Pembrolizumab for Squamous Cell Carcinoma
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Who Is on the Research Team?
Francis P. Worden
Principal Investigator
University of Michigan Rogel Cancer Center
Are You a Good Fit for This Trial?
This trial is for patients with orbital or periorbital cutaneous squamous cell carcinoma that has spread locally or recurred. Candidates must have a type of skin cancer near the eye with genetic changes, making them potentially responsive to immunotherapy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive pembrolizumab intravenously over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 35 cycles.
Follow-up
Participants are monitored for safety and effectiveness after treatment completion. Follow-up occurs at 30 days, then every 9 weeks for 52 weeks, and every 12 weeks for up to 2 years.
What Are the Treatments Tested in This Trial?
Interventions
- Pembrolizumab
Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Michigan Rogel Cancer Center
Lead Sponsor