Pembrolizumab for Squamous Cell Carcinoma

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Michigan Rogel Cancer Center

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 35

Duration: Approximately 24 months

22 Participants Needed

Trial Summary

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.

Research Team

Francis P. Worden

Principal Investigator

University of Michigan Rogel Cancer Center

Eligibility Criteria

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.

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.

Timeline

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)

Treatment Details

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.

Participant Groups

Group I: Treatment (pembrolizumab) Experimental Treatment 4 Interventions

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.

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

Approved in United States as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in European Union as KEYTRUDA for:

• Head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1
• Melanoma
• Non-small cell lung cancer (NSCLC)
• Urothelial carcinoma
• Colorectal cancer
• Gastric cancer
• Hepatocellular carcinoma
• Renal cell carcinoma
• Cervical cancer
• Endometrial carcinoma

Approved in United Kingdom as KEYTRUDA for:

• Untreated metastatic or unresectable recurrent head and neck squamous cell carcinoma (HNSCC) with PD-L1 CPS ≥1

Who Is Running the Clinical Trial?

University of Michigan Rogel Cancer Center

Lead Sponsor

Trials

303

Recruited

20,700+