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

A Randomized, Controlled, Open-Label Study of the Efficacy, Durability, and Safety of UGN-102 With or Without TURBT in Patients With Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer (LG IR NMIBC)


  • Org Study ID: BL006
  • Secondary ID:
  • NCT ID: NCT04688931
  • NCT Alias:
  • Sponsor: UroGen Pharma Ltd. - Industry
  • Source: UroGen Pharma Ltd.

Brief Summary

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).

Detailed Description


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 Outcomes:

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

Primary Outcome 1 - Time Frame: Up to 24 months

Condition:

  • Bladder Cancer
  • Urothelial Carcinoma
  • Urothelial Carcinoma Bladder

Eligibility

Criteria:
Inclusion Criteria:

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
protocol.

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
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.

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
post-treatment.

Exclusion Criteria:

1. History of carcinoma in situ (CIS) on preliminary cystoscopy within 5 years of
enrollment.

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
readily managed.

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

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
tract UC.

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
randomization.
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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: John Saviski

Phone: 610-247-5164

Email: john.saviski@urogen.com

Locations

Facility Status Contact
Adult & Pediatric Urology, PC
Omaha, Nebraska 68114
United States
Recruiting Andrew Trainer, MD
402-397-7989
atrainer@adultpediatricuro.com
Great Lakes Physician dba WNY Urology Associates
Cheektowaga, New York 14225
United States
Recruiting K. Kent Chevli, MD
716-844-5550
kchevli@wnyurology.com
Manhattan Medical Research
New York, New York 10016
United States
Recruiting William Huang, MD
212-480-3333
william.huang@NYUMC.org
UNC Chapel Hill Memorial Hospital
Chapel Hill, North Carolina 27599
United States
Recruiting Matthew Nielsen, MD
919-966-8217
mnielsen@med.unc.edu
Carolina Urologic Research Center
Myrtle Beach, South Carolina 29572
United States
Recruiting Neal Shore, MD
843-449-1010
Nshore@gsuro.com
Urology San Antonio
San Antonio, Texas 78229
United States
Recruiting Daniel Saltzstein, MD
210-617-4116
Daniel.Saltzstein@urologysa.com