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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

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Trial Profile

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

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 21 Feb 2025

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At a glance

  • Drugs Mitomycin (Primary)
  • Indications Bladder cancer; Urogenital cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms ENVISION
  • Sponsors UroGen Pharma
  • Most Recent Events

    • 14 Feb 2025 According to an UroGen Pharma media release, subgroup analysis results from this study presented at the American Society of Clinical Oncologys Genitourinary Cancers Symposium (ASCO GU 2025).
    • 14 Feb 2025 Results from subgroup analysis published in the UroGen Pharma Media Release
    • 15 Jan 2025 According to an UroGen Pharma media release, company announced that the 3-month complete response (CR) rate and 12-month durability of response from the Phase 3 ENVISION study of investigational drug UGN-102 in patients with low-grade intermediate-risk non-muscle-invasive bladder cancer (LG-IR-NMIBC) were published in the February issue of The Journal of Urology.

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