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

Conditions

• Locally Advanced Cutaneous Squamous Cell Carcinoma of the Head and Neck
• Recurrent Cutaneous Squamous Cell Carcinoma of the Head and Neck
• Stage III Cutaneous Squamous Cell Carcinoma of the Head and Neck AJCC v8

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Computed Tomography — PROCEDURE
  Undergo CT
• Digital Photography — OTHER
  Undergo photographs of tumor
• Magnetic Resonance Imaging — PROCEDURE
  Undergo MRI
• Pembrolizumab — BIOLOGICAL
  Given IV

Study Details

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.

Key Dates

Start date

Mar 5, 2025

Status verified

Mar 2026

Primary completion

Mar 1, 2028

Completion

Mar 1, 2030

Study Design

Enrollment

22 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Treatment (pembrolizumab)
  Patients receive pembrolizumab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 35 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo MRI or CT and photographs of tumor throughout the study.

Primary Outcome Measure

Objective response rate [ Time Frame: Up to 2 years ]

Locations (1)

Find similar trials in Ann Arbor, MI

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