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Bladder CancerPhase 3ENVISIONNCT05243550

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

A Phase 3 study testing UGN-102 in people with Bladder Cancer and Urothelial Carcinoma, run by UroGen Pharma Ltd. at 65 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
UGN-102
Could I receive a placebo?
No, everyone receives an active treatment
How many people
240 participants
Where
65 sitesin 10 countries
Study dates
1 Mar 2022to Mar 2028
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
Show all 19Show fewer
  • 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;
  • Alkaline phosphatase ≤ 2.5 × ULN;
  • Estimated glomerular filtration rate ≥ 30 mL/min.
  • Has an anticipated life expectancy of at least the duration of the trial.
  • Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. 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.

Who cannot join

  • 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;
Show all 19Show fewer
  • 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.
  • Has participated in a study with an investigational agent or device within 30 days of enrollment.
  • Has previously participated in a study in which they received UGN-102.
  • Has any other active malignancy requiring treatment with systemic anticancer therapy (eg, chemotherapy, immunotherapy, radiation therapy). Superficial cancers such as cutaneous basal cell or squamous cell carcinomas that can be treated locally are allowed.
  • Has any other clinically significant medical or surgical condition that in the Investigator's opinion could compromise patient safety or the interpretation of study results.

Trial locations and contacts

65 sites in 10 countries.

65 sites in 10 countries

Bulgaria18 sites

  • Multiprofile Hospital for Active Treatment - Blagoevgrad

    Blagoevgrad, 2700

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

    Gabrovo, 5300

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

    Lom, 3600

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

    Montana, 3400

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

    Pleven, 5800

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

    Pleven, 5800

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

    Plovdiv, 4002

  • University Multiprofile Hospital for Active Treatment, Plovdiv

    Plovdiv, 4003

  • Multiprofile Hospital for Active Treatment Park Hospital

    Plovdiv, 4109

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

    Rousse, 7000

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

    Shumen, 9700

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

    Sofia, 1527

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

    Sofia, 1606

  • Multiprofile Hospital for Active Treatment - Targovishte

    Targovishte, 7700

  • Multiprofile Hospital for Active Treatment "Life Hospital" Burgas

    Varna, 8008

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

    Varna, 9000

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

    Varna, 9002

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

    Yambol, 8600

Other trials in Bulgaria

United States16 sites

  • John Hopkins University

    Baltimore, Maryland, 21218

  • Great Lakes Physician dba WNY Urology Associates

    Cheektowaga, New York, 14225

  • University of Missouri

    Columbia, Missouri, 65212

  • AccuMed Research Associates

    Garden City, New York, 11530

  • Chesapeake Urology Research Associates

    Hanover, Maryland, 21076

  • Houston Methodist Research Institute

    Houston, Texas, 77030

  • Loma Linda University Medical Center

    Loma Linda, California, 92350

  • Atlantic Health System

    Morristown, New Jersey, 07960

  • Urology Associates, P.C.

    Nashville, Tennessee, 37209

  • Manhattan Medical Research

    New York, New York, 10016

  • NYU Langone Health

    New York, New York, 10016

  • Mount Sinai

    New York, New York, 10029

  • Genesis Research

    San Diego, California, 92123

  • Spokane Urology, P.S.

    Spokane, Washington, 99202

  • Arizona Urology Specialists

    Tucson, Arizona, 85704

  • Wichita Urology Group

    Wichita, Kansas, 67226

Other trials in United States

Estonia5 sites

  • East Viru Central Hospital, Surgery Clinic

    Kohtla-Järve, 31025

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

    Tallinn, 10138

  • West Tallinn Central Hospital Ltd., Department of Urology

    Tallinn, 10617

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

    Tallinn, 13419

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

    Tartu, 50406

Other trials in Estonia

Georgia5 sites

  • LTD Central University Clinic After Academic N. Kipshidze

    Tbilisi, 0160

  • JSC Jerarsi, Department of Urology

    Tbilisi

  • LTD Gidmedi, Urology Department

    Tbilisi

  • Pineo Medical Ecosystem Ltd., Department of Urology

    Tbilisi

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

    Tbilisi

Other trials in Georgia

Spain5 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital de Basurto

    Bilbao, 48013

  • University Hospital Foundation Jimenez Diaz

    Madrid, 28040

  • University Hospital 12 de Octubre

    Madrid, 28041

  • La Paz University Hospital

    Madrid, 28046

Other trials in Spain

Latvia4 sites

  • Liepajas Regional Hospital, Urology Department

    Liepāja, LV-3414

  • P. Stradins Clinical University Hospital, Center for Urology

    Riga, LV-1002

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

    Riga, LV-1038

  • Daugavpils Regional Hospital, Urology Department

    Riga, LV-5417

Other trials in Latvia

Poland4 sites

  • AKMED

    Gliwice, 44-100

  • SCM sp. z o.o. (LLC)

