Brief Title: UGN-102 With or Without TURBT in Patients With Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer (LG IR NMIBC)

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Disease-free survival (DFS)

Primary Outcome 1 - Timeframe: Up to 24 months

CONDITION

• Bladder Cancer
• Urothelial Carcinoma
• Urothelial Carcinoma Bladder

ELIGIBILITY

Inclusion Criteria:
Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.

- Patient who has newly diagnosed or historic LG NMIBC (Ta) histologically confirmed by cold cup biopsy at screening or within 8 weeks of screening.
Is at intermediate risk for progression, defined as having 1 or 2 of the following:
Presence of multiple tumors;

- Solitary tumor > 3 cm;

- Recurrence (≥ 1 occurrence of LG NMIBC within 1 year of the current diagnosis).

- Negative voiding cytology for high grade (HG) disease within 6 weeks of screening.
Has adequate organ and bone marrow function as determined by the following routine laboratory tests:
Leukocytes ≥ 3,000 cells per μL;

- Absolute neutrophil count ≥ 1,500 cells per μL;

- Platelets ≥ 100,000 per μL;

- Hemoglobin ≥ 9.0 g/dL;

- Total bilirubin ≤ 1.5 x upper limit of normal (ULN);

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 × ULN;

- Alkaline phosphatase (ALP) ≤ 2.5 × ULN;

- Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min.

- Has no evidence of active urinary tract infection (UTI).

- Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for clinical study participants. Women of childbearing potential (defined as premenopausal women who have not been sterilized), including female patients and female partners of male patients, must be willing to use 2 acceptable forms of effective contraception from enrollment through 6 months post-treatment.
Exclusion Criteria:
History of carcinoma in situ (CIS) on preliminary cystoscopy within 5 years of enrollment.

- Received Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma (UC) within previous 1 year.

- History of HG papillary UC in the past 2 years.

- Known allergy or sensitivity to mitomycin that in the investigator's opinion cannot be readily managed.

- Clinically significant urethral stricture that would preclude passage of a urethral catheter.

- History of pelvic radiotherapy.
History of:
Neurogenic bladder;

- Active urinary retention;

- Any other condition that would prohibit normal voiding.

- Past or current muscle invasive (ie, T2, T3, T4) or metastatic UC or concurrent upper tract UC.

- Current tumor grading of T1.

- Has an underlying substance abuse or psychiatric disorder such that, in the opinion of the investigator, the patient would be unable to comply with the protocol.

- History of prior treatment with an intravesical chemotherapeutic agent except for a single dose of chemotherapy immediately post any previous TURBT.

- Has previously participated in a study in which they received UGN-102.

- Has participated in a study with an investigational agent or device within 30 days of randomization.

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Sandip Prasad, MD

Role: Principal Investigator

Affiliation: Atlantic Health System

Overall Contact

Name: Sandip Prasad, MD

Phone: 646-809-2657, 646 768 9533

Email: christine.lentowski@urogen.com, madlen.malinowski@urogen.com

LOCATION