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A Phase 2, Randomized, Open-label Study of Gemcitabine/Cisplatin Plus Cemiplimab (REGN2810, Anti-PD-1) With or Without Fianlimab (REGN3767, Anti-LAG-3) for Organ Preservation in Patients With Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)

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Trial Profile

A Phase 2, Randomized, Open-label Study of Gemcitabine/Cisplatin Plus Cemiplimab (REGN2810, Anti-PD-1) With or Without Fianlimab (REGN3767, Anti-LAG-3) for Organ Preservation in Patients With Localized Muscle-invasive Bladder Cancer (NeoSTOP-IT)

Status: Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 19 Feb 2025

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At a glance

  • Drugs Fianlimab (Primary) ; Cemiplimab; Cisplatin; Gemcitabine
  • Indications Bladder cancer; Carcinoma; Urogenital cancer
  • Focus Therapeutic Use
  • Acronyms NeoSTOP-IT

Most Recent Events

  • 12 Feb 2025 Planned initiation date changed from 1 Nov 2024 to 1 Jun 2025.
  • 28 Aug 2024 New trial record

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