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Study of Axitinib and Avelumab for Patients with Localized Renal Cell Carcinoma at Moderate to High Risk of Recurrence

Registered drugNo placebo

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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 kidney cancer known as renal cell carcinoma (RCC). The study is investigating the effects of two medications, axitinib and avelumab, on patients with localized RCC who have a moderate to high risk of the cancer returning. Axitinib is taken as a tablet, while avelumab is given through an intravenous infusion, which means it is administered directly into a vein.

The purpose of the study is to explore how effective these medications are when used together before surgery to remove the cancer. This approach is known as "neoadjuvant" therapy, which means treatment given as a first step to shrink a tumor before the main treatment, which is usually surgery. The study will also look at the safety of using these two medications together and monitor any side effects that may occur.

Participants in the study will receive the medications for a period of up to three months. During this time, doctors will closely monitor the patients to see how the cancer responds to the treatment and to ensure the safety of the participants. After the treatment period, patients will continue to be followed for a longer time to check on their health and to see if the cancer returns or spreads. The study aims to provide valuable information on the potential benefits of using axitinib and avelumab together in treating renal cell carcinoma.

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
Initial treatment phase
The treatment begins with the administration of two medications: avelumab and axitinib.
Avelumab is given as an intravenous infusion. This means it is delivered directly into the bloodstream through a vein.
Axitinib is taken orally in the form of film-coated tablets.
Step 2
Avelumab administration
Avelumab is administered as a solution for infusion. The dosage is 20 mg/mL.
The frequency and duration of avelumab administration will be determined by the healthcare provider based on the specific needs of the patient.
Step 3
Axitinib administration
Axitinib is taken in the form of 5 mg film-coated tablets.
The dosage and frequency of axitinib will be prescribed by the healthcare provider, tailored to the patient's condition and response to treatment.
Step 4
Monitoring and follow-up
Throughout the trial, the patient's response to the treatment will be closely monitored.
Regular follow-up appointments will be scheduled to assess the effectiveness of the treatment and to check for any side effects or adverse events.
The primary goal is to evaluate the rate of partial remission after the treatment with avelumab and axitinib.
Step 5
Long-term follow-up
After the initial treatment phase, long-term follow-up will be conducted to monitor disease-free survival (DFS), overall survival (OS), and the rate of metastasis and local recurrence.
The safety and any adverse events related to the combination of avelumab and axitinib will be evaluated.
Additional research may be conducted to understand the broader implications of the treatment.

Who can join the trial?

10 criteria

Male or female patients who are **18 years or older**.
Use of **highly effective birth control** for both men and women if there is a chance of pregnancy.
Must provide **signed and written consent** to participate.
Must have a **confirmed diagnosis** of a type of kidney cancer called **non-metastatic clear-cell renal cell carcinoma** that is of **intermediate to high risk** and can be completely removed by surgery. This is determined by specific medical criteria.
Must have a **World Health Organization (WHO) performance status** of **0-1**, which means the patient is fully active or has some symptoms but can still carry out light work.
Must have **adequate blood clotting function**.
Must have **adequate blood health**, which means having enough white blood cells, platelets, and hemoglobin (a protein in red blood cells).
Must have **adequate liver function**, which means certain liver enzymes and bilirubin levels are within a normal range.
Must have **adequate kidney function**, which means the kidneys can filter waste from the blood at a certain rate.
Women who can become pregnant must have a **negative pregnancy test** before starting the study.

Who cannot join the trial?

8 criteria

Patients who have a different type of cancer other than renal cell carcinoma cannot participate. Renal cell carcinoma is a type of kidney cancer.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are part of a vulnerable population, such as those who may not be able to give informed consent, cannot participate.
Patients who have medical conditions or are taking medications that might interfere with the study treatment cannot participate.
Patients who have had previous treatments that could affect the study results cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have a history of allergic reactions to the study drugs cannot participate.
Patients who have any other serious health conditions that could affect their safety during the study cannot participate.

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Investigated drugs

Axitinib
is a medication used in this trial to help treat patients with localized renal cell carcinoma, which is a type of kidney cancer. It works by blocking certain proteins that help cancer cells grow, which may help slow down or stop the cancer from spreading.
Avelumab
is another medication used in the trial. It is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. By enhancing the immune response, it aims to reduce the risk of cancer returning after treatment.

What is already known about the treatment

Axitinib
Axitinib is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating renal cell carcinoma, particularly in patients with a moderate to high risk of recurrence. The medication works by inhibiting certain proteins that promote the growth of blood vessels in tumors, thereby slowing or stopping tumor growth. Axitinib is classified as a tyrosine kinase inhibitor, which is a type of targeted cancer therapy.
Avelumab
Avelumab is administered through intravenous infusion. It is being evaluated in clinical trials for its potential to treat renal cell carcinoma, especially in cases with a moderate to high risk of recurrence. Avelumab functions by blocking a protein that prevents the immune system from attacking cancer cells, thereby enhancing the body's immune response against the tumor. It is classified as a monoclonal antibody, which is a form of immunotherapy.

Investigated diseases

Renal Cell Carcinoma – Renal cell carcinoma is a type of kidney cancer that begins in the lining of the small tubes in the kidney. It is the most common type of kidney cancer in adults. The disease often grows as a single mass within the kidney, but it can sometimes be found in more than one part of the kidney or in both kidneys. As it progresses, it may spread to nearby lymph nodes and other organs, such as the lungs or bones. Symptoms may include blood in the urine, a lump in the abdomen, or back pain. The progression of the disease can vary, with some tumors growing slowly and others more rapidly.