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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: 25 Jul 2025

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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

  • 11 Jul 2025 According to a CEL-SCI media release, the company has reached an agreement with one of Saudi Arabia's premier pharmaceutical and healthcare companies for a partnership that spans regulatory and commercial activities for Multikine in Saudia Arabia. Saudi pharmaceutical partner will file a Breakthrough Medicine Designation application for Multikine with the SFDA in coming weeks.
  • 15 May 2025 According to a CEL-SCI media release, Based on guidance from the Saudi Food and Drug Authority (SFDA), we intend to file for drug approval based on the wealth of data from our completed Phase 3 study.
  • 23 Apr 2025 According to a CEL-SCI media release, CEL-SCI is preparing to submit a regulatory filing for the approval of Multikine as a neoadjuvant (pre-surgical) treatment of newly diagnosed previously untreated locally advanced head and neck cancer. The submission will be made based on all data from CEL-SCI's concluded 928-patient randomized controlled Phase 3 study and is expected to be filed as a Conditional Approval with Breakthrough Therapy designation.

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