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

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What is this study about?

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.

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.

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.

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.

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.

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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Netherlands Cancer Institute Amsterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not yet recruiting
25.09.2017

Trial locations

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.

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.

Trial ID:
2024-515825-27-00
Trial Phase:
Therapeutic exploratory (Phase II)

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