Testing a new treatment approach for advanced head and neck cancer

Plain-English translation of NCT04375384 on ClinicalTrials.gov ↗ · Source last updated March 2026 · 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 , a medication that works differently than the immunotherapy drugs you may have already tried. If your head and neck cancer stopped responding to immunotherapy (a type of treatment that helps your immune system fight cancer), this study asks whether might help. The medication is given as a weekly injection into your vein.

Some patients with advanced head and neck cancer find that immunotherapy alone doesn't work for them or stops working over time. This trial exists to see if switching to this medication might offer another treatment option when immunotherapy hasn't been successful.

Do you qualify?

You likely qualify if…

you have been diagnosed with head and neck squamous cell carcinoma that has returned or spread
you have already received immunotherapy treatment (with a PD-1 inhibitor), either alone or combined with chemotherapy
you have at least one measurable tumor that shows up on imaging scans
you are at least 18 years old
you are in reasonably good overall health (Performance Status 0–2)
you are willing to come for weekly infusions and follow-up visits

You likely don't qualify if…

you have received cetuximab or similar EGFR-targeting drugs in the past 5 years
you have a known allergy to cetuximab or similar medications
you have a history of lung scarring (interstitial lung disease or pneumonitis)
you have had a stroke, heart attack, blood clots, or serious heart problems in the past 6–12 months
you are pregnant, breastfeeding, or planning to become pregnant during the trial and for 6 months after treatment ends

What participation looks like

You would receive as an intravenous infusion (through a vein in your arm) once per week, with each infusion taking 60 to 120 minutes. You would continue receiving the medication as long as your cancer is not growing and you are not experiencing unacceptable side effects. After treatment ends, you would have a follow-up visit at one week, and then check-ins every 6 to 8 weeks to monitor how you are doing.

AI-generated summary from trial data · Jun 4, 2026 · Not medical advice

Trial locations(1 site)

United States

Wake Forest Baptist Comprehensive Cancer Center, Winston-Salem, North Carolina