Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

EMPIRE : Targeting MDM2 and PD1 in tumors with tertiary lymphoid structures

The EMPIRE study is investigating new treatment options for adults with solid cancers that have spread or are difficult to treat (locally advanced/metastatic). Researchers are testing a combination of medicines, including BI 907828 and Ezabenlimab, which aim to target specific features within the cancer. The main goal is to see how well these medicines can control the cancer, meaning if they can shrink it, prevent it from growing, or keep it stable for at least 24 weeks. They will also look at how long any positive effects last and how these treatments affect patients' overall health. This is a Phase II study, meaning it's still in the earlier stages of testing new treatments in people.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Institut Bergonie, Institut Bergonie

Enrolment target

120

Start

14 May 2024

Adult patients with locally advanced/metastatic solid tumors

What is this study about?

The EMPIRE study is an important research project looking for new ways to fight advanced solid cancers in adults. When we say 'solid cancers', we mean cancers that form a lump or growth, rather than blood cancers like leukaemia. 'Advanced' means the cancer may have spread to other parts of the body (metastatic) or is in a difficult position to treat locally.

This study is testing a combination of medicines. One of these is called BI 907828, and the other is Ezabenlimab. These medicines are designed to work in specific ways against cancer, by targeting certain processes within the cancer cells. Researchers want to understand if this combination can help control the cancer's growth or even shrink it. They will be closely watching to see if the treatments can keep the cancer stable for a significant amount of time.

The main aim is to find out the 'disease control rate'. This means measuring how many patients have their cancer either shrink, stay the same, or become stable for at least 24 weeks (about six months) after starting treatment. They also want to see how long any improvements last and how the treatments affect a patient's overall health and quality of life. This research is crucial in helping doctors find better ways to treat these challenging cancers.

Key takeaways

The study is for adults with advanced solid cancers.
It's testing new drug combinations (BI 907828 and Ezabenlimab).
The main goal is to see if the treatments can control cancer growth for at least 24 weeks.
It's an early-stage study (Phase II) exploring effectiveness and safety.
Participation involves regular medical checks and receiving the study medicines.

Who may be eligible?

This study is open to adults aged 18 and over, with no upper age limit. Both men and women can take part.

You would be considered for this study if you have a type of cancer known as a 'solid tumour' that has either spread to other parts of your body (metastatic) or is in an advanced stage that is difficult to treat locally.

It's important to remember that there will be other specific medical checks and requirements to make sure the study is safe and suitable for you. Your doctor will be able to discuss these with you in more detail.

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 solid tumour (not a blood cancer)?
Has your cancer spread or is it locally advanced?
Are you able to attend regular appointments for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the study medications, which include BI 907828 and Ezabenlimab. The doctors and nurses would regularly check on your health and how the treatment is affecting your cancer. This would involve regular scans and other tests to see if the cancer is shrinking, staying stable, or growing. You would have regular appointments for these check-ups, and the medical team would carefully monitor for any side effects. The exact number of visits, how often they occur, and the total duration of your participation would be explained fully by the study team, but it would involve ongoing monitoring and treatment.

Potential risks and benefits

Taking part in this study could potentially offer you access to new treatments that are not yet widely available, and these might help control your cancer. However, as with all new medicines, there could be side effects or risks that are currently unknown or not fully understood. Your doctors will explain all known potential risks to you. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
France

Common questions

What is a 'solid tumour'?

A solid tumour is a type of cancer that forms a lump or growth in the body, such as breast cancer, lung cancer, or bowel cancer, as opposed to cancers of the blood.

What does 'locally advanced/metastatic' mean?

This means the cancer has either grown significantly in its original location and is hard to treat, or it has spread from its original site to other parts of the body.

What is a 'Phase II' study?

A Phase II study is an early stage of clinical research where a new treatment is given to a larger group of people (usually 100-300) to see if it is effective and to further evaluate its safety.

What is 'disease control'?

In this study, 'disease control' means that the cancer has either shrunk, stayed the same size, or become stable for at least 24 weeks (about six months) since the treatment started.

Will I know if the treatment is working for me?

Yes, the study doctors will regularly check your progress with scans and tests. They will discuss the results with you and let you know how the treatment appears to be affecting your cancer.