This is a global, randomized, controlled, open-label Phase 3 study designed to assess the long-term efficacy and safety of UGN-102 (mitomycin) for intravesical solution with or without (±) transurethral resection of bladder tumors (TURBT) versus TURBT alone for the treatment of patients with low grade intermediate risk non-muscle-invasive bladder cancer (LG IR NMIBC).
Eligible patients will be randomized in a 1:1 ratio to UGN-102 ± TURBT or TURBT alone.
Randomization will be stratified by the presence of a previous LG NMIBC episode within 1 year
of the current diagnosis (yes or no). Starting at Day 1, patients randomized to the UGN-102 ±
TURBT group will receive 6 once-weekly intravesical instillations of UGN-102 and patients
randomized to the TURBT alone group will undergo TURBT.
Patients in both treatment groups will return to the clinic at approximately 3 months after
the initiation of treatment (7 weeks ± 1 week after the last weekly instillation for the
UGN-102 ± TURBT group and 12 weeks ± 1 week after TURBT for the TURBT alone group) to
determine response to treatment. Patients determined to have a complete response (CR) will
receive no further treatment and will enter the follow-up period of the study. Patients
determined to have a non-complete response (NCR) will undergo TURBT of any remaining lesions
and will then enter the follow-up period of the study.
During the follow-up period, patients will return to the clinic every 3 months to determine
durability of response. Patients will remain on study until completion of all follow-up
visits (approximately 24 months after the initiation of treatment) or until recurrence or
death is documented, whichever occurs first. Patients determined to have a protocol-defined
recurrence at any follow-up or unscheduled visit will be considered to have completed the
study and released to the care of their treating physician.
The study is event-driven and patients may be followed beyond 24 months or additional
patients may be enrolled to achieve the target number of events required for the study.
|Overal Status||Start Date||Phase||Study Type|
|Recruiting||January 2021||Phase 3||Interventional|
Primary Outcome 1 - Measure: Disease-free survival (DFS)
Primary Outcome 1 - Time Frame: Up to 24 months
1. Capable of giving signed informed consent which includes compliance with the
requirements and restrictions listed in the informed consent form (ICF) and in the
2. Patient who has newly diagnosed or historic LG NMIBC (Ta) histologically confirmed by
cold cup biopsy at screening or within 8 weeks of screening.
3. 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).
4. Negative voiding cytology for high grade (HG) disease within 6 weeks of screening.
5. Has adequate organ and bone marrow function as determined by the following routine
- 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.
6. Has no evidence of active urinary tract infection (UTI).
7. 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
1. History of carcinoma in situ (CIS) on preliminary cystoscopy within 5 years of
2. Received Bacillus Calmette-Guérin (BCG) treatment for urothelial carcinoma (UC) within
previous 1 year.
3. History of HG papillary UC in the past 2 years.
4. Known allergy or sensitivity to mitomycin that in the investigator's opinion cannot be
5. Clinically significant urethral stricture that would preclude passage of a urethral
6. History of pelvic radiotherapy.
7. History of:
- Neurogenic bladder;
- Active urinary retention;
- Any other condition that would prohibit normal voiding.
8. Past or current muscle invasive (ie, T2, T3, T4) or metastatic UC or concurrent upper
9. Current tumor grading of T1.
10. 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.
11. History of prior treatment with an intravesical chemotherapeutic agent except for a
single dose of chemotherapy immediately post any previous TURBT.
12. Has previously participated in a study in which they received UGN-102.
13. Has participated in a study with an investigational agent or device within 30 days of
Minimum Age: 18 Years
Maximum Age: N/A
Healthy Volunteers: No
Name: Sandip Prasad, MD
Role: Principal Investigator
Affiliation: Atlantic Health System
Name: John Saviski
|Adult & Pediatric Urology, PC
Omaha, Nebraska 68114
Andrew Trainer, MD
|Great Lakes Physician dba WNY Urology Associates
Cheektowaga, New York 14225
K. Kent Chevli, MD
|Manhattan Medical Research
New York, New York 10016
William Huang, MD
|UNC Chapel Hill Memorial Hospital
Chapel Hill, North Carolina 27599
Matthew Nielsen, MD
|Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
Neal Shore, MD
|Urology San Antonio
San Antonio, Texas 78229
Daniel Saltzstein, MD