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: 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
- 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.