Testing a new cancer vaccine combined with immunotherapy for head and neck cancer

Plain-English translation of NCT04534205 on ClinicalTrials.gov ↗ · Source last updated July 2026 · Translation generated August 2026 · How we translate trials

What is this trial?

This trial is testing whether a new cancer vaccine called , combined with an existing immunotherapy drug called , can help people with advanced head and neck cancer better than alone. The vaccine is designed to train your immune system to recognize and fight cancer cells. About 350 people will participate, with some receiving the vaccine plus the immunotherapy medication, and others receiving just the immunotherapy.

Head and neck cancer that has spread or come back is very difficult to treat. While the immunotherapy medication can help some patients, doctors want to see if adding a cancer vaccine can make this treatment work even better for people whose cancers have specific markers related to HPV and immune cell activity.

Do you qualify?

You likely qualify if…

you have been diagnosed with advanced head and neck squamous cell cancer caused by HPV16 that cannot be cured with surgery or radiation alone
your cancer has specific markers (PD-L1 expression) that indicate it may respond to immunotherapy
you have not received any systemic cancer treatments for your advanced disease (though prior treatments for earlier-stage disease may be allowed)
you have measurable disease that doctors can track on imaging scans
you can provide a tissue sample from your tumor for testing

You likely don't qualify if…

your cancer started in the nasopharynx (the upper part of the throat behind the nose)
you have another active cancer or had a different cancer within the past 2 years
you are currently taking high-dose steroids or other strong immunosuppressive medications
you have recently received other immune-modulating treatments that caused serious side effects

What participation looks like

The trial has two parts. First, some patients will receive the vaccine plus immunotherapy to confirm safety. Then, other patients will be randomly assigned to receive either the vaccine combined with the immunotherapy medication, or the immunotherapy medication alone. Treatment continues for up to 24 months, with regular visits to your doctor for check-ups, scans, and blood tests to monitor how you are responding and to watch for side effects.

Testing a new cancer vaccine combined with immunotherapy for head and neck cancer

What is this trial?

Do you qualify?

What participation looks like

Trial locations(195 sites)