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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

Fast replyRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

12 criteria

  • 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 trial?

8 criteria

  • 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.
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Investigated drugs

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.

What is already known about the treatment

Pembrolizumab – Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into a vein through a needle. It is currently being studied in clinical trials as a treatment for high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) after surgery and radiation. The main purpose of using pembrolizumab in this context is to help prevent the cancer from coming back. At the molecular level, pembrolizumab works by blocking a specific protein on immune cells, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, a type of drug that helps the body's immune system fight cancer.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-500395-57-00Protocol codeMK-3475-630Estimated enrolment536 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).