The goal of this clinical trial is to learn if the combination of the drug cemiplimab along with a short course of radiation therapy called Quad Shot can be successfully given in several rounds to elderly or frail patients with head and neck skin cancers. The main question it aims to answer is:
\- Can care providers successfully deliver at least 6 rounds of cemiplimab and 3 rounds of Quad Shot radiation to patients?
Patients will:
* Be given cemiplimab every 3 weeks for a total of up to 8 doses * Be given Quad Shot radiation (four treatments over two days) every 3 weeks for a total of up to 4 rounds
Locally advanced squamous cell carcinoma of the skin arising from the head and neck region.
Patients who have had prior treatment of a localized skin primary and now present with nodal recurrence or unresectable local recurrence are considered eligible as long as the recurrent disease has not been previously treated with radiation therapy
No prior systemic therapy including chemotherapy, targeted therapy or immunotherapy.
ECOG Performance status 3 or 4;
Prior systemic therapy for locally advanced cutaneous carcinoma of the head and neck (LACCHN)
Metastatic disease outside of the head and neck.
Prior treatment with checkpoint inhibitor therapy.
Planned re-irradiation: If disease is recurrent in a site previously treated with radiation, the patient will not be considered for study.
Single group
Cemiplimab
DrugCemiplimab 350mg (IV) will be administered every 3 weeks for a total of eight doses or until progression or treatment related toxicity requiring discontinuation of therapy. Cemiplimab may be continued at the treating physician's discretion beyond six months for up to one year (cycle 9 to 16) for patients who achieve a partial or complete objective response and are tolerating treatment.
Radiation Therapy
RadiationRadiation therapy will be delivered using a Quad Shot technique (two treatments per day for two days). Quad Shots will be repeated every three weeks for up to four consecutive cycles. The total planned radiation dose is 59.2 Gy. Patients achieving a complete clinical and radiographic response following the third Quad Shot may discontinue radiation after the third Quad Shot (44.4 Gy).
Feasibility, as measured by the percentage of subjects receiving at least 6 planned doses of cemiplimab and at least 3 "Quad Shots"
The treatment will be deemed feasible if \>80% of patients responding to therapy are able to complete at least six planned doses of cemiplimab and \>75% of patients responding to therapy are able to complete at least three "Quad Shots".
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Vanderbilt-Ingram Cancer Center
Lead sponsor
Regeneron Pharmaceuticals
Collaborator
