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Study on Cabozantinib and Drug Combination for Untreated Metastatic Renal Cell Carcinoma in Intermediate and Poor Risk Patients

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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 treatments for metastatic renal cell carcinoma, a type of kidney cancer that has spread to other parts of the body. The study will explore different treatment combinations to find the most effective approach for patients who have not received prior treatment for this condition. The treatments being tested include combinations of medications known as immune checkpoint inhibitors and VEGFR tyrosine kinase inhibitors. Specifically, the trial will compare the combination of nivolumab and ipilimumab (known as NIVO-IPI) with other combinations involving drugs like cabozantinib, axitinib, lenvatinib, pembrolizumab, and ipilimumab. Some of these medications are given as tablets, while others are administered through an infusion into a vein.

The purpose of the study is to determine which treatment combination is more effective in improving survival rates and delaying the progression of the disease. The study will also look at how these treatments affect patients' quality of life and any side effects they may experience. Participants will be randomly assigned to receive one of the treatment combinations, and some may receive a placebo. The trial will monitor patients over a period to assess the outcomes of the treatments.

Throughout the study, patients will have regular check-ups and assessments to track their health and the effectiveness of the treatment. The trial aims to provide valuable information that could help improve treatment strategies for people with metastatic renal cell carcinoma in the future.

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 assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    Blood tests and imaging studies may be performed to assess the current state of the metastatic renal cell carcinoma.

  2. Step 2

    Treatment assignment

    Participants are randomly assigned to one of the treatment groups. The study aims to compare different combinations of medications to optimize treatment.

  3. Step 3

    Medication administration

    Participants receive medications based on their assigned group. The medications include cabozantinib, nivolumab, axitinib, pembrolizumab, ipilimumab, and lenvatinib.

    Cabozantinib is administered orally as 40 mg film-coated tablets.

    Nivolumab is given as a solution for infusion, with a concentration of 10 mg/mL.

    Axitinib is taken orally as 5 mg film-coated tablets.

    Pembrolizumab is administered intravenously as a 25 mg/mL solution for infusion.

    Ipilimumab is given as a 5 mg/mL solution for infusion.

    Lenvatinib is taken orally as 10 mg hard capsules.

  4. Step 4

    Monitoring and follow-up

    Regular follow-up visits are scheduled to monitor the response to treatment and any side effects.

    Blood tests, imaging studies, and other assessments are conducted periodically to evaluate the progression of the disease and the effectiveness of the treatment.

  5. Step 5

    End of treatment evaluation

    At the end of the treatment period, a comprehensive evaluation is performed to assess the overall response to the therapy.

    The evaluation includes a review of the progression-free survival and overall survival rates, as well as any changes in quality of life.

Who can join the trial?

15 criteria

  • The patient must have a confirmed diagnosis of **metastatic renal cell carcinoma**. This means the cancer has spread from the kidney to other parts of the body.
  • Men who can father children must agree to use a **male condom** with spermicide. It is also recommended that their female partners use a highly effective method of birth control.
  • Women who can have children must not be pregnant at the start of the study.
  • The patient must be classified as **intermediate- or poor-risk** according to the **IMDC classification**. This is a way to assess the severity of the cancer.
  • The patient must be an adult, which means they are **18 years or older**.
  • The patient must have a **Karnofsky Performance Status** of 70% or higher. This is a scale that measures the patient's ability to perform daily activities.
  • The patient must have **adequate organ and marrow function**. This includes:
    • **Absolute neutrophil count** of at least 1000/μL. Neutrophils are a type of white blood cell important for fighting infections.
    • **Platelets** of at least 100,000/μL. Platelets help with blood clotting.
    • **Hemoglobin** of at least 8 g/dL. Hemoglobin is a protein in red blood cells that carries oxygen.
    • **Alanine aminotransferase (ALT)** and **aspartate aminotransferase (AST)** levels no more than 5 times the upper limit of normal. These are liver enzymes.
    • **Creatinine clearance** of at least 30 mL/min. This measures how well the kidneys are working.
    • The patient must understand and sign a **written informed consent form** before any study-specific procedures are done.
    • The patient must be able and willing to attend study visits and follow the procedures outlined in the study.
    • The patient must be part of a **social security system** or have similar benefits.
    • Female patients must either be unable to have children or have a negative **serum pregnancy test** within 14 days before starting the study drug. Women who can have children must agree to use at least one highly effective birth control method during the study and for up to 6 months after the last dose of the study treatment.

