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

NCT06580054 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 22

Last updated 2026-03-11

No results posted yet for this study

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.

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

Interventions

PROCEDURE

Computed Tomography

Undergo CT

OTHER

Digital Photography

Undergo photographs of tumor

PROCEDURE

Magnetic Resonance Imaging

Undergo MRI

BIOLOGICAL

Pembrolizumab

Given IV

Sponsors & Collaborators

  • University of Michigan Rogel Cancer Center

    lead OTHER

Principal Investigators

  • Francis P Worden · University of Michigan Rogel Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-05
Primary Completion
2028-03-01
Completion
2030-03-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06580054 on ClinicalTrials.gov