Study of Pembrolizumab as Additional Treatment for Patients with High-Risk Locally Advanced Cutaneous Squamous Cell Carcinoma After Surgery and Radiation

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What is this study about?

This clinical trial is focused on studying a type of skin cancer called Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC). The study is investigating the use of a medication called Pembrolizumab, also known by its code name MK-3475, as an additional treatment after surgery and radiation therapy. Pembrolizumab is a solution given through an intravenous infusion, which means it is administered directly into the bloodstream through a vein. The trial will compare the effects of Pembrolizumab with a placebo, which is a substance with no active medication, to see if it helps prevent the cancer from coming back.

The purpose of the study is to evaluate how well Pembrolizumab works in keeping the cancer from returning after the initial treatments. Participants in the study will have already undergone surgery to remove the cancer and completed radiation therapy. They will then receive either Pembrolizumab or a placebo as part of the trial. The study will monitor participants over a period of time to assess their health and any changes in their condition.

Throughout the study, researchers will look at various outcomes, including how long participants remain free of cancer and their overall survival. They will also assess the quality of life of participants using a questionnaire designed to measure physical functioning and other aspects of well-being. The study aims to provide valuable information on the effectiveness of Pembrolizumab as an additional treatment for people with high-risk LA cSCC.

1 randomization

Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the medication pembrolizumab, and the other group will receive a placebo, which is a substance with no active medication. This process is done to compare the effects of the medication against no treatment.

2 treatment administration

If you are in the group receiving pembrolizumab, you will be given the medication through an intravenous infusion. This means the medication will be delivered directly into your bloodstream through a vein. The dosage is 25 mg/mL and it will be administered as a solution for infusion.

The frequency and duration of the treatment will be determined by the study protocol, and you will be informed about the schedule by the study team.

3 monitoring and assessments

Throughout the study, you will undergo regular monitoring and assessments to evaluate your health and the effects of the treatment. This includes physical examinations, blood tests, and imaging studies as needed.

The primary goal is to assess recurrence-free survival, which means checking if the cancer returns after treatment. This will be confirmed by a biopsy, a procedure where a small sample of tissue is taken for examination.

4 quality of life assessments

Your quality of life will be assessed using a questionnaire called the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). This will help understand how the treatment affects your daily life and well-being.

You will be asked to complete this questionnaire at various points during the study.

5 adverse event monitoring

Any side effects or adverse events you experience during the study will be closely monitored. An adverse event is any unwanted or unexpected health problem that happens during the study.

If you experience any adverse events, the study team will assess whether you need to discontinue the study treatment.

6 end of study

The study is expected to end by August 29, 2028. At the end of the study, you will have a final assessment to evaluate your overall health and the outcomes of the treatment.

You will be informed about the results of the study and any further steps if necessary.

Who Can Join the Study?

Must have a diagnosis of cutaneous squamous cell carcinoma (cSCC), which is a type of skin cancer. The cancer should not have spread from another type of cancer or from an unknown source.
Must provide a sample of the tumor tissue for testing a specific protein called Programmed Cell Death Ligand 1 (PD-L1).
Must have a life expectancy of more than 3 months.
Must have a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale, which measures daily living abilities, within 10 days before starting the study treatment.
Must have a confirmed diagnosis of locally advanced cutaneous squamous cell carcinoma (LA cSCC) with at least one high-risk feature.
Must have had all visible cancer surgically removed. If there are any remaining cancer cells that cannot be surgically removed, this must be confirmed.
Must have completed radiation therapy for LA cSCC, with the last dose given between 4 and 16 weeks before being randomly assigned to a treatment group in the study.
Must have received an adequate dose of radiation therapy after surgery, either in a short or standard treatment schedule.
Must be free of disease as determined by the study doctor, with complete imaging tests done within 28 days before being randomly assigned to a treatment group in the study.
Must not be pregnant or breastfeeding.
Must not be a person who can become pregnant.
Must have a negative pregnancy test within 72 hours before the first dose of study treatment.

Who Cannot Join the Study?

Patients who have a different type of cancer other than Locally Advanced Cutaneous Squamous Cell Carcinoma (a type of skin cancer) cannot participate.
Patients who have had a previous treatment for this type of cancer that is not allowed in the study cannot participate.
Patients with a history of severe allergic reactions to the study medication or similar drugs cannot participate.
Patients with an active infection that requires treatment cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients with a known history of immune system disorders, such as autoimmune diseases, cannot participate.
Patients who have received a live vaccine within 30 days before the start of the study cannot participate.
Patients with any other medical condition that the study doctors believe would make it unsafe for them to participate cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Centre Hospitalier Universitaire De Lille	Lille	France
Institut Gustave Roussy	Villejuif	France
Oncopole Claudius Regaud	Toulouse	France
Oslo Universitetssykehus HF	Oslo	Norway
University Hospital Of Clermont-Ferrand	Clermont Ferrand	France

