NCT05243550: ENVISION

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

Active, enrolled Phase 3 Results posted Last updated 24 April 2026

What this trial tests

Phase 3 trial testing UGN-102 in Bladder Cancer in 240 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 March 2022

Primary endpoint
26 April 2023

1 March 2028

Quick facts

Lead sponsor	UroGen Pharma Ltd.
Phase	Phase 3
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	240
Start date	1 March 2022
Primary completion	26 April 2023
Estimated completion	1 March 2028
Sites	65 locations across United States, Austria, Bulgaria, Estonia, Georgia, Latvia, Lithuania, Poland

Drugs / interventions tested

• UGN-102 — full drug profile →

Conditions studied

• Bladder Cancer — all drugs for Bladder Cancer →
• Urothelial Carcinoma — all drugs for Urothelial Carcinoma →
• Urothelial Carcinoma Bladder — all drugs for Urothelial Carcinoma Bladder →

Sponsor

UroGen Pharma Ltd. — full company profile →

Who can join

18 and older, any sex, with Bladder Cancer or Urothelial Carcinoma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Complete Response Rate (CRR)
  Time frame: 3 months
  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.

Sponsor's own description

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).

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Hydrogels in the clinic: An update.
   Clegg JR, Adebowale K, Zhao Z, Mitragotri S. · · 2024 · cited 64× · PMID 39545079 · DOI 10.1002/btm2.10680
2. Treatment of Low-grade Intermediate-risk Nonmuscle-invasive Bladder Cancer With UGN-102 ± Transurethral Resection of Bladder Tumor Compared to Transurethral Resection of Bladder Tumor Monotherapy: A Randomized, Controlled, Phase 3 Trial (ATLAS).
   Prasad SM, Huang WC, Shore ND, Hu B, et al · · 2023 · cited 29× · PMID 37548555 · DOI 10.1097/ju.0000000000003645
3. Primary Chemoablation of Recurrent Low-Grade Intermediate-Risk Nonmuscle-Invasive Bladder Cancer With UGN-102: A Single-Arm, Open-Label, Phase 3 Trial (ENVISION).
   Prasad SM, Shishkov D, Mihaylov NV, Khuskivadze A, et al · · 2025 · cited 20× · PMID 39446087 · DOI 10.1097/ju.0000000000004296
4. Treatment Modalities for Non-Muscle Invasive Bladder Cancer: An Updated Review.
   McNall S, Hooper K, Sullivan T, Rieger-Christ K, et al · · 2024 · cited 16× · PMID 38791924 · DOI 10.3390/cancers16101843
5. Hydrogels as advanced drug delivery platforms for cancer immunotherapy: promising innovations and future outlook.
   Mohammadzadeh V, Atapour-Mashhad H, Shahvali S, Salehi B, et al · · 2025 · cited 13× · PMID 40717098 · DOI 10.1186/s12951-025-03613-6
6. 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.
   Stover AM, Mueller D, Carda-Auten J, Hilton A, et al · · 2025 · cited 7× · PMID 40048558 · DOI 10.1097/ju.0000000000004511
7. Clinical translation of injectable hydrogels: from bioactive polymers to long-acting drug delivery systems.
   Carballo-Pedrares N, Giménez VMM, Alonso MJ. · · 2026 · cited 2× · PMID 41571911 · DOI 10.1007/s13346-025-02033-1
8. Chemoablation with UGN-102 in intermediate-risk non-muscle invasive bladder cancer, are we there yet?
   González-Padilla DA, Subiela JD, Villacampa-Aubá F. · · 2024 · cited 2× · PMID 38721284 · DOI 10.21037/tau-23-563