Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID04375384

Pilot Phase II Study to Evaluate Cetuximab After Immunotherapy With PD-1 Inhibitors in Patients With Head and Neck Squamous Cell Carcinoma

Led by Wake Forest University Health Sciences · Updated on 2026-03-18

38

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

Sponsors

W

Wake Forest University Health Sciences

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are evaluating the use of Cetuximab as a single agent treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma who have not responded to or cannot tolerate immunotherapy with PD-1 inhibitors, alone or combined with chemotherapy. This Phase II, open-label study aims to measure how well Cetuximab works in this setting, focusing on overall response rate and additional outcomes like progression-free survival, overall survival, and treatment toxicity. Participants receive Cetuximab intravenously, starting with a loading dose of 400 mg/m2 infused over 2 hours followed by 1 hour of observation. Subsequent weekly maintenance doses of 250 mg/m2 are given over 1 hour without additional observation, continuing until disease progression or unacceptable side effects occur. The treatment is administered once every week, and patients are pre-medicated with diphenhydramine before each dose. After completing treatment, patients are followed up at 1 week and then every 6 to 8 weeks. During the study, patients undergo scans to measure tumor response before treatment, at 7 weeks, and then every 6 to 8 weeks for up to approximately 2 years. Researchers also monitor survival outcomes and assess treatment-related side effects using established criteria. Quality of life and other questionnaires are administered as ancillary studies. The total participation duration depends on treatment response and tolerability, with close safety monitoring throughout the study and follow-up periods.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must have histologically or cytologically confirmed head and neck squamous cell carcinoma.
  • At least one measurable lesion by scans.
  • Previous treatment with PD-1 inhibitor immunotherapy alone or combined with chemotherapy.
  • Performance Status of 0-2.
  • Age 18 years or older.
  • Willing and able to follow the study protocol.
  • Ability to understand and sign informed consent approved by Institutional Review Board.
Not Eligible

You will not qualify if you...

  • Prior treatment with Cetuximab or similar EGFR-targeting therapy within the last 5 years.
  • Previous allergic reaction to Cetuximab.
  • History of allergic reactions to compounds similar to Cetuximab.
  • Current use of other investigational agents.
  • Use of medications that interact with Cetuximab requiring continuation.
  • Any uncontrolled condition that could interfere with safe study completion.
  • History or evidence of interstitial lung disease.
  • Serious or non-healing wounds, ulcers, or bone fractures.
  • Recent history (within specified timeframes) of abdominal fistula, gastrointestinal perforation, abscess, cerebrovascular events, significant cardiac disease, or thrombosis.
  • Use of immunosuppressive therapy except stable corticosteroids for rheumatologic conditions.
  • Pregnancy, breastfeeding, or planning to conceive/father children during the study and for 6 months after last dose.

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - Up to approximately 2 years

Participants receive cetuximab intravenously once every week in the absence of disease progression or unacceptable toxicity.

Weekly visits for cetuximab infusion

Follow-up

Duration - Up to 2 years after treatment completion

Participants are followed up after completion of study treatment to monitor their health and response.

1 visit at 1 week after treatment, then visits every 6-8 weeks

Trial Site Locations

Total: 1 location

1

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, United States, 27157

Actively Recruiting

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Research Team

S

Study Coordinator

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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Published Research Related To This Trial

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.

Kimberly M Burcher, Chance H Bloomer, Elena Gavrila...

https://pubmed.ncbi.nlm.nih.gov/38249330