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

Recruiting now · Phase 2

Conditions studied: Head and Neck Squamous Cell Carcinoma, Recurrent Head and Neck Squamous Cell Carcinoma, Metastatic Head-and-neck Squamous-cell Carcinoma

In brief

This is a Phase II treatment, non-randomized, open label clinical trial to study the efficacy of the Cetuximab when administered as single agent in recurrent/ metastatic head and neck squamous cell carcinoma after the failure or intolerance of immuno-oncology or immuno-oncology combined with chemotherapy.

Key facts

Study ID

NCT04375384

Run by

Wake Forest University Health Sciences

People needed

38

Starts

2020-07-01

Expected to finish

2027-12-01

Last updated by the study team

2026-07-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 may not qualify 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.

Where it is running

• Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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