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Candin Therapeutic Vaccine for Head and Neck Cancer Recurrence

This study is testing a therapeutic vaccine called Candin® to see if it can help prevent head and neck cancer from coming back after treatment. You might be able to join if you are 18 or older, have squamous cell carcinoma of the head and neck, and have recently finished your cancer treatment (surgery, radiation, chemotherapy, or immunotherapy) and currently show no signs of cancer. The study aims to see if Candin® can reduce the rate of cancer recurrence over two years compared to a placebo (an inactive substance like saline). This is an immunotherapy, meaning it works with your body's immune system. The study plans to enroll up to 100 people.

Study design
This is a Phase II, randomized, double-blind, placebo-controlled study involving up to 100 participants. For every one person who receives placebo, three people will receive Candin®.
What's involved
You would receive a total of 7 injections over approximately 9 months: one injection every 3 weeks for the first 4 doses, then one injection every 3 months for the remaining 3 doses. You will also have two follow-up visits about 6 months apart after your last injection, and provide blood, stool, and oral wash samples at specific times.
Compensation
Not stated in the trial record.
Follow-up
Your clinical efficacy will be assessed through study completion, up to 2 years after starting the study.

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NCT05952934

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
University of Arkansas
~100 participants
Updated 2026-04-08 on ClinicalTrials.gov
What's tested:0.5 mL Candin®/injectionPlacebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline)

At a glance

Recruiting sites
6 of 6 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Assessment of clinical efficacy
Measured over Through study completion, up to 2 years

Conditions

Squamous Cell Carcinoma of Head and Neck

Explore related trials

Head and Neck Squamous Cell Carcinoma

Where it's being run

6 sites across 2 states
Arkansas4
New York2

Study leadership

  • Omar Atiq · PRINCIPAL_INVESTIGATOR · University of Arkansas

Who to contact

Madison Trujillo
[email protected]
501-686-8274
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Assessment of clinical efficacyThrough 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.