Actively Recruiting
Pembrolizumab for the Treatment of Locally Advanced and/or Recurrent Orbital or Periocular Cutaneous Squamous Cell Carcinoma
Led by University of Michigan Rogel Cancer Center · Updated on 2026-03-11
22
Participants Needed
1
Research Sites
260 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Pembrolizumab for the Treatment of Locally Advanced and/or Recurrent Orbital or Periocular Cutaneous Squamous Cell Carcinoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 years or older at consent
- Histologically confirmed diagnosis of locally advanced or recurrent orbital or periorbital cutaneous squamous cell carcinoma
- Female participants must not be pregnant, not breastfeeding, and either not of childbearing potential or agree to use contraception during treatment and for 120 days after last dose
- Provide written informed consent
- Have measurable disease by RECIST 1.1 criteria
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Absolute neutrophil count of at least 1500/uL
- Platelet count of at least 100,000/uL
- Hemoglobin level of at least 9.0 g/dL without recent red blood cell transfusion or erythropoietin use
- Creatinine within 1.5 times upper limit of normal or creatinine clearance of at least 30 mL/min if elevated
- Total bilirubin at or below 1.5 times upper limit of normal or direct bilirubin at or below upper limit of normal if total bilirubin is elevated
- AST/ALT less than or equal to 2.5 times upper limit of normal (up to 5 times if liver metastases present)
- INR, PT, or aPTT less than or equal to 1.5 times upper limit of normal unless on anticoagulants within therapeutic range
- Recovered from prior major surgery toxicities before starting treatment
- Life expectancy of at least 12 weeks
- HIV patients controlled on antiretroviral therapy
- Hepatitis B patients on suppressive therapy; Hepatitis C patients with completed antiviral treatment and viral load undetectable
You will not qualify if you...
- Any other skin cancer type besides invasive squamous cell carcinoma as primary disease
- Women of childbearing potential with positive pregnancy test within 72 hours before enrollment
- Prior treatment with anti-PD-1, anti-PD-L1, anti-PD-L2, or other T-cell receptor targeting agents
- Prior systemic anti-cancer therapy or investigational agents within 4 weeks before enrollment without recovery from adverse events
- Prior radiotherapy within 2 weeks before study start without recovery from toxicities
- Receipt of live vaccines within 30 days before first dose of study drug
- Participation in other investigational agent or device studies within 4 weeks before first dose
- Diagnosis of immunodeficiency or use of systemic steroids above 10 mg prednisone equivalent or immunosuppressive therapy within 7 days before first dose
- History of second malignancy unless treated curatively with no evidence for 2 years, except certain in situ or skin cancers
- Active central nervous system metastases or carcinomatous meningitis; stable treated brain metastases allowed
- Severe hypersensitivity to pembrolizumab or its components
- Active autoimmune disease requiring systemic treatment in past 2 years
- History or current pneumonitis requiring steroids
- Active infection requiring systemic therapy
- Known active tuberculosis
- Conditions, therapies, or abnormalities that could interfere with study participation
- Psychiatric or substance abuse disorders interfering with cooperation
- Pregnant, breastfeeding, or planning conception/fatherhood during study and 120 days post-treatment
- History of allogenic tissue or solid organ transplant
- Recent serious cardiovascular events including myocardial infarction, unstable angina, congestive heart failure (NYHA class II or higher), stroke, or serious arrhythmia requiring medication
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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