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

Trial Status: Active

This phase II trial studies how well cetuximab after immunotherapy with PD-1 inhibitors work in treating patients with head and neck squamous cell cancer. Cetuximab is an antibody (protein structure) that blocks receptors on cancer cells, called EGFR receptors, that favor the growth and multiplication of the cancer cells. Giving cetuximab may work better when given in patients who stopped responding to immunotherapy or who had to stop immunotherapy because of toxicity.

Inclusion Criteria

  • Patients must have histologically or cytologically confirmed HNSCC including cutaneous squamous cell cancer of the head and neck
  • 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 (PS) of 0-2
  • Willing to provide consent for collection of samples of blood and saliva as scheduled through the treatment
  • Subject is willing and able to comply with the protocol for the duration of the study
  • Willingness to donate 2 tablespoons of blood and one teaspoon of saliva before treatment, 4 times during the first 6 weeks of treatment and then every 6-8 weeks while patients is under treatment
  • Ability to understand and the willingness to sign an Institutional Review Board (IRB)-approved informed consent document

Exclusion Criteria

  • Prior treatment with cetuximab or prior therapy that specifically and directly targets the EGFR pathway
  • 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
  • Subject 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 * History of abdominal fistula, gastrointestinal perforation, or intraabdominal 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

North Carolina

Wake Forest University Health Sciences
Status: ACTIVE
Contact: Mercedes Porosnicu
Phone: 336-716-8664


I. To measure overall response rate to treatment with cetuximab as single agent following treatment with immunotherapy with PD-1 inhibitors alone or in combination with chemotherapy.


I. Measure duration of response (DUR), progression free survival (PFS) and overall survival (OS) for treatment with single agent cetuximab after immunotherapy with PD-1 inhibitors in head and neck squamous cell carcinoma (HNSCC).

II. Evaluate treatment toxicity with single agent cetuximab in this patient population.


I. Evaluate the early positron emission tomography (PET) scan ability to predict tumor response.

II. Collect quality of life (QOL) data on patient reported outcomes every six weeks and examine this data for overall tolerability of this treatment.

III. Bank saliva and blood for future studies of biomarkers.

IV. Correlate treatment response with human papillomavirus (HPV) and smoking status.


Patients receive cetuximab intravenously (IV) over 60-120 minutes once every week in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 1 week and then every 4-6 weeks thereafter.

Trial Phase Phase II

Trial Type Treatment

Lead Organization
Wake Forest University Health Sciences

Principal Investigator
Mercedes Porosnicu

  • Primary ID WFBCCC60220
  • Secondary IDs NCI-2020-04694, IRB00065239
  • ID NCT04375384