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Study of Avelumab and Axitinib for Patients with Unresectable or Metastatic Gastrointestinal Stromal Tumors After Standard Therapy Failure

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a type of cancer known as Gastrointestinal Stromal Tumors (GIST). These tumors occur in the digestive tract and can be challenging to treat, especially when they cannot be removed by surgery or have spread to other parts of the body. The study is testing a combination of two medications, avelumab and axitinib, to see how effective they are in treating patients with GIST who have not responded to standard treatments.

Avelumab is a type of medication known as an antibody, which helps the immune system recognize and attack cancer cells. It is given through an infusion, which means it is delivered directly into the bloodstream through a vein. Axitinib is a medication taken in tablet form that works by blocking certain proteins that help cancer cells grow. Together, these medications aim to slow down or stop the growth of the tumors.

The purpose of the study is to evaluate how well this combination of medications works in keeping the cancer from getting worse. Participants in the study will receive the treatment over a period of time and will be monitored regularly to assess the response of their tumors to the treatment. The study will also look at the overall survival of participants and any side effects they may experience. This research hopes to provide new insights into treating GIST and improve outcomes for patients with this challenging condition.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initiation of treatment
The treatment begins with the administration of avelumab, which is given as an intravenous infusion. This means the medication is delivered directly into the bloodstream through a vein.
The infusion is typically administered in a healthcare setting under the supervision of medical professionals.
Step 2
Oral medication
In addition to the infusion, axitinib is taken orally. This involves swallowing tablets with water.
The dosage includes Inlyta 5 mg and Inlyta 1 mg film-coated tablets. The specific dosage and frequency will be determined by the healthcare provider based on individual needs.
Step 3
Monitoring and assessment
Regular monitoring is conducted to assess the response to the treatment. This includes imaging tests and physical examinations to evaluate the size and progression of the tumor.
The primary goal is to achieve progression-free survival, meaning the disease does not worsen over a specified period.
Step 4
Evaluation of side effects
Potential side effects are monitored throughout the treatment. These are assessed every four weeks using established criteria to ensure patient safety.
Any adverse reactions are documented and managed according to medical guidelines.
Step 5
End of treatment
The treatment continues until the disease progresses or unacceptable side effects occur.
The overall duration of the trial is estimated to conclude by the end of 2025, with individual treatment plans varying based on patient response.

Who can join the trial?

16 criteria

Must sign a written informed consent form, which means you agree to participate in the study after understanding all the details.
Must have proper liver function, which is checked by specific blood tests. These tests measure substances like bilirubin, AST, and ALT in your blood.
Must have a certain level of kidney function, which is checked by a blood test called serum creatinine or a calculation called creatinine clearance.
Must not have serious heart problems, such as a recent stroke, heart attack, or uncontrolled high blood pressure.
Must not have any conditions that would make it hard to follow the study rules, like certain psychological or social issues.
If not taking blood thinners, must have certain blood clotting test results within a specific range. If taking blood thinners, the dose must be stable for at least two weeks before starting the study.
If there is a chance of pregnancy, must use effective birth control methods. This applies to both men and women.
Must provide a sample of the tumor tissue, which is stored in a special way called formalin-fixed paraffin-embedded (FFPE).
Must be 18 years or older.
Must have a confirmed diagnosis of a type of cancer called **Gastrointestinal Stromal Tumors (GIST)**, with specific characteristics detected by tests.
Must know the genetic status of the tumor, specifically related to KIT or PDGFRA genes.
Must have shown disease progression, meaning the cancer has gotten worse, within three months before joining the study.
Must not have had more than three different treatments for GIST, and these treatments must include drugs called imatinib and sunitinib.
Must have a performance status of 2 or less, which means you can do most daily activities, and have an expected life span of at least three months.
Must have measurable disease, meaning the cancer can be measured by scans or physical exams, within 21 days before joining the study.
Must have proper blood cell levels, which are checked by blood tests for white blood cells, neutrophils, lymphocytes, platelets, and hemoglobin.

Who cannot join the trial?

3 criteria

Patients who have not progressed on second or third line treatment for Gastrointestinal Stromal Tumors (GIST). This means the patient must have already tried at least two specific treatments, called imatinib and sunitinib, and these treatments did not work.
Patients who are not adults. The study is only for adults, so children and teenagers cannot participate.
Patients who are part of a vulnerable population. This means people who might need special protection or care, like those who cannot make decisions for themselves.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Azienda Unita Sanitaria Locale Di Bologna
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Bologna, Italy
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy
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Cracow, Poland

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Investigated drugs

Avelumab
is a type of medication known as an immune checkpoint inhibitor. It works by helping the body's immune system recognize and attack cancer cells more effectively. In this trial, avelumab is being used to treat patients with gastrointestinal stromal tumors that cannot be surgically removed or have spread to other parts of the body.
Axitinib
is a medication that targets specific proteins involved in the growth of cancer cells. It helps to slow down or stop the growth of tumors by blocking the blood supply that tumors need to grow. In this trial, axitinib is used in combination with avelumab to treat patients with advanced gastrointestinal stromal tumors.

What is already known about the treatment

Avelumab
Avelumab is administered as an intravenous infusion, typically given in a clinical setting. It is currently being studied in combination with axitinib for its effectiveness in treating unresectable or metastatic gastrointestinal stromal tumors (GIST) after standard therapies have failed. Avelumab works by targeting and inhibiting a protein called PD-L1, which helps cancer cells evade the immune system. It is classified as an immune checkpoint inhibitor, a type of immunotherapy that enhances the body's natural defenses to fight cancer.
Axitinib
Axitinib is taken orally in tablet form, usually under medical supervision. It is being investigated in combination with avelumab for patients with advanced gastrointestinal stromal tumors (GIST) who have not responded to previous treatments. Axitinib functions by blocking certain proteins that promote the growth of blood vessels in tumors, effectively starving the cancer cells. It belongs to a class of drugs known as tyrosine kinase inhibitors, which interfere with specific enzymes involved in cancer cell proliferation.

Investigated diseases

Gastrointestinal Stromal Tumors (GIST) – These are rare tumors that occur in the digestive tract, most commonly in the stomach or small intestine. They originate from special cells in the gastrointestinal tract wall known as interstitial cells of Cajal. GISTs can vary in size and may grow slowly or more rapidly, depending on their specific characteristics. As they progress, they may cause symptoms such as abdominal pain, bleeding, or a feeling of fullness. In some cases, they can spread to other parts of the body, such as the liver or the lining of the abdomen. The progression of GISTs can be influenced by genetic mutations, which may affect their growth and response to treatment.