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

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).

Timeline

Start

2022-03-01

Primary completion

2023-04-26

Completion

2028-03

Publications

• Results 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.
• 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 Non-Muscle-Invasive Bladder Cancer: A 24-Month Duration of Response Results From the Phase 3 ENVISION Trial. J Urol. 2026 Mar 25:101097JU0000000000005041. doi: 10.1097/JU.0000000000005041. Online ahead of print.
• 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.

Drugs

Indications