Recruiting
Phase 2

Cetuximab

Sponsor:

Wake Forest University Health Sciences

Code:

NCT04375384

Conditions

Head and Neck Squamous Cell Carcinoma

Recurrent Head and Neck Squamous Cell Carcinoma

Metastatic Head-and-neck Squamous-cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cetuximab

Questionnaire administration

Quality of life assessment

Study Details

Brief summary:

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.

Conditions

Head and Neck Squamous Cell Carcinoma

Recurrent Head and Neck Squamous Cell Carcinoma

Metastatic Head-and-neck Squamous-cell Carcinoma

Study ID

NCT04375384

Start date

Jul 1, 2020

Status verified date

Jul, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

38 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Cetuximab

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

Interventions

Cetuximab

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

Ancillary studies

Quality of life assessment

Ancillary studies

Primary outcome measure

  • Change in Overall Response Rate To Treatment with Cetuximab [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Ashley Fansler

13367133539Ashley.Fansler@Advocatehealth.org

Locations

Wake Forest Baptist Comprehensive Cancer Center

Recruiting

Winston-Salem, North Carolina, United States, 27157

Contacts

Ashley Fansler

Ashley.Fansler@Advocatehealth.org

Principal Investigator:

Mercedes Porosnicu, MD

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-07-17.