Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Lenvatinib (E7080/MK-7902) plus Pembrolizumab (MK-3475) plus Chemotherapy Compared with Standard of Care Therapy as First-line Intervention in Participants with Advanced/Metastatic Gastroesophageal Adenocarcinoma (LEAP-015)

This clinical trial is for people with advanced or metastatic gastroesophageal adenocarcinoma, which is a type of cancer affecting the stomach or the tube connecting your mouth to your stomach (oesophagus). The main goal is to see if a combination of new drugs, specifically Lenvatinib and Pembrolizumab, when given with standard chemotherapy, is more effective and safer than current standard treatments. Researchers will be looking at how long people live, how long they stay free from their cancer getting worse, and any side effects people might experience. It's a 'Phase 3' study, meaning it's one of the final steps before a new treatment might become widely available.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

231

Start

20 Dec 2023

Advanced/Metastatic Gastroesophageal Adenocarcinoma

What is this study about?

This clinical trial, called LEAP-015, is designed for people who have advanced or metastatic gastroesophageal adenocarcinoma. This is a type of cancer that starts in the stomach or the food pipe (oesophagus) and has either spread to other parts of the body or is no longer treatable with local surgery. The study is comparing a new treatment approach against what doctors currently consider the best standard treatment for this condition.

The new treatment being tested involves a combination of three different types of medication: Lenvatinib, Pembrolizumab (also known as Keytruda), and standard chemotherapy drugs (like capecitabine, oxaliplatin, and fluorouracil). Lenvatinib and Pembrolizumab are newer types of cancer medicines that work in different ways to fight cancer. Researchers want to find out if combining these with traditional chemotherapy can improve patient outcomes, such as how long patients live and how long their cancer is kept under control, compared to chemotherapy alone.

This is a Phase 3 study, which means it's a large trial involving many patients. It's an important step to determine if this new combination therapy is safe and more effective than existing treatments before it can be considered for wider use. The study will carefully monitor patients for any side effects and track how well the treatments work over time.

Key takeaways

This study evaluates new drug combinations for advanced stomach or food pipe cancer.
It compares a new treatment (Lenvatinib + Pembrolizumab + chemotherapy) to standard care.
The aim is to find out if the new treatment is more effective and safer.
Participation involves regular hospital visits, tests, and closely monitored treatment.
You might get the new treatment or standard care, decided randomly.
You can stop participating at any time if you wish.

Who may be eligible?

To be considered for this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

The main medical requirement is that you have advanced or metastatic gastroesophageal adenocarcinoma. This means your cancer has spread beyond its original site or is at an advanced stage where surgery is not an option. Your doctors will need to confirm this diagnosis.

There will be other specific health requirements and medical tests to make sure the study treatment is suitable and safe for you. These might include checking your general health, organ function, and any other medical conditions you have. Your study doctor and nurse will discuss all these criteria with you in detail.

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?
Have you been diagnosed with advanced or metastatic stomach or food pipe cancer?
Are you generally healthy enough to receive cancer treatment?
Are you able to attend regular hospital appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will receive either the new combination treatment or the standard treatment. You won't get to choose which one you receive; it's decided randomly, like flipping a coin. You will have regular visits to the hospital or clinic for your treatments and check-ups. These visits will involve blood tests, physical examinations, and scans (like CT scans) to monitor your cancer and check for any side effects.

The medications will be given either as infusions into your vein (like a drip) or as tablets, depending on the specific drug. You'll be closely monitored by the study team throughout your participation. The frequency of visits and specific tests will vary throughout the study but will be explained in detail before you agree to join. Treatment will continue as long as it's helping and you are tolerating it well, with follow-up appointments even after treatment ends to monitor your long-term health. The total duration someone participates will vary based on their response to treatment.

Potential risks and benefits

Taking part in a clinical trial offers potential benefits, such as access to new treatments that aren't yet widely available, and you'll receive close medical attention. While these new treatments might be more effective than current options, there are also potential risks involved. You might experience side effects, some of which could be serious, and the new treatment might not work for everyone. The study team will explain all known and potential risks in detail. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (7)

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

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Unverified
Spain
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Unverified
Belgium
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Unverified
Germany
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Unverified
France
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Unverified
Italy
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Unverified
Ireland
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Unverified
Poland

Common questions

What is gastroesophageal adenocarcinoma?

It's a type of cancer that affects the stomach or the food pipe (oesophagus), which is the tube that carries food from your mouth to your stomach.

What does 'metastatic' mean?

'Metastatic' means the cancer has spread from where it started to other parts of your body.

What are Lenvatinib and Pembrolizumab?

These are newer cancer medicines. Lenvatinib works by blocking signals that help cancer cells grow, and Pembrolizumab (Keytruda) helps your immune system fight cancer.

Will I know which treatment I'm getting?

In this type of study, participants are usually randomly assigned to either the new treatment or the standard treatment. Often, you won't know which one you're receiving, but your doctors will.

What is a 'Phase 3' study?

A Phase 3 study is a large study that compares new treatments to existing ones to see if they are better and safer before they can become widely available.