22 Participants Needed

Pembrolizumab for Squamous Cell Carcinoma

Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: University of Michigan Rogel Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Breakthrough TherapyThis drug has been fast-tracked for approval by the FDA given its high promise
Approved in 3 JurisdictionsThis treatment is already approved in other countries

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 | Faculty | Michigan ...

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

My liver function tests are within normal ranges.
My kidney function, measured by creatinine levels, is within the required range.
I am not pregnant and follow the required birth control measures.
See 10 more

Exclusion Criteria

I have not needed treatment for an autoimmune disease in the last 2 years.
I am currently on medication for an infection.
I have an active case of tuberculosis.
See 16 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive pembrolizumab intravenously over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 35 cycles.

Approximately 24 months
35 visits (in-person)

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.

Up to 2 years
Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Pembrolizumab
Trial Overview The study is testing pembrolizumab's effectiveness on advanced or recurrent eye-related skin cancer. It involves monitoring through digital photography and scans (CT and MRI), assessing if this immunotherapy can help the immune system fight the cancer.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Treatment (pembrolizumab)Experimental Treatment4 Interventions

Pembrolizumab is already approved in United States, European Union, United Kingdom for the following indications:

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Approved in United States as KEYTRUDA for:
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Approved in European Union as KEYTRUDA for:
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Approved in United Kingdom as KEYTRUDA for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials
303
Recruited
20,700+
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