Trials / Recruiting

RecruitingNCT06580054

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)

Status: Recruiting
Phase: Phase 2
Study type: Interventional
Enrollment: 22 (estimated)

Sponsor: University of Michigan Rogel Cancer Center · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

PRIMARY OBJECTIVE: I. To determine whether treatment of patients with locally advanced or recurrent orbital and/or periocular cSCC with pembrolizumab will be associated with tumor response. SECONDARY OBJECTIVES: I. To assess the globe preservation rate among patients with locally advanced or recurrent orbital and/or periocular cSCC treated with pembrolizumab. II. To determine whether treatment with pembrolizumab of patients with locally advanced or recurrent orbital and/or periocular cSCC will prevent progression of disease. EXPLORATORY OBJECTIVES: I. To evaluate next generation sequencing (NGS) and correlate with response to therapy for patients with available tissue. II. Correlate visual function to location and size of tumor over the course of treatment. III. To identify if the presence of human papillomavirus (HPV) in the cSCC affects the tumor response. IV. To determine the duration of response (DOR) at 2 years. OUTLINE: Patients receive pembrolizumab intravenously (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 magnetic resonance imaging (MRI) or computed tomography (CT) and photographs of tumor throughout the study. After completion of study treatment, patients are followed up at 30 days and then every 9 weeks for 52 weeks and then every 12 weeks for up to 2 years.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Computed Tomography	Undergo CT
OTHER	Digital Photography	Undergo photographs of tumor
PROCEDURE	Magnetic Resonance Imaging	Undergo MRI
BIOLOGICAL	Pembrolizumab	Given IV

Timeline

Start date: 2025-03-05
Primary completion: 2028-03-01
Completion: 2030-03-01
First posted: 2024-08-30
Last updated: 2026-03-11

Locations

1 site across 1 country: United States

Regulatory

FDA-regulated drug study

Source: ClinicalTrials.gov record NCT06580054. Inclusion in this directory is not an endorsement.