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Phase Ib/II Non-randomized Non-comparative Two-cohort Study of Niraparib and Dostarlimab Plus (Chemo)RadIotherapy in Locally-Advanced Head and Neck Squamous Cell Carcinoma

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Trial Profile

Phase Ib/II Non-randomized Non-comparative Two-cohort Study of Niraparib and Dostarlimab Plus (Chemo)RadIotherapy in Locally-Advanced Head and Neck Squamous Cell Carcinoma

Status: Recruiting
Phase of Trial: Phase I/II

Latest Information Update: 09 Jul 2024

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At a glance

  • Drugs Dostarlimab (Primary) ; Niraparib (Primary) ; Cisplatin
  • Indications Head and neck cancer; Hypopharyngeal cancer; Laryngeal cancer; Mouth neoplasm; Oropharyngeal cancer; Squamous cell cancer
  • Focus Therapeutic Use
  • Acronyms RADIAN

Most Recent Events

  • 04 Jun 2024 Patients (n=32) are evaluable for correlative studies are planned for enrollment (16/cohort). It is expected that experimental treatment will provide an increase of efficacy of 0.64 in terms of HR (1-year DFS of 75.9 % in cohort A and 68.2% in cohort B). Study activation: Nov 11th 2023, with 2 pts enrolled as of Feb 6th 2024, according to trial design presented at the 60th Annual Meeting of the American Society of Clinical Oncology.
  • 04 Jun 2024 Trial design presented at the 60th Annual Meeting of the American Society of Clinical Oncology.
  • 17 Nov 2023 Status changed from not yet recruiting to recruiting.

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