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

RecruitingPhase 3Ages 21 Years - anyAllMemorial Sloan Kettering Cancer Center
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In plain words

What the trial is, and whether it could suit you

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).

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Nadofaragene Firadenovec
  • Gemcitabine
  • Docetaxel
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Where

9 sites
Johns Hopkins University (Data Collection Only)
Baltimore, United States
Memorial Sloan Kettering Basking Ridge (Consent Only)
Basking Ridge, United States
Memorial Sloan Kettering Monmouth (Consent Only)
Middletown, United States
Memorial Sloan Kettering Bergen (Consent Only)
Montvale, United States
Memorial Sloan Kettering Suffolk - Commack (Consent Only)
Commack, United States
Memorial Sloan Kettering Westchester (Consent Only)
East White Plains, United States
Columbia University (Data Collection Only)
New York, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, United States

…and 1 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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