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

Last updated: May 12, 2025
Sponsor: University of Arkansas
Overall Status: Active - Recruiting

Phase

2

Condition

Head And Neck Cancer

Treatment

Placebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline)

0.5 mL Candin®/injection

Clinical Study ID

NCT05952934
275695
  • Ages 18-100
  • All Genders

Study 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 Criteria

Inclusion

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) within the previous 120 days.

  • No Evidence of Disease (NED) based on clinical and/or radiographic evaluations

  • Willing and able to comply with the requirements of the protocol

Exclusion

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 studyparticipation

  • Patients who are allergic to Candin®

  • If in the opinion of the PIs or other Investigators, it is not in the best interestof the patient to enter or continue in this study

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Placebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline)
Phase: 2
Study Start date:
February 12, 2024
Estimated Completion Date:
February 01, 2029

Study Description

This is a Phase II study to evaluate the efficacy and safety of a therapeutic vaccine called Candin® (Nielsen Biosciences, San Diego, CA) in adults over a two (2) year period. Each subject will be receiving a total of 7 injections of Candin (0.5 mL per dose) or placebo (saline) at a 3:1 ratio in a randomized double-blinded design. Subjects will receive one injection every 3 weeks until they receive 4 injections. Then, subjects will receive one injection every 3 months until they receive a total of 7 injections. Subjects will have 2 more visits approximately 6 months apart after the last injection. Immunological assessment T-cell repertoire analysis and by fluorescent activated cell sorter analysis (FACS) will be made at 4 time points (Visits 1, 5, 7, and 8). Stool and oral wash samples will be collected at the Screening Visit, Visit 5, Visit 7 and Visit 8 for microbiome diversity analysis.

Connect with a study center

  • Highlands Oncology Group, PA

    Fayetteville, Arkansas 72762
    United States

    Active - Recruiting

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas 72205
    United States

    Active - Recruiting

  • Highlands Oncology Group, PA

    Rogers, Arkansas 75758
    United States

    Active - Recruiting

  • Highlands Oncology Group, PA

    Springdale, Arkansas 72762
    United States

    Active - Recruiting

  • Perlmutter Cancer Center at NYU Langone Health

    Mineola, New York 11501
    United States

    Active - Recruiting

  • Perlmutter Cancer Center at NYU Langone Health

    New York, New York 10016
    United States

    Active - Recruiting

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