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RecruitingPHASE2INTERVENTIONAL

Zanidatamab in Combination With Pembrolizumab and Chemotherapy in HER2 and PD-L1 Positive Metastatic Gastroesophageal Adenocarcinoma (GEA) Patients

This research, called the ZANGEA trial, is testing a new way to treat advanced stomach or food pipe cancer (also known as gastroesophageal adenocarcinoma). Doctors are looking at a combination of three treatments: Zanidatamab, Pembrolizumab, and standard chemotherapy. This study is for people whose cancer has specific features (proteins called HER2 and PD-L1) and has spread to other parts of the body. Participants must not have had previous treatment for their advanced cancer. The main goal is to see how well this new combination works in shrinking the cancer and improving patients' health. It will also check for side effects and how it affects quality of life.

At a glance

Status
Recruiting
Phase
PHASE2
Sponsor
Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Enrolment target
80
Start
16 Jan 2026
Estimated completion
01 Mar 2029

What is this study about?

This study, called ZANGEA, is a clinical trial exploring a new combination of medicines to treat a type of cancer that affects the stomach or the tube connecting your throat to your stomach (doctors call this gastroesophageal adenocarcinoma). This cancer has spread to other parts of the body (we call this metastatic cancer). The trial is open to people whose cancer cells have specific markers on their surface, called HER2 and PD-L1, which are important because these new drugs are designed to target them. This is often the first treatment people receive for their advanced cancer, meaning they haven't had other treatments for it yet.

The main aim of this study is to see how effective this new combination therapy is. This means researchers want to find out how well it can shrink the cancer or stop it from growing. They will also pay close attention to any side effects patients might experience and how it impacts their overall well-being and daily life. By combining these different treatments, doctors hope to find a more powerful way to fight this type of cancer.

Researchers will also be comparing the results from this study with information from previous studies to better understand how this new combination performs. They will also look at different factors in patients' blood and cancer samples to try and find clues that might help predict which patients will respond best to this treatment. Around 80 patients will be involved in this study across about 30 hospitals in Germany and Austria.

Key takeaways

  • This study tests a new three-medicine combination for advanced stomach or food pipe cancer.
  • It's for people whose cancer has specific markers (HER2 and PD-L1 positive).
  • Participants must not have had earlier treatments for their advanced cancer.
  • The main goal is to see how well the treatment works and what side effects it has.
  • You'll have regular hospital visits for treatment and health checks.

Who may be eligible?

To join this study, you need to be at least 18 years old and have signed a form saying you understand the study and agree to take part. Your doctor will need to confirm that you are generally well enough to participate and can attend all the required appointments and tests.

Your cancer must be a type called gastroesophageal adenocarcinoma, and it must have spread to other parts of your body. Importantly, tests on your cancer tissue must show that you have specific markers present, known as HER2 and PD-L1. You should not have received any previous treatment for your cancer that has spread, although some earlier treatments for cancer that hadn't spread are allowed if they finished at least six months ago.

There are also some health checks you'll need to pass. For example, your blood tests for your liver, kidneys, and blood cells need to be within a healthy range. Your doctor will carefully review all these requirements with you to see if this study could be a good option.

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.

  1. Are you 18 years old or older?
  2. Do you have advanced stomach or food pipe cancer that has spread?
  3. Have your cancer tests shown that you are HER2 and PD-L1 positive?
  4. Have you NOT received any previous treatment for your cancer that has spread?
  5. Are your general health and blood test results within healthy ranges?
Answer every question to see your result.

What does participation involve?

If you join this study, you will receive a combination of three medicines: Zanidatamab, Pembrolizumab, and chemotherapy (mFOLFOX). This will involve regular visits to the hospital for treatment infusions and check-ups. The study is 'open-label,' meaning both you and your doctors will know which treatments you are receiving.

Throughout the study, you will have various tests and assessments to monitor your health, how the treatment is working, and to check for any side effects. These will include blood tests, imaging scans (like CT scans), and reviews of your general well-being. Researchers will also be looking at how the treatment impacts your quality of life. The total duration of your participation will depend on how you respond to the treatment and your health, but it will involve ongoing treatment and follow-up for a period of time.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as receiving a new combination of medicines that might be more effective in treating your advanced cancer than current standard treatments. You'll be closely monitored by a medical team, and your health will be carefully tracked. However, as with any new treatment, there are potential risks, including side effects from the medicines. These side effects can vary from person to person. It's important to remember that you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (20)

  • Charité CVK
    Verified postcode
    Berlin, Germany· Not yet recruiting
  • Vivantes Klinikum im Friedrichshain
    Verified postcode
    Berlin, Germany· Not yet recruiting
  • Klinikum Bielefeld
    Verified postcode
    Bielefeld, Germany· Not yet recruiting
  • Städtisches Klinikum Dresden
    Verified postcode
    Dresden, Germany· Not yet recruiting
  • Evang. Kliniken Essen Mitte
    Verified postcode
    Essen, Germany· Not yet recruiting
  • Krankenhaus Nordwest
    Verified postcode
    Frankfurt, Germany· Not yet recruiting
  • Universitätsklinikum Göttingen
    Verified postcode
    Göttingen, Germany· Not yet recruiting
  • Hämatologisch Onkologische Praxis Eppendorf (HOPE)
    Verified postcode
    Hamburg, Germany· Recruiting
  • Asklepios Klinik Altona
    Verified postcode
    Hamburg, Germany· Recruiting
  • Universitätsklinikum Hamburg Eppendorf
    Verified postcode
    Hamburg, Germany· Recruiting
  • St. Anna Hospital Herne
    Verified postcode
    Herne, Germany· Recruiting
  • Universitätsklinikum Jena
    Verified postcode
    Jena, Germany· Not yet recruiting

Common questions

What is gastroesophageal adenocarcinoma?

It's a type of cancer that starts in the stomach or the tube connecting your throat to your stomach (oesophagus).

What does 'HER2 and PD-L1 positive' mean?

These are special proteins found on the surface of some cancer cells. The medicines in this study are designed to target these specific proteins.

What is a 'clinical trial phase II'?

It means this is an early study to see how well a new treatment works and to check for side effects in a larger group of people than in a phase I study.

Will I know which treatment I'm getting?

Yes, this study is 'open-label,' meaning both you and your doctors will know you are receiving the combination of Zanidatamab, Pembrolizumab, and chemotherapy.

Can I leave the study at any time?

Yes, you have the right to withdraw from the study at any point without it affecting your future medical care.

How to find out more

Alexander Stein, Prof. Dr.

Always speak to your GP or specialist before deciding to take part in a study.

Interested in taking part?

Register your interest

Share your details and the research team for "Zanidatamab in Combination With Pembrolizumab and Chemothera…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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