Ongoing, recruitingPhase I and Phase II (Integrated)- OtherInterventional

Phase I-II Study to Assess the Safety, Tolerability and Efficacy of Lurbinectedin and Dostarlimab in Advanced/Recurrent Endometrial Cancer Patients with Disease Progression after Prior Therapy with Platinum-based Chemotherapy. LiDer trial

This research study, called the LiDer trial, investigates a new way to treat womb (endometrial) cancer when it has advanced, come back, or spread after initial chemotherapy. Doctors are testing a combination of two medicines, lurbinectedin and dostarlimab (also known as JEMPERLI), to see if they can work together to control the cancer. The first part of the study focuses on finding the safest and most effective dose of these medicines. The second part will then look more closely at how well this combined treatment shrinks tumours in patients. The main goal is to find better ways to help people with this type of cancer.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- Other

Sponsor

Vall D Hebron Institute Of Oncology

Enrolment target

Start

07 May 2024

Advanced/Recurrent Endometrial Cancer Patients with Disease Progression after Prior Therapy with Platinum-based Chemotherapy

What is this study about?

This study is called the LiDer trial, and it's looking into new ways to treat advanced or recurrent endometrial cancer. Endometrial cancer is cancer that starts in the lining of the womb. 'Advanced' means the cancer has spread, and 'recurrent' means it has come back after treatment. This particular study is for people whose cancer has progressed even after they've already had standard platinum-based chemotherapy.

The trial is testing a combination of two specific medicines: lurbinectedin and dostarlimab, which is sometimes called JEMPERLI. Dostarlimab is a type of immunotherapy, which helps your own body's immune system fight the cancer. The researchers want to find out if giving these two medicines together is safe and if it can help shrink or control the cancer.

The study has two main parts. The first part is about finding the right dose of the medicines that works best without too many side effects. This involves giving different doses to small groups of patients and carefully watching how they respond. Once the best dose is found, the second part of the study will involve more patients and will focus on how effective this combination treatment is at shrinking tumours.

Key takeaways

Targets advanced/recurrent womb cancer that has progressed after prior chemotherapy.
Investigates a new combination of two medicines: lurbinectedin and JEMPERLI (dostarlimab).
Aims to find the safest dose and assess how well the combination shrinks tumours.
Participation involves regular hospital visits for treatments, blood tests, and scans.
This is a clinical trial, so the benefits and risks are still being evaluated.
You can stop participating at any time.

Who may be eligible?

To join this study, you would need to be a woman aged 18 or older. The study is specifically for those who have advanced or recurrent endometrial cancer, meaning the cancer has spread or come back.

Crucially, your cancer must have continued to grow or spread even after you've already had a type of chemotherapy called platinum-based chemotherapy. If your cancer responded well to that chemotherapy and hasn't progressed, this study might not be suitable for you.

There will be other detailed criteria that the doctors will check to make sure the study is right and safe for you. This could include checking your general health, other medical conditions you might have, and results from blood tests or scans.

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 advanced or recurrent endometrial (womb) cancer?
Has your cancer progressed (grown or spread) after you've already had platinum-based chemotherapy?
Are you able to attend regular hospital 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, the first stage involves finding the right dose of the medicines. You would receive infusions of both lurbinectedin and dostarlimab. These are given directly into your bloodstream, usually through a drip.

Throughout the study, you would have regular appointments at the hospital. These visits will involve blood tests, physical examinations, and scans to monitor your health and see how the treatment is affecting your cancer. Doctors will be looking for any side effects and checking if the treatment is shrinking your tumours.

Once the safest and most effective dose is found, the second stage of the study will focus on how well this treatment works. You would continue to receive the infusions and have regular check-ups, scans, and blood tests. The total length of time you would be involved in the study can vary, depending on how you respond to the treatment and the study plan, but it generally involves regular treatment cycles and monitoring.

Potential risks and benefits

Taking part in a clinical trial has both potential benefits and risks. While this new combination treatment might help shrink or control your cancer more effectively than current options, it's important to remember that these medicines are still being studied, and there's no guarantee it will work for everyone. There is also the risk of side effects, which can vary from mild to more serious; the study team will monitor you very closely for these. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual 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
Spain

Common questions

What is endometrial cancer?

Endometrial cancer is a type of cancer that starts in the lining of the womb (uterus). It's one of the most common gynaecological cancers.

What does 'advanced' or 'recurrent' mean?

'Advanced' means the cancer has spread from where it started. 'Recurrent' means the cancer has come back after previous treatment, even if it responded initially.

What is 'platinum-based chemotherapy'?

This is a common type of chemotherapy that uses drugs containing platinum to kill cancer cells, and it's a standard treatment for many cancers, including endometrial cancer.

What are lurbinectedin and dostarlimab?

These are two different medicines. Dostarlimab is an immunotherapy that helps your immune system fight cancer. Lurbinectedin works in another way to target cancer cells. This study is testing them together.

Why are they combining these two medicines?

Sometimes, combining different medicines that work in different ways can be more effective at treating cancer than using just one. Researchers hope these two drugs will work well together.