AuthorisedTherapeutic exploratory (Phase II)Interventional

A Phase II single arm open label study of Pembrolizumab and Lenvatinib in patients with high risk locally advanced cervix cancer: an EMBRACE high risk study initiative

This research study is investigating a new treatment approach for women who have advanced womb-neck cancer or whose cancer hasn't fully responded to standard treatments like chemoradiation and brachytherapy. The study combines two medicines, Lenvatinib and Keytruda, which are already used for other cancers but are being tested together for womb-neck cancer. It's a 'Phase II' study, which means the main goal is to see how well this combination works and if it's safe for patients. Researchers will be especially interested in how long women in the study remain free from their cancer progressing over a two-year period. The study is open to women aged 18 and over.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)

Enrolment target

Start

25 Nov 2025

high risk or poor response after chemoradiation and brachytherapy for locally advanced cervix cancer

What is this study about?

This study is for women who have locally advanced womb-neck cancer, specifically those whose cancer is considered 'high risk' or hasn't responded as well as hoped to standard treatments. Locally advanced means the cancer has grown into nearby tissues but hasn't spread to distant parts of the body.

Usually, womb-neck cancer at this stage is treated with a combination of chemotherapy and radiotherapy (called chemoradiation), often followed by brachytherapy (a type of internal radiotherapy). This study is looking at what happens next if these initial treatments haven't been as effective as doctors would like, or if the cancer has a higher chance of coming back.

The research involves two medicines: Lenvatinib and Keytruda. Lenvatinib works by blocking signals that cancer cells need to grow and form new blood vessels. Keytruda is an immunotherapy, which means it helps your body's own immune system fight the cancer. By using these two medicines together, researchers hope to find a new and more effective way to treat this type of womb-neck cancer for patients who need more options.

Key takeaways

This study explores a new combination treatment (Lenvatinib and Keytruda) for advanced womb-neck cancer.
It's for women whose cancer is high risk or hasn't fully responded to standard treatments.
The main goal is to see how well this new treatment works and if it's safe.
It's a Phase II trial, an important step in developing new therapies.
Open to women aged 18 and over.

Who may be eligible?

This study is looking for women aged 18 and older.

You might be eligible if you have locally advanced womb-neck cancer that doctors consider 'high risk' or if your cancer hasn't responded well to the usual treatments like chemoradiation and brachytherapy.

There will be other specific medical checks and tests that your doctor will need to do to see if you can take part. For example, they will need to check your general health and how well your organs are working to make sure the study treatments are suitable for you.

Quick self-check

Are you 18 years old or older?
Do you have locally advanced womb-neck cancer?
Has your doctor told you your cancer is 'high risk' or hasn't responded well to previous treatments?
Are you able to attend regular hospital appointments for treatment and check-ups?

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

What does participation involve?

If you decide to take part in this study, you will receive two medicines: Lenvatinib and Keytruda. Lenvatinib is usually taken as a pill, and Keytruda is given through a drip into your vein (an infusion). You will have regular visits to the hospital for these treatments and to have check-ups. These check-ups will involve things like blood tests, physical examinations, and scans to see how you are responding to the treatment and to monitor for any side effects.

The doctors and nurses involved in the study will explain the full schedule of treatments and visits. They will also tell you about the follow-up appointments you'll need after the treatment phase ends, which will continue to monitor your health. The duration of your participation in the study, including follow-up, will be explained in detail by the study team.

Potential risks and benefits

Taking part in a clinical study can offer potential benefits, such as access to new treatments that aren't yet widely available. These medicines might help manage your cancer better, or for longer, than existing options. However, as with any medical treatment, there are potential risks and side effects from the medicines. The study team will explain all known and possible side effects, which can vary from mild to serious. Because these drugs are being tested together for this specific condition, not all side effects are fully understood. You have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (1)

—
Netherlands

Common questions

What does 'high risk' mean in this study?

It means your doctors believe your cancer has a higher chance of coming back or progressing based on its characteristics, or it hasn't responded fully to initial treatments.

Are Lenvatinib and Keytruda new medicines?

No, both medicines are already approved and used for other types of cancer, but they are being tested together for womb-neck cancer in this study.

What is a 'Phase II' study?

A Phase II study is a stage of research where doctors are mainly checking how well a new treatment works and its safety in a group of patients with a particular condition.

Will I know if the treatment is working?

The study team will monitor your progress with regular tests and scans, and they will discuss the results with you during your appointments.