Cetuximab treatment for advanced head and neck cancer after immunotherapy

Pilot Phase II Study to Evaluate Effect of Cetuximab Given as Single Agent After Immunotherapy With PD-1 Inhibitors in Patients With Head and Neck Squamous Cell Carcinoma

This study is testing if the drug Cetuximab can help people with advanced head and neck cancer who didn’t respond to or couldn’t tolerate previous immunotherapy treatments.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Wake Forest University Health Sciences (other)
• Drugs / interventions: Cetuximab, chemotherapy, immunotherapy
• Locations: 1 site (Winston-Salem, North Carolina)
• Trial ID: NCT04375384 on ClinicalTrials.gov

What this trial studies

This Phase II clinical trial evaluates the effectiveness of Cetuximab as a single agent in patients with recurrent or metastatic head and neck squamous cell carcinoma who have previously failed or been intolerant to immunotherapy with PD-1 inhibitors. The study aims to measure the overall response rate, duration of response, progression-free survival, and overall survival while also assessing treatment toxicity. Patients will receive Cetuximab intravenously once a week, and follow-up assessments will occur regularly after treatment.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with confirmed recurrent or metastatic head and neck squamous cell carcinoma who have previously received PD-1 inhibitors.

Not a fit: Patients who have had prior treatment with Cetuximab or have a history of allergic reactions to it may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with advanced head and neck cancer who have limited treatment choices.

How similar studies have performed: Other studies have shown promise in using targeted therapies like Cetuximab in similar patient populations, indicating potential for success.

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.

Where this trial is running

Winston-Salem, North Carolina

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

Study contacts

• Principal investigator: Mercedes Porosnicu, MD — Wake Forest University Health Sciences
• Study coordinator: Study Coordinator

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