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A Phase II Study of Pembrolizumab (MK-3475) as Monotherapy in Subjects With Previously Treated Locally Advanced Unresectable or Metastatic (Stage IV) Mismatched Repair Deficient or Microsatellite Instability-High Colorectal Carcinoma (KEYNOTE-164)

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A Phase II Study of Pembrolizumab (MK-3475) as Monotherapy in Subjects With Previously Treated Locally Advanced Unresectable or Metastatic (Stage IV) Mismatched Repair Deficient or Microsatellite Instability-High Colorectal Carcinoma (KEYNOTE-164)

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 13 Sep 2024

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At a glance

  • Drugs Pembrolizumab (Primary)
  • Indications Carcinoma; Colorectal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms KEYNOTE-164
  • Sponsors Merck Sharp & Dohme

    • Most Recent Events

    • 12 Sep 2024 According to a Merck & Co media release, company announced that Health Canada has granted approval of KEYTRUDA (pembrolizumab), Merck's anti-PD-1 therapy, as a monotherapy for the treatment of adult and pediatric patients with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumours.
    • 29 Mar 2023 Pooled data from KEYNOTE-158, KEYNOTE-164 and KEYNOTE-051 studies presented in a Merck & Co media release.
    • 29 Mar 2023 According to a Merck & Co media release, this conversion from accelerated to a full (regular) approval marks the first full approval for an immunotherapy based on a predictive biomarker, regardless of solid tumor type.

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