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: 01 Jul 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

25 Jun 2025 Planned End Date changed from 30 Jun 2025 to 29 Apr 2026.
25 Jun 2025 Planned primary completion date changed from 30 Jun 2025 to 29 Apr 2026.
24 Sep 2024 Planned primary completion date changed from 30 Aug 2024 to 30 Jun 2025.

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