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Study of Cabozantinib for Patients with Advanced Renal Cell Carcinoma Previously Treated with One Immunotherapy Drug

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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, specifically in patients whose cancer has spread and who have already been treated with a type of medicine called an immunocheckpoint inhibitor. These inhibitors are drugs that help the immune system recognize and attack cancer cells. The treatment being tested in this study is a medication called Cabozantinib, which is taken by mouth. Cabozantinib is designed to slow down or stop the growth of cancer cells.

The purpose of the study is to see how well Cabozantinib works in patients who have already received one immunocheckpoint inhibitor. Participants in the study will take Cabozantinib and will be monitored to see how their cancer responds to the treatment. The study will also look at how long patients live without their cancer getting worse, which is known as progression-free survival. Additionally, the study will gather information on the overall survival of patients, the response rates to the treatment, and the safety of the drug.

Throughout the study, patients will have regular check-ups and tests to monitor their health and the effects of the treatment. The study aims to provide valuable information on the effectiveness and safety of Cabozantinib for treating advanced kidney cancer in patients who have already tried other treatments. This research could help improve future treatment options for people with this type of 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

    Enrollment

    Upon joining the study, the patient must provide a signed written informed consent.

    Eligibility is confirmed based on specific health criteria, including blood counts, liver function, and kidney function.

    The patient must have previously received one treatment with a PD1/PDL1 inhibitor.

  2. Step 2

    Treatment initiation

    The patient begins treatment with cabozantinib, administered orally.

    The dosage and frequency of administration are determined by the study protocol and the patient's specific health needs.

  3. Step 3

    Treatment duration

    The treatment continues until the study's estimated end date of June 30, 2025, or until the patient experiences disease progression or unacceptable side effects.

    Regular monitoring of the patient's health and response to treatment is conducted throughout the study.

  4. Step 4

    Monitoring and assessments

    The patient's progression-free survival (PFS) is assessed as the primary endpoint.

    Secondary endpoints include overall survival (OS), objective response rates (ORR), and the safety profile of the drug.

    Regular assessments are conducted to monitor the patient's response to treatment and any side effects.

  5. Step 5

    Completion

    Upon completion of the study or withdrawal, the patient may receive follow-up care as needed.

    The study aims to provide valuable data on the effectiveness and safety of cabozantinib in treating advanced renal cell carcinoma.

Who can join the trial?

17 criteria

  • You must sign a written informed consent form, which means you agree to participate after understanding the study details.
  • Your blood test results need to meet certain levels:
    • Absolute neutrophil count (a type of white blood cell) should be more than 1.5 x 109 per liter.
    • Platelet count (cells that help with blood clotting) should be more than 100 x 109 per liter.
    • Hemoglobin (a protein in red blood cells) should be more than 9 grams per deciliter.
    • Total bilirubin (a substance made by the liver) should be less than 1.5 times the normal upper limit.
    • AST and ALT (liver enzymes) should be less than 2.5 times the normal upper limit if you don't have liver metastases, and less than 5 times if you do.
    • Serum creatinine (a waste product in the blood) should be less than 2.0 milligrams per deciliter.
    • Amylase and lipase (enzymes related to digestion) should be less than 1.5 times the normal upper limit.
    • If you are a woman who can have children, you must not be pregnant at the start of the study.
    • You must have had one previous cancer treatment with a PD1/PDL1 inhibitor, either alone or with another type of treatment.
    • You must be 18 years or older.
    • You must have a diagnosis of clear cell renal cell carcinoma, which is a type of kidney cancer.
    • You must have a measurable disease, meaning the cancer can be measured and has shown growth in scans.
    • If you are a woman who can have children or a man who can father children, you must use effective birth control during the study and for 4 months after the last treatment.
    • All areas of cancer, including those in the brain that are not causing symptoms, must be included.
    • Your Karnofsky performance status, which measures your ability to perform daily activities, must be 70% or higher.
    • You must have a life expectancy of more than 3 months.

Who cannot join the trial?

5 criteria

  • Patients who have not been treated with an immunocheckpoint inhibitor. These are medicines that help the immune system fight cancer.
  • Patients who have not been diagnosed with metastatic clear cell renal cell carcinoma. This is a type of kidney cancer that has spread to other parts of the body.
  • Patients who are not within the specified age range for the study.
  • Patients who are not part of the specified clinical trial group.
  • Patients who are not considered part of the vulnerable population selected for the study.
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Investigated drugs

  • Cabozantinib

    is a medication used in this trial to treat patients with advanced or unresectable renal cell carcinoma. It works by inhibiting certain proteins that promote cancer cell growth and spread. This medication is being studied to see how well it can stop the progression of cancer in patients who have already been treated with an immunocheckpoint inhibitor.

  • Immunocheckpoint Inhibitor (anti PD1/PDL1)

    refers to a type of therapy that helps the immune system recognize and attack cancer cells. These inhibitors block proteins that prevent the immune system from attacking cancer, allowing it to better target and destroy cancer cells. In this trial, patients have already been treated with one of these inhibitors before receiving cabozantinib.

What is already known about the treatment

Cabozantinib – This medication is administered orally in the form of tablets. It is currently being studied in clinical trials for its effectiveness in treating patients with advanced or unresectable renal cell carcinoma, specifically those who have been pretreated with immunocheckpoint inhibitors. Cabozantinib is primarily used for its ability to inhibit tumor growth and spread by targeting specific proteins involved in cancer cell proliferation and blood vessel formation. It belongs to the pharmacological class of tyrosine kinase inhibitors, which work by blocking the action of enzymes that promote cancer cell growth.

Investigated diseases

Metastatic Clear Cell Renal Cell Carcinoma – This is a type of kidney cancer that begins in the cells lining the small tubes within the kidney. It is characterized by the spread of cancer cells from the kidney to other parts of the body, which is referred to as metastasis. The disease often progresses as cancer cells grow and form tumors in other organs, such as the lungs, bones, or liver. Patients may experience symptoms like blood in the urine, pain in the side or back, and unexplained weight loss. The progression of the disease can vary, with some patients experiencing rapid growth of tumors, while others may have a slower progression.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514058-59-00Protocol codeBREAKPOINTEstimated enrolment49 patientsSponsorFondazione IRCCS Istituto Nazionale Dei Tumori

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).