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A Phase II, Open-Label, Single Arm, Prospective, Multicenter Study of Niraparib Plus Dostarlimab in Patients With Advanced NSCLC and/or MPM, and Positive for PD-L1 Expression and Germline or Somatic Mutations in the HRR Genes

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Trial Profile

A Phase II, Open-Label, Single Arm, Prospective, Multicenter Study of Niraparib Plus Dostarlimab in Patients With Advanced NSCLC and/or MPM, and Positive for PD-L1 Expression and Germline or Somatic Mutations in the HRR Genes

Status: Recruiting
Phase of Trial: Phase II

Latest Information Update: 21 Dec 2023

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At a glance

  • Drugs Dostarlimab (Primary) ; Niraparib (Primary)
  • Indications Malignant-mesothelioma; Non-small cell lung cancer
  • Focus Therapeutic Use
  • Acronyms UNITO-001
  • Most Recent Events

    • 18 Dec 2023 Interim Results (n=17) assessing safety and efficacy of Niraparib plus Dostarlimab in Pleural Mesothelioma or Non-Small Cell Lung Cancer harboring HRR mutations published in the Clinical Cancer Research
    • 10 May 2023 Planned End Date changed from 15 Jan 2024 to 30 Jun 2025.
    • 10 May 2023 Planned primary completion date changed from 30 Dec 2023 to 30 Jun 2024.

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