Squamous Cell Carcinoma of Head and NeckPhase 2NCT05952934
Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence
A Phase 2 study testing 0.5 mL Candin®/injection in people with Squamous Cell Carcinoma of Head and Neck, run by University of Arkansas at 6 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Squamous Cell Carcinoma of Head and Neck
- What is being tested?
- 0.5 mL Candin®/injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 6 sitesUnited States
- Study dates
- 12 Feb 2024to 31 Jul 2032
- Phase
- Phase 2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
6 sites in 1 country
United States6 sites, 6 recruiting
- Recruiting
Highlands Oncology Group, PA
Fayetteville, Arkansas, 72762
Jennifer Worth, 479-872-8130, Jworth@hogonc.com
Amy Purcell, 479-872-8130, apurcell@hogonc.com
- Recruiting
University of Arkansas for Medical Sciences
Little Rock, Arkansas, 72205
Madison Trujillo, MTrujillo@uams.edu
Aaron Holley, JAHolley@uams.edu
- Recruiting
Perlmutter Cancer Center at NYU Langone Health
Mineola, New York, 11501
Zujun Li, MD, (212) 731-6465, Zujun.li@nyulangone.org
NYU Langone Health, ct.gov@nyulangone.org
- Recruiting
Perlmutter Cancer Center at NYU Langone Health
New York, New York, 10016
Zujun Li, MD, (212) 731-6465, Zujun.li@nyulangone.org
NYU Langone Health, ct.gov@nyulangone.org
- Recruiting
Highlands Oncology Group, PA
Rogers, Arkansas, 75758
Jennifer Worth, 479-872-8130, Jworth@hogonc.com
Amy Purcell, 479-872-8130, apurcell@hogonc.com
- Recruiting
Highlands Oncology Group, PA
Springdale, Arkansas, 72762
Jennifer Worth, 479-872-8130, Jworth@hogonc.com
Amy Purcell, 479-872-8130, apurcell@hogonc.com
About this study
Official title: A Phase II Clinical Trial of Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence
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.
Read the detailed 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.
- Conditions
- Squamous Cell Carcinoma of Head and Neck
- Being tested
- 0.5 mL Candin®/injection, Placebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline)
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5 mL Candin®/injectionBiological
Candin or placebo injection every 3 weeks until 4 injections then every 3 months until a total of 7 injections.
Placebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline)Other
Placebo injection every 3 weeks until 4 injections then every 3 months until a total of 7 injections.
| Study group | Role | What they receive |
|---|---|---|
| Candin vaccine | Active comparator | Seven Candida (Candin). The route of administration is intradermal injection at subject's limbs at 0.5 mL/injection. The schedule is 1 injection every three weeks for the first 4 injections, and then one injection every 3 months until a total of 7 injections has been given. Receives: Biological: 0.5 mL Candin®/injection |
| Placebo | Placebo comparator | Seven placebo injections (sterile 0.9% Normal Saline). The route of administration is intradermal injection at subject's limbs at 0.5 mL/injection. The schedule is 1 injection every three weeks for the first 4 injections, and then one injection every 3 months until a total of 7 injections has been given. Receives: Other: Placebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of clinical efficacy
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.
Measured: Through study completion, up to 2 years
Secondary outcomes (1)
Assessment of adverse events
The secondary endpoints of this study is safety, and the AEs will be diligently recorded and reviewed.
Measured: Regularly throughout the study, up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start12 Feb 2024
- Primary completion31 Jul 2032 (estimated)
- Study completion31 Jul 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Squamous Cell Carcinoma of Head and NeckStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Phase II randomized, double-blind, placebo controlled, multi-site study of Candin.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Collaborators
- Highlands Oncology Group, PA, NYU Langone Health
- Responsible party
- Sponsor
- Investigators
- Omar Atiq, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952934
- Sponsor's protocol ID
- 275695
- Status last verified
- Oct 2026
- First submitted
- 3 Jul 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No