A Study Comparing Standard Treatments in People With Non-Muscle Invasive Bladder Cancer (NMIBC)
NCT ID: NCT06929286
Last Updated: 2025-10-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
125 participants
INTERVENTIONAL
2025-04-11
2028-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Nadofaragene firadenovec
The patient will receive nadofaragene firadenovec.
Nadofaragene Firadenovec
For patients randomized to receive nadofaragene firadenovec, the patient will receive nadofaragene firadenovec as of normal saline instilled intravesically every 3 months for up to 12 months.
Best usual care
For patients randomized to receive best usual care, the combination of intravesical GemDoce is the current standard of care at MSK for most patients with BCG failure.
Gemcitabine
gemcitabine instilled intravesically for 1 h, then drained completely out of the bladder
Docetaxel
followed by docetaxel instilled intravesically for 1 h. This is given once weekly for 6 weeks for induction. Those who have a complete response typically proceed with once-monthly instillations of GemDoce for up to 24 months as maintenance therapy
Interventions
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Nadofaragene Firadenovec
For patients randomized to receive nadofaragene firadenovec, the patient will receive nadofaragene firadenovec as of normal saline instilled intravesically every 3 months for up to 12 months.
Gemcitabine
gemcitabine instilled intravesically for 1 h, then drained completely out of the bladder
Docetaxel
followed by docetaxel instilled intravesically for 1 h. This is given once weekly for 6 weeks for induction. Those who have a complete response typically proceed with once-monthly instillations of GemDoce for up to 24 months as maintenance therapy
Eligibility Criteria
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Inclusion Criteria
* 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 Criteria
* Currently enrolled in a clinical trial of an experimental therapy for NMIBC
* Prior exposure to nadofaragene firadenovec
21 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Eugene Pietzak, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, United States
Countries
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Central Contacts
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Bernard Bochner, MD
Role: CONTACT
Facility Contacts
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Eugene Pietzak, MD
Role: primary
Bernard Bochner, MD
Role: backup
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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25-069
Identifier Type: -
Identifier Source: org_study_id
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