A Phase 2b Study of UGN-102 for Low Grade Intermediate Risk Non-Muscle-Invasive Bladder Cancer

NCT03558503 | Completed Phase 2 Results FDA Drug

• 1 other identifier: TC-BC-12
• Study Type: interventional
• Target: 63
• Locations: 2 countries
• Sites: 19

Brief Summary

This Phase 2b, single-arm, multicenter study evaluated the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with low grade intermediate risk non-muscle-invasive bladder cancer (LG IR NMIBC).

Conditions

Bladder Cancer; Urothelial Carcinoma; Urothelial Carcinoma Bladder

Keywords

Non-muscle invasive bladder cancer; Low grade non-muscle invasive bladder cancer; Intermediate risk non-muscle invasive bladder cancer; NMIBC; UGN-102; Mitomycin

Outcome Measures

Primary Outcomes (1)

• Complete Response (CR) Rate for UGN-102 Treatment

  To evaluate the tumor ablative effect of UGN-102 in patients with LG NMIBC. CR rate was defined as the percentage of patients with no detectable disease (NDD) as determined by cystoscopy, for cause biopsy, and urine cytology.

  3 months after the first instillation of UGN-102

Secondary Outcomes (6)

• Durable Complete Response (DCR) Rate

  6, 9, and 12 months after the first instillation of UGN-102

• Number of Participants With Treatment-emergent Adverse Events (TEAEs), Study Drug or Procedure Related TEAEs, TEAEs by Maximum Severity, TEAEs Leading to Treatment Discontinuation, and Serious TEAEs.

  Up to 12 months

• Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Laboratory Values

  Up to 12 months

• Number of Participants With Post-baseline PCS Vital Signs Values

  Up to 12 months

• Number of Participants With Post-baseline Clinically Significant (CS) Physical Examination Findings

  Up to 12 months

Other Outcomes (3)

• Mitomycin Plasma Concentrations

  0 (pre-instillation), 0.5, 1, 2, 3, 4, 5, and 6 hours after the first instillation of UGN-102

• Mitomycin Area Under the Plasma Concentration-time Curve (AUC)

  0 (pre-instillation) to 6 hours after the first instillation of UGN-102

• Mitomycin Maximum Plasma Concentration (Cmax)

  0 (pre-instillation), 0.5, 1, 2, 3, 4, 5, and 6 hours after the first instillation of UGN-102

Study Arms (1)

UGN-102

EXPERIMENTAL

Patients were treated with 6 once-weekly intravesical instillations of UGN-102.

Drug: UGN-102

Interventions

UGN-102 DRUG

UGN-102 consists of mitomycin and sterile hydrogel (a proprietary thermally responsive gel) that is used to reconstitute mitomycin before instillation. The reverse thermal properties of UGN-102 allow for local administration of mitomycin as a liquid, with subsequent conversion to a semi-solid gel depot following instillation into the bladder. The UGN-102 admixture for intravesical instillations contains 75 mg mitomycin in 56 mL admixture (1.33 mg mitomycin per 1 mL).

Also known as: UGN-102 (mitomycin) for intravesical solution

UGN-102

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to sign an informed consent and comply with the protocol.
• Has newly diagnosed or historic LG NMIBC (Ta) histologically confirmed by cold cup biopsy at screening or within 6 weeks of screening.
• Is at intermediate risk of recurrence, 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).
• Has negative voiding cytology for high grade (HG) disease at or within 6 weeks of enrollment.
• Willing to use 2 acceptable forms of effective contraception from enrollment through 6 months post treatment if the participant is female or the female partner of a male participant and is of childbearing potential (defined as premenopausal women who have not been sterilized).
• Has adequate organ and bone marrow function as determined by routine laboratory tests as below:
• Leukocytes ≥ 3,000 per μL;
• Absolute neutrophil count ≥ 1,500 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;

You may not qualify if:

• 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 2 years.
• History of HG papillary UC in the past 2 years.
• Known allergy or sensitivity to mitomycin.
• 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 urothelial carcinoma (UTUC).
• Has participated in a study with an investigational agent or device within 30 days of enrollment.
• History of prior treatment with an intravesical chemotherapeutic agent with the exception of a single dose of chemotherapy immediately after any previous transurethral resection of bladder tumors (TURBT).
• 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.

