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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.

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.

Completed
Phase of Trial: Phase III

Latest Information Update: 16 Nov 2018

At a glance

  • Drugs Buffy coat interleukins (Primary) ; Cyclophosphamide; Indometacin; Zinc
  • Indications Head and neck cancer; Oropharyngeal cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms IT-MATTERS
  • Sponsors CEL-SCI Corporation
  • Most Recent Events

    • 31 Aug 2018 Biomarkers information updated
    • 29 Aug 2018 Planned number of patients changed from 928 to 1273.
    • 12 Feb 2018 According to a CEL-SCI Corporation media release, Independent Data Monitoring Committee (IDMC) recommended continuing the study as constituted in a review.
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