drugset / Trial / NCT05952934
Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence
Phase 2
Recruiting
100 enrolled
University of Arkansas
Highlands Oncology Group, PA · collabNYU Langone Health · collab
RandomizedParallel-groupTriple-blindTreatment
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.
Timeline
- Start
- 2024-02-12
- Primary completion
- 2031-07-31
- Completion
- 2031-07-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Candin | Other / unclassified | 0.5 ml | Other |