Active not recruitingPHASE3INTERVENTIONAL

Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab for FGFR2b Overexpressed Untreated Advanced Gastric and Gastroesophageal Junction Cancer.

This study is for people with advanced stomach cancer or cancer where the food pipe joins the stomach, which cannot be cured by surgery. Researchers are testing a new treatment called bemarituzumab alongside standard chemotherapy (mFOLFOX6 or CAPOX) and another drug called nivolumab. The study has two main parts. Part 1 focuses on checking if the new combination is safe and well-tolerated. Part 2 then compares how effective this new combination is against receiving chemotherapy and nivolumab with a dummy drug (placebo) instead of bemarituzumab. The main goal is to see if adding bemarituzumab helps people live longer. This research focuses on cancers that have a specific marker called FGFR2b.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Amgen

Enrolment target

515

Start

14 Mar 2022

Estimated completion

29 Jan 2027

Gastric Cancer Gastroesophageal Junction Adenocarcinoma

What is this study about?

This clinical trial is designed for individuals diagnosed with advanced stomach cancer or cancer of the gastroesophageal junction – that's the area where your food pipe meets your stomach. When we say 'advanced,' it means the cancer has spread or is too widespread to be removed by surgery and treated completely. The study is investigating a new treatment approach that combines a medicine called bemarituzumab with standard chemotherapy (which might be mFOLFOX6 or CAPOX, depending on what's suitable for you) and another drug called nivolumab.

The trial is divided into two stages. The first stage, or Part 1, is all about making sure the new combination of bemarituzumab, chemotherapy, and nivolumab is safe for patients and that people can tolerate the treatment well. This is a very important step before widespread testing. If the treatment proves to be safe, the study moves to Part 2.

In Part 2, the main aim is to find out if adding bemarituzumab to the standard chemotherapy and nivolumab helps people live longer compared to receiving chemotherapy and nivolumab alongside a placebo (a dummy drug without active ingredients). This part of the study is a 'comparison' to see if the new drug makes a real difference. Researchers are particularly interested in patients whose cancer has a specific feature called 'FGFR2b overexpression.' This means their cancer cells have a lot of a certain protein that bemarituzumab is designed to target.

Key takeaways

This study evaluates a new drug, bemarituzumab, for advanced stomach or food pipe cancer.
It combines bemarituzumab with standard chemotherapy and an immunotherapy drug (nivolumab).
The study aims to see if this new combination is safe and helps patients live longer.
It's for cancers with a specific marker called FGFR2b.
Eligibility includes adults with advanced, uncurable cancer and good organ function.
Participants will receive either the new drug or a placebo, plus standard treatments.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged between 18 and 100 years, with stomach cancer or cancer of the gastroesophageal junction that is advanced and cannot be cured by surgery. Your general health and how well you can carry out daily activities will be assessed, usually needing a good performance status.

Your cancer needs to be measurable or evaluable by doctors, meaning they can track its progress. You must also be able to safely take the specific chemotherapy drugs (mFOLFOX6 or CAPOX) and nivolumab without any known medical reasons preventing it. Additionally, your organs, like your kidneys and liver, need to be working well enough to handle the treatments. There are specific blood test results that doctors will check to make sure your body systems are functioning properly.

It's important to discuss all your current health conditions and medications with the study team, as these can affect whether you can take part. The research team will review all your medical information carefully to determine if this study is right for you.

Quick self-check

Are you an adult (18-100 years old) with advanced stomach or gastroesophageal junction cancer?
Has your doctor told you that your cancer cannot be cured by surgery?
Are you generally well and able to manage daily activities without too much difficulty?
Are your major organs (like your liver and kidneys) working well enough as determined by blood tests?
Have you discussed with your doctor if your cancer has an FGFR2b marker?
Are you able to take chemotherapy and nivolumab without medical reasons preventing it?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part in this study, you would receive either the new drug, bemarituzumab, along with chemotherapy and nivolumab, or a placebo (a dummy drug) plus chemotherapy and nivolumab. The study team will explain exactly which chemotherapy regimen (mFOLFOX6 or CAPOX) would be suitable for you. You'll have regular appointments at the hospital for treatments, blood tests, and scans to monitor your health and how the treatment is working. These appointments will involve check-ups to make sure you are tolerating the treatment well and to manage any side effects. The total duration of your participation would depend on how your cancer responds to treatment and your individual health, and the study team will let you know what to expect regarding follow-up after treatment.

Potential risks and benefits

Participating in a clinical trial offers the potential benefit of accessing new and possibly more effective treatments before they are widely available. However, there are also potential risks involved, as the new drug's full side effects are still being evaluated. You may experience side effects from any of the medications in the study, and these could be mild or more serious. The study team will closely monitor you and manage any side effects. It's crucial to remember that participation is completely voluntary; you have the right to withdraw from the study at any time, for any reason, without affecting your standard medical care.

Locations (348)

Mayo Clinic - Arizona
Phoenix, United States
The Oncology Institute Clinical Research
Cerritos, United States
Cancer and Blood Specialty Clinic
Downey, United States
City of Hope National Medical Center
Duarte, United States
University of California Los Angeles
Los Angeles, United States
University of California Irvine
Orange, United States
Torrance Memorial Physician Network
Redondo Beach, United States
Translational Research in Oncology - US Inc
Santa Monica, United States
Translational Research in Oncology US Inc, Trio Central Pharmacy
Santa Monica, United States
Olive View-University of California in Los Angeles Medical Center
Sylmar, United States
Presbyterian Intercommunity Hospital Health Whitter Hospital
Whittier, United States
Yale New Haven Hospital Yale Cancer Center
New Haven, United States

+336 more sites — see the official record for the full list.

Common questions

What is advanced stomach or gastroesophageal junction cancer?

This means the cancer has spread beyond its original location or is too extensive to be removed by surgery with the aim of a cure. It's not usually curable at this stage, but treatments aim to control it and improve quality of life.

What is bemarituzumab?

Bemarituzumab is a new investigational drug that targets a specific protein called FGFR2b, which can be found on some cancer cells. It's being tested to see if it can help treat certain types of stomach and food pipe cancer.

What is nivolumab?

Nivolumab is a type of immunotherapy. It helps your body's immune system recognise and fight cancer cells more effectively.

What is a placebo?

A placebo is an inactive substance or dummy drug that looks exactly like the actual treatment but contains no active medicine. It's used in trials for comparison to see if the real drug is truly effective.

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

In Part 2 of the study, you would be randomly assigned to receive either bemarituzumab or the placebo, in addition to chemotherapy and nivolumab. Neither you nor your doctor would typically know which one you are receiving during the trial, as this helps ensure the study results are unbiased.