Cetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer

The film gives the main points. The full list below is copied from the registry; the study team makes the final decision.

• Age18 Years to no maximum
• SexAll
• Healthy volunteersNo

You may be able to join if

• Patients must have histologically or cytologically confirmed head and neck squamous cell carcinoma.
• Measurable disease by scans- at least one measurable lesion.
• Patients must have received previous treatment with immunotherapy with PD-1 inhibitor alone or in combination with chemotherapy.
• Patients must have a Performance Status of 0-2.
• Patients must be greater than or equal to 18 years old.
• Participant is willing and able to comply with the protocol for the duration of the study.
• Ability to understand and the willingness to sign an Institutional Review Board-approved informed consent document.

You cannot join if

• Prior treatment with Cetuximab or prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway in the last five (5) years.
• Prior allergic reaction to Cetuximab.
• History of allergic reactions attributed to compounds of chemical or biologic composition similar to those of Cetuximab.
• Patients receiving any other investigational agents.
• Patient is on medications that need to be continued and that might interact with Cetuximab.
• Any uncontrolled condition, which in the opinion of the investigator, would interfere in the safe and timely completion of study treatment and procedures.
• Participant with a history of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on screening chest imaging.
• Any of the following conditions:
• Serious or non-healing wound, ulcer, or bone fracture at the discretion of treating physician
• history of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 28 days of study enrollment
• history of cerebrovascular accident (CVA) or transient ischemic attack within 12 months prior to study enrollment
• history of myocardial infarction, ventricular arrhythmia, stable/unstable angina, -symptomatic congestive heart failure, coronary/peripheral artery bypass graft or stenting or other significant cardiac disease within 6 months prior to study enrollment
• history of arterial or venous thrombosis/thromboembolic event, including pulmonary embolism within 6 months of study enrollment
• any condition requiring the use of immunosuppression, excluding rheumatologic conditions treated with stable doses of corticosteroids.
• Pregnancy, breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the screening visit through 6 months after the last dose of trial treatment.

This is how the treatment is meant to work. Whether it helps, and how safe it is, is what this trial is testing.

cetuximab. A recombinant, chimeric monoclonal antibody directed against the epidermal growth factor (EGFR) with antineoplastic activity. Cetuximab binds to the extracellular domain of the EGFR, thereby preventing the activation and subsequent dimerization of the receptor; the decrease in receptor activation and dimerization may result in an inhibition in signal transduction and anti-proliferative effects. This agent may inhibit EGFR-dependent primary tumor growth and metastasis. EGFR is overexpressed on the cell surfaces of various solid tumors. NCI Drug Dictionary

Treatments listed in the registry

• Cetuximab (Drug): A loading dose of Cetuximab will be administered intravenously in the first day of treatment. The dose is 400 mg/m2 and will be infused over 2h followed by 1h observation. The maintenance dose of Cetuximab is 250 mg/m2 and will be infused over 1h. No further observation time needed. The maintenance dose of cetuximab will be given every 7 days (+/- 2 days) starting 7 days (+/- 2 days) after the loading dose of cetuximab. Pre-medicate with 50 mg Diphenhydramine IV before the loading dose of Cetuximab and as per standard of care before the maintenance treatment.
• Questionnaire administration (Other): Ancillary studies
• Quality of life assessment (Other): Ancillary studies

Na · Single Group · masking: None

As the registry describes them. Requirements to join, such as a tissue sample, are in the eligibility list above even when on-study procedures are optional. Ask the study team which steps apply to you.

• questionnaires: Part of the study plan

Main goals

• Change in Overall Response Rate To Treatment with Cetuximab (14 days before start of treatment, 7 weeks after start of treatment, and then every 6-8 weeks for the duration of treatment, up to approximately 2 years.)

Other goals

• Duration of Progression Free Survival
• Duration of Overall Survival
• Duration of Response
• Number of Treatment-Related Toxicities with Cetuximab as Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Planned enrollment: 38 (estimated).

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

Site status as of Oct 30, 2026. Check the live record before contacting a site.

These papers are listed in the registry record. Unless a paper is marked as about this trial, it is background research on the treatment or disease, not results from this study.

• Publication about this trial (to be verified before citing)Burcher KM, Bloomer CH, Gavrila E, Kalada JM, Chang MJ, Gebeyehu RR, Song AH, Khoury LM, Lycan TW, Kinney R, D'Agostino R Jr, Bunch PM, Shukla K, Triozzi P, Furdui CM, Zhang W, Porosnicu M. Study protocol: phase II study to evaluate the effect of cetuximab monotherapy after immunotherapy with PD-1 inhibitors in patients with head and neck squamous cell cancer. Ther Adv Med Oncol. 2024 Jan 19;16:17588359231217959. doi: 10.1177/17588359231217959. eCollection 2024.

• ClinicalTrials.gov NCT04375384
• NCI Drug Dictionary: C1723

Registry record reviewed as fetched Oct 30, 2026, last updated by the sponsor Jul 16, 2026. Public record; not medical advice.