Testing combination therapy for advanced head and neck cancer

Plain-English translation of NCT04857164 on ClinicalTrials.gov ↗ · Source last updated January 2025 · Translation generated June 2026 · How we translate trials

Phase 2 — Testing in a bigger group (up to a few hundred people) to see if the treatment actually works and is still safe.

What is this trial?

This trial is testing as a first-line treatment for people with recurrent or metastatic head and neck squamous cell carcinoma. Pembrolizumab is an immunotherapy drug that helps your immune system fight cancer. The medication is given intravenously every 3 weeks, along with chemotherapy that your doctor selects based on your individual health needs.

Head and neck cancers that have returned or spread to other parts of the body are very difficult to treat with standard options alone. This trial is testing whether adding immunotherapy to chemotherapy can improve how well the treatment works and help people live longer.

Do you qualify?

You likely qualify if…

you are between 18 and 75 years old
you have been diagnosed with squamous cell carcinoma of the head or neck that has returned or spread to other parts of your body
you have at least one measurable tumor that doctors can track on scans
your overall health is strong enough for treatment, with normal function of your heart, liver, kidneys, and blood cells
you have enough tumor tissue available for testing
your expected survival is at least 3 months

You likely don't qualify if…

you have already received chemotherapy for this cancer, unless it was part of multimodal treatment that ended more than 6 months ago
you are a candidate for surgery or radiation therapy and willing to pursue those options instead
your cancer progressed within 6 months after completing multimodal treatment for locally advanced disease
you have previously received immunotherapy drugs targeting PD-1
you are pregnant, breastfeeding, or unwilling to use contraception during and for 6 months after the study

What participation looks like

You will receive the medication intravenously on day 1 of each 3-week treatment cycle, combined with chemotherapy given at your doctor's discretion. Treatment continues for up to 35 cycles (about 2 years) or until your cancer progresses or side effects become unmanageable. You will have regular blood tests, scans, and physical exams to monitor how well the treatment is working and how your body is tolerating it.

AI-generated summary from trial data · Jun 7, 2026 · Not medical advice

Trial locations(1 site)

China

National Cancer Center/Cancer Hospitial,Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, Beijing Municipality