Overview
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.
Description
Primary Objective:
To measure Overall Response Rate to treatment with Cetuximab as single agent following treatment with immunotherapy with PD-1 inhibitors alone or in combination with chemotherapy.
Secondary Objective(s):
- Measure Duration of Response (DUR), Progression Free Survival and Overall Survival and for treatment with single agent Cetuximab after immunotherapy with PD-1 inhibitors in Head and Neck Squamous Cell Carcinoma.
- Evaluate treatment toxicity with single agent Cetuximab in this patient population.
Exploratory Objectives:
I. Evaluate the early positron emission tomography (PET) scan ability to predict tumor response.
II. Collect quality of life (QOL) data on patient reported outcomes every six weeks and examine this data for overall tolerability of this treatment.
III. Bank saliva and blood for future studies of biomarkers. IV. Correlate treatment response with human papillomavirus (HPV) and smoking status.
OUTLINE: Patients receive cetuximab intravenously (IV) over 60-120 minutes once every week in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 1 week and then every 6-8 weeks thereafter.
Eligibility
Inclusion Criteria:
- Patients must have histologically or cytologically confirmed head and neck squamous cell carcinoma including cutaneous squamous cell cancer of the head and neck.
- 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 in the last 6 months.
- Patients must have a Performance Status of 0-2.
- Patients must be greater than or equal to 18 years old.
- Willing to provide consent for collection of samples of blood and saliva as scheduled through the treatment.
- Subject is willing and able to comply with the protocol for the duration of the study.
- Willingness to donate 2 tablespoons of blood and one teaspoon of saliva before treatment, 4 times during the first 6 weeks of treatment and then every 6-8 weeks while patients is under treatment.
- 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.
- 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.
- Subject with a history of interstitial lung disease (e.g. pneumonitis or pulmonary fibrosis) or evidence of interstitial lung disease on screening chest CT scan.
- Any of the following conditions: Serious or non-healing wound, ulcer, or bone fracture, 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.