    Krakow, 31-559

  • Clinical Research Center Limited liability company Medic-R Limited partnership

    Poznan, 61-737

  • Mazovian Oncology Hospital, Subdepartment of Urology

    Wieliszew, 05-135

Other trials in Poland

Serbia4 sites

  • Clinical Center of Serbia, Clinic of Urology

    Belgrade, 11000

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

    Belgrade, 11080

  • Clinical Hospital Center Zemun, Urology unit

    Belgrade, 11080

  • Clinical Center Kragujevac, Clinic of Urology, Nephrology and Dialysis

    Kragujevac, 34000

Other trials in Serbia

Lithuania3 sites

  • Hospital of Lithuanian University of Health Sciences Kauno Klinikos

    Kaunas, LT-50161

  • Klaipeda University Hospital

    Klaipėda, LT-92288

  • Vilnius University Hospital Santaros Klinikos

    Vilnius, 08661

Other trials in Lithuania

Austria1 site

  • Medical University Vienna, Department of Urology

    Vienna, 1090

Other trials in Austria

About this study

Official title: A Phase 3, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of UGN-102 as Primary Chemoablative Therapy in Patients With Low-Grade (LG) Non-Muscle Invasive Bladder Cancer (NMIBC) at Intermediate Risk (IR) of Recurrence

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).

Read the detailed description

Eligible patients received 6 once-weekly intravesical instillations of UGN-102.

All patients returned to the clinic approximately 3 months after the first instillation for determination of response to treatment. Assessment of response was based on visual observation (white light cystoscopy), histopathology of any remaining or new lesions by central pathology lab (if applicable), and interpretation of urine cytology by central pathology lab.

Patients who had a complete response (CR) at the 3-month Visit, defined as having no detectable disease in the bladder, entered the Follow-up Period of the study. Patients who had a non-complete response (NCR) due to residual LG disease underwent investigator-designated standard of care (SOC) treatment of remaining lesions and then entered the Follow-up Period of the study.

During the Follow-up Period, patients return to the clinic every 3 months for up to 24 months (ie, 27 months after the first instillation) for evaluation of response. Patients who remain disease free at the 27-month Visit will continue to be followed every 6 months for up to 36 months (ie, 63 months after the first instillation) or until disease recurrence, disease progression, death, or the study is closed by the sponsor, whichever occurs first.

Patients who had a disease recurrence during the Follow-up Period or a disease progression at any time underwent investigator-designated SOC treatment and had a separate End of Study (EOS) Visit performed. The timing of the EOS Visit was approximately 3 months after SOC treatment of disease recurrence or progression.

Study conduct is ongoing and data are summarized through a cutoff date of 04 Apr 2024. As of the data cutoff date, ongoing patients were followed through at least Study Month 15, with the earliest enrolled patients followed through Study Month 21.

Being tested
UGN-102
Keywords
Non-muscle invasive bladder cancer, Low grade non-muscle invasive bladder cancer, Intermediate risk non-muscle invasive bladder cancer, NMIBC, UGN-102, Mitomycin
Medical subject headings
Urinary Bladder Neoplasms, Carcinoma, Transitional Cell, Non-Muscle Invasive Bladder Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UGN-102Drug

    Also called UGN-102 (mitomycin) for intravesical solution

    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.

Study groups in NCT05243550
Study groupRoleWhat they receive
UGN-102ExperimentalPatients will receive 6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
Receives: Drug: UGN-102

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 3 months

Secondary outcomes (6)

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

    DOR is defined as the time from the first documented CR to the earliest date of recurrence or progression as determined using the date of cystoscopy, for cause biopsy, or cytology, or death due to any cause, whichever occurred first.

    Measured: Up to 60 months

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

    DCR rate at scheduled disease assessment time points is defined as the percentage of patients who had a CR at the 3-month Visit and maintained CR up to that particular follow-up visit.

    Measured: Up to 60 months

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

    DFS is defined as the time from the first instillation to the earliest date of recurrence or progression as determined using the date of cystoscopy, for cause biopsy, or cytology, or death due to any cause, whichever occurred first.

    Measured: Up to 63 months

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

    The number of patients with each type of event is summarized. TEAEs were defined as adverse events (AEs) that started on or after the day of the first instillation of UGN-102 or pre-treatment AEs that worsened during the study.

    Measured: Up to 21 months

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

    The number of patients with each type of event is summarized.

    Measured: 6 months

  6. Number of Participants With Post-baseline PCS Chemistry Values

    The number of patients with each type of event is summarized.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Feb 2022
  2. Study start1 Mar 2022
  3. Primary completion26 Apr 2023
  4. Study completionMar 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
240 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05243550
Sponsor's protocol ID
BL011
Acronym
ENVISION
Status last verified
Apr 2026
First submitted
7 Feb 2022
Last updated
11 May 2026
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 39446087

  • Prasad SM, Shishkov D, Mihaylov NV, Genov P, Terzi V, Kates M, Huang WC, Louie MJ, Burger B, Meads A, Schoenberg M. UGN-102 for Recurrent Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer: 24-Month Duration of Response Results From the Phase 3 ENVISION Trial. J Urol. 2026 Aug;216(2):194-205. doi: 10.1097/JU.0000000000005041. Epub 2026 Mar 25.

    PubMed 41880645

  • 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.

    PubMed 40048558

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing UGN-102 in people with Bladder Cancer and Urothelial Carcinoma, run by UroGen Pharma Ltd. at 65 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in Bulgaria, United States, Estonia, Georgia, Spain and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete Response Rate (CRR) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05243550, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.

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