Active not recruitingPHASE1INTERVENTIONAL

Safety, Tolerability, and Immunogenicity of mRNA-4157 Alone and in Combination in Participants With Solid Tumors

This research is investigating a new treatment, mRNA-4157, for people with various solid tumours. The study aims to understand how safe this treatment is, if people experience many side effects, and how it helps the body's immune system fight cancer. It's being tested alone, and also combined with an existing cancer drug called pembrolizumab, or with standard chemotherapy (SoC). The study looks at different types of solid tumours, including those that have been removed by surgery and those that haven't. This is an early-stage study, meaning it's one of the first times this treatment is being tested in people to find the best and safest dose for future research.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

ModernaTX, Inc.

Enrolment target

161

Start

14 Aug 2017

Estimated completion

21 Nov 2027

Solid Tumors

What is this study about?

This study is an important step in understanding a new potential treatment for cancer called mRNA-4157. Think of mRNA-4157 as a special message delivered to your body, instructing your immune system to recognise and attack cancer cells. The main purpose of this study is to see if this new treatment is safe for people, how well they tolerate it (meaning, how many side effects they might have and how severe they are), and how it helps their immune system respond to their cancer. This type of research is crucial because it helps doctors find new ways to fight cancer more effectively.

The study involves several different groups of people, depending on their type of solid cancer and whether it has been surgically removed or not. Some people will receive mRNA-4157 on its own, while others will get it alongside other well-known cancer treatments such as pembrolizumab (which is an immunotherapy drug that also helps the immune system) or standard chemotherapy. By testing different combinations, researchers hope to find the most effective and safest ways to use mRNA-4157.

Because this is an early-stage study (called Phase 1), a big part of it involves carefully finding the right dose of mRNA-4157. This means some people might start with a lower dose, which then may be slowly increased. This careful approach ensures that the treatment is as safe as possible while still being effective. The insights gained from this study will be used to design future, larger studies, bringing us closer to new cancer treatment options.

Key takeaways

This study is testing a new cancer treatment called mRNA-4157.
It aims to find out if mRNA-4157 is safe, tolerable, and how it affects the immune system.
The treatment may be given alone or with other cancer medicines.
It includes people with different types of solid tumours, both treated and untreated.
As a Phase 1 study, finding the right dose is a key goal.
Participation involves regular checks and monitoring for side effects.

Who may be eligible?

To join this study, generally, you'll need to be an adult, at least 18 years old, and have a solid tumour. The exact type of cancer and whether it has been treated before or removed by surgery will determine which part of the study you might be suitable for.

For example, some parts of the study are for people whose solid tumour has been completely removed and they are currently free of disease. Other parts are for people with certain types of advanced solid tumours that haven't been removed, and who might be able to receive specific existing treatments like pembrolizumab or chemotherapy.

It's important that your doctor reviews your full medical history and current health to see if this study is a good fit for you, as there are many detailed requirements. They will check things like your specific cancer diagnosis, if your cancer can be measured, and your overall health status to make sure you meet the criteria for safe participation.

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?
Do you have a type of solid tumour?
Has your doctor confirmed your specific cancer diagnosis meets the study criteria?
Are you able to attend regular hospital visits for treatment and check-ups?
Are you considered well enough by your doctor to take part in a clinical trial?

Answer every question to see your result.

What does participation involve?

Taking part in this study means you would receive the study treatment, mRNA-4157, either by itself or in combination with other anti-cancer drugs like pembrolizumab or standard chemotherapy, depending on your assigned group. The specific schedule for your treatment, hospital visits, and tests will vary based on which part of the study you're in and the dose you receive.

Typically, study visits will involve blood tests to check how your body is responding and to monitor for any side effects. You may also have scans to measure your tumour if you have one. Doctors and nurses will regularly check your general health and ask about any symptoms or side effects you might be experiencing. The total length of your participation would depend on the study section you're in and your response to the treatment. You would be informed about the expected duration during the consent process.

Potential risks and benefits

Participating in research studies like this can offer potential benefits, such as gaining access to a new treatment that isn’t yet widely available, and helping doctors learn more about cancer, which could help future patients. However, there are also potential risks, as mRNA-4157 is a new treatment and its full range of side effects and how it interacts with other medications are still being understood. You might experience side effects from the study treatment or from any other treatments given alongside it. It's crucial to remember that you can decide to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (20)

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

Angeles Clinic and Research Institute
Verified postcode
Los Angeles, United States
The George Washington Cancer Center
Verified postcode
Washington D.C., United States
Orlando Health Cancer Institute
Verified postcode
Orlando, United States
Florida Cancer Specialists
Verified postcode
Sarasota, United States
H Lee Moffitt Cancer Center and Research Institute
Verified postcode
Tampa, United States
Massachusetts General Hospital
Verified postcode
Boston, United States
NYU Langone Medical Center
Verified postcode
New York, United States
The Cleveland Clinic Foundation
Verified postcode
Cleveland, United States
UPMC Hillman Cancer Center
Verified postcode
Pittsburgh, United States
UT Southwest Medical Center
Verified postcode
Dallas, United States
St Vincents Hospital Sydney
Verified postcode
Darlinghurst, Australia
Westmead Hospital-Cnr Hawkesbury and Darcy Road
Verified postcode
Westmead, Australia

Common questions

What is mRNA-4157?

It's a new type of treatment being studied that aims to teach your body's immune system to recognise and fight cancer cells.

What kind of cancers is this study looking at?

This study is for various 'solid tumours', which are cancers that form a lump or mass, such as pancreatic, lung, or stomach cancer, and melanoma.

What does 'Phase 1' mean?

Phase 1 means it's one of the first times this new treatment is being tested in people. The main goals are to check for safety and find the right dose.

Will I receive other treatments alongside the new drug?

Possibly. Depending on your cancer type, you might receive mRNA-4157 alone, or in combination with existing cancer drugs like pembrolizumab or standard chemotherapy.

Can I leave the study if I change my mind?

Yes, you are free to withdraw from the study at any time, and this will not affect the standard care you receive for your cancer.