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New treatment option for Squamous Cell Carcinoma of Head and Neck
Official title Candida Therapeutic Vaccine in Head and Neck Cancer Patients to Reduce Recurrence
ClinicalTrials.gov ID: NCT05952934
What this study is testing
What is 0.5 mL Candin®/injection?
0.5 mL Candin®/injection is an investigational medicine, given as a pill taken by mouth, being studied as a potential treatment for squamous cell carcinoma of head and neck.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 100
You may be able to join if
- 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)...
- No Evidence of Disease (NED) based on clinical and radiographic evaluations
- Willing and able to comply with the requirements of the protocol
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Fayetteville, Arkansas, United States
- Little Rock, Arkansas, United States
- Rogers, Arkansas, United States
- Springdale, Arkansas, United States
- Mineola, New York, United States
- New York, New York, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 100 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fayetteville, Arkansas, United States; Little Rock, Arkansas, United States; Rogers, Arkansas, United States; Springdale, Arkansas, United States; Mineola, New York, United States; New York, New York, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.