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A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients With Muscle-Invasive Bladder Cancer

Trial Profile

A Phase III, Randomized, Open-Label, Multi-Center, Global Study to Determine the Efficacy and Safety of Durvalumab in Combination With Gemcitabine+Cisplatin for Neoadjuvant Treatment Followed by Durvalumab Alone for Adjuvant Treatment in Patients With Muscle-Invasive Bladder Cancer

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

Latest Information Update: 02 Jun 2025

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At a glance

  • Drugs Durvalumab (Primary) ; Cisplatin; Gemcitabine
  • Indications Bladder cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms NIAGARA
  • Sponsors AstraZeneca

Most Recent Events

  • 27 May 2025 According to an AstraZeneca media release, Imfinzi is approved in the US and other countries in this setting based on the NIAGARA results. Regulatory applications are currently under review in Japan and several other countries.
  • 27 May 2025 According to an AstraZeneca media release, company recommended Imfinzi for approval in the EU by CHMP as first and only perioperative immunotherapy for muscle-invasive bladder cancer, based on results from this trial.
  • 06 Dec 2024 According to an AstraZeneca media release, data from the NIAGARA Phase III trial which was presented during a Presidential Symposium at the 2024 European Society for Medical Oncology (ESMO) Congress and simultaneously published in The New England Journal of Medicine.

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