Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase 2 Exploratory, Multicenter, Open-Label Trial to Determine the Safety and Preliminary Clinical Activity of GEN1046 in Combination With Anticancer Agents in Subjects With Advanced Endometrial Cancer

This study is trying out a new treatment for advanced endometrial cancer, which is a type of womb cancer that has spread. Researchers are testing a new medicine, DuoBody®-PD-L1x4-1BB, alongside a standard cancer drug called KEYTRUDA. The main goal is to find out if this combination is safe and if it helps shrink the cancer. They will also look at how long any shrinkage lasts, how quickly it happens, and how many people see their cancer stop growing or shrink. Researchers will also carefully monitor any side effects from the treatment. This is a Phase 2 study, meaning it's an early stage of testing this new combination in people.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Genmab A/S

Enrolment target

Start

27 Jul 2023

Advanced Endometrial Cancer

What is this study about?

This study is about finding new and better ways to treat advanced endometrial cancer. This is a type of cancer that starts in the lining of the womb and has grown or spread to other parts of the body.

Doctors are exploring a new approach that combines two different medicines. One is a new drug called DuoBody®-PD-L1x4-1BB, which works by helping your body's immune system fight the cancer. The other is a well-known cancer drug called KEYTRUDA (its full name is pembrolizumab), which also helps your immune system target cancer cells. By using these two drugs together, researchers hope to get a stronger effect against the cancer.

The main purpose of this study is to see if this combination treatment is safe for patients and if it can make tumours smaller. They will also be looking closely at other things like how long the treatment keeps the cancer under control and what side effects might occur. This information will help doctors understand if this new combination could be a useful treatment option in the future.

Key takeaways

This study is for women with advanced endometrial cancer.
It tests a new drug combination to fight cancer.
The main aim is to check safety and see if tumours shrink.
It's an early-stage clinical trial (Phase 2).
Participation involves regular hospital visits for treatments and checks.

Who may be eligible?

To join this study, you must be a woman with advanced endometrial cancer. This means your cancer has either spread or come back after previous treatments.

You need to be at least 18 years old to take part. There isn't an upper age limit, as long as you are otherwise well enough to join a clinical trial.

Other specific medical checks will also be done to make sure the treatment is suitable and safe for you. This will involve reviewing your medical history and recent test results.

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.

I am female.
I have been diagnosed with advanced endometrial cancer.
I am 18 years old or older.
I understand I will need to have other medical checks to see if I qualify.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll receive the two study drugs (DuoBody®-PD-L1x4-1BB and KEYTRUDA) as an infusion, which means they will be given into your vein, usually in your arm. The exact schedule for these infusions will be explained to you by the study team.

You will have regular hospital visits for check-ups, blood tests, and scans to monitor how you are responding to the treatment and to keep an eye on any side effects. These visits might be quite frequent at the start and then become less often over time. The study will continue for as long as the treatment is helping you and you are not experiencing severe side effects. After you stop the treatment, there will be follow-up visits or contact to see how you are doing.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as gaining access to a new treatment before it's widely available, and helping doctors learn more about cancer care, which could benefit others in the future. However, there are also potential risks; new drugs can have side effects that are not yet fully understood, and the treatment might not work for everyone. Your safety will be a priority, and you'll be closely monitored for any reactions. Remember, taking part in any study is entirely voluntary, and you have the right to withdraw at any time without giving a reason, and this will not affect your future medical care.

Locations (5)

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

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Unverified
Italy
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Unverified
Spain
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Unverified
Belgium
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Unverified
Denmark
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Unverified
Poland

Common questions

What is endometrial cancer?

Endometrial cancer is a type of cancer that starts in the inner lining of the womb (uterus). Advanced means it has spread or come back.

What is a 'Phase 2' study?

A Phase 2 study is an early stage of testing for new medicines. It focuses on whether the treatment is safe and if it shows promising signs of working in a small group of patients.

What are the drugs being tested?

The study is testing a new drug called DuoBody®-PD-L1x4-1BB together with an existing cancer medicine called KEYTRUDA. Both aim to help your immune system fight cancer.

What does 'objective response rate' mean?

This is how doctors measure if the treatment is working. It means looking to see if the tumours have shrunk or disappeared altogether.

Will I get a placebo (dummy treatment)?

No, this study is 'open-label', which means everyone who takes part will receive the active study treatments (both DuoBody®-PD-L1x4-1BB and KEYTRUDA).