A Phase 1b/3 Study of Bemarituzumab Plus Chemotherapy and Nivolumab Versus Chemotherapy and Nivolumab Alone in Subjects With Previously Untreated Advanced Gastric and Gastroesophageal Junction Cancer With FGFR2b Overexpression (FORTITUDE-102)
This study, called FORTITUDE-102, is designed for individuals with advanced stomach cancer or cancer where the food pipe joins the stomach. Participants must have a specific finding in their cancer called FGFR2b overexpression, meaning their cancer cells have too much of a particular protein. The study aims to find out if adding a new drug, bemarituzumab, to the existing combination of chemotherapy and nivolumab is more effective than chemotherapy and nivolumab alone. Researchers will look at how safe the new combination is, how it affects the cancer's growth, and how long people live. This is a later-stage study, meaning the treatment has shown promise in earlier research.
At a glance
What is this study about?
This research study, known as FORTITUDE-102, is for people diagnosed with advanced stomach cancer or cancer that affects the area where your food pipe (gullet) meets your stomach. Importantly, the cancer must show a specific feature called 'FGFR2b overexpression'. This means that the cancer cells have larger amounts of a particular protein that can sometimes help them grow.
The main goal of this study is to see if adding a new drug, called bemarituzumab, to the standard treatment for this type of cancer is more effective. The standard treatment currently includes a combination of chemotherapy drugs (like oxaliplatin, capecitabine, fluorouracil, and folinic acid) and another drug called nivolumab. The study will compare two groups: one receiving bemarituzumab alongside the standard treatment, and another receiving standard treatment with a dummy drug (placebo) instead of bemarituzumab.
Researchers will carefully monitor participants to understand how safe the treatments are and what side effects they might cause. They will also look at how well the treatments stop the cancer from growing or shrinking it, and ultimately, how long people live. This is a 'Phase 1b/3' study, which means it’s partly looking at the best dose and safety of the new drug combination, and largely comparing the new treatment with the existing one to confirm its benefits.
Key takeaways
- This study explores a new drug (bemarituzumab) for advanced stomach or gastroesophageal junction cancer.
- It's for people whose cancer has a specific marker called 'FGFR2b overexpression'.
- The new drug is being tested alongside standard chemotherapy and nivolumab.
- The study aims to see if this new combination is more effective than standard treatment alone.
- Participation involves regular hospital visits, tests, and closely monitoring your health.
- It's a comparison study, meaning some participants will receive a dummy drug instead of bemarituzumab.
Who may be eligible?
To be considered for this study, you would generally need to be at least 18 years old. The study is open to both men and women. A crucial requirement is that you have advanced stomach cancer or cancer at the junction of your food pipe and stomach, and your cancer has not been treated before with certain therapies for its advanced stage.
Most importantly, your cancer must have a specific feature called FGFR2b overexpression. This is found through special tests on your cancer tissue. You would also need to be fit enough to take part in the study, which means your overall health and organ functions (like your heart, liver, and kidneys) need to be working reasonably well.
There are also some reasons why you might not be able to join, such as having certain other health conditions, or if you have had other cancer treatments recently. The study team will review all your medical information to see if this study is suitable for you.
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 at least 18 years old?
- Do you have advanced stomach cancer or cancer of the gastroesophageal junction?
- Has your cancer been tested for FGFR2b overexpression, and was it positive?
- Have you not received prior general treatment for your advanced cancer?
- Are you generally well enough to take part in a study?
- Are you willing to undergo regular medical tests and scans?
What does participation involve?
If you decide to take part in this study, you would first go through screening tests to make sure you're a good fit. If eligible, you would be randomly assigned to one of two groups, like flipping a coin – either receiving bemarituzumab plus chemotherapy and nivolumab, or a placebo (dummy drug) plus chemotherapy and nivolumab. You wouldn't know which group you are in, and neither would your doctors.
Your treatment would involve regular visits to the hospital for medications. These would be given either through a drip into your vein or as tablets, depending on the specific drug. You would have frequent check-ups, including blood tests, physical examinations, and scans (like CT scans) to monitor your health and how the cancer is responding. These appointments would be scheduled regularly throughout the treatment period. The study will also involve follow-up visits and checks even after your main treatment period ends, to continue monitoring your health.
Potential risks and benefits
Locations (12)
- —UnverifiedGermany
- —UnverifiedPoland
- —UnverifiedAustria
- —UnverifiedCzechia
- —UnverifiedPortugal
- —UnverifiedSpain
- —UnverifiedBulgaria
- —UnverifiedFrance
- —UnverifiedRomania
- —UnverifiedBelgium
- —UnverifiedItaly
- —UnverifiedHungary
Common questions
What is 'FGFR2b overexpression'?
It means your cancer cells have too much of a specific protein called FGFR2b, which can sometimes help the cancer grow.
What are chemotherapy and nivolumab?
Chemotherapy uses medicines to kill cancer cells, and nivolumab is an immunotherapy that helps your body’s immune system fight cancer.
Will I definitely get the new drug, bemarituzumab?
You might. You'll be randomly assigned to receive either the new drug plus standard treatment or a dummy drug plus standard treatment.
How long will I be in the study?
The active treatment phase will vary depending on your response, and there will be follow-up appointments even after treatment ends.
What happens if the treatment doesn't work?
Your doctors will discuss other treatment options available to you, and you can withdraw from the study at any time.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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