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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 15 Dec 2023

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At a glance

  • Drugs Pembrolizumab (Primary) ; Docetaxel; Paclitaxel; Vinflunine
  • Indications Bladder cancer; Carcinoma; Pelvic cancer; Renal cancer; Ureteral neoplasms; Urethral cancer; Urogenital cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms KEYNOTE-045
  • Sponsors Merck Sharp & Dohme; Merck Sharp & Dohme Corp.

Most Recent Events

  • 24 Oct 2023 Results of post hoc pooled analysis (n=49) assessing the efficacy and safety outcomes with pembrolizumab rechallenge for patients with advanced/metastatic urothelial cancer from KEYNOTE-045, KEYNOTE-052 and KEYNOTE-361 trials, presented at the 48th European Society for Medical Oncology Congress.
  • 06 Jun 2023 Results assessing the efficacy and safety of pembrolizumab (pembro) monotherapy for advanced urothelial carcinoma (UC) in the phase 3 KEYNOTE-045 and KEYNOTE-361 presented at the 59th Annual Meeting of the American Society of Clinical Oncology
  • 19 Apr 2023 Results assessing plasma circulating tumor DNA (ctDNA)-based whole genome sequencing (pWGS) and whole exome sequencing (pWES) and concordance with tumor tissue whole exome sequencing from two studies KEYNOTE-040 and KEYNOTE-045 presented at the 114th Annual Meeting of the American Association for Cancer Research

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