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A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination With Standard of Care Chemotherapy and Durvalumab in Combination With Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients With Unresectable Locally Advanced or Metastatic Urothelial Cancer

Trial Profile

A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line Durvalumab in Combination With Standard of Care Chemotherapy and Durvalumab in Combination With Tremelimumab and Standard of Care Chemotherapy Versus Standard of Care Chemotherapy Alone in Patients With Unresectable Locally Advanced or Metastatic Urothelial Cancer

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

Latest Information Update: 08 Feb 2025

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At a glance

  • Drugs Durvalumab (Primary) ; Tremelimumab (Primary) ; Carboplatin; Cisplatin; Gemcitabine
  • Indications Bladder cancer; Renal cancer; Urethral cancer; Urogenital cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms NILE
  • Sponsors AstraZeneca; AstraZeneca AB

Most Recent Events

  • 24 Sep 2024 Planned primary completion date changed from 30 Aug 2024 to 30 Jun 2025.
  • 09 Feb 2024 Planned End Date changed from 30 Oct 2025 to 30 Jun 2025.
  • 09 Feb 2024 Planned primary completion date changed from 15 Jan 2024 to 30 Aug 2024.

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