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A Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426)

Trial Profile

A Phase III Randomized, Open-label Study to Evaluate Efficacy and Safety of Pembrolizumab (MK-3475) in Combination With Axitinib Versus Sunitinib Monotherapy as a First-line Treatment for Locally Advanced or Metastatic Renal Cell Carcinoma (mRCC) (KEYNOTE-426)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 13 Mar 2024

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At a glance

  • Drugs Axitinib (Primary) ; Pembrolizumab (Primary) ; Sunitinib
  • Indications Renal cell carcinoma
  • Focus Registrational; Therapeutic Use
  • Acronyms KEYNOTE-426
  • Sponsors Merck Sharp & Dohme Corp.
  • Most Recent Events

    • 04 Mar 2024 Planned End Date changed from 29 Dec 2023 to 31 Dec 2025.
    • 01 Nov 2023 Results of final protocol-prespecified analysis, published in the European Urology
    • 06 Jun 2023 Results of pooled exploratory analysis (n=2631 from four studies (KEYNOTE-426, JAVELIN Renal 100, CheckMate 9ER, CheckMate 214) assessing relationship of week 12 DepOR as a continuous variable with OS, hypothesizing not only complete but also deep partial responses might portend favorable longer-term survival in frontline advanced immuno-oncology renal cell carcinoma trials presented at the 59th Annual Meeting of the American Society of Clinical Oncology
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