Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

Monalizumab and MEDI5752 in patients with MSI and/or dMMR metastatic cancer (MONAMI)

The MONAMI study is a Phase II clinical trial investigating two new medications, Monalizumab and MEDI5752 (also known as volrustomig), for adults with advanced cancer that has spread. This study is specifically for cancers with certain genetic characteristics called MSI (microsatellite instability) and/or dMMR (deficient mismatch repair). The main goals are to find out how safe these new treatments are, including any side effects, and how effectively they can shrink tumours. Researchers will also look at how long people live without their cancer getting worse and overall survival. The study will carefully monitor participants' health throughout the trial.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

Start

14 Nov 2024

cancerology

What is this study about?

This study, called MONAMI, is looking into two new experimental drugs, Monalizumab and MEDI5752 (which is also known as volrustomig). These drugs are being tested for people who have advanced cancer that has spread to other parts of the body. This particular study is for cancers with specific genetic markers, meaning certain changes in the cancer cells that doctors can identify. These markers are called MSI (microsatellite instability) and/or dMMR (deficient mismatch repair).

The main aim of this study is to understand two important things. Firstly, how safe these new drugs are and what kind of side effects they might cause. This is always the first step when testing new treatments. Secondly, the study wants to see how well these drugs work at shrinking cancerous tumours or stopping them from growing further. Doctors will carefully measure how many patients' tumours shrink or completely disappear after taking the treatment.

This is a 'Phase II' study, which means the treatments have already been tested for safety in a smaller group of people. Now, researchers are looking at a larger group to get a better idea of both safety and how effective the drugs are. They will also collect information on how long patients live without their cancer getting worse and how long they live overall, which are important measures for new cancer treatments.

Key takeaways

Tests new drugs, Monalizumab and MEDI5752, for advanced cancer.
Specifically for cancers with MSI and/or dMMR genetic features.
Aims to check drug safety and how well they shrink tumours.
Involves regular health checks, blood tests, and scans.
Participants are closely monitored for side effects.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or older. Both men and women can take part.

You would need to have advanced cancer that has spread throughout your body. Your cancer must also have specific genetic features known as MSI (microsatellite instability) and/or dMMR (deficient mismatch repair).

There might be other health requirements or previous treatments that could affect whether you can join, so it's always best to discuss it in detail with your doctor.

Quick self-check

Are you 18 years old or older?
Do you have advanced cancer that has spread?
Has your cancer been tested and found to have MSI and/or dMMR features?
Are you able to attend regular clinic visits and appointments?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you will receive either Monalizumab or MEDI5752 (volrustomig) as treatment. You will have regular visits to your doctor or clinic for check-ups. These visits will involve blood tests, checking your general health (like your blood pressure and heart rate), and tests such as ECGs to monitor your heart.

Your tumour size will be regularly measured with scans to see if the treatment is working. Throughout the study, doctors will closely monitor any side effects you might experience. The total duration of your participation will depend on how you respond to the treatment and the study's design. You will be closely followed up, even after your treatment on the study ends.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving new treatments for your cancer that are not yet widely available. However, there's no guarantee that the treatment will work for everyone, and it might not shrink your cancer or improve your symptoms. Like all medications, these new drugs can have side effects, which could range from mild to serious. The research team will carefully monitor you for these. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
France

Common questions

What does 'MSI and/or dMMR' mean?

These are genetic features found in some cancer cells. Your doctor can test for these to see if your cancer is suitable for this study.

What is a 'Phase II' study?

It means the drugs have already been tested in a small group for safety. Now, researchers are testing them in a larger group to see how well they work and to learn more about side effects.

What are the main things the study is looking for?

The study primarily aims to understand how safe the drugs are and how well they shrink tumours. It also looks at how long people live without their cancer getting worse.

Will I get 'new' drugs?

Yes, Monalizumab and MEDI5752 are experimental drugs, meaning they are not yet approved for general use. You would be among the first to receive them in a controlled setting.

What happens if the treatment doesn't work?

The medical team will discuss your options with you, and your regular cancer care will continue as usual. You can stop participating in the study at any time.