drugset / Trial / NCT05952934

Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence

NCT05952934

RandomizedParallel-groupTriple-blindTreatment

Summary

This is a Phase II randomized, double-blind, placebo controlled, multi-site study of Candin. It is designed to show the efficacy and safety of a 7-dose regimen of Candin over a two-year period in terms of reducing cancer recurrence rate by comparing the recurrence rates between the Candin and the placebo arm. The ratio of the number of subjects who will receive Candin versus placebo will be 3:1. Up to 100 subjects will be screened until 80 subjects are eligible for injection.

Timeline

Start
2024-02-12
Primary completion
2031-07-31
Completion
2031-07-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Candin Other / unclassified 0.5 ml Other