Status:
RECRUITING
A Study Comparing Standard Treatments in People With Non-Muscle Invasive Bladder Cancer (NMIBC)
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Non-Muscle Invasive Bladder Cancer
Eligibility:
All Genders
21+ years
Phase:
PHASE3
Brief 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 co...
Eligibility Criteria
Inclusion
- 21 years of age or older
- Being treated for high-grade NMIBC (Tis, Ta, or T1) with one of the participating treating urologists at MSK
- 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
- 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
- Opting for treatment with radical cystectomy
- Currently enrolled in a clinical trial of an experimental therapy for NMIBC
- Prior exposure to nadofaragene firadenovec
Key Trial Info
Start Date :
April 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2028
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT06929286
Start Date
April 11 2025
End Date
April 1 2028
Last Update
October 30 2025
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States, 10065