RecruitingPHASE1, PHASE2INTERVENTIONAL

Study of mRNA-4359 Administered Alone and in Combination With Immune Checkpoint Blockade in Participants With Advanced Solid Tumors

This research study is testing a new treatment called mRNA-4359. We want to find out how safe it is and what its side effects are when given alone, or when combined with other well-known cancer drugs like pembrolizumab, ipilimumab, and nivolumab. The study is for people who have advanced solid tumours, meaning their cancer has spread. It involves different stages (Phase 1 and Phase 2) to carefully check the treatment. The main goal is to make sure the treatment is safe for patients, and also to see if it might help to slow down or shrink the cancer. Your safety is the top priority throughout the study.

At a glance

Status

Recruiting

Phase

PHASE1, PHASE2

Sponsor

ModernaTX, Inc.

Enrolment target

361

Start

01 Sep 2022

Estimated completion

18 Feb 2032

Advanced Solid Tumors

What is this study about?

This study is looking into a new medicine called mRNA-4359 for people with advanced solid tumours. Advanced solid tumours are cancers that have grown or spread to other parts of the body. The study wants to understand if this new medicine is safe and what side effects it might cause, both on its own and when given together with other cancer treatments that are already in use, such as pembrolizumab, ipilimumab, and nivolumab.

The study has two main parts, called Phase 1 and Phase 2. In Phase 1, a small group of people are given different doses of the new medicine to find the safest and most effective amount. In Phase 2, a larger group of people take the medicine at the dose found in Phase 1, to see more about its safety and how well it works. Your participation helps doctors learn more about potential new ways to treat cancer.

The doctors running this study want to make sure any new treatments are as safe as possible and to understand how they might help patients with different types of advanced solid tumours, including melanoma, lung cancer, and breast cancer. They will carefully monitor everyone involved throughout the study.

Key takeaways

This study is testing a new cancer medicine, mRNA-4359.
It's for people with advanced solid tumours, including those where previous treatments haven't worked.
The study aims to check the safety and side effects of the new medicine.
It tests mRNA-4359 alone and with other known cancer drugs.
You can be as young as 12 in some parts of the study, but generally 18 or older.
Your health will be closely watched throughout the treatment.

Who may be eligible?

To join this study, you generally need to be at least 18 years old. However, for a specific part of the study (Arm 2d), people aged 12 and above may be able to take part. Before starting, you'll need to give your permission by signing a form.

You might be able to join if you have certain types of advanced cancer, like melanoma, lung cancer (NSCLC), or breast cancer, which have spread or are locally advanced. You'll need to have a tumour that doctors can measure and check. Also, you should have already tried and not responded well to, or couldn't take, at least one standard cancer treatment that's usually given for advanced cancer.

Some parts of the study also look for people with melanoma or lung cancer that has stopped responding to certain immune checkpoint treatments. This means your cancer may have grown even after you've had treatments that help your immune system fight cancer. Doctors will need to be able to take a small sample (biopsy) from one of your tumours, and there must be another tumour they can watch to see if the treatment works.

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.

Am I at least 18 years old (or 12 for a specific part of the study)?
Do I have an advanced solid tumour (cancer that has spread or is locally advanced)?
Have I already tried at least one standard cancer treatment that didn't work for me, or that I couldn't take?
Do I have a tumour that doctors can measure and also take a small sample from if needed?
For some parts, has my cancer gotten worse even after having certain immune-boosting treatments?

Answer every question to see your result.

What does participation involve?

If you join this study, you will have regular visits to the clinic so doctors can monitor your health and the effects of the treatment. These visits will involve blood tests, physical examinations, and scans (like CT or MRI scans) to check your tumour size. You will receive the study medication, mRNA-4359, either by itself or in combination with other anti-cancer drugs. The way you receive the medication (e.g., injection or infusion) will depend on the specific treatment plan.

Throughout the study, doctors and nurses will closely watch you for any side effects and to see how your body is responding to the treatment. The total length of your participation will vary depending on which part of the study you are in and how you respond to the treatment. You will also have follow-up appointments after you stop taking the study drugs to ensure your health is stable. You will be told exactly what to expect regarding appointments and treatments before you agree to take part.

Potential risks and benefits

Taking part in a clinical study might offer the chance to try a new treatment that isn't widely available yet, which could potentially help your cancer. However, there's no guarantee the treatment will work for everyone, and it might not improve your condition. Like all medicines, mRNA-4359 and the other drugs used in this study can cause side effects. These side effects can range from mild to more serious, and the study team will monitor you closely for them. You will be given detailed information about all known and potential side effects. Remember, joining this study is completely your choice, and you are free to withdraw at any time, for any reason, without it affecting your future medical care.

Locations (31)

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

The Angeles Clinic and Research Institute
Verified postcode
Los Angeles, United States· Recruiting
UCSF Helen Diller Family Comprehensive Cancer Center
Verified postcode
San Francisco, United States· Recruiting
University of Colorado Cancer Center
Verified postcode
Aurora, United States· Recruiting
George Washington University
Verified postcode
Washington D.C., United States· Recruiting
Orlando Health UF Health Cancer Center
Verified postcode
Orlando, United States· Recruiting
The University of Chicago Medicine
Verified postcode
Chicago, United States· Recruiting
Massachusetts General Hospital
Verified postcode
Boston, United States· Recruiting
Dana Farber Cancer Institute
Verified postcode
Boston, United States· Recruiting
Henry Ford Hospital
Verified postcode
Detroit, United States· Recruiting
Washington University
Verified postcode
St Louis, United States· Recruiting
John Theurer Cancer Center
Verified postcode
Hackensack, United States· Recruiting
NYU Langone Health-Perlmutter Cancer Center
Verified postcode
New York, United States· Recruiting

Common questions

What is mRNA-4359?

It's a new type of medicine being tested in this study to treat advanced cancers.

What are immune checkpoint blockade drugs?

These are medicines that help your body's immune system fight cancer, like pembrolizumab, ipilimumab, and nivolumab.

What does 'advanced solid tumours' mean?

It means cancers that started in an organ and have either grown in the original area or spread to other parts of the body.

Will I get the new drug or a placebo (dummy drug)?

All participants in this study will receive the active treatment (mRNA-4359), either alone or with other cancer drugs. There is no placebo group.

How long will I be in the study?

The length of time you participate will depend on how you respond to the treatment and the specific part of the study you are in. The study team will explain this to you.

How to find out more

Moderna WeCare Team

WeCareClinicalTrials@modernatx.com 1-866-663-3762 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.