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An Open Label, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab (MK-3475) Before Cystectomy for Patients With Muscle-invasive Urothelial Bladder Cancer

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Trial Profile

An Open Label, Single-arm, Phase 2 Study of Neoadjuvant Pembrolizumab (MK-3475) Before Cystectomy for Patients With Muscle-invasive Urothelial Bladder Cancer

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 05 Mar 2024

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At a glance

  • Drugs Pembrolizumab (Primary)
  • Indications Bladder cancer; Carcinoma
  • Focus Therapeutic Use
  • Acronyms PURE-01

Most Recent Events

  • 27 Jan 2024 Results assessing the shifting spectrum of genomic alterations (GA) in matched pre-post therapy samples could orient novel therapeutic sequences from patients with cT2-4N0M0 MIBC who received neoadjuvant pembrolizumab in the PURE-01 (n=129) study, or standard cisplatin-based neoadjuvant chemotherapy (NACT), preceding RC center (n=27; from 2017 to 2022), presented at the 2024 Genitourinary Cancers Symposium.
  • 06 Oct 2023 Results (n=110) assessing the predictive capability of the pre- and post-pembrolizumab vesical imaging-reporting and data system (VI-RADS) to identify ypT0N0 or ypT less than equal to 1N0 response in muscle-invasive bladder cancer (MIBC) within the PURE-01 trial, published in the BJU International.
  • 14 Jul 2023 Status changed from recruiting to completed.

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