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: 19 Apr 2018

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

    • 28 Mar 2018 Results (n=519) assessing health related quality-of-life effects, published in the Journal of Clinical Oncology.
    • 10 Feb 2018 Updated results (data cut off 26 Oct 2017) after 2 years of follow up presented at the 2018 Genitourinary Cancers Symposium
    • 02 Jan 2018 According to a Merck & Co media release, KEYTRUDA (pembrolizumab), the company's anti-PD-1 therapy, has been approved by the Japanese Ministry of Health, Labor and Welfare (MHLW) for the treatment of patients with radically unresectable urothelial carcinoma who progressed after cancer chemotherapy, based on data from this trial.
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