TriangleNCT05243550 · CITED IN SOURCE DOCUMENTS
A Phase 3 Single-Arm Study of UGN-102 for Treatment of Low-Grade Intermediate-Risk Non-Muscle Invasive Bladder Cancer
An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.
- Phase
- PHASE3
- Status at capture
- ACTIVE NOT RECRUITING
- Registry last update
- 2026-05-11
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).
Open the original ClinicalTrials.gov record → · Download preserved record
What did the study report?
Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.
Participant flow
Baseline characteristics
Complete Response Rate (CRR)
Duration of Response (DOR) in Patients Who Achieved CR at the 3-month Visit
Durable Complete Response (DCR) Rate in Patients Who Achieved CR at the 3-month Visit
Disease-free Survival (DFS) in Patients Who Achieved CR at the 3-month Visit
Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs of Special Interest
Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Hematology Values
Number of Participants With Post-baseline PCS Chemistry Values
Adverse events
Limitations, agreements, and source contact
Who could take part
- eligibility Criteria
- Inclusion Criteria: 1. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and the protocol. 2. Patient who has LG-NMIBC (Ta) histologically confirmed by cold cup biopsy 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; * 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. 7. Has an anticipated life expectancy of at least the duration of the trial. 8. 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. 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. Clinically significant 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 metastatic 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 biopsy 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 investigational 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 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. 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.
- healthy Volunteers
- false
- minimum Age
- 18 Years
- sex
- ALL
- std Ages
- ADULT
- OLDER_ADULT
Treatment arms and interventions
- arm Groups
- description
- Patients will receive 6 once-weekly intravesical instillations of UGN-102 (75 mg mitomycin).
- intervention Names
- Drug: UGN-102
- label
- UGN-102
- type
- EXPERIMENTAL
- interventions
- arm Group Labels
- UGN-102
- description
- 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.
- name
- UGN-102
- other Names
- UGN-102 (mitomycin) for intravesical solution
- type
- DRUG
Study design
- allocation
- NA
- intervention Model
- SINGLE_GROUP
- masking Info
- masking
- NONE
- primary Purpose
- TREATMENT
Enrollment
- count
- 240
- type
- ACTUAL
Registered outcome plans (not posted results)
- primary Outcomes
- description
- 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.
- measure
- Complete Response Rate (CRR)
- time Frame
- 3 months
- secondary Outcomes
- description
- 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.
- measure
- Duration of Response (DOR) in Patients Who Achieved CR at the 3-month Visit
- time Frame
- Up to 60 months
- description
- 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.
- measure
- Durable Complete Response (DCR) Rate in Patients Who Achieved CR at the 3-month Visit
- time Frame
- Up to 60 months
- description
- 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.
- measure
- Disease-free Survival (DFS) in Patients Who Achieved CR at the 3-month Visit
- time Frame
- Up to 63 months
- description
- 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.
- measure
- Number of Participants With Treatment-emergent Adverse Events (TEAEs), Serious TEAEs, and TEAEs of Special Interest
- time Frame
- Up to 21 months
- description
- The number of patients with each type of event is summarized.
- measure
- Number of Participants With Post-baseline Potentially Clinically Significant (PCS) Hematology Values
- time Frame
- 6 months
- description
- The number of patients with each type of event is summarized.
- measure
- Number of Participants With Post-baseline PCS Chemistry Values
- time Frame
- 6 months
Full study description
- 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).
- 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.
Source references
- references
- citation
- 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
- type
- RESULT
- citation
- 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.
- pmid
- 41880645
- type
- DERIVED
- citation
- 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
- type
- DERIVED
Source notices and limitations
Discovery and provenance
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Preserved source evidence · Not medical advice