NCT04375384 Cetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer
| NCT ID | NCT04375384 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Wake Forest University Health Sciences |
| Condition | Head and Neck Squamous Cell Carcinoma |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2020-07-01 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 38 participants in total. It began in 2020-07-01 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Mercedes Porosnicu, MD
PRINCIPAL INVESTIGATOR
Wake Forest University Health Sciences
Frequently Asked Questions
Who can join the NCT04375384 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Squamous Cell Carcinoma. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04375384 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT04375384 currently recruiting?
Yes, NCT04375384 is actively recruiting participants. Contact the research team at Holly.Maize@Advocatehealth.org for enrollment information.
Where is the NCT04375384 trial being conducted?
This trial is being conducted at Winston-Salem, United States.
Who is sponsoring the NCT04375384 clinical trial?
NCT04375384 is sponsored by Wake Forest University Health Sciences. The principal investigator is Mercedes Porosnicu, MD at Wake Forest University Health Sciences. The trial plans to enroll 38 participants.