NCT05952934 · University of Arkansas
Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence
What this study is about
This is a Phase II randomly assigned, where neither patients nor doctors know which treatment is given, placebo controlled, multi-site study of Candin. It is designed to show the effectiveness 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 treatment group$1.
View original scientific 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
BIOLOGICAL
0.5 mL Candin®/injection
Candin or placebo injection every 3 weeks until 4 injections then every 3 months until a total of 7 injections.
OTHER
Placebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline)
Placebo injection every 3 weeks until 4 injections then every 3 months until a total of 7 injections.
Primary outcome measures
Assessment of clinical efficacy
Time frame: Through study completion, up to 2 years
Studying the efficacy of Candida and the schedule in which this protocol specifically outlines the clinical response (i.e., reduced cancer recurrence rate) of subjects is the primary endpoint.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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 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
Where
- Fayetteville, Arkansas
- Little Rock, Arkansas
- Rogers, Arkansas
- Springdale, Arkansas
- Mineola, New York
- New York, New York
Collaborators
Highlands Oncology Group, PA, NYU Langone Health
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 8, 2026 · Source of record for eligibility and locations