ClinicalTrials.gg
Active, not recruitingNCT05243550ENVISIONUpdated May 11, 2026Results posted

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

A Phase 3 interventional study of UGN-102 in Bladder Cancer, Urothelial Carcinoma and Urothelial Carcinoma Bladder, sponsored by UroGen Pharma Ltd.. Active, not recruiting at 65 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-11.

Primary conditionNon-Muscle Invasive Bladder NeoplasmsRegistry: Urinary Bladder NeoplasmsReclassifiedWhy we changed it
Registry
Urinary Bladder Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Non-Muscle Invasive Bladder Neoplasms
Why
  1. The study's title name Non-Muscle Invasive Bladder Neoplasms, a narrower term within Urinary Bladder Neoplasms.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by UroGen Pharma Ltd. · Phase 3, Interventional, and Treatment

Help build ClinicalTrials.gg — short surveys, remote interviews or testing, in your language. Take part →

Phase
Phase 3
Study type
Interventional
Enrollment
240
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 16 studies testing mitomycin in Non-Muscle Invasive Bladder Neoplasms — 5 open to participants now, 6 under way, 2 of them phase 3. Mitomycin · Non-Muscle Invasive Bladder Neoplasms.

Enrollment
5th of 16
240 · median 96
Started
2022
the only one that year
Phase 3
6 of 16
1 open now
Registered
11th of 16
by date
Lead sponsor
5 of 16
UroGen Pharma Ltd.

Among the 16 studies testing mitomycin in Non-Muscle Invasive Bladder Neoplasms, this one is the 5th largest by enrollment, is the only one that started in 2022, is one of 6 in phase 3, and was the 11th registered.

Non-Muscle Invasive Bladder Neoplasms

294 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 126 are open to participants now.

Browse Non-Muscle Invasive Bladder Neoplasms studies →

Open to participants now

5 of the 16 studies testing mitomycin in Non-Muscle Invasive Bladder Neoplasms are open now, in 7 countries. Recruiting first, the newest first:

By country, each count listing its studies:

All 5 open studies →

About mitomycin

Mitomycin: first FDA approval 1981 (MUTAMYCIN). What it is approved for, and how studies give it, is on its page →

Who these studies take

Of the 92 Non-Muscle Invasive Bladder Neoplasms studies recruiting now, 77 (84%) set no upper age limit and 5 (5%) stop at 75 or younger; 2 take children under 18; 2 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 16 studies testing mitomycin in Non-Muscle Invasive Bladder Neoplasms, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • 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
04

In context

Non-Muscle Invasive Bladder Neoplasms Reclassified

294 studies on the registry are indexed under Non-Muscle Invasive Bladder Neoplasms; 126 are open to participants now.

This study's enrollment of 240 is above the median of 62 across 231 interventional studies indexed under Non-Muscle Invasive Bladder Neoplasms.

Browse Non-Muscle Invasive Bladder Neoplasms studies →

Lead sponsor

UroGen Pharma Ltd. is the lead sponsor of 19 studies on the registry; 3 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 5 (83%) have results posted.

Compared within Non-Muscle Invasive Bladder Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Urinary Bladder Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Capable of giving written , which includes compliance with the requirements and restrictions listed in the informed consent form and the protocol.
  2. Patient who has LG-NMIBC (Ta) confirmed by cold cup at Screening or within 8 weeks before Screening.
  3. 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.
  4. 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).
  5. Negative voiding cytology for high-grade (HG) disease within 8 weeks before Screening.
  6. Has adequate organ and bone marrow function as determined by routine laboratory tests as below:

    • Leukocytes ≥ 3,000 per μL;
    • ≥ 1,500 per μL;
    • ≥ 100,000 per μL;
    • ≥ 9.0 g/dL;
    • Total ≤ 1.5 x (ULN);
    • and alanine aminotransferase ≤ 2.5 × ULN;
    • Alkaline phosphatase ≤ 2.5 × ULN;
    • Estimated ≥ 30 mL/min.
  7. Has an anticipated of at least the duration of the trial.
  8. use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women of (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

