Pembrolizumab for Squamous Cell Carcinoma

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Michigan Rogel Cancer Center

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Other skin cancers, Active infection, others

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how well the drug pembrolizumab works for people with skin cancer near the eyes, specifically squamous cell carcinoma (SCC) that has spread or returned. Pembrolizumab, a type of immunotherapy, helps the body’s immune system target and attack cancer cells. This trial may suit those with SCC around the eye area that isn’t responding to surgery or radiation. Participants will receive pembrolizumab through an IV every three weeks and will undergo regular scans and photos of their tumors to track progress.

As a Phase 2 trial, this research measures how well the treatment works in an initial, smaller group of people, offering participants a chance to contribute to important advancements in cancer therapy.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot participate if you are on certain treatments like systemic anti-cancer therapy or immunosuppressive therapy close to the trial start. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that pembrolizumab is likely to be safe for humans?

Research has shown that pembrolizumab is generally safe across different conditions. In studies with patients who had recurring or spreading skin cancer, pembrolizumab effectively fought tumors and was well-tolerated. Reported side effects were usually manageable.

The FDA has already approved pembrolizumab for certain types of skin cancer, indicating its safety for similar conditions. This approval may reassure those considering joining a trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Pembrolizumab is unique because it is an immunotherapy that specifically targets and blocks the PD-1 pathway, helping the body's immune system recognize and attack cancer cells more effectively. Unlike traditional chemotherapy or radiation, which directly target cancer cells but can also harm healthy cells, pembrolizumab empowers the immune system to fight the cancer with potentially fewer side effects. Researchers are excited about pembrolizumab for squamous cell carcinoma because it offers a novel approach that may provide better outcomes for patients, especially those whose tumors are resistant to conventional treatments.

What evidence suggests that pembrolizumab might be an effective treatment for locally advanced or recurrent orbital and/or periorbital cSCC?

Research has shown that pembrolizumab effectively treats certain types of squamous cell carcinoma (SCC), a kind of skin cancer. In the KEYNOTE-048 study, pembrolizumab helped patients with head and neck SCC that had returned or metastasized. Specifically, it stopped the cancer from growing or spreading. Pembrolizumab boosts the immune system to attack cancer cells and is already approved for skin SCC cases that cannot be treated with surgery or radiation. This trial will evaluate pembrolizumab for treating advanced or recurring SCC around the eye area. ^{6 7 8 9 10}

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

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

Pregnancy, breastfeeding, or planning to conceive during the study period

I have an active case of tuberculosis.

I have not needed treatment for an autoimmune disease in the last 2 years.

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?

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+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36219809/

Updated Results of the Phase III KEYNOTE-048 Study - PubMed Pembrolizumab and pembrolizumab-chemotherapy demonstrated efficacy in recurrent/metastatic head and neck squamous cell carcinoma in KEYNOTE-048.

2. keytrudahcp.com keytrudahcp.com/efficacy/hnscc-squamous-cell-carcinoma/

KEYNOTE-689 - Clinical Trial Results | HCP In the neoadjuvant phase of KEYNOTE-689, of the 361 patients who received at least one dose of single agent KEYTRUDA, 11% experienced serious adverse reactions.

3. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.6000

Phase 3 randomized trial (KEYNOTE-630) of adjuvant ... The safety profile of adjuvant pembro was consistent with reports from similar studies and there were no treatment-related deaths. The study was ...

4. nejm.org nejm.org/doi/full/10.1056/NEJMoa2415434

Neoadjuvant and Adjuvant Pembrolizumab in Locally ... The addition of pembrolizumab to established neoadjuvant and adjuvant regimens led to significant improvement in efficacy outcomes in phase 3 ...

5. merck.com merck.com/news/european-commission-approves-keytruda-pembrolizumab-as-part-of-a-treatment-regimen-for-adults-with-resectable-locally-advanced-head-and-neck-squamous-cell-carcinoma-la-hnscc-expressing-pd-l1/

European Commission Approves KEYTRUDA® ... “This approval brings a promising advancement to patients in Europe with resectable locally advanced head and neck squamous cell carcinoma,” ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34293460/

an open-label, nonrandomized, multicenter, phase II trial Pembrolizumab demonstrated clinically meaningful and durable antitumor activity with a manageable safety profile in recurrent/metastatic (R/M) cutaneous ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.e14593

Safety of pembrolizumab in advanced head and neck ... However, its safety profile in Head and Neck Squamous Cell Carcinoma (HNSCC) remains inadequately studied. This meta-analysis aims to ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0959804924000066

Safety profile of pembrolizumab monotherapy based on an ... This pooled analysis of 31 clinical trials showed that pembrolizumab has a consistent safety profile across indications.

9. merck.com merck.com/news/mercks-keytruda-pembrolizumab-met-primary-endpoint-of-event-free-survival-efs-as-perioperative-treatment-regimen-in-patients-with-resected-locally-advanced-head-and-neck-squamous-c/

Merck's KEYTRUDA® (pembrolizumab) Met Primary ... KEYNOTE-689 is the first Phase 3 trial to demonstrate statistically significant and clinically meaningful improvement in EFS in the intent-to-treat population.

10. annalsofoncology.org annalsofoncology.org/article/S0923-7534(21)02186-4/fulltext

an open-label, nonrandomized, multicenter, phase II trial Pembrolizumab demonstrated clinically meaningful and durable antitumor activity with a manageable safety profile in recurrent/metastatic (R/M) ...