Ongoing, recruitingPhase II and Phase III (Integrated)Interventional

A Phase 2/3, adaptive, randomized, open-label, clinical study to evaluate neoadjuvant and adjuvant V940 (mRNA-4157) in combination with pembrolizumab (MK-3475) versus standard of care, and pembrolizumab monotherapy in participants with resectable locally advanced cutaneous squamous cell carcinoma (LA cSCC) (INTerpath-007).

This research study, named INTerpath-007, is focusing on people diagnosed with a type of skin cancer called cutaneous squamous cell carcinoma (cSCC) that can be removed by surgery. The study is comparing a new treatment combination, which includes a vaccine (mRNA-4157) and an existing cancer drug called pembrolizumab, with the usual care someone would receive for this condition. We want to find out if this new combination helps prevent the cancer from coming back or spreading more effectively. The study is also looking at pembrolizumab on its own for some participants. This is an important step to find better ways to treat this kind of skin cancer.

At a glance

Status

Ongoing, recruiting

Phase

Phase II and Phase III (Integrated)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

242

Start

23 May 2024

What is this study about?

This study, called INTerpath-007, is for people who have a specific type of skin cancer known as cutaneous squamous cell carcinoma (often shortened to cSCC). This type of cancer has grown locally but can still be removed by surgery. The main goal of this research is to see if a new treatment combination is more effective than the standard treatment currently offered.

The new treatment involves two parts: a vaccine called mRNA-4157 and an existing cancer fighting drug called pembrolizumab (also known as KEYTRUDA). Pembrolizumab works by helping your own immune system fight the cancer. Researchers are hoping that adding the mRNA-4157 vaccine to pembrolizumab might make the treatment even more powerful by teaching your immune system to specifically target your cancer. Some people in the study will receive this new combination, while others will have pembrolizumab on its own, and another group will get standard care, which usually involves surgery and possibly other treatments.

By comparing these different approaches, the study aims to find out if the new treatment can help prevent the cancer from returning or spreading, improve how completely the cancer responds to treatment, and ultimately, whether it helps people live longer and better. This study is an important step in developing new and more effective ways to manage cSCC. It's designed to be a thorough investigation to gather reliable information.

Key takeaways

This study explores new treatments for a type of skin cancer called cSCC.
It combines a new vaccine (mRNA-4157) with an existing drug (pembrolizumab).
The goal is to see if this combination works better than standard care.
It's for people whose cSCC can be removed by surgery.
Participation involves regular hospital visits and health monitoring.

Who may be eligible?

This study is for adults, aged 18 or older, who have been diagnosed with a specific type of skin cancer called cutaneous squamous cell carcinoma (cSCC). This diagnosis must be confirmed by a biopsy (a small sample of tissue). The cancer must be located in a way that it can be removed by surgery. We are specifically looking for the primary site of the cancer.

It's important that this skin cancer is not a spread from another cancer somewhere else in your body. Also, if the original source of the cancer is unknown, then this study would not be suitable. The study includes both men and women.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with cutaneous squamous cell carcinoma (cSCC) that has been confirmed by a doctor?
Has your doctor said that your cSCC can be removed by surgery?
Is your skin cancer the primary cancer, and not a spread from another cancer or from an unknown origin?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be assigned to one of several treatment groups. This decision is made randomly, like flipping a coin. You might receive the new combination of the mRNA-4157 vaccine and pembrolizumab infusions, pembrolizumab infusions on its own, or standard care which your doctor normally recommends.

Taking part will involve regular visits to the hospital for checks, assessments, and to receive your study medication (if you're in one of the active treatment groups). These visits will include physical exams, blood tests, and scans to monitor your health and how the treatment is working. After your main treatment period, there will be a follow-up period to continue monitoring your health over time. The total duration of your participation in the study, including treatment and follow-up, will be explained in detail by the study team.

Potential risks and benefits

Participating in this study might offer potential benefits, such as receiving a new and potentially more effective treatment for your cancer, or closer monitoring of your health than you might usually receive. However, there are also potential risks involved. The new treatments could cause side effects, which the study team will monitor closely. These might include reactions at the injection site for the vaccine, or other side effects related to pembrolizumab or standard treatments. You will receive a detailed list of all possible side effects. It's very important to remember that participating in any clinical trial is voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (10)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy
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Unverified
Czechia
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Unverified
Romania
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Unverified
Hungary
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Unverified
Poland
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Unverified
Belgium
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Unverified
France
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Unverified
Spain
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Unverified
Norway
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Unverified
Germany

Common questions

What is cutaneous squamous cell carcinoma (cSCC)?

It's a common type of skin cancer that starts in the flat cells on the outer layer of your skin. This study focuses on cSCC that has grown locally but can still be removed by surgery.

What is 'standard of care'?

This refers to the usual and most accepted treatment that doctors would currently recommend for your condition outside of a research study. For cSCC, it often involves surgery.

What is pembrolizumab (KEYTRUDA)?

It's a medicine that helps your body's immune system find and fight cancer cells. It's already used for several types of cancer.

What is mRNA-4157?

This is a new type of vaccine designed to teach your immune system to recognise and attack your specific cancer cells. It's still being investigated in studies like this one.

What does 'resectable locally advanced' mean?

It means the cancer has grown into nearby tissues but hasn't spread far, and doctors believe it can be completely removed with surgery.