Exclusion Criteria:

  1. Received Bacillus Calmette-Guérin treatment for urothelial carcinoma (UC) within previous 1 year.
  2. History of HG bladder cancer (papillary or carcinoma in situ) in the past 2 years.
  3. Known allergy or sensitivity to mitomycin that in the Investigator's opinion cannot be readily managed.
  4. urethral stricture that would preclude passage of a urethral catheter.
  5. History of:

    • Neurogenic bladder;
    • Active urinary retention;
    • Any other condition that would prohibit normal voiding.
  6. Past or current muscle invasive bladder cancer (ie, T2, T3, T4) or UC.
  7. Current tumor grading of T1.
  8. Concurrent upper tract UC.
  9. Evidence of active urinary tract infection that in the Investigator's opinion cannot be treated and resolved prior to and/or administration of study treatment.
  10. Is pregnant or breastfeeding.
  11. 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.
  12. 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.
  13. Has participated in a study with an agent or device within 30 days of enrollment.
  14. Has previously participated in a study in which they received UGN-102.
  15. Has any other active 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.
  16. 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.
Terms in these criteria, in plain language(17)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Histologically or cytologically confirmed

The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).

Your pathology report is the document that shows this.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Absolute neutrophil count (ANC)

The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.

It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

Hemoglobin (Hb)

The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).

Bilirubin

A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.

Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

ALT and AST (liver enzymes)

Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.

Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Metastases

Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

06

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
240 participants (actual)

Study arms

  • Experimental
    UGN-102

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

    Drug: UGN-102

Interventions

  • DrugUGN-102

    Drug pages: Mitomycin · SR Mitomycin 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.

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

07

What researchers measure

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.

    Time frame: 3 months

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 6 months

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

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

    Time frame: 6 months

08

Results

Posted Nov 4, 2024

Participant flow

Participant flow — Overall Study
MilestoneUGN-102
Started240
Completed43
Not completed197
Withdrew: Ongoing in the study171
Withdrew: Withdrawal by subject10
Withdrew: Lost to follow-up7
Withdrew: Adverse event3
Withdrew: Noncompliance1
Withdrew: Physician decision1
Withdrew: Other reason4

Outcome measures

PrimaryComplete 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.

Time frame:
3 months
Reported as:
Number · percentage of participants
Complete Response Rate (CRR)
percentage of participantsUGN-102
Complete Response Rate (CRR)76.7 (70.8 to 81.9)
SecondaryDuration 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.

Time frame:
Up to 60 months

Results for this outcome have not been posted.

SecondaryDurable 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.

Time frame:
Up to 60 months

Results for this outcome have not been posted.

SecondaryDisease-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.

Time frame:
Up to 63 months

Results for this outcome have not been posted.

SecondaryNumber 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.

Time frame:
Up to 21 months
Reported as:
Count of participants · Participants
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs of Special Interest
ParticipantsUGN-102
Any TEAEs137
Any serious TEAEs29
Any TEAEs of special interest100
SecondaryNumber of Participants With Post-baseline Potentially Clinically Significant (PCS) Hematology Values

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

Time frame:
6 months
Reported as:
Count of participants · Participants
Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Hematology Values
ParticipantsUGN-102
Hemoglobin < 0.8 × lower limit of normal and > 20% decrease from baseline8
Hemoglobin > 1.3 × upper limit of normal (ULN) and > 30% increase from baseline0
Lymphocytes < 0.5 × 10^9/L1
Lymphocytes > 20 × 10^9/L0
Neutrophils < 1.0 × 10^9/L1
Platelets < 75 × 10^9/L1
Platelets ≥ 700 × 10^9/L0
Leukocytes ≤ 2.8 × 10^9/L2
Leukocytes ≥ 16.0 × 10^9/L5
SecondaryNumber of Participants With Post-baseline PCS Chemistry Values

