Recruiting

Testing a new immunotherapy combination for advanced head and neck cancer

Plain-English translation of NCT05260671 on ClinicalTrials.gov ↗ · Source last updated October 2023 · 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 whether penpulimab, a new immunotherapy medication, works better when combined with cetuximab (a drug already approved for head and neck cancer) as a first-line treatment for people with recurrent or metastatic squamous cell carcinoma of the head and neck. The study will enroll 48 patients who haven't received treatment yet for their advanced cancer. Researchers want to see if this medication combination is effective and safe.

Currently, cetuximab is used with chemotherapy drugs to treat this type of advanced head and neck cancer, but outcomes for many patients could be better. This medication represents a new approach—using the immune system to fight cancer—and early research suggests that combining it with cetuximab might improve results compared to older treatment methods.

Do you qualify?

You likely qualify if…

you are 18 years or older
you have been diagnosed with squamous cell carcinoma of the head and neck that has come back or spread, and surgery or radiation are not options for you
you have at least one measurable tumor that shows PD-L1 expression (a marker your doctor can test for)
your overall health is good enough to tolerate the treatment (ECOG score of 0 or 1)
your major organs (liver, kidneys, heart, bone marrow) are functioning well based on blood tests and imaging
you have never received immunotherapy or cetuximab before, though you may have received chemotherapy as part of earlier treatment for locally advanced disease

You likely don't qualify if…

you have received previous immunotherapy treatments targeting PD-1, PD-L1, or similar immune checkpoint pathways
you have received previous treatment with cetuximab or other EGFR-targeted drugs
you are pregnant, breastfeeding, or planning to become pregnant during the study
you have active, uncontrolled cancer that has spread to your brain or spinal cord causing symptoms
you have an active autoimmune disease or significant history of autoimmune disease

What participation looks like

You would receive an initial dose of cetuximab alone for two weeks, then start receiving both medications together by intravenous infusion every two weeks. The immunotherapy medication would continue for up to 96 weeks (about 2 years), while cetuximab continues until the cancer progresses, side effects become unacceptable, or you choose to stop. You'll have regular blood tests, imaging scans, and clinic visits to monitor how well the treatment is working and to watch for side effects.

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

Trial locations(2 sites)

China

Department of radiotherapy,The First Bethune Hospital of Jilin University, Changchun, Jilin

Department of Radiotherapy, Eye & ENT Hospital of Fudan University, Shanghai