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

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.

Trial Details

NCT ID

NCT05952934

Phase

PHASE2

Sponsor

University of Arkansas

Status

RECRUITING

Cancer Type

Head and Neck Cancer

Interventions

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

Locations (sample)

Fayetteville, Arkansas, United States|36.06258,-94.15743
Little Rock, Arkansas, United States|34.74648,-92.28959
Rogers, Arkansas, United States|36.33202,-94.11854
Springdale, Arkansas, United States|36.18674,-94.12881
Mineola, New York, United States|40.74927,-73.64068

Key Eligibility 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…
No Evidence of Disease (NED) based on clinical and radiographic evaluations

For full eligibility, visit ClinicalTrials.gov.

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