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

Time frame:
6 months
Reported as:
Count of participants · Participants
Number of Participants With Post-baseline PCS Chemistry Values
ParticipantsUGN-102
Alanine aminotransferase > 3 × ULN1
Aspartate aminotransferase > 3 × ULN1
Bilirubin > 1.5 × ULN6
Creatinine > 194 μmol/L8
Gamma glutamyl transferase > 2.5 × ULN11
Potassium < 3.0 mmol/L0
Potassium > 5.5 mmol/L20
Sodium ≤ 130 mmol/L1
Sodium > 150 mmol/L0

Adverse events

Collected over Up to 21 months. 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.. Non-serious events are listed at a 3% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
UGN-1023/240 (1.3%)29/240 (12.1%)129/240 (53.8%)
Most frequent serious events
Showing 10 of 36
Most frequent serious events
EventUGN-102
Atrial fibrillationCardiac disorders2/240
COVID-19Infections and infestations2/240
Urinary retentionRenal and urinary disorders2/240
Angina pectorisCardiac disorders1/240
Atrioventricular block second degreeCardiac disorders1/240
Cardiac failureCardiac disorders1/240
Cardiac failure acuteCardiac disorders1/240
Cardiac failure congestiveCardiac disorders1/240
Sinus node dysfunctionCardiac disorders1/240
Fournier's gangreneInfections and infestations1/240
Most frequent other events
Most frequent other events
EventUGN-102
DysuriaRenal and urinary disorders54/240
HaematuriaRenal and urinary disorders20/240
Urinary tract infectionInfections and infestations17/240
PollakiuriaRenal and urinary disorders16/240
FatigueGeneral disorders13/240
Urinary retentionRenal and urinary disorders11/240
Urethral stenosisRenal and urinary disorders11/240
ConstipationGastrointestinal disorders9/240
Micturition urgencyRenal and urinary disorders8/240
NauseaGastrointestinal disorders8/240

Baseline characteristics

All patients who received any dose of UGN-102.

Age, Categorical
Age, Categorical(Participants)UGN-102
<=18 years0
Between 18 and 65 years78
>=65 years162
Age, Continuous
Age, Continuous(years)UGN-102
Median70 (30 to 92)
Sex: Female, Male
Sex: Female, Male(Participants)UGN-102
Female93
Male147
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)UGN-102
Hispanic or Latino3
Not Hispanic or Latino237
Unknown or Not Reported0
Race (NIH/OMB)
Race (NIH/OMB)(Participants)UGN-102
American Indian or Alaska Native0
Asian2
Native Hawaiian or Other Pacific Islander0
Black or African American3
White234
More than one race0
Unknown or Not Reported1
Region of Enrollment
Region of Enrollment(Participants)UGN-102
Bulgaria85
United States41
Latvia38
Georgia20
Serbia18
Estonia14
Spain8
Lithuania7
Poland7
Austria2
Previous Low-grade Non-muscle Invasive Bladder Cancer (LG-NMIBC) Episode(s)
Previous Low-grade Non-muscle Invasive Bladder Cancer (LG-NMIBC) Episode(s)(Participants)UGN-102
Yes229
No11
Previous LG-NMIBC Episode(s) Within 1 Year
Previous LG-NMIBC Episode(s) Within 1 Year(Participants)UGN-102
Yes124
No116

5 further baseline measures are reported on the registry.

09

Study locations

65 sites
10

References and documents

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 ↗

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

11

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Mar 2022 to primary completion in Apr 2023, 13 months.

Results were first posted in Nov 2024, 1 year 6 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 7, 2022
First posted
Feb 17, 2022
StartActual
Mar 1, 2022
Primary completionActual
Apr 26, 2023
CompletionEst.
Mar 2028
Results first posted
Nov 4, 2024
Last update
May 11, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
12

Registry details

Key details

Study ID
NCT05243550
Lead sponsor
UroGen Pharma Ltd.
Responsible party
Sponsor
First posted
Feb 17, 2022
Start date
Mar 1, 2022
Primary completion
Apr 26, 2023
Completion
Mar 2028 (estimated)
Results posted
Nov 4, 2024
Last update
May 11, 2026

Study contacts

Sandip Prasad, MD
principal investigator · Atlantic Health System

Oversight

FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Mitomycin · SR Mitomycin Intravesical Solution

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