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.
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.
Has any other histologic type of skin cancer other than invasive squamous cell carcinoma as the primary disease under study.
A WOCBP who has a positive pregnancy test within 72 hours prior to enrollment. If the urine test is positive or cannot be confirmed as negative, a negative serum pregnancy test will be required.
Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX 40, CD137).
Has received prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to enrollment. Participants must have recovered from all adverse events (AEs) due to previous therapies to ≤ grade 1 or baseline. Participants with ≤ grade 2 neuropathy may be eligible.
Single group
Computed Tomography
Procedure/SurgeryUndergo CT
Digital Photography
Other interventionUndergo photographs of tumor
Magnetic Resonance Imaging
Procedure/SurgeryUndergo MRI
Pembrolizumab
Biological/VaccineGiven IV
Objective response rate
Will be calculated from the tumor partial and complete responses based on immune-related Response Evaluation Criteria In Solid Tumors. Will be reported with exact 95% binomial confidence intervals.
Globe preservation
To assess the globe preservation rate among patients. External and slit lamp photography will be obtained during the Ophthalmic exams
Time to progression
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