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Study of mRNA-4157 and Pembrolizumab for Patients with Resectable Locally Advanced Cutaneous Squamous Cell Carcinoma

Verified siteRegistered 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 cutaneous squamous cell carcinoma (cSCC), which is a form of cancer that can be surgically removed. The study is testing a new treatment approach using a combination of two medications: V940 (also known as mRNA-4157) and pembrolizumab (also known as KEYTRUDA). V940 is a special type of treatment that uses a synthetic messenger RNA (mRNA) to help the body recognize and fight cancer cells. Pembrolizumab is a medication that helps the immune system attack cancer cells more effectively.

The purpose of this study is to compare the effectiveness of the combination of V940 and pembrolizumab with the standard treatment options available for cSCC. Participants in the study will receive either the combination of V940 and pembrolizumab, pembrolizumab alone, or the standard treatment. The study will follow participants over a period of time to observe how well the treatments work in preventing the cancer from returning or spreading. Participants will receive the treatments through injections or infusions, and their health will be monitored regularly by the study team.

This study aims to provide valuable information on whether the new combination treatment can improve outcomes for people with resectable locally advanced cSCC. By participating in this study, researchers hope to find better ways to treat this type of skin cancer and improve the quality of life for those affected by it.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    The trial begins with an initial assessment to confirm eligibility. This includes verifying a diagnosis of resectable cutaneous squamous cell carcinoma (cSCC) and ensuring adequate organ function.

    Participants must have a tumor sample suitable for next-generation sequencing and meet other health criteria, such as controlled HIV or undetectable hepatitis viral loads if applicable.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of the study groups. This could involve receiving the combination of V940 (mRNA-4157) and pembrolizumab, pembrolizumab alone, or the standard of care treatment.

  3. Step 3

    Treatment administration

    For those receiving V940 (mRNA-4157), it is administered as an intramuscular injection. Pembrolizumab is given as an intravenous infusion.

    The specific dosage and frequency of administration are determined by the study protocol and the assigned treatment group.

  4. Step 4

    Monitoring and follow-up

    Participants undergo regular monitoring to assess the treatment's effectiveness and any side effects. This includes physical examinations, imaging studies, and laboratory tests.

    The primary goal is to evaluate event-free survival, while secondary outcomes include response to treatment and overall survival.

  5. Step 5

    Completion of treatment

    Upon completion of the treatment phase, participants continue to be monitored for long-term outcomes and any delayed side effects.

    The study is expected to conclude by May 2033, with ongoing assessments to ensure participant safety and gather comprehensive data.

Who can join the trial?

14 criteria

  • The participant must have a confirmed diagnosis of a type of skin cancer called cutaneous squamous cell carcinoma (cSCC) that can be surgically removed without causing major functional loss or severe disfigurement.
  • The participant should have a performance status of 0 to 1, which means they are fully active or have some symptoms but can still carry out light work.
  • The participant must have adequate organ function, meaning their organs are working well enough to participate in the study.
  • If the participant has Hepatitis B, they must have been on antiviral therapy for at least 4 weeks and have no detectable virus in their blood before starting the study.
  • If the participant has a history of Hepatitis C, they must have no detectable virus in their blood at the start of the study.
  • If the participant is infected with HIV, their condition must be well controlled with medication.
  • The participant must have locally advanced cSCC, which means the cancer has not spread to distant parts of the body.
  • The cSCC must be removable by surgery with the aim of curing the cancer.
  • The participant must have a tumor sample available that meets the study's requirements for genetic testing.
  • The participant can be of any sex or gender and must be at least 18 years old.
  • If the participant is male, they must agree to avoid pregnancy by either abstaining from intercourse or using effective birth control during and after the study.
  • If the participant is female, they must not be pregnant or breastfeeding and must use effective birth control or abstain from intercourse during and after the study.
  • The participant must have measurable disease, meaning the cancer can be measured by the study's criteria.
  • The participant must have a life expectancy of more than 3 months, as assessed by the study doctor.

Who cannot join the trial?

3 criteria

  • Participants cannot have skin cancer that has spread from another primary cancer or from an unknown primary cancer.
  • Participants must have a confirmed diagnosis of a type of skin cancer called cSCC, which means cutaneous squamous cell carcinoma.
  • Participants must have a type of cSCC that can be surgically removed.
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Investigated drugs

  • V940 (mRNA-4157)

    is an investigational treatment being studied for its potential to help the immune system recognize and fight cancer cells. It is used in combination with another medication to see if it can improve outcomes for patients with a specific type of skin cancer.

  • Pembrolizumab (MK-3475)

    is a medication that helps the immune system attack cancer cells. It is already used in various cancer treatments and is being tested in this trial to see how well it works when combined with V940 for treating a type of skin cancer.

What is already known about the treatment

  • Pembrolizumab

    This medication is administered through an intravenous infusion, typically in a clinical setting. It is currently well-established in medical literature as an immunotherapy used to treat various types of cancer. The main therapeutic indication for pembrolizumab in this trial is for resectable locally advanced cutaneous squamous cell carcinoma. It works by blocking a protein called PD-1 on the surface of immune cells, which helps the immune system recognize and attack cancer cells more effectively. Pembrolizumab is classified as a monoclonal antibody and is part of the immune checkpoint inhibitor class of drugs.

  • V940 (mRNA-4157)

    This investigational medication is administered via injection and is currently being studied in clinical trials. It is designed to be used in combination with pembrolizumab for the treatment of resectable locally advanced cutaneous squamous cell carcinoma. V940 works by using mRNA technology to instruct cells to produce specific proteins that can trigger an immune response against cancer cells. It is classified as a therapeutic cancer vaccine, aiming to enhance the body's natural defenses to fight cancer.

Investigated diseases

Cutaneous Squamous Cell Carcinoma (cSCC) – This is a type of skin cancer that begins in the squamous cells, which are flat cells found in the outer part of the epidermis. It often appears as a rough, scaly patch on sun-exposed areas of the skin, such as the face, ears, neck, lips, and back of the hands. Over time, these patches can grow larger and may develop into a sore that does not heal. cSCC can invade deeper layers of the skin and spread to other parts of the body if not treated. It is more common in individuals with fair skin and those who have had significant sun exposure. Early detection and management are crucial to prevent progression.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-505712-37-00Protocol codeV940-007Estimated enrolment581 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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