Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) + Lenvatinib (E7080/MK-7902) + Chemotherapy Compared with Standard of Care as First-line Intervention in Participants with Metastatic Esophageal Carcinoma

This study, called a Phase 3 trial, is investigating new treatment options for people with advanced oesophageal cancer (cancer of the food pipe). It aims to find out if combining two new drugs, Pembrolizumab and Lenvatinib, with standard chemotherapy is more effective and safer than current usual care. Researchers will be observing the side effects closely and measuring how long people live comfortably on the treatment. The study involves comparing these new combinations against existing treatments to understand which approach offers the best results for patients, helping improve future care for this type of cancer. It's a key step in finding better ways to fight advanced oesophageal cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

136

Start

25 Jul 2023

Esophageal Carcinoma

What is this study about?

This research study is about finding better treatments for oesophageal cancer that has spread to other parts of the body, which doctors call 'metastatic'. When cancer has spread, it can be harder to treat, so finding new and more effective options is really important. This study is a Phase 3 trial, which means it's a large, careful study comparing a new treatment idea with what's currently considered the best available care.

The study involves looking at a combination of different medications. These include two newer drugs, Pembrolizumab (also known as Keytruda) and Lenvatinib, along with several chemotherapy drugs like Fluorouracil, Oxaliplatin, and Cisplatin. Pembrolizumab works by helping your own immune system fight the cancer, while Lenvatinib aims to stop cancer cells from growing and spreading. By combining these with chemotherapy, researchers hope to give patients a stronger and more effective treatment.

The main goals of the study are to understand if these new combinations are safe and if they help people with metastatic oesophageal cancer live longer and with a better quality of life. The researchers will be carefully monitoring for any side effects and comparing how patients respond to the new treatment compared to those receiving standard care.

Key takeaways

This study evaluates new combinations of drugs for advanced oesophageal cancer.
It compares new treatments with standard care to find more effective options.
The study focuses on patient safety, how long people live, and how well treatments work.
Pembrolizumab and Lenvatinib are two of the new drugs being tested with chemotherapy.
Participation involves regular hospital visits for treatment and monitoring.
You can withdraw from the study at any time without affecting your medical care.

Who may be eligible?

To join this study, you would need to be at least 18 years old. Both men and women can take part.

Like all clinical trials, there will be other specific health requirements or conditions that you need to meet to be eligible. These are put in place to ensure your safety and that the study results are as clear and accurate as possible. For example, doctors will check your overall health, the type and stage of your oesophageal cancer, and whether you have any other serious medical conditions.

It's very important to talk to your own doctor or the study team to find out if this particular study is right for you. They will be able to explain all the details and assess if you meet all the necessary 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?
Do you have oesophageal cancer that has spread?
Are you able to attend regular appointments for treatment and check-ups?
Are you willing to potentially receive either the new treatment or standard care?
Are you in generally good health, apart from your cancer?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be assigned to either receive the new combination treatment or standard care; this is usually decided randomly, like flipping a coin. You would attend regular appointments at the study site for treatments, check-ups, and to have various tests done, such as blood tests or scans, to monitor your health and how the treatment is working.

The treatments themselves would involve taking medications as prescribed, which could be infusions (given into a vein) or tablets, depending on the specific drug. The study team would carefully explain the schedule and how to take any medicines. You would be closely monitored for any side effects, and the team would help manage these.

The total length of your participation would vary. Some parts of the study focus on safety in the short term, while the main part of the study will follow patients for a longer period to understand the full effects of the treatments on overall survival and disease progression. You will have regular follow-up visits even after treatment ends.

Potential risks and benefits

Taking part in a clinical trial might offer potential benefits, such as access to new treatments that aren't yet widely available and close medical monitoring. However, there are also potential risks, as any medication can have side effects, and new treatments may have unknown ones. The study team will inform you of all known risks. It's important to remember that joining a study is always voluntary. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

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
Hungary
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Unverified
France
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Unverified
Denmark
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Unverified
Italy
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Unverified
Romania

Common questions

What is oesophageal cancer?

Oesophageal cancer is cancer that starts in the food pipe, which connects your throat to your stomach.

What does 'metastatic' mean?

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

What is a Phase 3 study?

A Phase 3 study is a large research trial that compares a new treatment idea to current standard treatments to see which works best and if it's safe.

What are Pembrolizumab and Lenvatinib?

These are newer medications. Pembrolizumab helps your immune system fight cancer, and Lenvatinib aims to stop cancer cells from growing and spreading.

Will I definitely get the new treatment if I join?

Not necessarily. In this type of study, participants are usually randomly assigned to either receive the new combination treatment or the standard treatment, so researchers can compare them fairly.