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

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: high-grade recurrence-free survival

Primary Outcome 1 - Timeframe: up to 24 months

CONDITION

• Non-Muscle Invasive Bladder Cancer

ELIGIBILITY

Inclusion Criteria:
* 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 Criteria:
* Opting for treatment with radical cystectomy

- * Currently enrolled in a clinical trial of an experimental therapy for NMIBC

- * Prior exposure to nadofaragene firadenovec

Gender: All

Minimum Age: 21 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Eugene Pietzak, MD

Role: Principal Investigator

Affiliation: Memorial Sloan Kettering Cancer Center

Overall Contact

Name: Eugene Pietzak, MD, Bernard Bochner, MD

Phone: 646-422-4781, 646-422-4387

Email: [email protected]

LOCATION