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

StatusRecruiting
PhasePhase 3
Started2025-04-11
View on ClinicalTrials.gov ↗

Amendment history

2026-08-19
Study Status, Eligibility v5
Eligibility criteria-1 characters
[...] ong as there is evidence/suspicion of recurrent disease (by positiveurinary cytology, imaging, or cystoscopy) within 12 months of last [...]
2026-07-30
Study Status, Eligibility, Contacts/Locations v4
Eligibility criteria+326 characters
Inclusion Criteria: 21 years of age or older Being treated for high-grade NMIBC (Tis, Ta, or T1) withunder onethe care of the participating treating urologists One or more prior [...] 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 intr [...] [...]
Study sitesdetails revised at 3 of 9 sites
2026-05-07
Study Status, Eligibility, Contacts/Locations v3
Study sites1→9
Eligibility criteria-7 characters
[...] Ta, or T1) with one of the participating treating urologists at MSK One or more prior induction course of BCG at any point in t [...]
2025-10-28
2 amendments v1-v2
2 re-verifications since 2025-06-27, no change to tracked fields
2025-04-14
Original filing
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).
Trial Details
NCT Number NCT06929286
Lead Sponsor Memorial Sloan Kettering Cancer Center
Conditions Non-Muscle Invasive Bladder Cancer
Enrollment 125 participants
Start Date 2025-04-11
Primary Completion 2028-04 (estimated)
Study Completion 2028-04 (estimated)
Updated on ClinicalTrials.gov 2026-08-20