Adjuvant Cemiplimab for Squamous Cell Carcinoma

Not currently recruiting at 330 trial locations

Overseen By Clinical Trials Administrator

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Regeneron Pharmaceuticals

Must not be taking: Systemic immunosuppressants, Anti-cancer immunotherapy

Disqualifiers: Non-cutaneous SCCs, Hematologic malignancies, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether cemiplimab, an immunotherapy, can help people with high-risk skin cancer (cutaneous squamous cell carcinoma) live longer without cancer recurrence after surgery and radiation. Participants will receive either cemiplimab or a placebo to determine if cemiplimab more effectively prevents the cancer's return or spread. The trial seeks individuals who have undergone surgery and radiation for high-risk skin cancer and are 2 to 10 weeks post-treatment. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that cemiplimab is generally well-tolerated and effective in treating patients with advanced skin cancer, specifically cutaneous squamous cell carcinoma (CSCC), including older patients or those with other health issues. Most patients handle the treatment well.

One study found that cemiplimab reduced the risk of the disease returning or causing death by 68%, demonstrating its effectiveness and manageable side effects. Reports indicate that any side effects are usually not severe for most patients.

While all treatments can have side effects, the data so far suggest that cemiplimab is safe for many patients. This information can help those considering joining a clinical trial feel more informed about the treatment's safety record. ^{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 immune checkpoint, helping the body's immune system better recognize and attack cancer cells. Unlike traditional treatments for squamous cell carcinoma, such as surgery and radiation, which physically remove or destroy cancer cells, cemiplimab enhances the immune response without directly targeting the tumor itself. Researchers are excited about cemiplimab because it has shown promise in improving patient outcomes by potentially offering a more precise and less invasive approach to treatment. This could lead to fewer side effects and improved quality of life for patients.

What evidence suggests that cemiplimab might be an effective treatment for high-risk cutaneous squamous cell carcinoma?

Studies have shown that cemiplimab effectively treats cutaneous squamous cell carcinoma (CSCC), a type of skin cancer. Research found it reduced the risk of cancer recurrence or death by 68%, a significant result. More than 60% of patients with advanced CSCC experienced complete cancer remission with cemiplimab treatment. The FDA has approved it specifically for this type of skin cancer, underscoring its effectiveness. In this trial, some participants will receive cemiplimab to evaluate its ability to prevent cancer from returning after surgery, while others will receive a placebo for comparison. ^{1 4 6 7 8}

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 adults with high-risk cutaneous squamous cell carcinoma (CSCC) who've had surgery and radiation. They should be in good physical condition, have no other cancers or significant autoimmune diseases, and their major organs must function well.

Inclusion Criteria

My skin cancer is considered high risk.

My liver, kidneys, and bone marrow are working well.

I am 21 years old or older and live in Japan.

Exclusion Criteria

I have received immunotherapy for skin cancer.

I have been free from advanced skin cancer spread for at least 3 years.

I have a blood cancer but haven't needed treatment for it in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

4 weeks

Treatment

Participants receive cemiplimab or placebo every 3 weeks for 12 weeks, then every 6 weeks for approximately 48 weeks

48 weeks

Every 3 weeks initially, then every 6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

Up to 5 years

Optional Extension

Participants who received placebo and experience cancer recurrence may receive cemiplimab for approximately 96 weeks

96 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Cemiplimab
• Placebo

Trial Overview The study tests if Cemiplimab improves disease-free survival compared to a placebo in patients with CSCC after surgery and radiation. It also looks at overall survival, local/regional recurrence, distant recurrence, second primary tumors, safety of the drug, and its effects on the body.

How Is the Trial Designed?

Group I: Cemiplimab Experimental Treatment 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

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-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, an anti-PD-1 monoclonal antibody, has been shown to be effective in treating locally advanced or metastatic cutaneous squamous cell carcinoma (cSCC), as demonstrated in a clinical case of an elderly woman who responded well after just one course of therapy.

The treatment was well tolerated, highlighting the potential of immunotherapy as a promising option for patients with cSCC.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cemiplimab in cutaneous squamous cell carcinomas (SCC): an overview and a clinical case. Ghidini, A., Santangelo, D., Vaccaro, G., et al.[2022]

Cemiplimab, administered as monotherapy or in combination with hypofractionated radiation therapy, showed a 10% objective response rate in patients with recurrent or metastatic cervical cancer, particularly in those with squamous histology, indicating its potential efficacy in this subgroup.

The most common side effects were diarrhea, fatigue, and hypokalemia, affecting 35%, 25%, and 25% of patients respectively, suggesting that while cemiplimab has anti-tumor activity, it also has a manageable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

PD-1 blockade in recurrent or metastatic cervical cancer: Data from cemiplimab phase I expansion cohorts and characterization of PD-L1 expression in cervical cancer. Rischin, D., Gil-Martin, M., González-Martin, A., 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 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]

The updated population pharmacokinetic model for cemiplimab, based on data from 1062 patients, demonstrated improved stability and robustness, successfully validating its pharmacokinetics in patients with recurrent or metastatic cervical cancer.

Despite the improved model, the analysis revealed no significant exposure-response relationships for efficacy (overall survival, progression-free survival, duration of response, objective response rate) or safety (immune-related adverse events), indicating that higher drug exposure did not correlate with better outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Population pharmacokinetics modeling and exposure-response analyses of cemiplimab in patients with recurrent or metastatic cervical cancer. Nguyen, JH., Epling, D., Dolphin, N., et al.[2023]

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. 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/ ...

3. 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, ...

4. libtayohcp.com libtayohcp.com/cscc/efficacy/response-duration

Up to 5 years of Long-term follow-up data Cemiplimab in locally advanced cutaneous squamous cell carcinoma: results from an open-label, phase 2, single-arm trial. Lancet Oncol. 2020;21(2):294-305. 8 ...

5. 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-free ...

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

Real-World Treatment Patterns and Outcomes of Cemiplimab ... Most cases of CSCC are cured by surgery/radiation, but an estimated 1% to 5% of patients will develop advanced disease, which is associated with ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2772611823000071

Real-world data on tolerability and clinical response of ... Cemiplimab demonstrated to be well-tolerated, even in elderly patients with severe comorbidities, achieving an objective response in 52% of patients.

8. annalsofoncology.org annalsofoncology.org/article/S0923-7534(22)02802-2/fulltext

825P CemiplimAb-rwlc Survivorship and Epidemiology ... A prospective study of the safety and efficacy of cemiplimab in patients (pts) with advanced cutaneous squamous cell carcinoma (CSCC) in a real-world setting.