Cemiplimab for Skin Cancer

Not currently recruiting at 4 trial locations

Overseen By Charlean Ketchens, RN

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Southern California

Must not be taking: Immune modulators, Corticosteroids

Disqualifiers: Unresectable metastases, Autoimmune disease, 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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 9-12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of cemiplimab, an immunotherapy drug, before surgery for certain types of skin cancer. It targets high-risk cancers, those that have returned after treatment, or those that have spread locally but remain operable. The trial aims to determine if cemiplimab can enhance the immune system's ability to fight cancer and inhibit tumor growth. It suits patients with cutaneous squamous cell carcinoma that can be surgically removed and has not spread to distant areas. As a Phase 2 trial, it measures cemiplimab's effectiveness in an initial, smaller group, providing valuable insights for potential participants.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop your current medications. However, you cannot be on other cancer treatments or certain immune therapies while participating.

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

Research has shown that cemiplimab is generally safe. In studies involving patients with certain types of skin cancer, cemiplimab significantly reduced the risk of cancer recurrence or death. While it can cause side effects, these are usually manageable. One study found that cemiplimab likely controlled the disease for at least a year in most patients. This indicates that, despite potential side effects, the treatment is often well-tolerated. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Cemiplimab is unique because it leverages the power of the immune system to combat skin cancer. Unlike traditional treatments like surgery, chemotherapy, or radiation, which directly target cancer cells, cemiplimab is a type of immunotherapy known as a PD-1 inhibitor. It works by blocking the PD-1 pathway, which cancer cells use to hide from the immune system. This allows the body's natural defenses to recognize and attack the cancer more effectively. Researchers are excited about its potential to provide a more targeted approach with potentially fewer side effects compared to conventional therapies.

What evidence suggests that cemiplimab might be an effective treatment for skin cancer?

Research has shown that cemiplimab is very effective in treating certain skin cancers. In one study, over 60% of patients with advanced squamous cell skin cancer experienced complete cancer remission after receiving cemiplimab. The treatment also reduced the risk of cancer recurrence or death by 68%. On average, patients lived about 14.7 months without their cancer worsening. In this trial, participants will receive cemiplimab, and those with potentially resectable tumors will also undergo surgical resection. These findings suggest that cemiplimab could be a promising option for treating high-risk skin cancers. ^{1 6 7 8 9}

Who Is on the Research Team?

Gino K. In

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for adults with high-risk, resectable skin cancer that's localized, locally recurrent, or regionally advanced. They must have measurable disease and not have had prior PD-1/PD-L1 inhibitors or immune therapies within 4 weeks. Major organ functions need to be stable, no uncontrolled illnesses are allowed, and they can't be pregnant or breastfeeding. Participants should agree to use contraception during the study.

Inclusion Criteria

My cancer is considered possibly removable by surgery.

Patients must have a disease that can be measured.

You must have at least 75,000 platelets per microliter of blood.

Exclusion Criteria

I haven't taken high doses of steroids like prednisone (10 mg or more) in the last 2 weeks.

I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

I haven't needed drugs for an autoimmune disease in the last 2 years, except for hormone replacements.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive cemiplimab intravenously every 21 days for up to 3 cycles, with an optional 4th cycle if disease is unresectable

9-12 weeks

3-4 visits (in-person)

Surgical Resection

Patients with potentially resectable tumors undergo surgical resection within 6 weeks of last dose of therapy

Up to 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 months

Every 3 months

What Are the Treatments Tested in This Trial?

Interventions

• Cemiplimab
• Resection

Trial Overview The trial tests if cemiplimab given before surgery can help treat patients with certain types of skin cancer. Cemiplimab is a monoclonal antibody designed to boost the body's immune response against cancer cells by blocking the PD-1 pathway which tumors use to evade attack.

How Is the Trial Designed?

Group I: Treatment (cemiplimab, surgical resection) Experimental Treatment 2 Interventions

Patients receive cemiplimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles (or up to 4 cycles for patients whose disease is unresectable after 3 cycles) in the absence of disease progression or unacceptable toxicity. Within 6 weeks of last dose of therapy, patients with potentially resectable tumors undergo surgical resection.

Cemiplimab is already approved in European Union, United States, Canada, Brazil for the following indications:

Approved in European Union as Libtayo for:

• Cutaneous squamous cell carcinoma (CSCC)
• Non-small cell lung cancer (NSCLC)

Approved in United States as Libtayo for:

• Cutaneous squamous cell carcinoma (CSCC)
• Basal cell carcinoma (BCC)
• Non-small cell lung cancer (NSCLC)

Approved in Canada as Libtayo for:

• Cutaneous squamous cell carcinoma (CSCC)
• Non-small cell lung cancer (NSCLC)

Approved in Brazil as Libtayo for:

• Cutaneous squamous cell carcinoma (CSCC)

Who Is Running the Clinical Trial?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

Cemiplimab demonstrated significant antitumor activity in patients with locally advanced cutaneous squamous cell carcinoma, with 44% of the 78 patients showing an objective response, including 13% achieving a complete response.

The treatment had an acceptable safety profile, with 44% of patients experiencing grade 3-4 adverse events, the most common being hypertension and pneumonia, and one treatment-related death due to aspiration pneumonia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cemiplimab in locally advanced cutaneous squamous cell carcinoma: results from an open-label, phase 2, single-arm trial. Migden, MR., Khushalani, NI., Chang, ALS., et al.[2021]

Cemiplimab (Libtayo®) is the first approved immunotherapy for patients with locally advanced or metastatic cutaneous squamous cell carcinoma (CSCC) who cannot undergo surgery or radiotherapy, showing a clinically significant objective response rate in the phase II EMPOWER-CSCC 1 trial.

