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A Phase II/III Randomized Study of Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma

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Trial Profile

A Phase II/III Randomized Study of Pembrolizumab in Patients With Advanced Malignant Pleural Mesothelioma

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

Latest Information Update: 31 May 2024

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At a glance

  • Drugs Pembrolizumab (Primary) ; Carboplatin; Cisplatin; Pemetrexed
  • Indications Malignant-mesothelioma
  • Focus Registrational; Therapeutic Use
  • Acronyms KEYNOTE 483
  • Most Recent Events

    • 29 May 2024 According to a Merck Sharp & Dohme media release, based on data from this trial the U.S. Food and Drug Administration (FDA) has accepted for priority review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA, in combination with chemotherapy, for the first-line treatment of patients with unresectable advanced or metastatic malignant pleural mesothelioma. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of September 25, 2024.
    • 12 Jan 2024 Planned End Date changed from 31 Dec 2023 to 30 Jun 2024.
    • 07 Nov 2023 Results assessing whether the addition of pembrolizumab to platinum pemetrexed would improve overall survival in patients with pleural mesothelioma, published in the Lancet
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