A Phase 3 Randomized, Open-Label, Study of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for First-line Treatment of Advanced or Recurrent Endometrial Carcinoma (LEAP-001)
This research study is investigating new treatment options for people with advanced or recurrent womb cancer. It's called "LEAP-001" and is a large, stage 3 study, meaning it's comparing new treatments against existing ones to see if they're better. The study is testing a combination of two medicines, pembrolizumab (also known as KEYTRUDA) and lenvatinib, against standard chemotherapy. Researchers want to find out which treatment is more effective at stopping the cancer from progressing and helping patients live longer. They will also look at how patients feel and any side effects. This study aims to confirm if these new drugs can offer a better first-line treatment for this type of cancer.
At a glance
What is this study about?
This study is focused on advanced or recurrent womb cancer, which means the cancer has spread from where it started or has come back after previous treatment. The main goal of this research is to find out if a new combination of medicines is better than the usual chemotherapy treatment for people in this situation.
The new treatment being tested involves two drugs: pembrolizumab (also known as KEYTRUDA) and lenvatinib. Pembrolizumab is an immunotherapy that works by helping your own immune system fight the cancer. Lenvatinib is a targeted therapy that helps stop cancer cells from growing. These are being compared to chemotherapy, which uses strong drugs to kill cancer cells.
We want to see which treatment best slows down or stops the cancer from growing, and importantly, which helps people live longer and have a better quality of life. The study will also carefully monitor any side effects from the treatments.
Key takeaways
- This study is for advanced or recurrent womb cancer.
- It tests new drug combinations against standard chemotherapy.
- The goal is to find better ways to stop cancer growth and improve survival.
- Participation involves regular hospital visits for treatment and monitoring.
- You can withdraw from the study at any time.
- It's a 'Phase 3' study, comparing new treatments with existing ones.
Who may be eligible?
To join this study, you would need to be at least 18 years old. There is no upper age limit, meaning older adults can also take part. The study is open to both men and women.
Crucially, you must have advanced or recurrent womb cancer. This means the cancer has spread beyond the original site or has returned after previous treatment. Your doctors would need to confirm that your cancer fits these criteria.
There will also be other specific medical checks and tests to make sure the treatment is suitable for you and that you are healthy enough to participate. Your medical team can discuss all these details with you.
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 womb cancer?
- Are you able to travel to the study clinic for regular appointments?
- Are you willing to potentially receive either the new drug combination or standard chemotherapy?
- Are you prepared to undergo various medical tests and scans as part of the study?
What does participation involve?
If you decide to take part in this study, you would be assigned to receive one of the study treatments – either the combination of pembrolizumab and lenvatinib, or standard chemotherapy. This assignment is done randomly, like flipping a coin, to ensure fairness.
You would have regular hospital visits for your treatments and to have check-ups, blood tests, and scans. These repeated checks would help the study team see how your body is responding to the treatment and to monitor your general health. They will also ask you to complete questionnaires about how you are feeling to understand your quality of life.
The total duration of your participation would depend on how your cancer responds to the treatment and your overall health. You would continue treatment as long as it is helping you and you are tolerating it well. There would also be follow-up appointments after your treatment finishes to monitor your long-term health.
Potential risks and benefits
Locations (7)
- —UnverifiedIreland
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- —UnverifiedItaly
- —UnverifiedSpain
- —UnverifiedBelgium
- —UnverifiedGermany
- —UnverifiedPoland
Common questions
What type of cancer is this study for?
This study is for people with advanced or recurrent womb (endometrial) cancer, meaning it has spread or come back.
What treatments are being tested?
The study is comparing a combination of two drugs (pembrolizumab and lenvatinib) against standard chemotherapy.
Will I get to choose my treatment?
No, you would be randomly assigned to one of the treatment groups, like drawing lots, to ensure a fair comparison.
What is the main goal of the study?
The study aims to see if the new drug combination is better at stopping cancer growth and helping people live longer compared to chemotherapy.
What age do I need to be to join?
You need to be 18 years or older to participate in this study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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