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

A Phase II Clinical Trial of Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence

Who can join

Ages 18 to 100 · All sexes

Inclusion Criteria:

* Able to provide informed consent
* Male or female 18 years of age or older
* Squamous cell carcinoma of the head and neck who have completed curative therapy (surgery and/or radiation and/or chemotherapy and/or immunotherapy) within the 120 days prior to the screening visit
* No Evidence of Disease (NED) based on clinical and radiographic evaluations
* Willing and able to comply with the requirements of the protocol

Exclusion Criteria:

* Positive urine pregnancy test for women of childbearing potential
* Being pregnant or attempting to be pregnant with the period of study participation
* Women who are breast feeding or plan to breast feed within the period of study participation
* Patients who are allergic to Candin®
* If in the opinion of the PIs or other Investigators, it is not in the best interest of the patient to enter or continue in this study

About the study

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.

What is being tested

• 0.5 mL Candin®/injection (biological)
• Placebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline) (other)

Sponsor: University of Arkansas · Participants: 100 · Started: Feb 12, 2024

Contact the study team

• Madison Trujillo · Phone: 501-686-8274
• Aaron Holley · Phone: 501-686-8274

Official record on ClinicalTrials.gov — NCT05952934

Locations in the U.S.

Conditions

• Head and Neck Squamous Cell Carcinoma

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.