Active not recruitingOBSERVATIONAL

A Study of Nivolumab Plus Chemotherapy in First Line Treatment of Adult Participants With Advanced or Metastatic Gastric Cancer

This study is for adults with stomach cancer, or cancer in the area where the food pipe meets the stomach, or cancer of the food pipe (oesophagus). All these cancers should be advanced or have spread (metastatic) and haven't been treated before. The main goal is to understand how effective and safe a medicine called nivolumab is when given together with standard chemotherapy. Doctors want to see if this combination helps people with these types of cancer, especially if their cancer cells show a certain marker called PD-L1. This is an observational study, meaning doctors will watch how participants respond to their treatment, which includes nivolumab, as part of their regular care.

At a glance

Status

Active not recruiting

Sponsor

Bristol-Myers Squibb

Enrolment target

600

Start

16 Feb 2022

Estimated completion

31 Dec 2026

Gastric Cancer

What is this study about?

This study focuses on a type of cancer that affects the stomach, the area where your food pipe joins your stomach, or your food pipe itself (oesophagus). When these cancers are advanced or have spread to other parts of the body, and it's the first time they're being treated, doctors are looking at a specific medicine called nivolumab. Nivolumab is an immunotherapy, which helps your body's own immune system fight cancer cells.

The study aims to understand how well nivolumab works when it's given along with chemotherapy, which is a common cancer treatment. They also want to see if it causes any side effects. This is important because finding effective and safe treatments for advanced cancers can make a big difference in people's lives.

It's an "observational" study. This means that if your doctor has already decided that nivolumab combined with chemotherapy is the right treatment for you based on its approval in Germany, the study will simply follow your progress. They won't ask you to do anything different from your usual medical care, but they will collect information about your treatment and how you're doing to learn more about this approach.

Key takeaways

This study is for adults with advanced stomach, gastro-oesophageal junction, or oesophageal cancer.
It looks at a specific medicine called nivolumab combined with chemotherapy.
The treatment prescribed is already decided by your doctor based on its approval in Germany.
It's an 'observational' study, meaning your regular treatment and progress will be monitored.
The aim is to learn more about the effectiveness and safety of this treatment combination.

Who may be eligible?

To join this study, you need to be an adult (18 or older) with advanced stomach cancer, cancer where the food pipe meets the stomach, or cancer of the food pipe. Your cancer must be a specific type called 'HER2 negative' and show a certain marker called PD-L1. Importantly, this must be the first treatment you're receiving for this advanced cancer, and your doctor must have already decided that nivolumab, as approved in Germany, is the right treatment for you.

There are also some reasons why you might not be able to join. For example, if you've had another cancer in the last three years (unless it was a very common and easily treated skin cancer or a specific type of cervical cancer).

You also can't be taking part in another active treatment study for your stomach or related cancer. However, if you've finished a previous study and are just in the follow-up phase (meaning you've stopped taking any study medicines), you might still be able to join.

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.

I am 18 years old or older.
I have advanced stomach cancer, cancer where the food pipe meets the stomach, or cancer of the food pipe.
My cancer is 'HER2 negative' and shows a 'PD-L1' marker.
This is the first time I'm receiving treatment for my advanced cancer.
My doctor has already decided I will be treated with nivolumab as part of my care.
I am not currently taking part in another active treatment study for my cancer.

Answer every question to see your result.

What does participation involve?

If you join this study, you won't be asked to do anything differently from your standard medical care. Your doctor will have already decided to treat your advanced stomach cancer (or related cancer) with nivolumab plus chemotherapy. The study will mainly involve your medical team collecting information about your treatment, how your cancer responds, and any side effects you might experience. This information will come from your regular hospital visits, scans, and blood tests that you'd be having anyway as part of your treatment. The total duration you'll be followed will depend on your individual treatment plan and how long your doctor feels it's necessary to monitor your progress.

Potential risks and benefits

The main benefit of taking part is that your treatment is being carefully monitored, which contributes to a better understanding of how nivolumab and chemotherapy work together. While you won't receive any experimental treatment beyond what your doctor has already prescribed, the information gathered could help future patients. Potential risks are related to the nivolumab and chemotherapy treatments themselves, which your doctor will discuss with you in detail, as these can have side effects. You are always in control and have the right to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (1)

Local Institution - 0001
Verified postcode
Hamburg, Germany

Common questions

What is nivolumab?

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

What does 'observational study' mean?

It means the study will watch and collect information about your normal treatment. You won't be asked to change anything about your care that your doctor has already planned for you.

Will I get a new medicine if I join this study?

No, you will only receive the nivolumab and chemotherapy treatment that your doctor has already decided is best for you, as per normal medical care.

What is 'HER2 negative' and 'PD-L1 positive'?

These are markers found on cancer cells. HER2 negative means your cancer doesn't have too much of the HER2 protein. PD-L1 positive means your cancer has enough of the PD-L1 marker, which suggests immunotherapy like nivolumab might work.

Can I leave the study if I change my mind?

Yes, you are completely free to leave the study at any time, and this will not affect your medical care in any way.