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Phase III, Open-label, Randomized, Multi-center Study of the Effects of Leukocyte Interleukin, Injection [Multikine] Plus Standard of Care (Surgery + Radiotherapy or Surgery + Concurrent Chemoradiotherapy) in Subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity / Soft Palate Versus Standard of Care Only

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Trial Profile

Phase III, Open-label, Randomized, Multi-center Study of the Effects of Leukocyte Interleukin, Injection [Multikine] Plus Standard of Care (Surgery + Radiotherapy or Surgery + Concurrent Chemoradiotherapy) in Subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity / Soft Palate Versus Standard of Care Only

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 20 Feb 2024

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At a glance

  • Drugs Buffy coat interleukins (Primary) ; Cisplatin; Cyclophosphamide; Indometacin; Multivitamin; Zinc
  • Indications Carcinoma; Head and neck cancer; Mouth neoplasm; Oropharyngeal cancer; Squamous cell cancer; Tongue cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms IT-MATTERS
  • Sponsors CEL-SCI Corporation

    • Most Recent Events

    • 15 Feb 2024 According to a CEL-SCI media release, company plans to submit target population data to the U.S. Food and Drug Administration (FDA) this quarter Q1 2024, also Meetings with the UK regulators and the EMA are expected in H1 2024.
    • 06 Feb 2024 According to a CEL-SCI media release, company plan to submit the proposed study protocol to the FDA in Q1 2024, with the goal to get FDA buy-in for a confirmatory clinical trial, and also to discuss potential accelerated approval pathways.
    • 22 Dec 2023 According to a CEL-SCI media release, Additional results from trial were presented at 10th European Congress on Head & Neck Oncology (ECHNO) 2023.
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