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NCT06929286PHASE3Recruiting

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

Memorial Sloan Kettering Cancer Center

Start Date

4/11/2025

Completion Date

4/1/2028

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 Criteria

Age Range: 21 years to No maximum

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 positive 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

Interventions

DRUG

Nadofaragene Firadenovec

DRUG

Gemcitabine

DRUG

Docetaxel

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Conditions

Non-Muscle Invasive Bladder Cancer

Locations

Johns Hopkins University (Data Collection Only)

Baltimore, Maryland 21287

United States

Memorial Sloan Kettering Basking Ridge (Consent Only)

Basking Ridge, New Jersey 07920

United States

Memorial Sloan Kettering Monmouth (Consent Only)

Middletown, New Jersey 07748

United States

Memorial Sloan Kettering Bergen (Consent Only)

Montvale, New Jersey 07645

United States

Memorial Sloan Kettering Suffolk - Commack (Consent Only)

Commack, New York 11725

United States

Memorial Sloan Kettering Westchester (Consent Only)

East White Plains, New York 10604

United States

Columbia University (Data Collection Only)

New York, New York 10032

United States

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York 10065

United States

Memorial Sloan Kettering Nassau (Consent Only)

Uniondale, New York 11553

United States