Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Memorial Sloan Kettering Cancer Center
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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
