Actively Recruiting

Phase 2
Age: 18Years - 100Years
All Genders
NCT05952934

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

Led by University of Arkansas · Updated on 2026-04-08

100

Participants Needed

6

Research Sites

389 weeks

Total Duration

On this page

Sponsors

U

University of Arkansas

Lead Sponsor

H

Highlands Oncology Group, PA

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 100Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Able to provide informed consent
  • Male or female 18 years of age or older
  • Diagnosed with squamous cell carcinoma of the head and neck
  • Completed curative therapy (surgery, radiation, chemotherapy, or immunotherapy) within 120 days prior to screening
  • No evidence of disease based on clinical and radiographic evaluations
  • Willing and able to comply with study requirements
Not Eligible

You will not qualify if you...

  • Positive urine pregnancy test for women of childbearing potential
  • Pregnant or attempting to become pregnant during the study
  • Breastfeeding or planning to breastfeed during the study period
  • Allergy to Candin
  • Considered by investigators to be unsuitable for study participation

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 6 locations

1

Highlands Oncology Group, PA

Fayetteville, Arkansas, United States, 72762

Actively Recruiting

2

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States, 72205

Actively Recruiting

3

Highlands Oncology Group, PA

Rogers, Arkansas, United States, 75758

Actively Recruiting

4

Highlands Oncology Group, PA

Springdale, Arkansas, United States, 72762

Actively Recruiting

5

Perlmutter Cancer Center at NYU Langone Health

Mineola, New York, United States, 11501

Actively Recruiting

6

Perlmutter Cancer Center at NYU Langone Health

New York, New York, United States, 10016

Actively Recruiting

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Research Team

M

Madison Trujillo

CONTACT

A

Aaron Holley

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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