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A Phase III Randomized, Controlled Clinical Trial of Pembrolizumab With or Without Platinum-Based Combination Chemotherapy Versus Chemotherapy in Subjects With Advanced or Metastatic Urothelial Carcinoma

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Trial Profile

A Phase III Randomized, Controlled Clinical Trial of Pembrolizumab With or Without Platinum-Based Combination Chemotherapy Versus Chemotherapy in Subjects With Advanced or Metastatic Urothelial Carcinoma

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Jul 2024

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At a glance

  • Drugs Pembrolizumab (Primary) ; Carboplatin; Cisplatin; Gemcitabine
  • Indications Bladder cancer; Carcinoma; Renal cancer; Ureteral neoplasms; Urethral cancer; Urogenital cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms KEYNOTE-361
  • Sponsors Merck & Co; Merck Sharp & Dohme Corp.

    • Most Recent Events

    • 04 Jun 2024 Results of Quantitative circulating tumor DNA (ctDNA) assessment in patients (pts) with advanced urothelial carcinoma (UC) treated with pembrolizumab (pembro) or platinum-based chemotherapy , presented at the 60th Annual Meeting of the American Society of Clinical Oncology
    • 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.
    • 24 Oct 2023 Results of post hoc exploratory analysis evaluating patients who received chemo by eligibility for post chemo maintenance therapy, presented at the 48th European Society for Medical Oncology Congress
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