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RECRUITING Phase 2 ClinicalTrials.gov

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

Sponsor: University of Arkansas • ClinicalTrials.gov ID: NCT05952934

Registry updated: 2026-10-15
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Description

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.

Interventions

  • 0.5 mL Candin®/injection (Biological)
    Candin or placebo injection every 3 weeks until 4 injections then every 3 months until a total of 7 injections.
  • Placebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline) (Other)
    Placebo injection every 3 weeks until 4 injections then every 3 months until a total of 7 injections.

Eligibility criteria

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

Conditions

Squamous Cell Carcinoma of Head and Neck

Locations

  • Highlands Oncology Group, PA — Fayetteville, Arkansas, United States
  • University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
  • Highlands Oncology Group, PA — Rogers, Arkansas, United States
  • Highlands Oncology Group, PA — Springdale, Arkansas, United States
  • Perlmutter Cancer Center at NYU Langone Health — Mineola, New York, United States
  • Perlmutter Cancer Center at NYU Langone Health — New York, New York, United States
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record