A Phase 3 Study of UGN-102 for Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer

(ATLAS Trial)

Recruiting at141 trial locations

Overseen by Sandip Prasad, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: UroGen Pharma Ltd.

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This global, randomized, controlled, open-label Phase 3 study was 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).

Research Team

Sandip Prasad, MD

Principal Investigator

Atlantic Health System

Eligibility Criteria

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.

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.

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.

Treatment Details

Interventions

• TURBT (Procedure)
• UGN-102 (Anti-tumor antibiotic)

Participant Groups

Group I: UGN-102 ± TURBT Experimental Treatment 2 Interventions

6 weekly intravesical instillations of UGN-102 (75 mg mitomycin) starting on Day 1 + TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the start of treatment with UGN-102).

Group II: TURBT Alone Active Control 1 Intervention

TURBT on Day 1 + repeat TURBT for patients with NCR due to residual LG disease at the 3-month Visit (3 months after the initial TURBT).

Who Is Running the Clinical Trial?

UroGen Pharma Ltd.

Lead Sponsor

Trials

20

Recruited

1,400+