RecruitingPhase 2NCT06580054

Pembrolizumab for the Treatment of Locally Advanced and/or Recurrent Orbital or Periocular Cutaneous Squamous Cell Carcinoma

Pembrolizumab for Orbital and Periocular Cutaneous Squamous Cell Carcinoma (cSCC)


Sponsor

University of Michigan Rogel Cancer Center

Enrollment

22 participants

Start Date

Mar 5, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying whether pembrolizumab — an immunotherapy drug that helps the immune system fight cancer — can treat a rare and aggressive form of skin cancer around the eye area (orbital or periocular squamous cell carcinoma). This cancer is difficult to treat when it has spread locally or come back after prior treatment. **You may be eligible if...** - You are 18 or older - You have been diagnosed with locally advanced, diffuse, or recurrent skin cancer around the eye (confirmed by tissue biopsy) - You meet certain health requirements including organ function and performance status - Women of childbearing age must agree to use contraception **You may NOT be eligible if...** - You have active autoimmune disease or are on immunosuppressive medications - You have had prior immunotherapy treatment - You have serious heart, liver, or kidney problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREComputed Tomography

Undergo CT

OTHERDigital Photography

Undergo photographs of tumor

PROCEDUREMagnetic Resonance Imaging

Undergo MRI

BIOLOGICALPembrolizumab

Given IV


Locations(1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

View Full Details on ClinicalTrials.gov

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NCT06580054


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