Adjuvant Cemiplimab for Squamous Cell Carcinoma

Recruiting at 301 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

415 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the drug cemiplimab for squamous cell carcinoma?

Cemiplimab has been shown to be effective in treating advanced cutaneous squamous cell carcinoma, with studies indicating a significant anti-cancer response and durable effects. It was approved by the FDA based on positive results from clinical trials, demonstrating its ability to shrink tumors and improve survival in patients who are not candidates for surgery or radiation. ^{1 2 3 4 5}

Is cemiplimab generally safe for humans?

Cemiplimab has been shown to have acceptable safety in clinical trials for advanced cutaneous squamous cell carcinoma, with low rates of treatment discontinuation (7%) and death (3%). Safety data from studies in other cancers, like cervical cancer, also showed no significant trends in immune-related adverse events, indicating it is generally safe for humans. ^{1 2 4 6 7}

How is the drug cemiplimab unique in treating squamous cell carcinoma?

Cemiplimab is unique because it is the first approved immunotherapy for advanced cutaneous squamous cell carcinoma, working by blocking the PD-1 receptor to enhance the immune system's ability to fight cancer. It is administered intravenously and has shown durable responses in patients who are not candidates for surgery or radiation. ^{1 2 3 4 5}

What is the purpose of this trial?

The primary objective of the study is to compare disease-free survival (DFS) of patients with high-risk cutaneous squamous cell carcinoma (CSCC) treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and radiation therapy (RT). The secondary objectives of the study are: * To compare the overall survival (OS) of high-risk CSCC patients treated with adjuvant cemiplimab, versus those treated with placebo, after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from locoregional recurrence (FFLRR) after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on patients' freedom from distant recurrence (FFDR) after surgery and RT * To compare the effect of adjuvant cemiplimab with that of placebo on the cumulative incidence of second primary CSCC tumors (SPTs) after surgery and RT * To evaluate the safety of adjuvant cemiplimab and that of placebo in high-risk CSCC patients after surgery and RT * To assess cemiplimab pharmacokinetics and immunogenicity in human serum

Research Team

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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 (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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Cemiplimab-rwlc as first and only treatment for advanced cutaneous squamous cell carcinoma. [2019]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Cemiplimab: First Global Approval. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Cemiplimab in cutaneous squamous cell carcinomas (SCC): an overview and a clinical case. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Cemiplimab in advanced cutaneous squamous cell carcinoma. [2022]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Cemiplimab: A Review in Advanced Cutaneous Squamous Cell Carcinoma. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Population pharmacokinetics modeling and exposure-response analyses of cemiplimab in patients with recurrent or metastatic cervical cancer. [2023]

7. United States 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. [2021]