CEL-SCI Corporation announced on March 17, 2025, that the clinical protocol for its 212-patient Confirmatory Registration Study for Multikine cleared FDA review. The company is now in the final stages for the launch of this pivotal trial.
The study is specifically designed to confirm the statistically significant efficacy and safety results observed in CEL-SCI’s previously completed randomized controlled Phase 3 trial. It targets previously untreated resectable stage 3 and 4 head and neck cancer patients who had no lymph node involvement and low PD-L1 tumor expression.
The final clinical protocol was submitted to the FDA in December 2024. CEL-SCI is actively signing up investigators and opening clinical sites, with the first site expected to initiate in the United States, across four countries on three continents.
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