AuthorisedTherapeutic confirmatory (Phase III)Interventional

A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator’s Choice (IC) in Patients With Endometrial Cancer After Platinum-Based Chemotherapy and PD(L)-1 Therapy

This research study is for women with advanced endometrial cancer that has returned, spread, or can't be removed by surgery. These women have already had chemotherapy (platinum-based) and another type of treatment called PD(L)-1 therapy. The study is comparing a new drug, Rinatabart Sesutecan (Rina-S), with treatments doctors usually choose from. Researchers want to find out if Rina-S is more effective at stopping the cancer from growing or spreading (called 'progression-free survival') and if it helps people live longer overall. They will also look at how many people respond to the treatment and their quality of life. This is a 'Phase 3' study, which means it's one of the final steps before a new drug might be approved for wider use.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Genmab A/S

Enrolment target

226

Start

26 Mar 2026

Endometrial Cancer Advanced, Recurrent, Metastatic, or Primary Unresectable Endometrial Cancer

What is this study about?

This research project is looking into new ways to treat advanced endometrial cancer. This is cancer that has either spread to other parts of the body (metastatic), come back after treatment (recurrent), or can't be removed through surgery. You might be considered for this study if you've already had two specific types of treatment for your cancer: chemotherapy that uses drugs like platinum, and another treatment called PD(L)-1 therapy.

The main aim of this study is to compare a new drug, called Rinatabart Sesutecan (Rina-S), with the standard treatments that doctors currently use. The research team wants to see if Rina-S is better at slowing down or stopping the cancer from growing or spreading. They also want to find out if it helps people live longer and if it improves their quality of life. It’s important to find new and more effective treatments for endometrial cancer, especially for those cases that are more advanced.

This is a Phase 3 study, which means it's a large and important step in checking if a new treatment is effective and safe. In this type of study, some participants will receive the new drug, while others will receive a treatment that their doctor would normally choose. This helps researchers understand how the new drug compares to existing options. The study will carefully track how the cancer responds to treatment and how participants feel over time.

Key takeaways

This study is for women with advanced endometrial cancer.
It tests a new drug (Rinatabart Sesutecan) against standard treatments.
You must have already had specific chemotherapy and PD(L)-1 therapy.
The study aims to see if the new drug slows cancer growth and improves quality of life.
Participation involves regular clinic visits, scans, and health checks for up to 3 years.

Who may be eligible?

To join this study, you must be a woman aged 18 or older. Your medical team will need to confirm that you have advanced endometrial cancer. This means your cancer has either spread, come back after previous treatment, or cannot be removed with surgery.

Crucially, you must have already had two specific types of treatment for your cancer. These are chemotherapy that includes platinum-based drugs, and a further treatment called PD(L)-1 therapy.

There will be other detailed medical checks to make sure the study is a safe and suitable option for you. Your study doctor and nurse will carefully review your full medical history to confirm if you meet all the criteria.

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?
Are you a woman diagnosed with advanced endometrial cancer?
Have you already received platinum-based chemotherapy?
Have you also received PD(L)-1 therapy for your cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive either the new drug, Rinatabart Sesutecan, or one of the standard treatments for endometrial cancer, such as Doxorubicin or Paclitaxel. Which treatment you receive will be decided by chance, like flipping a coin, but neither you nor your doctor will get to choose.

You would have regular visits to the clinic for check-ups, blood tests, and scans to monitor your health and how the treatment is working. These assessments, including scans, will help the team measure if the cancer is growing, shrinking, or staying the same. You will also be asked questions about your general health and how you're feeling, which helps the researchers understand the treatment's effect on your quality of life.

The treatment and follow-up could last for up to about three years, or until your cancer progresses, you experience side effects that prevent you from continuing, or you decide to stop. Throughout this time, your health will be closely monitored by the study team.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as access to a new treatment that isn't widely available yet, which might be more effective than current options for your condition. However, there are also potential risks involved. The new drug or even standard treatments can have side effects, which could be mild or more serious, and there's no guarantee the treatment will work for you. Your health and wellbeing will be closely monitored, and you will always have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (11)

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

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Unverified
Poland
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Unverified
Denmark
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Unverified
Finland
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Unverified
Lithuania
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Unverified
France
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Unverified
Germany
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Unverified
Spain
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Unverified
Belgium
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Unverified
Greece
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Unverified
Norway
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Unverified
Italy

Common questions

What is endometrial cancer?

Endometrial cancer is a type of cancer that starts in the lining of the uterus (womb). It's sometimes called uterine cancer.

What does 'advanced' cancer mean?

Advanced cancer means the cancer has either spread to other parts of your body, come back after previous treatment, or is in a place where it can't be fully removed by surgery.

What is a 'Phase 3' study?

A Phase 3 study is one of the final and largest steps in testing a new drug. It compares the new treatment against existing ones to see if it's safe and works better.

Will I definitely get the new drug?

In this study, you will be randomly assigned to either receive the new drug (Rinatabart Sesutecan) or a standard treatment. Neither you nor your doctor can choose which one you'll get.

How long would I be in the study?

Your participation in the study, including treatment and follow-up, could last for up to about three years, or until your treatment needs to change.