Feasibility Study of Cemiplimab and Quad Shot Radiation in Elderly, Frail, or High Comorbidity Patients With Locally Advanced Cutaneous Squamous Cell Carcinomas of the Skin Arising in the Head and Neck Region

Summary

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

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  Cemiplimab

  Cemiplimab 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
  Radiation Therapy

  Radiation 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).

Location