A Study of Radiation Therapy and Cemiplimab for People With Skin Cancer

What this study involves

The registry does not currently label this study as recruiting. Ask about its status before planning a screening visit.

Study type

Interventional

Phase

Phase 2

Age range

18 years - Not specified

Sex eligible

All sexes

Healthy volunteers

Not accepted

Participants

34 Actual

These are starting points, not an eligibility decision. The research team must review the full requirements.

About the research

The purpose of the study is to see if the combination of radiation therapy and cemiplimab immunotherapy is an effective treatment for people with locally advanced, unresectable CSCC.

Who may be able to participate?

The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.

Inclusion Criteria:

• Biopsy proven cutaneous squamous cell carcinoma which is locally advanced

• Mixed histology tumors that are predominantly squamous cell carcinoma are eligible
• Locally advanced primary tumor is T3-T4 and/or N+ by AJCC and/or UICC 8th edition clinical criteria
• T3-T4 primary tumor characteristics noted below:

• Non-eyelid tumor \>4 cm in maximum dimension or with bone erosion or invasion, perineural invasion of nerve 0.1 mm or larger, or invasion beyond subcutaneous fat or \>6 mm from granular layer of adjacent normal epidermis
• Eyelid tumor \>2 cm or invading adjacent ocular, orbital or facial structures
• ≥18 years old
• Unresectable or medically inoperable according to local multidisciplinary consensus for reasons such as:

• Tumor or regional lymph node metastases that has recurred despite ≥2 prior surgical procedures, with another curative resection unlikely
• Tumor or nodal disease with significant local invasion that precludes complete resection
• Tumor or nodal disease in anatomically challenging area where surgery may result in significant disfigurement or dysfunction (amputation of nose, ear, eye, digit, limb, etc)
• Medical contraindication to surgery
• Patient refusal of surgery due to anticipate morbidity
• ECOG ≤2
• Adequate bone marrow and metabolic function (by blood tests)

• Total bilirubin ≤1.5 x upper limit of normal
• Aspirate aminotransferase (AST) ≤3 x upper limit of normal
• Alanine aminotransferase (ALT) ≤3 x upper limit of normal
• Alkaline phosphatase ≤2.5 x upper limit of normal
• Serum creatinine ≤1.5 x upper limit of normal or estimated creatinine clearance \>30 mL/min according to Cockcroft-Gault formula
• Hemoglobin \>9 g/dL
• Absolute neutrophil count ≥1.5 x10\^9/L
• Platelet count ≥75 x10\^9/L
• Able to provide informed consent
• Acceptable candidate for curative intent radiotherapy and Cemiplimab immunotherapy, in opinion of radiation and medical oncologist, respectively
• Life expectancy \>18 months

Exclusion Criteria:

• Primary tumor originating on the mucosal (non-hair bearing) lip or nose, anogenital (penis, scrotum, vulva, perianal) area
• Iatrogenic immunosuppression (\>prednisone 10 mg/day or equivalent within 14 days of initiation of treatment)
• Women of child bearing potential unwilling or unable to use effective contraception while receiving treatment with cemiplimab and for 4 months thereafter
• Distant metastases
• Clinically significant autoimmune disease that requires iatrogenic immunosuppression

o For example, severe rheumatoid arthritis requiring disease modifying antirheumatic drugs, such as methotrexate
* Current or previous hematopoietic malignancy (leukemia, lymphoma)
* Prior allogeneic transplant of solid organ or bone marrow
* Concurrent malignancies with \>10% risk of metastasis or death within 2 years
* Prior aPD1 immunotherapy or PI3Kδ inhibitor use
* Prior radiotherapy for the cutaneous squamous cell carcinoma requiring treatment
* Other ongoing cancer therapy

o Adjuvant endocrine therapy is permitted for patients with prostate or breast cancer
* Uncontrolled HIV or infectious hepatitis (viral load detectable in patient with known infection)
* Pregnancy or breastfeeding
* Comorbid or diagnostic abnormalities within the last year that would interfere with interpretation of study results

Treatment, groups and participation

The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.

Assignment

Not applicable

Masking

No masking

What researchers are measuring

Outcome measures describe what is being studied. They are not proof that a treatment works.

Primary measures

Research locations (13)

The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.

13 locations

Study team and timeline

Lead sponsor

Memorial Sloan Kettering Cancer Center

Study start

Oct 6, 2022 Actual

Primary completion

Oct 6, 2027 Estimated

Study completion

Oct 6, 2027 Estimated

First posted

Oct 10, 2022 Actual

Last updated

Nov 10, 2026 Actual

Official study contacts

No central contact is listed. Check the locations and the official record.