A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination With Tremelimumab Versus Standard of Care Chemotherapy in Patients With Unresectable Stage IV Urothelial Cancer

Trial Profile

A Phase III, Randomized, Open-Label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 (Durvalumab) Monotherapy and MEDI4736 (Durvalumab) in Combination With Tremelimumab Versus Standard of Care Chemotherapy in Patients With Unresectable Stage IV Urothelial Cancer

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 08 Dec 2017

At a glance

  • Drugs Durvalumab (Primary) ; Tremelimumab (Primary) ; Carboplatin; Cisplatin; Gemcitabine
  • Indications Urogenital cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms DANUBE
  • Sponsors AstraZeneca
  • Most Recent Events

    • 05 Dec 2017 Planned number of patients changed from 1185 to 1200.
    • 05 Dec 2017 Planned End Date changed from 15 Jul 2019 to 23 Sep 2019.
    • 05 Dec 2017 Planned primary completion date changed from 2 Apr 2018 to 23 Sep 2019.
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