RecruitingPhase 2NCT05952934

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

Sponsor

University of Arkansas

Enrollment

100 participants

Start Date

Feb 12, 2024

Study Type

INTERVENTIONAL

Conditions

Squamous Cell Carcinoma of Head and Neck

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.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Inclusion Criteria5

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 Criteria5

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

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