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.
Sponsored by UroGen Pharma Ltd. · Phase 3, Interventional, and Treatment
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).
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.
Has intermediate-risk disease, defined as having 1 or 2 of the following:
Has adequate organ and bone marrow function as determined by routine laboratory tests as below:
Exclusion Criteria:
History of:
Patients will receive 6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
Drug: UGN-102
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
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
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
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
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
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
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
Number of Participants With Post-baseline PCS Chemistry Values
The number of patients with each type of event is summarized.
Time frame: 6 months
| Milestone | UGN-102 |
|---|---|
| Started | 240 |
| Completed | 43 |
| Not completed | 197 |
| Withdrew: Ongoing in the study | 171 |
| Withdrew: Withdrawal by subject | 10 |
| Withdrew: Lost to follow-up | 7 |
| Withdrew: Adverse event | 3 |
| Withdrew: Noncompliance | 1 |
| Withdrew: Physician decision | 1 |
| Withdrew: Other reason | 4 |
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.
| percentage of participants | UGN-102 |
|---|---|
| Complete Response Rate (CRR) | 76.7 (70.8 to 81.9) |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
| Participants | UGN-102 |
|---|---|
| Any TEAEs | 137 |
| Any serious TEAEs | 29 |
| Any TEAEs of special interest | 100 |
The number of patients with each type of event is summarized.
| Participants | UGN-102 |
|---|---|
| Hemoglobin < 0.8 × lower limit of normal and > 20% decrease from baseline | 8 |
| Hemoglobin > 1.3 × upper limit of normal (ULN) and > 30% increase from baseline | 0 |
| Lymphocytes < 0.5 × 10^9/L | 1 |
| Lymphocytes > 20 × 10^9/L | 0 |
| Neutrophils < 1.0 × 10^9/L | 1 |
| Platelets < 75 × 10^9/L | 1 |
| Platelets ≥ 700 × 10^9/L | 0 |
| Leukocytes ≤ 2.8 × 10^9/L | 2 |
| Leukocytes ≥ 16.0 × 10^9/L | 5 |
The number of patients with each type of event is summarized.
| Participants | UGN-102 |
|---|---|
| Alanine aminotransferase > 3 × ULN | 1 |
| Aspartate aminotransferase > 3 × ULN | 1 |
| Bilirubin > 1.5 × ULN | 6 |
| Creatinine > 194 μmol/L | 8 |
| Gamma glutamyl transferase > 2.5 × ULN | 11 |
| Potassium < 3.0 mmol/L | 0 |
| Potassium > 5.5 mmol/L | 20 |
| Sodium ≤ 130 mmol/L | 1 |
| Sodium > 150 mmol/L | 0 |
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.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| UGN-102 | 3/240 (1.3%) | 29/240 (12.1%) | 129/240 (53.8%) |
| Event | UGN-102 |
|---|---|
| Atrial fibrillationCardiac disorders | 2/240 |
| COVID-19Infections and infestations | 2/240 |
| Urinary retentionRenal and urinary disorders | 2/240 |
| Angina pectorisCardiac disorders | 1/240 |
| Atrioventricular block second degreeCardiac disorders | 1/240 |
| Cardiac failureCardiac disorders | 1/240 |
| Cardiac failure acuteCardiac disorders | 1/240 |
| Cardiac failure congestiveCardiac disorders | 1/240 |
| Sinus node dysfunctionCardiac disorders | 1/240 |
| Fournier's gangreneInfections and infestations | 1/240 |
| Event | UGN-102 |
|---|---|
| DysuriaRenal and urinary disorders | 54/240 |
| HaematuriaRenal and urinary disorders | 20/240 |
| Urinary tract infectionInfections and infestations | 17/240 |
| PollakiuriaRenal and urinary disorders | 16/240 |
| FatigueGeneral disorders | 13/240 |
| Urinary retentionRenal and urinary disorders | 11/240 |
| Urethral stenosisRenal and urinary disorders | 11/240 |
| ConstipationGastrointestinal disorders | 9/240 |
| Micturition urgencyRenal and urinary disorders | 8/240 |
| NauseaGastrointestinal disorders | 8/240 |
All patients who received any dose of UGN-102.
| Age, Categorical(Participants) | UGN-102 |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 78 |
| >=65 years | 162 |
| Age, Continuous(years) | UGN-102 |
|---|---|
| Median | 70 (30 to 92) |
| Sex: Female, Male(Participants) | UGN-102 |
|---|---|
| Female | 93 |
| Male | 147 |
| Ethnicity (NIH/OMB)(Participants) | UGN-102 |
|---|---|
| Hispanic or Latino | 3 |
| Not Hispanic or Latino | 237 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | UGN-102 |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 2 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 3 |
| White | 234 |
| More than one race | 0 |
| Unknown or Not Reported | 1 |
| Region of Enrollment(Participants) | UGN-102 |
|---|---|
| Bulgaria | 85 |
| United States | 41 |
| Latvia | 38 |
| Georgia | 20 |
| Serbia | 18 |
| Estonia | 14 |
| Spain | 8 |
| Lithuania | 7 |
| Poland | 7 |
| Austria | 2 |
| Previous Low-grade Non-muscle Invasive Bladder Cancer (LG-NMIBC) Episode(s)(Participants) | UGN-102 |
|---|---|
| Yes | 229 |
| No | 11 |
| Previous LG-NMIBC Episode(s) Within 1 Year(Participants) | UGN-102 |
|---|---|
| Yes | 124 |
| No | 116 |
5 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
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UroGen Pharma Ltd.