Sponsors & Collaborators

• UroGen Pharma Ltd.: lead

Study Sites (19)

Mayo Clinic Cancer Center

Phoenix, Arizona, 85054, United States

Location

Arkansas Urology

Little Rock, Arkansas, 72211, United States

Location

Loma Linda University

Loma Linda, California, 92350, United States

Location

Providence Medical Institute

Santa Monica, California, 90404, United States

Location

Clinical Research Center of Florida

Pompano Beach, Florida, 33060, United States

Location

John Hopkins University

Baltimore, Maryland, 21218, United States

Location

Adult & Pediatric Urology, PC

Omaha, Nebraska, 68114, United States

Location

Urology Las Vegas

Las Vegas, Nevada, 89144, United States

Location

Manhattan Medical Research

New York, New York, 10016, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Montefiore Medical Center (Albert Einstein)

New York, New York, 10461, United States

Location

Western New York Urology Associates

New York, New York, 14225, United States

Location

The University of North Carolina

Chapel Hill, North Carolina, 27572, United States

Location

Penn State Hershey State College

Hershey, Pennsylvania, 17033, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Urology Associates, PC

Nashville, Tennessee, 37209, United States

Location

Urology San Antonio

Fredericksburg, Texas, 78233, United States

Location

Carmel Medical Center

Haifa, 3436212, Israel

Location

Rabin Medical Center

Petah Tikva, 49372, Israel

Location

Related Publications (3)

• Chevli KK, Shore ND, Trainer A, Smith AB, Saltzstein D, Ehrlich Y, Raman JD, Friedman B, D'Anna R, Morris D, Hu B, Tyson M, Sankin A, Kates M, Linehan J, Scherr D, Kester S, Verni M, Chamie K, Karsh L, Cinman A, Meads A, Lahiri S, Malinowski M, Gabai N, Raju S, Schoenberg M, Seltzer E, Huang WC. Primary Chemoablation of Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer Using UGN-102, a Mitomycin-Containing Reverse Thermal Gel (Optima II): A Phase 2b, Open-Label, Single-Arm Trial. J Urol. 2022 Jan;207(1):61-69. doi: 10.1097/JU.0000000000002186. Epub 2021 Aug 26.

  PMID: 34433303 RESULT

• Prasad SM, Louie MJ, Burger B, Tsurutis V, Ugwuoke N, Strauss-Ayali D. Pharmacokinetics of UGN-102, an investigational mitomycin-containing reverse thermal gel for the treatment of non-muscle invasive bladder cancer. Cancer Chemother Pharmacol. 2025 Oct 11;95(1):100. doi: 10.1007/s00280-025-04821-5.

  PMID: 41074972 DERIVED

• Stover AM, Basak R, Mueller D, Lipman R, Teal R, Hilton A, Giannone K, Waheed M, Smith AB. Minimal Patient-Reported Side Effects for a Chemoablative Gel (UGN-102) Used as Frontline Treatment in Adults with Nonmuscle-Invasive Bladder Cancer. J Urol. 2022 Sep;208(3):580-588. doi: 10.1097/JU.0000000000002747. Epub 2022 May 31.

  PMID: 35640276 DERIVED

MeSH Terms

Conditions

Urinary Bladder Neoplasms; Carcinoma, Transitional Cell; Non-Muscle Invasive Bladder Neoplasms

Interventions

Mitomycin

Condition Hierarchy (Ancestors)

Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urinary Bladder Diseases; Urologic Diseases; Male Urogenital Diseases; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Mitomycins; Indolequinones; Quinones; Organic Chemicals; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Elyse Seltzer, MD
• Organization: UroGen Pharma

elyse.seltzer@urogen.com

1-646-492-8518

Study Officials

• Elyse Seltzer, MD

  UroGen Pharma

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2018
• First Posted: June 15, 2018
• Study Start: October 15, 2018
• Primary Completion: January 3, 2020
• Study Completion: October 21, 2020
• Last Updated: September 16, 2022
• Results First Posted: July 25, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (17); IL (2)