Study on Radiation Therapy and Cemiplimab for People with Advanced Skin Cancer

Inclusion Criteria

• Have a confirmed diagnosis of locally advanced cutaneous squamous cell carcinoma (CSCC).
  • Tumors that are mostly squamous cell carcinoma are eligible.
  • The primary tumor is classified as T3-T4 and/or N+ based on specific clinical criteria.
• Characteristics of T3-T4 primary tumors include:
  • Non-eyelid tumors larger than 4 cm, or with bone erosion, nerve invasion, or deep tissue invasion.
  • Eyelid tumors larger than 2 cm or invading nearby structures.
• Be 18 years or older.
• Cancer that cannot be surgically removed or is not operable due to:
  • Tumor recurrence after at least two surgeries, with further surgery unlikely to cure.
  • Significant local invasion preventing complete removal.
  • Tumor location that would cause major disfigurement or loss of function if surgically removed.
  • Medical reasons preventing surgery.
  • Personal choice to avoid surgery due to expected side effects.
• Have a performance status score of 2 or less, indicating ability to carry out light work.
• Have adequate blood and organ function based on specific blood tests.
• Be able to provide informed consent.
• Be considered a suitable candidate for radiation therapy and cemiplimab immunotherapy by medical professionals.
• Have a life expectancy of more than 18 months.

Exclusion Criteria

• Primary tumor located on the lip, nose, or anogenital area.
• Use of immunosuppressive medications exceeding a certain dose within 14 days before treatment.
• Women who can become pregnant and are not using effective birth control during and for 4 months after treatment.
• Cancer that has spread to distant parts of the body.
• Significant autoimmune diseases requiring immunosuppressive treatment.
• Current or past blood cancers like leukemia or lymphoma.
• Previous organ or bone marrow transplant from a donor.
• Other cancers with a high risk of spreading or causing death within 2 years.
• Previous treatment with certain immunotherapy drugs or PI3Kδ inhibitors.
• Previous radiation therapy for the skin cancer being treated.
• Ongoing cancer treatments, except for certain hormone therapies for prostate or breast cancer.
• Uncontrolled HIV or hepatitis infections.
• Pregnancy or breastfeeding.
• Other health issues that could affect the study results.