Cemiplimab for Skin Cancer

Not currently recruiting at 27 trial locations

Overseen By Clinical Trial Administrator

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Regeneron Pharmaceuticals

Must not be taking: Immunosuppressants, PD-1/PD-L1 blockers

Disqualifiers: Autoimmune disease, Metastatic cancer, Transplant, others

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

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

Compensation: Varies

Number of Visits: 13

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an experimental drug called cemiplimab for certain types of skin cancer, specifically Cutaneous Squamous Cell Carcinoma (CSCC) and Basal Cell Carcinoma (BCC). The main goal is to assess the drug's safety and patient tolerance. Researchers also examine potential side effects and cemiplimab's impact on tumors. Individuals with recurrent CSCC or BCC and a measurable tumor (1-2 cm in size) might be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, if you are on medications that affect the immune system or have had certain treatments in the past, you might not be eligible. It's best to discuss your specific medications with the trial team.

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

Research shows that cemiplimab is generally safe for patients with certain skin cancers. The FDA has approved it for treating cutaneous squamous cell carcinoma (CSCC), indicating it is well-tolerated for this condition. Studies have found that most side effects, such as tiredness, rash, or changes in lab tests, are manageable, and serious side effects are rare.

Although limited information exists for basal cell carcinoma (BCC), the approval for CSCC provides some confidence in its safety. As this trial is in the early stages, the researchers are focusing on understanding how the body responds to the drug. ^{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, an innovative approach compared to traditional treatments like surgery, radiation, or chemotherapy for skin cancer. This mechanism helps the immune system recognize and attack cancer cells more effectively. Researchers are excited about cemiplimab because it has shown promise in providing a more precise and potentially less invasive option, which could lead to better outcomes and fewer side effects for patients.

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). In studies, cemiplimab reduced the risk of cancer recurrence or death by 68% in people with CSCC. Over 60% of patients with advanced forms of this skin cancer experienced complete tumor disappearance. The FDA has approved cemiplimab for treating CSCC, underscoring its effectiveness. This trial will evaluate cemiplimab in various dose cohorts to further understand its potential benefits. These findings suggest that cemiplimab might also be beneficial for basal cell carcinoma (BCC), but more research is needed for that condition. ^{1 2 4 6 7}

Who Is on the Research Team?

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

Adults with Cutaneous Squamous Cell Carcinoma or Basal Cell Carcinoma that can be measured and has recurred. Participants should have good performance status (ECOG ≤1) and no other serious illnesses or recent vaccinations. Those with a history of certain cancers, immune diseases, organ transplants, or previous PD-1/PD-L1 pathway treatments are excluded.

Inclusion Criteria

My cancer can be measured and is at least 1 cm in size.

I have had skin cancer that was removed more than once.

I am fully active and can carry on all my pre-disease activities without restriction.

Exclusion Criteria

My skin cancer has spread to nearby lymph nodes but not elsewhere, and if it had, I've been disease-free for 3 years.

I have been treated with drugs that target the PD-1/PD-L1 pathway.

I have an autoimmune disease treated with immunosuppressants in the last 5 years.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive weekly doses of cemiplimab for 12 weeks to evaluate safety and tolerability

12 weeks

12 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

13 weeks

1 visit (in-person)

Long-term follow-up

Participants are monitored for long-term safety and pharmacokinetic observations

Up to 90 days after last dose

What Are the Treatments Tested in This Trial?

Interventions

• Cemiplimab

Trial Overview The trial is testing the safety and effects of an experimental drug called cemiplimab on skin cancer tumors. It involves weekly doses for 12 weeks to see how the body reacts, what side effects occur, the impact on tumors, and how much drug stays in the blood over time.

How Is the Trial Designed?

Group I: Cemiplimab Experimental Treatment 1 Intervention

Three dose cohorts are planned and will follow a 3 + 3 dose-escalation design with cohort expansion. After completion of the above, three additional cohorts (A, B and C) of patients will be evaluated. Cohorts D, H and I may open after completion of Cohort B. Note: Cohort E through G will not be opened for participation.

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 (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 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-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]

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. 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. 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/40075670/

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

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

1# 33 10 33k - LIBTAYO® (cemiplimab-rwlc) NCCN Guidelines® for Basal Cell Skin Cancer V.2.2025 include cemiplimab-rwlc. (LIBTAYO®) as a recommended systemic therapy option for appropriate patients.