A Phase III Randomized Clinical Trial of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel or Vinflunine in Subjects With Recurrent or Progressive Metastatic Urothelial Cancer

Trial Profile

A Phase III Randomized Clinical Trial of Pembrolizumab (MK-3475) Versus Paclitaxel, Docetaxel or Vinflunine in Subjects With Recurrent or Progressive Metastatic Urothelial Cancer

Discontinued
Phase of Trial: Phase III

Latest Information Update: 21 Jul 2017

At a glance

  • Drugs Pembrolizumab (Primary) ; Docetaxel; Paclitaxel; Vinflunine
  • Indications Urogenital cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms KEYNOTE-045
  • Sponsors Merck Sharp & Dohme
  • Most Recent Events

    • 21 Jul 2017 According to a Merck AG media release, based on the data from KEYNOTE-045 and KEYNOTE-052 trials, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of KEYTRUDA (pembrolizumab) for the treatment of certain patients with locally advanced or metastatic urothelial carcinoma.
    • 10 Jun 2017 Biomarkers information updated
    • 06 Jun 2017 Results of the prespecified HRQoL analysis of KEYNOTE-045, presented at the 53rd Annual Meeting of the American Society of Clinical Oncology.
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