Clinical trial · Interventional
Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence
A Phase II Clinical Trial of Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 16, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260916-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Squamous Cell Carcinoma of Head and Neck | Head and Neck Squamous Cell Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 0.5 mL Candin®/injection | Biological | — | UNRESOLVED |
| Placebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Candin vaccine
- description
- 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.
- interventionNames
- Biological: 0.5 mL Candin®/injection
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- 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.
- interventionNames
- Other: Placebo: 0.5 mL Intravenous 0.9% NaCl solution (Saline)
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available