kettering Nassau (Consent Only)Uniondale, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Memorial Sloan Kettering Cancer Center
- Trial code
- NCT06929286
- Record updated
- 20 August 2026
- Original description
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).Read full original descriptionShow less
COMparative Prospective Assessment Through Clinically Integrated Randomized Trials Evaluating Intravesical Treatments: The COMPARE IT Trial
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).
Inclusion: 21 years of age or older; Being treated for high-grade NMIBC (Tis, Ta, or T1) under the care 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; Up to 15 months from the last instillation is allowed for the treating physician to perform a transurethral resection of bladder tumor (TURBT) so long as there is evidence/suspicion of recurrent disease (by urinary cytology, imaging, or cystoscopy) within 12 months of last exposure to an intravesical agent; 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".
Exclusion: Opting for treatment with radical cystectomy; Currently receiving treatment on a clinical trial of an experimental therapy for NMIBC; Prior exposure to nadofaragene firadenovec.