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.
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
- 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.