Status:
RECRUITING
Cetuximab After Immunotherapy for the Treatment of Head and Neck Squamous Cell Cancer
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Head and Neck Squamous Cell Carcinoma
Recurrent Head and Neck Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 ca...
Detailed Description
Primary Objective: • To measure Overall Response Rate to treatment with Cetuximab as single agent in patients with recurrent or metastatic head and neck squamous cell cancer who failed PD-1 inhibitor...
Eligibility Criteria
Inclusion
- 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
- Prior treatment with Cetuximab or prior therapy that specifically and directly targets the epidermal growth factor receptor (EGFR) pathway in the last five (5) days.
- 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.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT04375384
Start Date
July 1 2020
End Date
December 1 2027
Last Update
July 16 2025
Active Locations (1)
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1
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157