Pembrolizumab for Orbital and Periocular Cutaneous Squamous Cell Carcinoma (cSCC)
This phase II trial studies how well pembrolizumab works in treating patients with orbital (eye socket) and/or periorbital (surrounding the eye socket) cutaneous squamous cell cancer (cSCC) that has spread to nearby tissue or lymph nodes (locally advanced) or has come back after a period of improvement (recurrent). Skin cancers that are close to the eye or on the eyelid often have more genetic (heredity) changes than other types of cancers. This means that the deoxyribonucleic acid (DNA) (the building blocks of the body that determine such things as the color of the hair) in tumor tissue has been altered compared to normal tissue. It is thought cancer cells with these DNA changes are more likely to respond to a type of drug called immunotherapy. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Pembrolizumab is approved for patients with recurrent or metastatic cSCC not amenable (responsive) to cure by surgery or radiation. Giving pembrolizumab may work better in treating patients with locally advanced or recurrent orbital and/or periorbital cSCC.
• Male/female participants who are at least 18 years of age on the day of signing informed consent.
• Histologically confirmed diagnosis of locally advanced or diffuse or recurrent orbital or periorbital cutaneous squamous cell carcinoma.
• Female participants:
⁃ A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
∙ Not a woman of childbearing potential (WOCBP) as defined.
‣ A WOCBP who agrees to follow the contraception guidance during the treatment period and for at least 120 days after the last dose of study treatment.
• The participant provides written informed consent for the trial.
• Have measurable disease based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. Lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
• Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1.
• Absolute neutrophil count (ANC) ≥ 1500/uL.
• Platelets ≥ 100000/uL.
• Hemoglobin ≥ 9.0 g/dL or ≥ 5.6 mmol/L.
⁃ Criteria must be met without erythropoietin dependency and without packed red blood cell (pRBC) transfusion within last 2 weeks.
• Creatinine ≤ 1.5 x upper limit of normal (ULN) OR measured or calculated creatinine clearance (glomerular filtration rate \[GFR\] can also be used in place of creatinine or creatinine clearance \[CrCl\]) ≥ 30 mL/min for participant with creatinine levels \> 1.5 x institutional ULN.
⁃ Creatinine clearance (CrCl) should be calculated per institutional standard.
• Total bilirubin ≤ 1.5 x ULN OR direct bilirubin ≤ ULN for participants with total bilirubin levels \> 1.5 x ULN.
• Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase \[SGPT\]) ≤ 2.5 x ULN (≤ 5 x ULN for participants with liver metastases).
• International normalized ratio (INR) OR prothrombin time (PT) or activated partial thromboplastin time (aPTT) ≤ 1.5 x ULN unless participant is receiving anticoagulant therapy as long as PT or aPTT is within therapeutic range of intended use of anticoagulants.
• Have recovered from toxicities and/or complications from any prior major surgery before starting study treatment.
• Have a life expectancy of at least 12 weeks.
• Patients with human immunodeficiency virus (HIV) adequately controlled on antiretroviral therapy.
• Patients with known hepatitis B infection (defined as hepatitis B surface antigen \[HbsAg\] reactive) should be on suppressive anti hepatitis B virus (HBV) therapy, and patients with history of hepatitis C infection (defined as hepatitis C virus \[HCV\] ribonucleic acid \[RNA\] detected) must complete curative antiviral treatment with HCV viral load below limit of quantification. Note: no testing for Hepatitis B and Hepatitis C is required unless mandated by local health authority.