Cemiplimab with Surgery for High-Risk Skin Cancer

Overseen By Michael Lowe, MD

Age: 18+

Sex: Any

Trial Phase: Phase 1

Sponsor: Emory University

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Pregnancy, HIV, Heart failure, 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: 33

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of cemiplimab, an immunotherapy drug, when administered before and after surgery for individuals with high-risk skin cancer. The goal is to enhance the immune system's ability to combat the cancer and reduce the likelihood of recurrence post-surgery. Patients with high-risk cutaneous squamous cell cancer, particularly those with complications such as skin metastases or recurring tumors, may be suitable candidates for this trial. As a Phase 1 trial, the research focuses on understanding the treatment's effects in people, providing participants the opportunity to be among the first to receive this innovative therapy.

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

The trial does not specify if you need to stop taking your current medications. However, if you are on chronic immunosuppressants or require systemic treatment with corticosteroids above a certain dose, 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 well-tolerated by people with cutaneous squamous cell carcinoma. One study found that cemiplimab reduced the risk of cancer recurrence or death by 68%, suggesting its effectiveness and safety for many patients.

The FDA has approved cemiplimab for treating this type of skin cancer, confirming its safety through careful evaluation. However, some participants in earlier studies experienced side effects, though these were not detailed. Awareness of this is important.

Overall, cemiplimab has demonstrated promise in being both effective and safe, but individual experiences may vary. Discuss any concerns with the trial team or your doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Cemiplimab is unique because it harnesses the power of the immune system to fight high-risk skin cancer. Unlike traditional treatments like surgery and radiation, which physically remove or destroy cancer cells, cemiplimab is an immunotherapy that blocks the PD-1 protein on immune cells, enhancing the body's natural ability to attack cancer cells. Researchers are excited about cemiplimab because it offers a novel approach by potentially boosting long-term survival rates and reducing the need for more invasive treatments.

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

Research has shown that cemiplimab, a treatment that aids the immune system in fighting cancer, effectively treats cutaneous squamous cell cancer, a common skin cancer. In this trial, participants will receive cemiplimab both before and after surgery. Previous studies demonstrated that patients using cemiplimab after surgery and radiation had a 68% lower chance of cancer recurrence or death. This significant reduction indicates cemiplimab's potential to prevent cancer from returning. The FDA has approved cemiplimab specifically for this type of skin cancer, underscoring its effectiveness. These findings suggest cemiplimab could be a promising option for people with high-risk skin cancer. ^{1 2 3 6 7}

Who Is on the Research Team?

Michael Lowe, MD

Principal Investigator

Emory University

Are You a Good Fit for This Trial?

This trial is for adults with high risk cutaneous squamous cell cancer that can be removed by surgery. They must have certain blood and organ function levels, no severe allergies to monoclonal antibodies, not be pregnant or breastfeeding, and agree to use contraception. People who've had recent immunosuppressants, organ transplants, uncontrolled illnesses like heart failure or HIV on treatment are excluded.

Inclusion Criteria

Evidence of a personally signed informed consent

My cancer can be removed with surgery, and I will be evaluated before the surgery.

My kidney function, measured by creatinine, is within the normal range.

Exclusion Criteria

I do not have any uncontrolled illnesses.

I haven't taken steroids or immunosuppressants in the last 14 days.

I have or had immune-related lung, gut, liver, kidney, or skin conditions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Phase

Participants receive cemiplimab intravenously every 21 days for up to 3 cycles before surgery

9 weeks

3 visits (in-person)

Adjuvant Phase

Participants receive cemiplimab intravenously every 21 days for up to 18 cycles after surgery or radiation therapy

54 weeks

18 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 10 years

Every 12 weeks for 2 years, every 6 months for 3 years, then annually

What Are the Treatments Tested in This Trial?

Interventions

• Cemiplimab

Trial Overview The study tests if cemiplimab given before and after surgery can prevent the return of high risk skin cancer. Cemiplimab is an immune therapy drug designed to help the body's defense system target cancer cells more effectively.

How Is the Trial Designed?

Group I: Treatment (cemiplimab) Experimental Treatment 3 Interventions

NEOADJUVANT PHASE: Prior to standard of care surgery, patients receive cemiplimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 3 cycles in the absence of disease progression or unacceptable toxicity. ADJUVANT PHASE: Within 2-6 weeks after standard of care radiation therapy (or surgery if no radiation therapy), patients receive cemiplimab IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 18 cycles in the absence of disease progression or unacceptable toxicity.

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?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

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 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 (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, an antibody treatment for locally advanced and metastatic cutaneous squamous cell carcinoma, shows promising efficacy with objective response rates between 32% and 77%, indicating it is a viable option for patients who cannot undergo surgery or radiation.

The treatment is generally safe and well-tolerated, with only 9.8% of patients experiencing adverse events severe enough to stop therapy, although there is a 3% risk of treatment-related death due to immune-mediated side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cemiplimab for the Treatment of Advanced Cutaneous Squamous Cell Carcinoma: Appropriate Patient Selection and Perspectives. Mager, L., Gardeen, S., Carr, DR., et al.[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]

Citations

1. 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).

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 · Efficacy and Safety · Recommended Dosage · Expedited ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12385630/

Impact of Adjuvant Cemiplimab in High-Risk Cutaneous ... In the adjuvant setting, cemiplimab achieves a 68% reduction in the risk of recurrence of CSCC after surgery and radiation therapy [3]. It is ...

4. onclive.com onclive.com/view/adjuvant-cemiplimab-approval-redefines-management-of-high-risk-cscc

Adjuvant Cemiplimab Approval Redefines Management of ... The trial demonstrated a 68% reduction in the risk of recurrence or death with adjuvant cemiplimab vs placebo, reinforcing its role as an ...

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

Cemiplimab and Cutaneous Squamous Cell Carcinoma In the group treated with cemiplimab, the median overall survival was not reached compared to 14.2 months in those treated with chemotherapy. Median progression ...

6. ascopubs.org ascopubs.org/doi/10.1200/JCO.2025.43.16_suppl.6001

Phase 3 trial of adjuvant cemiplimab (cemi) versus placebo ... Cemiplimab is the first systemic therapy to demonstrate a statistically significant and clinically meaningful reduction in disease recurrence as adjuvant ...

7. 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.