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Phase II Single Arm Study of Gemcitabine and Cisplatin Plus Pembrolizumab as Neoadjuvant Therapy Prior to Radical Cystectomy in Patients With Muscle-Invasive Bladder Cancer

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Trial Profile

Phase II Single Arm Study of Gemcitabine and Cisplatin Plus Pembrolizumab as Neoadjuvant Therapy Prior to Radical Cystectomy in Patients With Muscle-Invasive Bladder Cancer

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

Latest Information Update: 19 Sep 2023

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At a glance

  • Drugs Cisplatin (Primary) ; Gemcitabine (Primary) ; Pembrolizumab (Primary)
  • Indications Bladder cancer; Carcinoma; Urogenital cancer
  • Focus Therapeutic Use

    • Most Recent Events

    • 24 Aug 2021 Protocol amendment: patients treated with lead-in pembrolizumab discontinued treatment because of adverse events therefore now treated with pembrolizumab, cisplatin, gemcitabine
    • 24 Aug 2021 Results assessing safety and efficacy of gemcitabine and cisplatin in combination with the immune checkpoint inhibitor pembrolizumab as neoadjuvant therapy before radical cystectomy (RC) in muscle-invasive bladder cancer published in the Journal of Clinical Oncology
    • 07 Jun 2021 Planned End Date changed from 30 Sep 2025 to 30 Jan 2026.

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