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A Study Comparing Standard Treatments in People With Non-Muscle Invasive Bladder Cancer (NMIBC)

RecruitingPhase 3

COMparative Prospective Assessment Through Clinically Integrated Randomized Trials Evaluating Intravesical Treatments: The COMPARE IT Trial

Who can join

Ages 21 and older · All sexes

Full eligibility criteria
Inclusion Criteria:

* 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 Criteria:

* Opting for treatment with radical cystectomy
* Currently receiving treatment on a clinical trial of an experimental therapy for NMIBC
* Prior exposure to nadofaragene firadenovec

About the study

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).

What is being tested

Sponsor: Memorial Sloan Kettering Cancer Center · Participants: 125 · Started: Apr 11, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06929286

Locations in the U.S.

MarylandJohns Hopkins University (Data Collection Only), Baltimore (Not yet recruiting)
New JerseyMemorial Sloan Kettering Basking Ridge (Consent Only), Basking Ridge
Memorial Sloan Kettering Monmouth (Consent Only), Middletown
Memorial Sloan Kettering Bergen (Consent Only), Montvale
New YorkMemorial Sloan Kettering Suffolk - Commack (Consent Only), Commack
Memorial Sloan Kettering Westchester (Consent Only), East White Plains
Columbia University (Data Collection Only), New York (Not yet recruiting)
Memorial Sloan Kettering Cancer Center (All Protocol Activities), New York
Memorial Sloan Kettering Nassau (Consent Only), Uniondale

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.