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A Phase III, Open Label, Randomized, Controlled, Multi-Center Study of the Effects of Neoadjuvant Leukocyte Interleukin, Injection (LI) Plus Standard of Care Versus Standard of Care Only in Treatment Naïve Adults With Resectable Locally Advanced Primary Squamous Cell Carcinoma of the Head and Neck

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Trial Profile

A Phase III, Open Label, Randomized, Controlled, Multi-Center Study of the Effects of Neoadjuvant Leukocyte Interleukin, Injection (LI) Plus Standard of Care Versus Standard of Care Only in Treatment Naïve Adults With Resectable Locally Advanced Primary Squamous Cell Carcinoma of the Head and Neck

Status: Planning
Phase of Trial: Phase III

Latest Information Update: 21 May 2025

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At a glance

  • Drugs Buffy coat interleukins (Primary) ; Antineoplastics
  • Indications Head and neck cancer; Squamous cell cancer
  • Focus Registrational; Therapeutic Use

Most Recent Events

  • 15 May 2025 According to CEL-SCI Corporation media release, company is in final stages. This final Registration Study is specifically designed to confirm the statistically significant efficacy and safety results from CEL-SCI previously completed randomized controlled Phase 3 trial.
  • 17 Mar 2025 According to CEL-SCI Corporation media release , based on the data from the completed randomized controlled Phase 3 study, the FDA concurred with CEL-SCI's target patient selection criteria and gave the go-ahead to conduct a confirmatory Registration Study.
  • 17 Mar 2025 According to CEL-SCI Corporation media release, the FDA stated no response to their comments were required from CEL-SCI and that the agency presently has no comments on the confirmatory study protocol, which was submitted for FDA review contemporaneously with the SAP in December 2024.

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