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: 05 Mar 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

    • 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.
    • 14 Dec 2017 According to a CEL-SCI Corporation media release, no further patient enrollment is required in this trial. The accrual and treatment phases of this Phase 3 study are complete. All of the 928 enrolled patients in the study are being followed-up as required by the study protocol. The primary endpoint will be determined after a total of 298 deaths have occurred in these two main comparator arms of the study and have been recorded in the study database.
    • 07 Dec 2017 According to a CEL-SCI Corporation media release, Independent Data Monitoring Committee (IDMC) has completed its review of data from all 928 enrolled patients and recommended to continue the study.
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