Cemiplimab for Skin Cancer
Recruiting in Palo Alto (17 mi)
+19 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1
Recruiting
Sponsor: Regeneron Pharmaceuticals
Must not be taking: Immunosuppressants, PD-1/PD-L1 blockers
Disqualifiers: Autoimmune disease, Metastatic cancer, Transplant, others
No Placebo Group
Approved in 4 Jurisdictions
Trial Summary
What is the purpose of this trial?This study is researching an experimental drug called cemiplimab. The study is focused on Cutaneous Squamous Cell Carcinoma (CSCC) and Basal Cell Carcinoma (BCC).
The aim of the study is to evaluate the safety and tolerability (how your body reacts to the drug) of cemiplimab (also known as REGN2810).
The first part of the study tested several different doses of cemiplimab given weekly for 12 weeks.
The study is also looking at several other research questions, including:
* What side effects may happen from taking the study drug
* To see effect of cemiplimab on the tumor
* How much study drug is in the blood at different times
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.
What data supports the effectiveness of the drug cemiplimab for skin cancer?
Cemiplimab has been shown to be effective for advanced cutaneous squamous cell carcinoma (CSCC), with clinical trials demonstrating significant and durable responses in patients. It was approved by the FDA based on these positive results, and it helps the immune system fight cancer by blocking a protein that usually stops immune cells from attacking tumors.
12345What makes the drug cemiplimab unique for treating skin cancer?
Cemiplimab is unique because it is the first approved treatment specifically for advanced cutaneous squamous cell carcinoma (CSCC) that cannot be treated with surgery or radiation. It works by blocking a protein called PD-1, which helps the immune system attack cancer cells more effectively.
12367Eligibility Criteria
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.
+2 more
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.
+4 more
Trial Timeline
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
Participant Groups
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.
1Treatment groups
Experimental Treatment
Group I: CemiplimabExperimental Treatment1 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)
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
MetroDerm P.C.Atlanta, GA
The University of Texas MD Anderson Cancer CenterHouston, TX
TCR Medical CorporationSan Diego, CA
MetroDermAtlanta, GA
More Trial Locations
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Who Is Running the Clinical Trial?
Regeneron PharmaceuticalsLead Sponsor
SanofiIndustry Sponsor
References
Cemiplimab: First Global Approval. [2023]Cemiplimab (LIBTAYO®; cemiplimab-rwlc), a human programmed death receptor-1 (PD-1) monoclonal antibody that binds to PD-1 and blocks its interaction with programmed death ligands 1 (PD-L1) and 2 (PD-L2), is being developed by Regeneron Pharmaceuticals and Sanofi Genzyme. The drug is being investigated as a treatment for various cancers and in September 2018 received approval in the USA for the treatment of patients with metastatic cutaneous squamous cell carcinoma or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. This article summarizes the milestones in the development of cemiplimab leading to this first global approval for the treatment of advanced cutaneous squamous cell carcinoma.
Cemiplimab-rwlc as first and only treatment for advanced cutaneous squamous cell carcinoma. [2019]Introduction: In September of 2018, the United States Federal Drug Administration (FDA) approved cemiplimab-rwlc (Libtayo) for advanced cutaneous squamous cell carcinoma (CSCC). Cemiplimab is an intravenous human monoclonal antibody directed against programmed cell death-1 receptor (PD-1). Cemiplimab blocks T-cell inactivation and enhances the immune system's anti-tumor response. Areas Covered: We review CSCC and the studies leading to cemiplimab's approval, including common side effects and safety issues experienced during the clinical trials. Expert Opinion: Immunotherapy, specifically checkpoint inhibitors, represents an increasingly utilized class of medications that is proving to be an effective treatment option for those with certain cancers. Over time, immunotherapy is likely to be the standard of care for immune-sensitive tumors. There are many challenges that the field faces, including the identification of reliable biomarkers to better predict response, decreasing toxicity, and the potential treatment of organ transplant patients.
