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A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects With Advanced Solid Tumors (KEYNOTE 158)

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Trial Profile

A Clinical Trial of Pembrolizumab (MK-3475) Evaluating Predictive Biomarkers in Subjects With Advanced Solid Tumors (KEYNOTE 158)

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

Latest Information Update: 06 Aug 2025

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At a glance

  • Drugs Pembrolizumab (Primary)
  • Indications Adenocarcinoma; Anal cancer; Appendiceal cancer; Biliary cancer; Carcinoma; Cervical cancer; Cholangiocarcinoma; Colon cancer; Colorectal cancer; Endometrial cancer; Gallbladder cancer; Gastric cancer; Gynaecological cancer; Intestinal cancer; Lung cancer; Mesothelioma; Neuroendocrine tumours; Pancreatic cancer; Rectal cancer; Salivary gland cancer; Small cell lung cancer; Solid tumours; Squamous cell cancer; Thyroid cancer; Vulvovaginal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms KEYNOTE-158
  • Sponsors Merck Sharp & Dohme Corp.

Most Recent Events

  • 23 Jul 2025 Status changed from recruiting to active, no longer recruiting.
  • 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.
  • 04 Jun 2024 Results(n=30) of final analysis assessing the antitumor activity of pembrolizumab in pts of Chinese descent with MSI-H/dMMR solid tumors, presented at the 60th Annual Meeting of the American Society of Clinical Oncology.

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