Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

INTEGRATE IIb A Randomised Phase III Open Label Study of regorafenib + nivolumab vs standard chemotherapy in Refractory Advanced Gastro-Oesophageal Cancer (AGOC)

This research study, called INTEGRATE IIb, is looking at how well a new combination of two medicines works for people with advanced cancer in their stomach or gullet (oesophagus). This type of cancer has already been treated with other therapies but hasn't responded as hoped. We are comparing the combination of regorafenib and nivolumab (brand names OPDIVO and BAY 734506) against the usual chemotherapy treatments. The main goal is to see if people taking the new combination live longer. We will also check how long people live without their cancer growing, how many see their tumours shrink, their quality of life, and any side effects. The study is open to adults aged 18 and over, both men and women.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Institut fuer Klinische Krebsforschung IKF GmbH

Enrolment target

125

Start

04 Sep 2023

refractory advanced gastro-oesophageal cancer

What is this study about?

This study, known as INTEGRATE IIb, is designed to help us understand the best treatment options for advanced cancer that affects the stomach or gullet (oesophagus). This particular study focuses on people whose cancer has already been treated with other medicines but has unfortunately started growing again or hasn't responded well. We are comparing two different approaches: one group of patients will receive a combination of two specific study medicines, regorafenib and nivolumab, while another group will receive standard chemotherapy treatments that are already commonly used.

The main aim of this study is to see if the combination of regorafenib and nivolumab helps people live longer compared to standard chemotherapy. We will carefully track how long people live from when they start the study. We will also look at other important details, such as how long people live without their cancer getting worse, whether their tumours get smaller, how their general well-being and quality of life are affected, and any side effects they might experience. By gathering all this information, we hope to find better ways to treat this type of cancer in the future.

Understanding the effectiveness of new treatments for advanced cancers is really important, especially when previous treatments haven't worked as well as hoped. This study is a 'Phase III' trial, which means it’s a big, final step in testing new medicines to see if they are safe and effective enough to become standard treatments. Your participation could help improve care for many people in the future.

Key takeaways

This study evaluates new treatment for advanced stomach or gullet cancer.
It tests a combination of regorafenib and nivolumab against standard chemotherapy.
The primary aim is to see if the new combination helps people live longer.
Participation involves regular hospital visits, tests, and taking study medicines.
You can withdraw from the study at any time.
Your involvement could help improve future cancer care.

Who may be eligible?

To be part of this study, you need to be an adult, aged 18 or older. Both men and women are welcome to take part. The study is specifically for people who have advanced cancer related to their stomach or gullet (oesophagus).

Importantly, your cancer must be considered 'refractory', which means it hasn't responded well to previous treatments, or it has returned despite past therapies. The study team will review your medical history to make sure that the type of cancer you have and your previous treatments fit the study requirements.

There will be other detailed medical checks to make sure the study is a safe and suitable option for you. These checks will make sure that the study treatments won't cause unnecessary risks to your health and that you'll be able to follow the study plan. Your doctor will discuss all these criteria with 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 18 years old or older?
Do you have advanced stomach or gullet (oesophageal) cancer?
Has your cancer been treated before, but not responded well?
Are you able to attend regular hospital visits for treatment and check-ups?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be randomly assigned to one of two groups: one receiving the combination of regorafenib and nivolumab, and the other receiving standard chemotherapy. This is like flipping a coin to decide which group you are in. You won't know which group you are in, but your medical team will.

Taking part will involve regular visits to the hospital or clinic. During these visits, you will have various assessments, including blood tests, scans to check your cancer, and questionnaires about your quality of life and how you are feeling. The study medicines will be given as an infusion (drip) for nivolumab, and tablets for regorafenib, or as chemotherapy infusions, depending on your assigned group.

These visits will continue as long as the treatment is working and you are tolerating it well. After you stop taking the study medicine, you will continue to have follow-up appointments for a period of time to monitor your health and how your cancer is progressing. The total duration for which you will be involved in the study – from the start of treatment to the end of follow-up – will be explained fully by the study team.

Potential risks and benefits

Taking part in a clinical trial has potential benefits and risks. You might benefit from receiving a new treatment that could be more effective than standard options, or your participation could directly help others by improving medical knowledge. However, there's no guarantee the new treatment will work for you, and you may experience side effects from the study medicines, which will be carefully monitored. Discussing all potential side effects with your doctor is important. You are free to withdraw from the study at any time, for any reason, without affecting your current or future medical care.

Locations (4)

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

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Unverified
Austria
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Unverified
Germany
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Unverified
Italy
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Unverified
Spain

Common questions

What kind of cancer is this study for?

This study is for advanced stomach or gullet (oesophageal) cancer that hasn't responded well to previous treatments.

What are the two medicines being tested?

The study is testing a combination of two medicines called regorafenib and nivolumab.

Will I definitely get the new medicines?

You will be randomly assigned to either receive the new combination of medicines or standard chemotherapy, so you might not receive the new combination.

What is the main goal of the study?

The main goal is to see if the new combination of medicines helps people live longer compared to standard chemotherapy.

Can I leave the study if I change my mind?

Yes, you can choose to leave the study at any time, and it won't affect your medical care.