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Study Comparing Nivolumab and Cabozantinib with Sunitinib for Patients with Untreated Advanced Kidney Cancer

Fast replyRegistered 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 advanced or metastatic renal cell carcinoma, a type of kidney cancer that has either progressed to an advanced stage or spread to other parts of the body. The study aims to evaluate the safety and effectiveness of a combination treatment using Nivolumab and Cabozantinib compared to another medication called Sunitinib. Nivolumab is a medication that helps the immune system fight cancer, while Cabozantinib and Sunitinib are drugs that target specific proteins in cancer cells to stop their growth.

The purpose of this study is to determine whether the combination of Nivolumab and Cabozantinib is more effective and safe compared to Sunitinib in treating patients who have not received any prior treatment for their advanced or metastatic kidney cancer. Participants in the study will be randomly assigned to receive either the combination treatment or Sunitinib. The study will monitor the participants over a period to assess the progression of the disease and any side effects experienced.

Throughout the study, participants will receive their assigned treatment and undergo regular check-ups to track their health and the cancer's response to the treatment. The study will help researchers understand which treatment option provides better outcomes for patients with this type of kidney cancer. A placebo may be used in some parts of the study to compare the effects of the actual medications. The study is expected to continue until 2025, providing valuable insights into the treatment of advanced or metastatic renal cell carcinoma.

The research process

The trial runs in 6 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 verifying a diagnosis of advanced or metastatic renal cell carcinoma with a clear-cell component.

    The assessment ensures no prior systemic therapy for renal cell carcinoma, except for specific cases of adjuvant or neoadjuvant therapy.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two treatment groups. This process is essential to compare the effectiveness of the treatments without bias.

  3. Step 3

    Treatment administration - nivolumab and cabozantinib

    Participants in the first group receive nivolumab and cabozantinib. Nivolumab is administered as a solution for infusion, which means it is given intravenously.

    Cabozantinib is provided in the form of film-coated tablets for oral use. The specific dosage and frequency are determined by the study protocol.

  4. Step 4

    Treatment administration - sunitinib

    Participants in the second group receive sunitinib. This medication is provided as hard capsules for oral use.

    The dosage and frequency of sunitinib are specified in the study protocol.

  5. Step 5

    Monitoring and follow-up

    Throughout the study, participants undergo regular monitoring to assess the treatment's effectiveness and safety.

    This includes tracking progression-free survival, overall survival, and response rates, as well as recording any adverse events.

  6. Step 6

    Study completion

    The study is estimated to conclude by March 31, 2025. At this point, all data will be analyzed to determine the safety and effectiveness of the treatments.

Who can join the trial?

5 criteria

  • The patient must have a confirmed diagnosis of **Renal Cell Carcinoma (RCC)**, which is a type of kidney cancer. The cancer should have a **clear-cell component**, which is a specific type of cell found in this cancer. It can also have **sarcomatoid features**, which means the cancer cells look like a type of tissue called sarcoma.
  • The cancer must be **advanced**, meaning it cannot be cured with surgery or radiation, or it must be **metastatic**, which means it has spread to other parts of the body.
  • The patient should not have received any previous **systemic therapy** for RCC. Systemic therapy is treatment that affects the whole body, like chemotherapy. There is an exception if the patient had one previous treatment after surgery to remove the cancer, as long as it did not include drugs targeting **VEGF** (a protein that helps cancer grow) or its receptors, and the cancer came back at least 6 months after the last treatment.
  • Both men and women can participate in the study.
  • The study does not include vulnerable populations, which means people who might need special protection or care.

Who cannot join the trial?

9 criteria

  • Patients who have received previous treatment for their kidney cancer.
  • Patients with other serious health conditions that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have allergies to the study medications.
  • Patients with a history of another type of cancer, unless it has been successfully treated and is not expected to come back.
  • Patients with active infections that require treatment.
  • Patients with certain heart conditions that could be affected by the study medications.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who are participating in another clinical trial.
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Investigated drugs

  • Nivolumab

    is a medication used in this trial to help the immune system attack cancer cells. It works by blocking a protein that stops the immune system from working properly, allowing it to better target and destroy cancer cells.

  • Cabozantinib

    is another medication in the trial that helps to slow down or stop the growth of cancer cells. It works by blocking certain proteins that cancer cells need to grow and spread.

  • Sunitinib

    is a medication used as a comparison in this trial. It is designed to block proteins that help cancer cells grow and spread, and it is commonly used to treat kidney cancer.

What is already known about the treatment

  • Nivolumab

    Nivolumab is administered as an intravenous infusion. It is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic renal cell carcinoma. The main therapeutic indication is kidney cancer that is advanced or has spread. Nivolumab works by blocking a protein called PD-1, which helps the immune system attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor.

  • Cabozantinib

    Cabozantinib is taken orally in tablet form. It is being evaluated in clinical trials for its role in treating advanced or metastatic renal cell carcinoma. The primary therapeutic use is for kidney cancer that is advanced or has metastasized. Cabozantinib inhibits multiple tyrosine kinases, which are involved in tumor growth and blood vessel development. It is classified as a tyrosine kinase inhibitor.

  • Sunitinib

    Sunitinib is administered orally in capsule form. It is a well-established treatment for advanced or metastatic renal cell carcinoma and is being compared to other treatments in clinical trials. The main therapeutic indication is for kidney cancer that is advanced or has spread. Sunitinib works by blocking multiple enzymes that promote cancer cell growth and blood vessel formation. It is classified as a tyrosine kinase inhibitor.

Investigated diseases

Advanced or Metastatic Renal Cell Carcinoma – This is a type of kidney cancer that has progressed to an advanced stage or has spread to other parts of the body. It originates in the lining of the small tubes in the kidney and can grow into a large mass. As the disease advances, it may invade nearby tissues and organs, and cancer cells can travel through the bloodstream or lymphatic system to distant sites. Symptoms may include blood in the urine, pain in the side or back, and a lump in the abdomen. The disease can also cause fatigue, weight loss, and fever. The progression of the disease varies, and it can affect individuals differently.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-509711-83-00Protocol codeCA209-9EREstimated enrolment755 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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