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Phase I Study of Single Agent Pembrolizumab (MK-3475) in Patients With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, and Non-Small Cell Lung Carcinoma (KEYNOTE 001)

Trial Profile

Phase I Study of Single Agent Pembrolizumab (MK-3475) in Patients With Progressive Locally Advanced or Metastatic Carcinoma, Melanoma, and Non-Small Cell Lung Carcinoma (KEYNOTE 001)

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 19 Nov 2025

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At a glance

  • Drugs Pembrolizumab (Primary)
  • Indications Carcinoma; Malignant melanoma; Non-small cell lung cancer; Solid tumours
  • Focus Adverse reactions; First in man; Therapeutic Use
  • Acronyms KEYNOTE-001
  • Sponsors Merck Sharp & Dohme Corp.

Most Recent Events

  • 20 Oct 2025 According to the Merck and Co Media Release, Edward B. Garon, MD, MS, professor of medicine, David Geffen School of Medicine, the University of California, Los Angeles, is the principal investigator for KEYNOTE-001.
  • 20 Oct 2025 According to the Merck and Co Media Release, the 10-year analyses of KEYNOTE-001 and -010, were presented during a poster session at the European Society for Medical Oncology (ESMO) Congress 2025.
  • 20 Oct 2025 Results presented in the Merck and Co Media Release.

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