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Study on Cabozantinib and Nivolumab for Older Patients with Kidney Cancer

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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 the effects of two medications, Cabozantinib and Nivolumab, in older patients with a type of kidney cancer known as renal cell carcinoma. The purpose of the study is to observe how these medications are used in real-life settings among patients who have advanced or metastatic forms of this cancer. Cabozantinib is taken as a tablet, while Nivolumab is given through an infusion, which means it is administered directly into the bloodstream.

The study will follow patients over a period to see how they respond to the treatment, including any changes in their cancer and their overall health. It will also look at how well patients tolerate the medications, any side effects they experience, and how the treatment affects their quality of life. The study aims to gather information on the starting doses of Cabozantinib, any changes in dosage, and any interruptions in treatment due to side effects.

Participants in the study will be monitored for various outcomes, such as how long they live without the cancer getting worse, their overall survival, and their response to the treatment based on medical imaging. The study will also track any unplanned hospital visits and assess the quality of life reported by the patients themselves. This information will help to better understand the use of Cabozantinib and Nivolumab in treating older patients with this type of kidney cancer.

The research process

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

  1. Step 1

    Initial treatment phase

    The treatment begins with the administration of nivolumab through an intravenous infusion. This is a solution for infusion, and the dosage is 10 mg/mL.

    Following the infusion, cabozantinib is taken orally. The medication is available in two forms: 40 mg and 20 mg film-coated tablets. The specific dosage and frequency will be determined by the healthcare provider based on individual needs.

  2. Step 2

    Treatment monitoring

    Regular monitoring is conducted to assess the treatment's effectiveness and any side effects. This includes evaluating the overall response rate through radiological assessments.

    The healthcare team will also monitor for any dose interruptions or modifications due to side effects, particularly within the first 24 weeks.

  3. Step 3

    Ongoing assessment

    Throughout the trial, assessments will be made regarding overall survival, progression-free survival, and duration of response.

    Patient tolerance to the treatment will be evaluated based on reports from both physicians and patients.

  4. Step 4

    Quality of life evaluation

    Quality of life is assessed using specific questionnaires, such as FACT-G and FACIT-TS-G, to understand the impact of the treatment on daily living.

    Exploratory analyses may be conducted to explore potential associations between treatment parameters and outcomes related to safety, efficacy, and quality of life.

  5. Step 5

    Completion of trial

    The trial is expected to conclude by April 5, 2028. The duration of participation may vary depending on individual response and treatment outcomes.

Who can join the trial?

7 criteria

  • Patients must be **70 years old or older**.
  • Must have a confirmed diagnosis of **advanced or metastatic renal-cell carcinoma**. This means the kidney cancer has spread to other parts of the body.
  • Patients should not have received any treatment for their cancer in the **metastatic setting**. This means they haven't been treated for cancer that has spread.
  • Must have a **Performance Status** between 0 to 2. This is a scale that measures how well a patient can perform ordinary tasks and carry out daily activities.
  • **Sexually active male patients** must agree to use a condom during the study and for at least 5 months after the last treatment. It is also recommended that their female partners who can become pregnant use a highly effective method of birth control.
  • Patients should understand, sign, and date the **informed consent form** before any study-specific procedures are done. This means they agree to participate and understand what the study involves.
  • Patients must be part of a **social security system** or be a beneficiary of one. This means they should have access to healthcare coverage.

Who cannot join the trial?

4 criteria

  • Patients who do not have **renal carcinoma**. This is a type of cancer that starts in the kidneys.
  • Patients who are not diagnosed with **metastatic clear-cell renal cell cancer**. This means the cancer has spread from the kidney to other parts of the body.
  • Patients who are not in the specified age range for the study. The study is focused on older patients.
  • Patients who are part of a vulnerable population. This means groups of people who might need special protection or care.
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Investigated drugs

  • Cabozantinib

    is a medication used to treat certain types of cancer, including renal cell carcinoma. It works by blocking the action of proteins that promote the growth of cancer cells, helping to slow down or stop the spread of the cancer.

  • Nivolumab

    is an immunotherapy drug used to treat various types of cancer, including renal cell carcinoma. It helps the immune system recognize and attack cancer cells more effectively, enhancing the body's natural defenses against the cancer.

What is already known about the treatment

  • Cabozantinib

    This medication is administered orally in the form of a tablet. It is currently used in the treatment of renal carcinoma, particularly in cases of metastatic clear-cell renal cell cancer. Cabozantinib works by inhibiting certain proteins that promote cancer cell growth and blood vessel formation, effectively slowing down the progression of the disease. It is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

  • Nivolumab

    This medication is given as an intravenous infusion. It is used in the treatment of renal carcinoma, specifically for metastatic clear-cell renal cell cancer. Nivolumab functions by blocking a protein called PD-1 on immune cells, which enhances the body's immune response against cancer cells. It is classified as an immune checkpoint inhibitor, a form of immunotherapy that helps the immune system recognize and attack cancer cells.

Investigated diseases

Renal Cell Carcinoma – This 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 there can be more than one tumor in one or both kidneys. As it progresses, it may spread to nearby tissues and organs, including the lungs, bones, or liver. Symptoms may include blood in the urine, a lump in the abdomen, or persistent pain in the side. The exact cause is not always clear, but factors like smoking and high blood pressure can increase risk.
Trial detailsLast updated 2 Oct 2026
Age65+ yearsPhasePhase IIITrial ID2024-516650-22-00Protocol code2024/3873 CABOLDEstimated enrolment50 patientsSponsorInstitut Gustave Roussy

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