Study of Cemiplimab Compared to Placebo After Surgery and Radiation for Patients with High-Risk Skin Squamous Cell Carcinoma

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What is this study about?

This clinical trial is focused on studying a type of skin cancer known as Cutaneous Squamous Cell Carcinoma (CSCC). The study is investigating the effects of a treatment called Cemiplimab, which is also known by its code name R2810. Cemiplimab is a medication given as an infusion, which means it is administered directly into the bloodstream through a vein. The trial will compare the outcomes of patients receiving Cemiplimab with those receiving a placebo, which is a substance with no active medication, after they have undergone surgery and radiation therapy.

The purpose of the study is to see if Cemiplimab can help prevent the return of cancer in patients who are at high risk of their cancer coming back after initial treatment. Participants in the study will be randomly assigned to receive either Cemiplimab or a placebo. The study will monitor patients over time to see how long they remain free of cancer and to track their overall health and survival. The trial will also look at the safety of Cemiplimab by observing any side effects or health changes that occur during the study.

Throughout the study, patients will have regular check-ups and tests to monitor their health and the status of their cancer. The study aims to provide valuable information on whether Cemiplimab can be an effective additional treatment for patients with high-risk CSCC, potentially improving their chances of staying cancer-free after surgery and radiation therapy.

1 randomization

After completing surgery and radiation therapy, the patient is randomly assigned to one of two groups: one receiving cemiplimab and the other receiving a placebo.

This process ensures that each patient has an equal chance of receiving either treatment.

2 treatment administration

The patient receives the assigned treatment through an intravenous infusion.

The treatment consists of LIBTAYO 350 mg concentrate for solution for infusion or a matching placebo.

The frequency and duration of the treatment are determined by the study protocol.

3 monitoring and follow-up

The patient’s health is monitored regularly to assess the effectiveness of the treatment and to identify any side effects.

Regular check-ups include blood tests and other necessary examinations to ensure the patient’s safety.

4 evaluation of outcomes

The primary outcome measured is disease-free survival (DFS), which is the time from randomization to the first documented recurrence of the disease or death from any cause.

Secondary outcomes include overall survival, freedom from locoregional and distant recurrence, and the occurrence of new primary tumors.

5 completion of the study

The study is estimated to conclude by March 25, 2029.

Upon completion, the data collected will be analyzed to determine the effectiveness and safety of cemiplimab compared to the placebo.

Who Can Join the Study?

  • The patient must have had surgery to remove a confirmed case of Cutaneous Squamous Cell Carcinoma (CSCC). This can be the main skin cancer lesion, the main lesion with cancer spread to nearby lymph nodes, or cancer spread to lymph nodes with a known main lesion that was treated before.
  • The patient must have a high-risk form of CSCC.
  • The patient must have completed radiation therapy aimed at curing the cancer within 2 to 10 weeks before being randomly assigned to a treatment group in the study.
  • The patient must have an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0 or 1. This is a scale that measures how well a patient can perform daily activities, with 0 being fully active and 1 being restricted in physically strenuous activity but able to carry out light work.
  • The patient must have adequate liver, kidney, and bone marrow function as defined in the study protocol. This means the organs are working well enough to safely participate in the study.
  • The study is open to both male and female patients.
  • The study includes patients who may be considered vulnerable, meaning they might need extra protection or care during the study.

Who Cannot Join the Study?

  • Patients who have not had surgery and radiation therapy for their skin cancer.
  • Patients who have other types of cancer, not just cutaneous squamous cell carcinoma.
  • Patients who have a serious infection or illness that could affect their participation.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures or attend follow-up visits.
  • Patients who have received another experimental treatment within a certain time frame before the study.
  • Patients who have a known allergy to the study medication or its ingredients.
  • Patients who have a history of certain heart conditions or other serious health issues.
  • Patients who are taking medications that could interfere with the study treatment.
  • Patients who have a history of drug or alcohol abuse that could affect their participation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Hospital Clinic De Barcelona Barcelona Spain
SLK-Kliniken Heilbronn GmbH Heilbronn Germany
Centre Hospitalier Universitaire De Nantes Nantes France
Centre Hospitalier Universitaire De Nice Nice France
Istituto Europeo Di Oncologia S.r.l. Milan Italy
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Universita Degli Studi Di Brescia Brescia Italy
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Ippokratio General Hospital Of Thessaloniki Thessaloniki Greece
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Hopital Ambroise Pare Boulogne-Billancourt France
University Hospital Galway Galway Ireland
Andreas Syngros Hospital Of Venereal And Dermatological Diseases Athens Greece
Azienda USL Toscana Centro Prato Italy
Uhnzfeknel Helgwrqp Corpeuh Cologne Germany
Agacqhx Oktkenyytam Usddbglxcekpq Ccodgmonubgr Dwpal Sfjcff E Dzsjc Skilnpa Di Tadzgf Turin Italy
Kydfxyoj dix Uzykbtgnapfs Mimtzuwd Aqd Munich Germany
Ahvnhdr Ukpxx Susnyhfur Lahfxa Db Bheofds Bologna Italy
Sv Vlnasdcqvaqtshg Uujutuvcbr Hyyoozzb Dublin Ireland
Cexyka Lghx Bmcbfg Lyon France
Uzqsnbfulllhoebkeddxe Eqnmq Aqt Essen Germany
Cead Umnwvblkzr Mmxwpdygs Hylkxamg Cork Ireland
Idrxydsbt Do Igwabuzxrdwec Eq Cartdeid Dt Ld Sitqx Gkkkago Tbnhh I Phxgl Barcelona Spain
Glpzcia Czfj Hwhmgwsw Sxl Fotejrnmk ds Atrm Madrid Spain
Coniin Hlwfmafaxro Uvxygdkbiodso Dx Dtxpz Dijon France
Nnfjmrfw Ibfrxacw Onyzvffuq Iod Mfzng Snhleistddqjvrbdrpnwehgcayep Igfwiejn Bwacydvj Cracow Poland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
04.06.2019
France France
Not recruiting
04.06.2019
Germany Germany
Not recruiting
04.06.2019
Greece Greece
Not recruiting
04.06.2019
Ireland Ireland
Not recruiting
04.06.2019
Italy Italy
Not recruiting
04.06.2019
Poland Poland
Not recruiting
04.06.2019
Spain Spain
Not recruiting
04.06.2019

Trial locations

Investigated Drugs:

Cemiplimab is a medication being studied for its potential to help patients with high-risk cutaneous squamous cell carcinoma. It is used after surgery and radiation therapy to see if it can improve the time patients remain free from the disease. This medication works by helping the immune system to better recognize and attack cancer cells.

Investigated Diseases:

Cutaneous Squamous Cell Carcinoma – This is a type of skin cancer that originates in the squamous cells, which are flat cells located in the outer part of the skin. It often appears as a rough, scaly patch or a sore that may bleed or crust over. The disease can develop on any part of the body but is most commonly found in areas frequently exposed to the sun, such as the face, ears, neck, and hands. Over time, the carcinoma can grow larger and may spread to other parts of the body if not treated. It is generally more aggressive than basal cell carcinoma but less so than melanoma. Early detection and management are crucial to prevent further progression.

Trial ID:
2024-511653-22-00
Protocol code:
R2810-ONC-1788
NCT ID:
NCT03969004
Trial Phase:
Therapeutic confirmatory (Phase III)

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