Who cannot join the trial?

5 criteria

  • Patients who have already received treatment for their metastatic renal cell carcinoma (mRCC) cannot participate. This means if you have been treated for this type of kidney cancer that has spread to other parts of the body, you are not eligible.
  • Patients who do not fall within the specified age range for the study are excluded. The study has specific age requirements that must be met.
  • Patients who are not classified as intermediate or poor risk according to the IMDC criteria are not eligible. The IMDC is a system used to assess the risk level of patients with mRCC.
  • Patients who are not able to provide informed consent or who are considered part of a vulnerable population may be excluded. This means if you cannot understand the study or are in a situation that makes you vulnerable, you might not be able to join.
  • Patients with certain medical conditions or health issues that could interfere with the study's results may be excluded. This includes any health problems that might affect how the study treatments work.
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Investigated drugs

  • Nivolumab

    is a type of medication known as an immune checkpoint inhibitor. It works by helping the immune system recognize and attack cancer cells more effectively. In this trial, it is used in combination with another immune checkpoint inhibitor to treat patients with metastatic renal cell carcinoma.

  • Ipilimumab

    is another immune checkpoint inhibitor that is used alongside nivolumab. It enhances the immune system's ability to fight cancer by targeting specific proteins that can suppress immune responses. This combination aims to improve treatment outcomes for patients with certain types of kidney cancer.

  • VEGFR TKI

    refers to a class of medications known as vascular endothelial growth factor receptor tyrosine kinase inhibitors. These medications work by blocking signals that promote the growth of blood vessels in tumors, which can help slow down or stop the growth of cancer. In this trial, a VEGFR TKI is combined with an immune checkpoint inhibitor to evaluate its effectiveness in treating metastatic renal cell carcinoma.

What is already known about the treatment

  • Nivolumab

    Nivolumab is administered as an intravenous infusion. It is currently used in medicine for treating various cancers, including metastatic renal cell carcinoma (mRCC). The main therapeutic indication for nivolumab in this trial is to improve survival rates in patients with mRCC. At the molecular level, nivolumab works by blocking the PD-1 protein on immune cells, enhancing the body's immune response against cancer cells. It is classified as an immune checkpoint inhibitor.

  • Ipilimumab

    Ipilimumab is also given through intravenous infusion. It is well-established in medical literature for its role in cancer treatment, particularly in combination therapies for mRCC. The primary therapeutic use of ipilimumab in this context is to boost the immune system's ability to fight cancer. It functions by targeting the CTLA-4 protein on T-cells, thereby promoting a stronger immune attack on cancer cells. Ipilimumab is categorized as an immune checkpoint inhibitor.

Investigated diseases

Metastatic Renal Cell Carcinoma – This is a type of kidney cancer that has spread beyond the kidney to other parts of the body. It often begins in the lining of the small tubes in the kidney and can spread to areas such as the lungs, bones, or liver. The disease progresses as cancer cells travel through the bloodstream or lymphatic system, forming new tumors in other organs. Symptoms may include blood in the urine, pain in the side or back, and unexplained weight loss. As the cancer advances, it can lead to more severe symptoms depending on the organs affected. The progression of the disease can vary greatly among individuals, influenced by factors such as the cancer's genetic characteristics and the patient's overall health.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-503317-29-00Protocol code2023/3764Estimated enrolment1 523 patientsSponsorInstitut Gustave Roussy

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