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.

Recruiting
Phase of Trial: Phase III

Latest Information Update: 14 Aug 2017

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

    • 14 Aug 2017 According to a CEL-SCI Corporation media release, the U.S. FDA has removed clinical hold on this trial.
    • 14 Aug 2017 According to a CEL-SCI Corporation media release, status changed from suspended to recruiting
    • 05 Jun 2017 According to a CEL-SCI Corporation media release, the company revised the documents (Investigator Brochure (IB) and the Dear Investigator letter) as directed by the FDA for which a clinical hold was imposed on this trial. Also, the company anticipates the FDA will consider lifting the clinical hold which was placed on 26 Sep 2016.
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