A Phase III, Randomized, Open-label, Controlled, Multi-Center, Global Study of First-Line MEDI4736 Monotherapy and MEDI4736 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 Monotherapy and MEDI4736 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: 22 Mar 2018

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 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.
    • 15 Nov 2017 Planned number of patients changed from 1005 to 1185.
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