Cemiplimab: A Review in Advanced Cutaneous Squamous Cell Carcinoma. [2020]Cemiplimab (Libtayo®) is an antibody immunotherapy that stimulates an anti-cancer response via programmed cell death protein-1 (PD-1) blockade. It is the first approved treatment in the USA and EU for patients with locally advanced (laCSCC) or metastatic (mCSCC) cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiotherapy. Approval was based largely on positive results from the phase II EMPOWER-CSCC 1 trial in this patient population. In this pivotal trial, treatment with intravenous cemiplimab 3 mg/kg once every 2 weeks or 350 mg once every 3 weeks resulted in a clinically significant objective response rate across laCSCC and mCSCC patient groups. Furthermore, responses appear to be durable, as the median duration of response has not yet been reached. Similarly, the median overall survival has also not yet been reached as of the latest data cut-off date. The safety and tolerability profile of cemiplimab was acceptable, with most immune-related adverse events being clinically manageable with appropriate therapy or discontinuation of cemiplimab. Overall, cemiplimab has a durable, clinically significant effect and an acceptable tolerability and safety profile. As the first approved treatment for this indication, cemiplimab represents a welcome therapeutic advance for patients with advanced CSCC.
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. [2022]To provide pooled longer term data from three groups of a phase 2 study of cemiplimab in patients with advanced cutaneous squamous cell carcinoma (CSCC), and to determine duration of response (DOR) and impact on quality of life (QoL).
Spotlight on Cemiplimab-rwlc in the Treatment of Non-Small Cell Lung Cancer (NSCLC): Focus on Patient Selection and Considerations. [2023]In metastatic non-small cell lung cancer (NSCLC), tumors that do not harbor driver mutations in EGFR or gene fusions in ALK and ROS, PD-1 and PD-L1 inhibitors have become a cornerstone in first line treatment, either as monotherapy or in combination with chemotherapy. This paper reviews cemiplimab-rwlc, the third PD-1/L1 inhibitor to be approved in the setting for first line treatment in NSCLC, as monotherapy or in combination therapy with chemotherapy, to provide a perspective on the subtle differences in patient population for the cemiplimab studies and consideration of its primary and subgroup results in the context of first line therapies for NSCLC.
Cemiplimab in locally advanced cutaneous squamous cell carcinoma: results from an open-label, phase 2, single-arm trial. [2021]Cemiplimab has shown substantial antitumour activity in patients with metastatic cutaneous squamous cell carcinoma. Patients with locally advanced cutaneous squamous cell carcinoma have poor prognosis with conventional systemic therapy. We present a primary analysis of the safety and antitumour activity of cemiplimab in patients with locally advanced cutaneous squamous cell carcinoma.
Cemiplimab in advanced cutaneous squamous cell carcinoma. [2022]Cemiplimab, a high-affinity, highly potent human monoclonal antibody that binds to the programmed death-1 (PD-1)/programmed death ligand-1 (PD-L1) receptor, is the only drug to attain Food and Drug Administration (FDA) approval and marketing authorization from the European Commission for use in patients with metastatic and locally advanced cutaneous squamous cell carcinoma (CSCC) who are not candidates for curative surgery or curative radiation therapy as a first- or later-line treatment. In pivotal phase II clinical testing, cemiplimab showed rapid and substantial antitumor efficacy and acceptable safety. This systematic review was aimed at evaluating the efficacy and safety of cemiplimab in patients with advanced CSCC. To this end, I reviewed EMBASE, MEDLINE, PubMed, and clinical trial registries/databases by using the following keywords alone or in combination: "cemiplimab," "Libtayo," "cutaneous squamous cell carcinoma," "REGN2810," and "SER439684." Cemiplimab showed clinical efficacy and considerable safety and was associated with low rates of treatment discontinuation (7%) and death (3%). However, the current recommendation is primarily based on only phase II clinical testing due to the absence of an approved comparator agent.