A Phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
A Phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants With Intermediate Risk Non-Muscle Invasive Bladder Cancer
A phase 3b, Randomized, Controlled Trial of Nadofaragene Firadenovec vs. Observation in Participants with Intermediate Risk Non-Muscle Invasive Bladder Cancer (IR NMIBC)
Inclusion Criteria:
Diagnosed with intermediate risk non-muscle invasive bladder cancer (IR NMIBC) as defined by American Urological Association (AUA)/Society of Urologic Oncology [SUO] Guideline (2020)
Has undergone adequate transurethral resection of bladder tumor (TURBT; with or without peri-operative chemotherapy) within 60 days prior to randomization:
Recurrence within 1 year, low-grade Ta
Solitary low-grade Ta >3 cm
Low-grade Ta, multifocal
Solitary high-grade Ta, ≤3 cm
Low-grade T1
Exclusion Criteria:
High risk NMIBC defined as:
Low risk NMIBC defined as:
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Washington D.C., District of Columbia 20007, United States
Lexington, Kentucky 40536, United States
Boston, Massachusetts 02115, United States
Creve Coeur, Missouri 63141, United States
Cheektowaga, New York 14225, United States
Lake Success, New York 11042, United States
New York, New York 10010, United States
Philadelphia, Pennsylvania 19104, United States
Pittsburgh, Pennsylvania 15232, United States
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