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

NCT05243550 | Active Not Recruiting Phase 3 Results FDA Drug

• 1 other identifier: BL011
• Study Type: interventional
• Target: 240
• Locations: 9 countries
• Sites: 60

Brief Summary

This Phase 3, multinational, single-arm study was designed to evaluate the efficacy and safety of UGN-102 as primary chemoablative therapy in patients with recurrent 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 Rate (CRR)

  CRR is defined as the percentage of patients who achieved a complete response (CR) at the 3-month Visit. A patient was considered a CR if there was no detectable disease in the bladder based on visual observation (white light cystoscopy), biopsy of remaining lesions (if applicable), and voiding urine cytology.

  3 months

Secondary Outcomes (6)

• Duration of Response (DOR) in Patients Who Achieved CR at the 3-month Visit

  Up to 60 months

• Durable Complete Response (DCR) Rate in Patients Who Achieved CR at the 3-month Visit

  Up to 60 months

• Disease-free Survival (DFS) in Patients Who Achieved CR at the 3-month Visit

  Up to 63 months

• Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs of Special Interest

  Up to 21 months

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

  6 months

Study Arms (1)

UGN-102

EXPERIMENTAL

Patients will receive 6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).

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 under chilled conditions, with subsequent conversion to a semi-solid gel depot following instillation into the bladder.

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:

• Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and the protocol.
• Patient who has LG-NMIBC (Ta) histologically confirmed by cold cup biopsy at Screening or within 8 weeks before Screening.
• History of LG-NMIBC requiring treatment with transurethral resection of bladder tumors (TURBT). Note: This refers to a previous episode(s) and not to the current episode for which the patient is being screened.
• Has intermediate-risk disease, defined as having 1 or 2 of the following:
• Presence of multiple tumors;
• Solitary tumor \> 3 cm;
• Early or frequent recurrence (≥ 1 occurrence of LG-NMIBC within 1 year of the current diagnosis at the initial Screening Visit).
• Negative voiding cytology for high-grade (HG) disease within 8 weeks before Screening.
• 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 and alanine aminotransferase ≤ 2.5 × ULN;

You may not qualify if:

• Received Bacillus Calmette-Guérin treatment for urothelial carcinoma (UC) within previous 1 year.
• History of HG bladder cancer (papillary or carcinoma in situ) 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:
• Neurogenic bladder;
• Active urinary retention;
• Any other condition that would prohibit normal voiding.
• Past or current muscle invasive bladder cancer (ie, T2, T3, T4) or metastatic UC.
• Current tumor grading of T1.
• Concurrent upper tract UC.
• Evidence of active urinary tract infection that in the Investigator's opinion cannot be treated and resolved prior to biopsy and/or administration of study treatment.
• Is pregnant or breastfeeding.
• 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 in the past 2 years except for a single dose of chemotherapy immediately after any previous TURBT.

Sponsors & Collaborators

• UroGen Pharma Ltd.: lead

Study Sites (65)

Arizona Urology Specialists

Tucson, Arizona, 85704, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92350, United States

Location

Genesis Research

San Diego, California, 92123, United States

Location

Wichita Urology Group

Wichita, Kansas, 67226, United States

Location

John Hopkins University

Baltimore, Maryland, 21218, United States

Location

Chesapeake Urology Research Associates

Hanover, Maryland, 21076, United States

Location

University of Missouri

Columbia, Missouri, 65212, United States

Location

Atlantic Health System

Morristown, New Jersey, 07960, United States

Location

Great Lakes Physician dba WNY Urology Associates

Cheektowaga, New York, 14225, United States

Location

AccuMed Research Associates

Garden City, New York, 11530, United States

Location

Manhattan Medical Research

New York, New York, 10016, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Mount Sinai

New York, New York, 10029, United States

Location

Urology Associates, P.C.

Nashville, Tennessee, 37209, United States

Location

Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location

Spokane Urology, P.S.

Spokane, Washington, 99202, United States

Location

Medical University Vienna, Department of Urology

Vienna, 1090, Austria

Location

Multiprofile Hospital for Active Treatment - Blagoevgrad

Blagoevgrad, 2700, Bulgaria

Location

Multiprofile Hospital for Active Treatment "Dr. Tota Venkova", Gabrovo, Department of Urology

Gabrovo, 5300, Bulgaria

Location

Multiprofile Hospital for Active Treatment "Sveti Nikolai Chudotvorets", Lom

Lom, 3600, Bulgaria

Location

Multiprofile Hospital for Active Treatment "City Clinic - Sveti Georgi"

Montana, 3400, Bulgaria

Location

University Multiprofile Hospital for Active Treatment "Dr. Georgi Stranski", Pleven, Urology Clinic

Pleven, 5800, Bulgaria

Location

University Multiprofile Hospital for Active Treatment "Sveta Marina" - Pleven, Department of Urology

Pleven, 5800, Bulgaria

Location

University Multiprofile Hospital for Active Treatment "Sveti Georgi", Plovdiv

Plovdiv, 4002, Bulgaria

Location

University Multiprofile Hospital for Active Treatment, Plovdiv

Plovdiv, 4003, Bulgaria

Location

Multiprofile Hospital for Active Treatment Park Hospital

Plovdiv, 4109, Bulgaria

Location

University Multiprofile Hospital for Active Treatment 'Kanev', Ruse, Department of Urology

Rousse, 7000, Bulgaria

Location

Multiprofile Hospital for Active Treatment - Shumen, Shumen, Department of Urology

Shumen, 9700, Bulgaria

Location

University Multiprofile Hospital for Active Treatment "Tsaritsa Yoanna - ISUL", Sofia

