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

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Institut Gustave Roussy Villejuif France
Oncopole Claudius Regaud Toulouse France
Oslo Universitetssykehus HF Oslo Norway
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Centre Hospitalier Universitaire De Lille Lille France

Other Sites

Site Name City Country Status
Sigmedical Services S.R.L. Suceava Romania
Centrum Onkologii Im. Prof. Franciszka Lukaszczyka W Bydgoszczy Bydgoszcz Poland
Klinikum Dortmund gGmbH Dortmund Germany
Universitair Ziekenhuis Gent Gent Belgium
Centre Hospitalier Lyon Sud Pierre Benite France
Elias University Emergency Hospital Bucharest Romania
Radiotherapy Center Cluj S.R.L. Floresti Romania
Centrum Medyczne Hcp Sp. z o.o. Poznan Poland
Del-Budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz Budapest Hungary
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital Universitario Ramon Y Cajal Madrid Spain
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
University Of Debrecen Debrecen Hungary
Hospital Clinic De Barcelona Barcelona Spain
Fakultni Nemocnice Kralovske Vinohrady Prague Czechia
Jessa Ziekenhuis Hasselt Belgium
Pratia S.A. Skorzewo Poland
Centre Hospitalier Universitaire De Nantes Nantes France
Swietokrzyskie Centrum Onkologii Samodzielny Publiczny Zaklad Opieki Zdrowotnej W Kielcach Kielce Poland
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Of Pecs Pecs Hungary
Hopital Beaujon Clichy France
University Of Szeged Szeged Hungary
Cplkatdzk Uhpxmbowecixdf Szpqeaesl Woluwe-Saint-Lambert Belgium
Cbumza Httndkmsvwu Udethwfusamru Dk Deylt Dijon France
Axaehxqsqf Paczialx Hkkryqmp Dk Mchcddadh Marseille France
Abrfxhp Ocysrmulvnb Ullzoozxlhzss Snnwmp Siena Italy
Gafvmzjustsyedvtl Vjdccexlo Pndz Artlgw Ensmrwfq Ofbxvc Khkrsu Gyor Hungary
Niuxnaws Ierpzobt Owhpmxfok Iyp Mansu Sbnmyojcmwksfdwseydddtzyuicy Ivwknsgc Bdpdehdi Cracow Poland
Uxuprvjzururnz Ccruyfm Klahzasuy Gdansk Poland
Hjvvyzgb Vpyv djbdofgz Barcelona Spain

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
07.06.2024
Czechia Czechia
Not recruiting
07.06.2024
France France
Not recruiting
07.06.2024
Germany Germany
Not recruiting
07.06.2024
Hungary Hungary
Not recruiting
07.06.2024
Italy Italy
Not recruiting
07.06.2024
Norway Norway
Not recruiting
07.06.2024
Poland Poland
Not recruiting
07.06.2024
Romania Romania
Not recruiting
07.06.2024
Spain Spain
Not recruiting
07.06.2024

Trial locations

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.

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 ID:
2023-505712-37-00
Protocol code:
V940-007
Trial Phase:
Therapeutic use (Phase IV)

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