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

RecruitingPhase 2Ages 18 Years - 100 YearsAllUniversity of Arkansas
NCT05952934 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

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

6 sites
Highlands Oncology Group, PA
Fayetteville, United States
University of Arkansas for Medical Sciences
Little Rock, United States
Highlands Oncology Group, PA
Rogers, United States
Highlands Oncology Group, PA
Springdale, United States
Perlmutter Cancer Center at NYU Langone Health
Mineola, United States
Perlmutter Cancer Center at NYU Langone Health
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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