Therapeutic vaccine to reduce cancer recurrence in head and neck cancer patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase II clinical trial evaluates the efficacy and safety of a therapeutic vaccine called Candin in adults with squamous cell carcinoma of the head and neck who have completed curative therapy. Participants will receive a total of 7 injections of either Candin or a placebo over a two-year period, with a focus on reducing cancer recurrence rates. The study employs a randomized, double-blind, placebo-controlled design and includes immunological assessments and microbiome diversity analysis at various time points. Up to 100 subjects will be screened to enroll 80 eligible participants.

Why it matters

Who can join: the full rules

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

Where it's running

• Highlands Oncology Group, PA
  Fayetteville, Arkansas, United States Recruiting
• University of Arkansas for Medical Sciences
  Little Rock, Arkansas, United States Recruiting
• Highlands Oncology Group, PA
  Rogers, Arkansas, United States Recruiting
• Highlands Oncology Group, PA
  Springdale, Arkansas, United States Recruiting
• Perlmutter Cancer Center at NYU Langone Health
  Mineola, New York, United States Recruiting
• Perlmutter Cancer Center at NYU Langone Health
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Omar Atiq — University of Arkansas
• Study coordinator: Emily Baker
• Email: EBaker2@uams.edu
• Phone: 501-214-2068

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• Amivantamab added to pembrolizumab and platinum chemotherapy versus pembrolizumab with platinum/5‑FU for recurrent/metastatic head and neck squamous cell carcinoma

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.