Sofia, 1527, Bulgaria

Location

University Multiprofile Hospital for Active Treatment and Emergency Medicine "N.I. Pirogov", Sofia, Urology Clinic

Sofia, 1606, Bulgaria

Location

Multiprofile Hospital for Active Treatment - Targovishte

Targovishte, 7700, Bulgaria

Location

Multiprofile Hospital for Active Treatment "Life Hospital" Burgas

Varna, 8008, Bulgaria

Location

Multiprofile Hospital for Active Treatment, Varna part of Military Medical Academy, Clinic of Urology

Varna, 9000, Bulgaria

Location

Multiprofile Hospital for Active Treatment "Sveta Anna", Varna, Urology Clinic

Varna, 9002, Bulgaria

Location

Multiprofile Hospital for Active Treatment "Sveti Pantaleymon", Yambol, Department of Urology

Yambol, 8600, Bulgaria

Location

East Viru Central Hospital, Surgery Clinic

Kohtla-Järve, 31025, Estonia

Location

East Tallinn Central Hospital Ltd., Surgery Clinic, Centre of Urology

Tallinn, 10138, Estonia

Location

West Tallinn Central Hospital Ltd., Department of Urology

Tallinn, 10617, Estonia

Location

North Estonia Medical Centre Foundation Ltd., Surgery Clinic, General and Oncology Urology Centre

Tallinn, 13419, Estonia

Location

Tartu University Hospital, Surgery Clinic, Department of Urology and Kidney Transplantation

Tartu, 50406, Estonia

Location

LTD Central University Clinic After Academic N. Kipshidze

Tbilisi, 0160, Georgia

Location

JSC Jerarsi, Department of Urology

Tbilisi, Georgia

Location

LTD Gidmedi, Urology Department

Tbilisi, Georgia

Location

Pineo Medical Ecosystem Ltd., Department of Urology

Tbilisi, Georgia

Location

Tbilisi State Medical University and Ingorokva High Technology Medical Center University Clinic LTD, Urology Department

Tbilisi, Georgia

Location

Liepajas Regional Hospital, Urology Department

Liepāja, LV-3414, Latvia

Location

P. Stradins Clinical University Hospital, Center for Urology

Riga, LV-1002, Latvia

Location

LLC Riga East University Hospital, Clinic of Urology and Oncologic Urology

Riga, LV-1038, Latvia

Location

Daugavpils Regional Hospital, Urology Department

Riga, LV-5417, Latvia

Location

Hospital of Lithuanian University of Health Sciences Kauno Klinikos

Kaunas, LT-50161, Lithuania

Location

Klaipeda University Hospital

Klaipėda, LT-92288, Lithuania

Location

Vilnius University Hospital Santaros Klinikos

Vilnius, 08661, Lithuania

Location

AKMED

Gliwice, 44-100, Poland

Location

SCM sp. z o.o. (LLC)

Krakow, 31-559, Poland

Location

Clinical Research Center Limited liability company Medic-R Limited partnership

Poznan, 61-737, Poland

Location

Mazovian Oncology Hospital, Subdepartment of Urology

Wieliszew, 05-135, Poland

Location

Clinical Center of Serbia, Clinic of Urology

Belgrade, 11000, Serbia

Location

Clinical Hospital Center Bezanijska Kosa, Clinic of Surgery, Department of Urology

Belgrade, 11080, Serbia

Location

Clinical Hospital Center Zemun, Urology unit

Belgrade, 11080, Serbia

Location

Clinical Center Kragujevac, Clinic of Urology, Nephrology and Dialysis

Kragujevac, 34000, Serbia

Location

Hospital del Mar

Barcelona, 08003, Spain

Location

Hospital de Basurto

Bilbao, 48013, Spain

Location

University Hospital Foundation Jimenez Diaz

Madrid, 28040, Spain

Location

University Hospital 12 de Octubre

Madrid, 28041, Spain

Location

La Paz University Hospital

Madrid, 28046, Spain

Location

Related Publications (2)

• Prasad SM, Shishkov D, Mihaylov NV, Khuskivadze A, Genov P, Terzi V, Kates M, Huang WC, Louie MJ, Raju S, Burger B, Meads A, Schoenberg M. Primary Chemoablation of Recurrent Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer With UGN-102: A Single-Arm, Open-Label, Phase 3 Trial (ENVISION). J Urol. 2025 Feb;213(2):205-216. doi: 10.1097/JU.0000000000004296. Epub 2024 Oct 24.

  PMID: 39446087 RESULT

• Stover AM, Mueller D, Carda-Auten J, Hilton A, Tsurutis V, Smith AB. Perceived Impact on Patient Routines/Responsibilities for Surgery and a Nonsurgical Primary Treatment Option in Recurrent Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer: Findings From the ENVISION Phase 3 Trial. J Urol. 2025 Jul;214(1):18-31. doi: 10.1097/JU.0000000000004511. Epub 2025 Mar 6.

  PMID: 40048558 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: Head of Clinical Development
• Organization: UroGen Pharma

info@urogen.com

+1 855-987-6436

Study Officials

• Sandip Prasad, MD

  Atlantic Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 7, 2022
• First Posted: February 17, 2022
• Study Start: March 1, 2022
• Primary Completion: April 26, 2023
• Study Completion (Estimated): February 1, 2028
• Last Updated: November 4, 2024
• Results First Posted: November 4, 2024

Record last verified: 2024-10

Locations

BU (18); ES (5); US (16); LI (3); LA (4); SE (4); AU (1); PL (4); GE (5)