Cemiplimab for Skin Cancer

Not currently recruiting at 21 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Regeneron Pharmaceuticals

Must not be taking: Corticosteroids, Immunosuppressants

Disqualifiers: Solid malignancy, Metastatic disease, Autoimmune, others

Stay on Your Current Meds You can continue your current medications while participating

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: Unknown

Duration: 6-9 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests cemiplimab, administered through an IV drip, to determine its effectiveness in treating skin cancer before surgery. The main goal is to assess how well cemiplimab can shrink the cancer, potentially making it less severe at the time of surgery. The trial also evaluates whether the medication improves survival rates and alters the surgery plan. Suitable participants have skin cancer that hasn't spread to distant parts of the body and require surgery as part of their treatment. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering a chance to contribute to important findings.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are on corticosteroids (a type of medication that reduces inflammation) at a dose higher than 10 mg of prednisone per day, you may not be eligible to participate.

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

Research has shown that cemiplimab is generally safe for treating skin cancer. Studies indicate it has a good safety record, with most side effects being manageable. Although the FDA has approved it for other types of skin cancer, such as cutaneous squamous cell carcinoma, some individuals might experience immune-related side effects. These side effects can affect any part of the body but are usually rare. Overall, patients tolerate cemiplimab well, with its benefits often outweighing the risks. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Cemiplimab is unique because it targets the PD-1 pathway, a mechanism that helps the immune system recognize and attack cancer cells. Unlike traditional treatments for skin cancer, such as surgery or chemotherapy, cemiplimab offers a non-invasive option with the potential for fewer side effects. Researchers are excited about cemiplimab because it has shown promise in earlier studies for effectively shrinking tumors and improving patient outcomes by boosting the body’s natural defenses against cancer.

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

Research has shown that cemiplimab effectively treats cutaneous squamous cell carcinoma (CSCC). One study found it reduced the risk of cancer recurrence or death by 68%. Due to its strong trial results, the FDA approved cemiplimab for this skin cancer. Patients using cemiplimab have demonstrated clear improvements in survival rates. While further research is needed to understand long-term effects, current evidence supports its use in managing this skin cancer. ^{4 6 7 8 9}

Who Is on the Research Team?

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for individuals with Stage II to IV cutaneous squamous cell carcinoma (CSCC), a type of skin cancer, who are recommended for surgery. Participants must have at least one lesion larger than 3 cm and be in good physical condition with proper organ and bone marrow function.

Inclusion Criteria

You have at least one detectable and measurable lesion according to a specific medical guideline called RECIST 1.1.

I am fully active or can carry out light work.

My skin cancer is at a stage where surgery is advised, and if it's stage II, the lesion is at least 3 cm big.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive neoadjuvant cemiplimab via IV infusion every 3 weeks

6-9 weeks

Surgery

Participants undergo definitive surgery to assess pathologic response

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Cemiplimab

Trial Overview The study tests the effectiveness of Cemiplimab before surgery (neoadjuvant therapy) by looking at how many patients achieve complete disappearance of their cancer as judged by independent review. It also examines other disease responses, survival rates, safety profile, and changes in surgical plans.

How Is the Trial Designed?

Group I: Cemiplimab Experimental Treatment 1 Intervention

Will receive IV infusion Q3W

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?

Regeneron Pharmaceuticals

Lead Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Sanofi

Industry Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Published Research Related to This Trial

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 (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-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]

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 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 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 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]

Citations

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

Cemiplimab and Cutaneous Squamous Cell Carcinoma This study will report on outcomes and long-term effectiveness of cemiplimab ... squamous cell carcinoma (CSCC): Longer follow-up efficacy and safety data.

2. 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 ...

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

CemiplimAb-rwlc survivorship and epidemiology (CASE) The interim results of this Phase IV study demonstrate robust effectiveness and a generally manageable safety profile of cemiplimab in patients with laCSCC/ ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40869427/

Efficacy of Neoadjuvant Cemiplimab Treatment for ... Despite more research still being needed to confirm its long-term benefits and the effects of the drug's use outside of clinical trials, there ...

5. 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).

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/PMC11083599/

Efficacy and Safety of Cemiplimab for the Management of Non ... Cemiplimab has a durable and significant effect for the management of BCC and CSCC, with a favorable safety profile. Abstract. Non-melanoma skin ...

8. libtayohcp.com libtayohcp.com/resource/pdf/skin-brochure-for-HCPs.pdf

1# 33 10 33k - LIBTAYO® (cemiplimab-rwlc) Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue at any time after starting treatment. While immune-.

9. onclive.com onclive.com/view/fda-approves-adjuvant-cemiplimab-for-cutaneous-squamous-cell-carcinoma

FDA Approves Adjuvant Cemiplimab for Cutaneous ... The FDA approved cemiplimab-rwlc for the adjuvant treatment of cutaneous squamous cell carcinoma at high risk of recurrence after surgery ...