NCT05952934 Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence
| NCT ID | NCT05952934 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of Arkansas |
| Condition | Squamous Cell Carcinoma of Head and Neck |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2024-02-12 |
| Primary Completion | 2031-07-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2024-02-12 with a primary completion date of 2031-07-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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 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 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
Contact & Investigator
Omar Atiq
PRINCIPAL INVESTIGATOR
University of Arkansas
Frequently Asked Questions
Who can join the NCT05952934 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Squamous Cell Carcinoma of Head and Neck. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05952934 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05952934 currently recruiting?
Yes, NCT05952934 is actively recruiting participants. Contact the research team at MTrujillo@uams.edu for enrollment information.
Where is the NCT05952934 trial being conducted?
This trial is being conducted at Fayetteville, United States, Little Rock, United States, Rogers, United States, Springdale, United States and 2 additional locations.
Who is sponsoring the NCT05952934 clinical trial?
NCT05952934 is sponsored by University of Arkansas. The principal investigator is Omar Atiq at University of Arkansas. The trial plans to enroll 100 participants.