The treatment has a durable effect, with the median duration of response and overall survival not yet reached, and it has an acceptable safety profile, with manageable immune-related adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cemiplimab: A Review in Advanced Cutaneous Squamous Cell Carcinoma. Lee, A., Duggan, S., Deeks, ED.[2020]

Cemiplimab demonstrated a significant objective response rate of 46.1% in patients with advanced cutaneous squamous cell carcinoma (CSCC), with complete response rates of 20.3% for metastatic CSCC and 12.8% for locally advanced CSCC, indicating its efficacy as a treatment option.

Patients experienced durable improvements in quality of life and pain control, with significant enhancements observed as early as the second treatment cycle, highlighting the treatment's positive impact on overall well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated analysis of a phase 2 study of cemiplimab in advanced cutaneous squamous cell carcinoma: extended follow-up of outcomes and quality of life analysis. Rischin, D., Khushalani, NI., Schmults, CD., et al.[2022]

Cemiplimab-rwlc (Libtayo) is an FDA-approved immunotherapy for advanced cutaneous squamous cell carcinoma (CSCC) that works by blocking the PD-1 receptor, enhancing the immune system's ability to fight tumors.

Clinical trials have shown that cemiplimab is effective in treating CSCC, although common side effects and safety issues were noted, highlighting the need for ongoing research to improve treatment outcomes and reduce toxicity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cemiplimab-rwlc as first and only treatment for advanced cutaneous squamous cell carcinoma. Ahmed, SR., Petersen, E., Patel, R., et al.[2019]

Cemiplimab is a PD-1 monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, which is crucial for enhancing the immune response against cancer cells.

In September 2018, cemiplimab received FDA approval for treating patients with metastatic or locally advanced cutaneous squamous cell carcinoma who cannot undergo curative surgery or radiation, marking a significant advancement in cancer treatment options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cemiplimab: First Global Approval. Markham, A., Duggan, S.[2023]

Cemiplimab is the first FDA-approved treatment for patients with advanced cutaneous squamous cell carcinoma (CSCC) who cannot undergo curative surgery or radiation, demonstrating rapid and substantial antitumor efficacy in phase II clinical trials.

The treatment has an acceptable safety profile, with low rates of treatment discontinuation (7%) and death (3%), although current recommendations are based mainly on phase II data due to the lack of an approved comparator agent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cemiplimab in advanced cutaneous squamous cell carcinoma. Naik, PP.[2022]

Cemiplimab-rwlc is a newly approved PD-1/L1 inhibitor for first-line treatment of metastatic non-small cell lung cancer (NSCLC) without EGFR or ALK mutations, either alone or with chemotherapy.

This review highlights the differences in patient populations studied for cemiplimab compared to other treatments, emphasizing its role in expanding options for NSCLC patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Spotlight on Cemiplimab-rwlc in the Treatment of Non-Small Cell Lung Cancer (NSCLC): Focus on Patient Selection and Considerations. Ahn, J., Nagasaka, M.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40075670/

Effectiveness and Toxicity of Cemiplimab Therapy for ... Conclusions: Cemiplimab produced complete remissions in over 60% of patients with locally advanced and metastatic squamous cell skin cancers, ...

2. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.9533

CemiplimAb-rwlc survivorship and epidemiology (CASE) Median PFS was 14.7 (95% CI: 12.5, 21.1) months, with survival at 12 months estimated at 59.5% (95% CI: 51.4, 66.7). Treatment-related irAEs ...

3. fda.gov fda.gov/drugs/resources-information-approved-drugs/fda-approves-cemiplimab-rwlc-adjuvant-treatment-cutaneous-squamous-cell-carcinoma

FDA approves cemiplimab-rwlc for adjuvant treatment ... FDA approves cemiplimab-rwlc for adjuvant treatment of cutaneous squamous cell carcinoma ... The major efficacy outcome measure was disease ...

4. newsroom.regeneron.com newsroom.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-phase-3-data-adjuvant-treatment-post

Libtayo® (cemiplimab) Phase 3 Data in the Adjuvant ... Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death, the primary endpoint of the trial (p<0.0001).

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39050978/

Real-World Treatment Patterns and Outcomes of ... This retrospective cohort study included US patients with advanced CSCC initiating cemiplimab monotherapy in a real-world database (2018-2021).

6. investor.regeneron.com investor.regeneron.com/news-releases/news-release-details/libtayor-cemiplimab-rwlc-approved-us-first-and-only

Libtayo® (cemiplimab-rwlc) Approved in the U.S. as First ... Approval based on pivotal Phase 3 C-POST trial showing Libtayo significantly reduced the risk of disease recurrence or death by 68% compared ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9421083/

Cemiplimab and Cutaneous Squamous Cell Carcinoma The authors reported that the estimated probability of progression-free survival at 12 months was 81%. Adverse events in the metastatic-disease cohort occurred ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2772611824002611

Efficacy and safety of cemiplimab in cutaneous squamous ... Cemiplimab showed promise in aggressive squamous cell carcinoma from chronic wound. Median progression-free survival was 6.1 months with a 47% response rate.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11268751/

Real-World Treatment Patterns and Outcomes of Cemiplimab ... Cemiplimab is a preferred systemic treatment option in US guidelines for patients with locally advanced, recurrent, or metastatic CSCC if curative radiation or ...