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Cetuximab After Immunotherapy for Head and Neck Cancer

This study is looking at how well Cetuximab works in people with head and neck squamous cell carcinoma (a type of cancer that starts in flat cells lining the mouth, throat, or voice box) that has come back or spread. You might be able to join if you've already had immunotherapy (treatment that helps your immune system fight cancer) with a PD-1 inhibitor, either alone or with chemotherapy, and it didn't work or you couldn't tolerate it. The main goal is to see how many people respond to Cetuximab treatment. The study is currently unclear on its recruitment status and plans to enroll 38 participants.

Study design
This is a Phase II, non-randomized, open-label study involving 38 participants.
What's involved
You would receive Cetuximab intravenously once a week. You will have assessments before treatment, at 7 weeks, and then every 6-8 weeks for up to approximately 2 years.
Compensation
Not stated in the trial record.
Follow-up
After treatment, you will be followed up at 1 week and then every 6-8 weeks thereafter.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04375384

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
Wake Forest University Health Sciences
~38 participants
Updated 2026-07-17 on ClinicalTrials.gov
What's tested:CetuximabQuestionnaire administrationQuality of life assessment

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change in Overall Response Rate To Treatment with Cetuximab
Measured over 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.

Conditions

Head and Neck Squamous Cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma
Metastatic Head-and-neck Squamous-cell Carcinoma

Explore related trials

Head and Neck Squamous Cell Carcinoma

Where it's being run

1 sites across 1 states
North Carolina1

Study leadership

  • Mercedes Porosnicu, MD · PRINCIPAL_INVESTIGATOR · Wake Forest University Health Sciences

Who to contact

Ashley Fansler
[email protected]
13367133539
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.

Exclusion

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.
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.

What this trial measures

  • Change in Overall Response Rate To Treatment with Cetuximab14 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.

    Overall response rate is defined as the proportion patients achieving partial response or complete response per RECIST v1.1 criteria. An estimate of a 95% Exact Clopper Pearson confidence interval will be used. RECIST 1.1 criteria will be used to measure tumor size: Measurable disease is defined by the presence of at least 1 measurable lesion. A lesion, not previously irradiated per the protocol prior to enrollment, that can be accurately measured at baseline as ≥10 mm in the longest diameter (except lymph nodes which must have short axis ≥15 mm) with CT or MRI and that is suitable for accurate repeated measurements. Non-measurable: All other lesions, including small lesions (longest diameter \<10 mm or pathological lymph nodes with ≥10 mm to \<15 mm short axis at baseline). Only participants with measurable disease at baseline will be included in the study.