A Study Comparing Standard Treatments in People With Non-Muscle Invasive Bladder Cancer (NMIBC)
Recruiting now · Phase 3
Conditions studied: Non-Muscle Invasive Bladder Cancer
In brief
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).
Key facts
- Study ID
- NCT06929286
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 125
- Starts
- 2025-04-11
- Expected to finish
- 2028-04-01
- Last updated by the study team
- 2026-07-31
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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"
You may not qualify if…
- Opting for treatment with radical cystectomy
- Currently receiving treatment on a clinical trial of an experimental therapy for NMIBC
- Prior exposure to nadofaragene firadenovec
Where it is running
- Memorial Sloan Kettering Nassau (Consent Only) — Uniondale, New York, United States (enrolling)
- Memorial Sloan Kettering Basking Ridge (Consent Only) — Basking Ridge, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Monmouth (Consent Only) — Middletown, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Bergen (Consent Only) — Montvale, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Suffolk - Commack (Consent Only) — Commack, New York, United States (enrolling)
- Memorial Sloan Kettering Westchester (Consent Only) — East White Plains, New York, United States (enrolling)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (enrolling)
- Johns Hopkins University (Data Collection Only) — Baltimore, Maryland, United States
- Columbia University (Data Collection Only) — New York, New York, United States
Full record on ClinicalTrials.gov
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