Other Sites

Site Name	City	Country
Centrul De Oncologie SF Nectarie S.R.L.	Craiova	Romania
Instituto Portugues De Oncologia De Lisboa Francisco Gentil E.P.E.	Lisbon	Portugal
Centre Hospitalier Universitaire De Montpellier	Montpellier	France
Andreas Syngros Hospital Of Venereal And Dermatological Diseases	Athens	Greece
Oncomed S.R.L.	Timisoara	Romania
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca	Cluj Napoca	Romania
Hopital Saint Joseph	Marseille	France
Centre Hospitalier Universitaire De Nice	Nice	France
Cardiomed S.R.L.	Cluj Napoca	Romania
Spitalul De Psihiatrie Titan Dr. Constantin Gorgos	Bucharest	Romania
University Of Pecs	Pecs	Hungary
Klinikum Nuernberg	Nürnberg	Germany
Hôpital Avicenne	Bobigny	France
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy	Warsaw	Poland
Universita’ Di Pisa	Pisa	Italy
Istituto Europeo Di Oncologia S.r.l.	Milan	Italy
Centre Hospitalier Universitaire De Nimes	Nimes	France
IRCCS Istituto Nazionale Tumori Fondazione Pascale	Naples	Italy
Fundacio De Recerca Clinic Barcelona-Institut D’Investigacions Biomediques August Pi I Sunyer	Barcelona	Spain
Centre Hospitalier Universitaire De Poitiers	Poitiers	France
Elbe Kliniken Stade-Buxtehude gGmbH	Buxtehude	Germany
Charite Research Organisation GmbH	Berlin	Germany
Centre Hospitalier Lyon Sud	Pierre Benite	France
Istituto Tumori Bari Giovanni Paolo II	Bari	Italy
CF Clinical Hospital	Cluj Napoca	Romania
Del-Budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz	Budapest	Hungary
Fundacion Onkologikoa Fundazioa	Donostia / San Sebastian	Spain
Pelican Impex S.R.L.	Oradea	Romania
Fondazione I.R.C.C.S. Istituto Neurologico Besta	Milan	Italy
University Of Szeged	Szeged	Hungary
Centre Hospitalier Universitaire De Caen Normandie	Caen	France
CHU Bordeauxt	Bordeaux	France
Semmelweis University	Budapest	Hungary
Uohfgbiwcsdbinzliwabp Gsiprsn usc Mjjiiuo Gdlr	Marburg	Germany
Hskdb Bpbgil Ht	Bergen	Norway
Aqiubi Mngtohr Cjrzpp Stex	Thessaloniki	Greece
Ctu dyclanaytlnwai	Epagny Metz Tessy	France
Arclzxkodo Prpvdxjq Hozkofnb Dj Mzyfnhrep	Marseille	France
Becaqrqk Uqbuifevyi Hclgnjnt Cpqesd	Besançon	France
Uucbfqjprvunub Cuawhmf Kiwuuojmt	Gdansk	Poland
Uxoqvisxcu Mcrfwfh Cnrnwt Hrzsiiapazgrhvruc	Hamburg	Germany
Ueliokbewythrsmkfyxjp Eiobb Ape	Essen	Germany
Chioah Hcppboprblb Velhyly	Valence	France
Hbfxykhr Vvhh dnzcerqv	Barcelona	Spain
Ufhzbuvonw Ggajubu Hswfwjpj Alagqfp	Athens	Greece

Trial status

Country	Status	Recruitment Start
France	Not recruiting	01.04.2019
Germany	Not recruiting	01.04.2019
Greece	Not recruiting	01.04.2019
Hungary	Not recruiting	01.04.2019
Ireland	Not recruiting	01.04.2019
Italy	Not recruiting	01.04.2019
Norway	Not recruiting	01.04.2019
Poland	Not recruiting	01.04.2019
Portugal	Not recruiting	01.04.2019
Romania	Not recruiting	01.04.2019
Spain	Not recruiting	01.04.2019

Trial locations

Investigated drugs:

Pembrolizumab

Pembrolizumab is a type of medication known as an immunotherapy. It works by helping your immune system fight cancer. Specifically, it blocks a protein called PD-1 on the surface of certain immune cells. This action allows your immune system to better recognize and attack cancer cells. In this trial, pembrolizumab is being tested to see if it can help prevent the return of a type of skin cancer called cutaneous squamous cell carcinoma after surgery and radiation treatment.

Investigated diseases:

Squamous cell carcinoma

Locally Advanced Cutaneous Squamous Cell Carcinoma – This is a type of skin cancer that arises from the squamous cells, which are flat cells found in the outer layer of the skin. It is considered locally advanced when the cancer has grown deeply into the skin or spread to nearby tissues, but not to distant parts of the body. The disease often begins as a rough, scaly patch on sun-exposed areas of the skin, such as the face, ears, neck, lips, and back of the hands. As it progresses, the lesion may become a firm, red nodule or a flat sore with a scaly crust. Over time, the cancer can invade deeper layers of the skin and surrounding tissues, potentially causing significant damage. The progression of the disease can vary, with some cases growing slowly and others advancing more rapidly.

Trial ID:

2022-500395-57-00

Protocol code:

MK-3475-630

NCT ID:

NCT03833167

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of Pembrolizumab as Additional Treatment for Patients with High-Risk Locally Advanced Cutaneous Squamous Cell Carcinoma After Surgery and Radiation

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?