Actively Recruiting
Cetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer
Led by Wake Forest University Health Sciences · Updated on 2026-03-18
38
Participants Needed
1
Research Sites
387 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
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
Official Title
Cetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients must have histologically or cytologically confirmed head and neck squamous cell carcinoma.
- Measurable disease by scans with 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 will not qualify if you...
- Prior treatment with Cetuximab or prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway in the last five years.
- Prior allergic reaction to Cetuximab.
- History of allergic reactions to compounds similar in chemical or biological composition to 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 that could interfere with safe and timely study completion.
- History of interstitial lung disease or evidence of it on screening chest imaging.
- Serious or non-healing wounds, ulcers, or bone fractures.
- Recent history (within 28 days) of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess.
- History of stroke or transient ischemic attack within 12 months prior to enrollment.
- History of major heart problems or interventions within 6 months prior to enrollment.
- History of arterial or venous thrombosis or thromboembolic events within 6 months prior to enrollment.
- Any condition requiring immunosuppression, except stable corticosteroid use for rheumatologic conditions.
- Pregnancy, breastfeeding, or plans to conceive or father children during the study and for 6 months after last dose.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
Research Team
S
Study Coordinator
CONTACT
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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