Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, randomized, double-blind clinical study of pembrolizumab (MK-3475) plus chemotherapy versus placebo plus chemotherapy as first-line treatment in participants with HER2 negative, previously untreated, unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma (KEYNOTE-859)

This research is a 'Phase 3' study, which means it's a large trial testing a new treatment combination for advanced stomach or food pipe cancer that has spread or can't be removed by surgery. The treatment involves a drug called pembrolizumab (also known as Keytruda) given together with standard chemotherapy medicines. Some participants will receive pembrolizumab plus chemotherapy, while others will receive a dummy drug (placebo) plus chemotherapy. This helps researchers compare the effects fairly. The main goal is to find out if the pembrolizumab combination helps people live longer. They are also looking at how long people live without their cancer getting worse, and how many people respond to the treatment. The study is for adults whose cancer doesn't have high levels of a protein called HER2 and haven't had previous treatment for their advanced cancer.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

268

Start

30 Apr 2024

Gastric and gastric esophageal junction (GEJ) adenocarcinoma

What is this study about?

This study is looking at a type of cancer that affects the stomach or where the food pipe joins the stomach. This cancer is often called gastric or gastroesophageal junction adenocarcinoma. In this study, they are focusing on cancer that has either spread to other parts of the body (metastatic) or cannot be removed through surgery (unresectable), and has not been treated before for its advanced stage. Doctors are very keen to find new and more effective ways to treat this condition.

The main aim of this study is to see if adding a new drug called pembrolizumab (which you might hear referred to as Keytruda) to standard chemotherapy can improve how long people live and how well they do. Pembrolizumab is a type of immunotherapy, which works by helping your body's own immune system fight cancer cells. The study is comparing this new combination against chemotherapy given with a placebo (a dummy drug that looks like pembrolizumab but contains no active medicine). This comparison helps the researchers understand if pembrolizumab truly makes a difference.

They're particularly interested in how long people live overall, how long they live without the cancer getting worse, and how many people's cancers shrink or respond to the treatment. They're also carefully monitoring any side effects to make sure the treatment is as safe as possible. This type of research is crucial because it helps doctors find better treatments for patients in the future.

Key takeaways

This study is for advanced stomach or food pipe cancer.
It tests a new drug (Keytruda/pembrolizumab) with standard chemotherapy.
The goal is to see if the new combination helps people live longer and better.
It's a large, well-designed study where some get a dummy drug for comparison.
Participants will have regular check-ups and scans to monitor their health.
Only for cancers that are 'HER2 negative' and haven't had prior treatment for advanced disease.

Who may be eligible?

To be able to take part in this study, you would need to meet certain conditions. It's designed for adults aged 18 years and older, regardless of whether you are male or female.

The study is specifically for people who have advanced cancer of the stomach or the place where the food pipe meets the stomach. This means your cancer has either spread to other parts of your body or cannot be removed by an operation.

Critically, you should not have received any previous treatment for your advanced cancer. Also, your cancer cells must not show high levels of a protein called HER2. Your doctor can check if your cancer meets these specific requirements through special tests.

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 stomach or food pipe cancer (gastric or gastroesophageal junction adenocarcinoma)?
Has your cancer spread or cannot be removed by surgery?
Have you NOT had any previous treatment for your advanced cancer?
Has your doctor confirmed your cancer is 'HER2 negative'?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be split into one of two groups by chance, like flipping a coin. Neither you nor your doctor will know which group you are in. One group will receive pembrolizumab plus chemotherapy, and the other will receive a placebo (dummy drug) plus chemotherapy. The chemotherapy medicines used could include a combination of capecitabine, fluorouracil, oxaliplatin, or cisplatin. These treatments are given as infusions into your vein or as tablets, depending on the specific chemotherapy chosen by your doctor.

Taking part will involve regular visits to the hospital or clinic. These visits will include physical examinations, blood tests, and scans (like CT or MRI scans) to check how well the treatment is working and to monitor for any side effects. You'll also be asked questions about how you are feeling. The frequency of visits will be more often at the beginning of the study and may become less frequent over time. The total duration of your participation could vary, as you would continue treatment for as long as it is helping you and you are not experiencing severe side effects. After stopping treatment, there will be a follow-up period where doctors will continue to check on your health status.

Potential risks and benefits

Taking part in a clinical trial may offer potential benefits, such as receiving close medical attention and access to a promising new treatment that might be more effective than standard care. However, there are also potential risks involved. The treatments, both pembrolizumab and chemotherapy, can cause side effects. These can range from mild, like feeling tired or sick, to more serious issues, which your doctor will explain in detail. There's also no guarantee that the treatment will work for everyone, or that it will be better than existing treatments. It is important to remember that you are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

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

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Unverified
Denmark
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Unverified
France
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Unverified
Ireland
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Unverified
Czechia
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Unverified
Poland
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Unverified
Spain
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Unverified
Germany
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Unverified
Italy

Common questions

What is Keytruda?

Keytruda is the brand name for pembrolizumab, which is an immunotherapy drug that helps your body's immune system fight cancer.

What is HER2 negative cancer?

HER2 negative means that your cancer cells do not have a large amount of a specific protein called HER2. This is important because some treatments work best for HER2-positive cancers, so knowing this helps doctors choose the right treatment.

What does 'unresectable or metastatic' mean?

Unresectable means the cancer cannot be removed by surgery. Metastatic means the cancer has spread from where it started to other parts of the body.

Will I know if I'm getting the new drug or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your doctors will know if you are receiving pembrolizumab or the placebo. This helps make the study fair and accurate.

What is a 'Phase 3' study?

A Phase 3 study is a large study that compares a new treatment with the best existing treatment (or a placebo). It's to confirm if the new treatment is safe and effective before it can be widely used.