Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A Phase II, single arm Study of avelumab in combination with Axitinib in Patients with unresectable/metastatic Gastrointestinal Stromal Tumor after failure of standard therapy - AXAGIST

This study is investigating a new way to treat a type of cancer called Gastrointestinal Stromal Tumor (GIST) which has spread or cannot be removed by surgery. It focuses on patients whose previous treatments haven't been successful. The study combines two existing medications: avelumab (Bavencio) and axitinib (Inlyta). Researchers want to see if this combination helps stop the cancer from growing for at least three months. They will also look at how long people live, how much the tumors shrink, and any side effects the treatment might cause. It's an important step to find better treatments for GIST.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy

Enrolment target

Start

11 Jan 2025

Gastrointestinal Stromal Tumors (GIST)

What is this study about?

This study is called AXAGIST, and it's looking into a new treatment approach for a type of cancer known as Gastrointestinal Stromal Tumor (GIST). GIST is a relatively rare form of cancer that typically starts in the digestive tract. This specific trial is for patients whose GIST has either spread to other parts of the body (metastatic) or cannot be removed through surgery (unresectable), and importantly, for whom standard treatments have not worked or have stopped working.

The main goal of this study is to see if combining two existing medicines, avelumab (which you might know as Bavencio) and axitinib (also known as Inlyta), can help control the cancer. The researchers want to find out how many patients receiving this combination treatment will have their cancer stop growing for at least three months. This is an important step to understand if this new combination could be a useful way to fight GIST after other treatments have been tried.

Beyond just looking at how the cancer responds in the short term, the study will also track other important things. This includes how long patients live after starting the treatment, if their tumors shrink, how long any positive effects last, and whether the cancer is generally kept under control. Safety is also a top priority, so researchers will carefully monitor any side effects. They hope to learn more about how these drugs work together and if certain factors in a patient's blood or tissue can predict who might benefit most from this treatment.

Key takeaways

This study is for people with advanced GIST whose current treatments aren't working.
It tests a combination of two existing drugs: avelumab and axitinib.
The main goal is to see if the treatment stops cancer growth for at least three months.
Both new treatments and close monitoring of your health are part of participation.
You can withdraw from the study at any time without affecting your normal care.

Who may be eligible?

To join this study, people generally need to be at least 18 years old. There's no upper age limit, meaning older adults are welcome to participate if they meet all other requirements.

Both men and women can take part in this research. The most important thing is that participants have been diagnosed with Gastrointestinal Stromal Tumor (GIST) that has either spread or can't be surgically removed, and their usual treatments haven't been effective anymore.

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?
Have you been diagnosed with Gastrointestinal Stromal Tumor (GIST)?
Has your GIST spread to other parts of your body or can it not be removed by surgery?
Have your previous GIST treatments not worked as well as hoped?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive two different medications: avelumab given as an infusion into a vein, and axitinib taken as tablets. You would have regular visits to the hospital or clinic for treatments, check-ups, and tests. These tests might include blood samples, scans to check your cancer, and physical examinations. The doctors and nurses would carefully monitor how you are responding to the treatment and any side effects you might experience. They would follow you closely throughout the treatment period and for a time afterward to see the long-term effects. The total duration of participation would depend on how your body responds to the treatment.

Potential risks and benefits

Taking part in any clinical trial involves both potential benefits and potential risks. The potential benefit of this study is that you might receive a new combination treatment for your GIST that could help control your cancer when standard treatments haven't worked. However, there's no guarantee that the treatment will work for you. Like all medications, avelumab and axitinib can cause side effects, and the study team will carefully monitor you for these. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Italy
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Unverified
Poland

Common questions

What kind of cancer is GIST?

GIST stands for Gastrointestinal Stromal Tumor. It's a rare type of cancer that usually starts in the digestive system, like the stomach or intestines.

Why is this study important?

This study is important because it's looking for new ways to treat GIST when initial treatments haven't worked or the cancer has spread. It tries a new combination of two existing drugs.

What drugs are being tested?

The study is testing a combination of avelumab (also called Bavencio) and axitinib (also called Inlyta).

Will I know if the treatment is working?

Yes, the study doctors will regularly check your cancer with scans and tests. They will discuss your progress with you during your appointments.

Can I stop the study if I want to?

Yes, you can choose to leave the study at any time, for any reason. Your decision will not affect your future medical care.