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Study Comparing Nivolumab and Ipilimumab with Sunitinib for Patients with Advanced or Metastatic 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 a type of kidney cancer known as advanced or metastatic renal cell carcinoma. The study is comparing two different treatment approaches for this condition. One group of participants will receive a combination of two medications, Nivolumab and Ipilimumab, while the other group will receive a single medication called Sunitinib. Nivolumab and Ipilimumab are given as an infusion, which means they are administered directly into the bloodstream through a vein. Sunitinib is taken orally in the form of capsules.

The purpose of the study is to compare how well these treatments work in terms of how long patients live and how long they live without the cancer getting worse. Participants in the study will be randomly assigned to one of the two treatment groups. The study will follow participants over a period of time to monitor their health and the effects of the treatments. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the actual treatments.

Throughout the study, participants will have regular check-ups and tests to assess their health and the progress of their cancer. The study aims to provide valuable information on the effectiveness and safety of these treatments for people with advanced or metastatic renal cell carcinoma. This research could help improve future treatment options for 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

    Joining the study

    Upon joining the study, you will be randomly assigned to one of two groups. One group will receive a combination of nivolumab and ipilimumab, while the other group will receive sunitinib alone.

    The purpose of this study is to compare the effectiveness of these treatments in patients with advanced or metastatic renal cell carcinoma, a type of kidney cancer.

  2. Step 2

    Treatment with nivolumab and ipilimumab

    If assigned to the combination treatment group, you will receive nivolumab and ipilimumab through an intravenous infusion. This means the medication will be given directly into your vein.

    The dosage and frequency of administration will be determined by the study team and will be explained to you in detail.

  3. Step 3

    Treatment with sunitinib

    If assigned to the sunitinib group, you will take sunitinib in the form of hard capsules. These capsules are taken orally, which means you will swallow them with water.

    The dosage is typically 12.5 mg, but the exact dosage and schedule will be provided by the study team.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, your health will be closely monitored. This includes regular check-ups, blood tests, and imaging tests to assess how the treatment is affecting your cancer.

    You will be asked to report any side effects or changes in your health to the study team immediately.

  5. Step 5

    Completion of the study

    The study is expected to continue until August 2028. However, your participation may end earlier if you experience significant side effects or if the study team determines it is in your best interest to stop.

    Upon completion, you will have a final evaluation to assess your overall health and the impact of the treatment.

Who can join the trial?

7 criteria

  • You must have a confirmed diagnosis of renal cell carcinoma (RCC) with a clear-cell component. RCC is a type of kidney cancer.
  • Your cancer must be advanced (cannot be cured with surgery or radiation) or metastatic (has spread to other parts of the body).
  • You must not have had any previous treatments for RCC, except if you had one prior treatment after surgery that did not include drugs targeting VEGF (a protein that helps cancer grow) or its receptors, and if your cancer returned at least 6 months after the last dose of that treatment.
  • You need to have a Karnofsky Performance Status (KPS) of at least 70%. This is a score that measures your ability to perform everyday activities, with 100% being fully active and 0% being unable to care for yourself.
  • Your disease must be measurable according to specific criteria used by doctors to assess cancer size and spread.
  • A sample of your tumor tissue must be provided for the study. This sample can be from a previous surgery or a recent one, but it cannot be from a fine needle aspiration or bone sample.
  • You must be an adult, as the study includes both male and female participants.

Who cannot join the trial?

10 criteria

  • Patients with other types of cancer cannot participate.
  • Patients who have received treatment for renal cell carcinoma before cannot participate.
  • Patients with severe heart problems cannot participate.
  • Patients with uncontrolled high blood pressure cannot participate.
  • Patients with active infections cannot participate.
  • Patients with autoimmune diseases cannot participate. Autoimmune diseases are conditions where the body's immune system attacks its own tissues.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients with a history of severe allergic reactions cannot participate.
  • Patients who are taking certain medications that might interfere with the study cannot participate.
  • Patients with a history of drug or alcohol abuse cannot participate.
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Investigated drugs

  • Nivolumab

    is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, it is used in combination with another medication to see if it can improve outcomes for patients with advanced kidney cancer.

  • Ipilimumab

    is another immunotherapy drug that is used alongside nivolumab in this study. It helps to boost the immune system's response against cancer cells. The combination of ipilimumab and nivolumab is being tested to determine if it can provide better results than using a single medication alone for treating advanced kidney cancer.

  • Sunitinib

    is a medication that is used on its own in this trial. It works by blocking certain proteins that cancer cells need to grow and spread. This medication is being compared to the combination of nivolumab and ipilimumab to see which treatment is more effective for patients with advanced kidney cancer.

What is already known about the treatment

  • Nivolumab

    Nivolumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic renal cell carcinoma, a type of kidney cancer. Nivolumab works by helping the immune system recognize and attack cancer cells, specifically by blocking a protein that prevents immune cells from killing cancer cells. It is classified as an immune checkpoint inhibitor, a type of drug that enhances the body's immune response against cancer.

  • Ipilimumab

    Ipilimumab is also given as an intravenous infusion, allowing it to enter the bloodstream directly. It is being tested in combination with nivolumab for treating advanced or metastatic renal cell carcinoma. Ipilimumab boosts the immune system's ability to fight cancer by blocking a protein that normally keeps immune cells in check, thus allowing them to attack cancer cells more effectively. Like nivolumab, it is classified as an immune checkpoint inhibitor, which helps the immune system target and destroy cancer cells.

  • Sunitinib

    Sunitinib is taken orally in the form of a capsule, which means it is swallowed and absorbed through the digestive system. It is currently used as a standard treatment for advanced or metastatic renal cell carcinoma. Sunitinib works by blocking certain proteins that promote the growth of cancer cells and blood vessels that supply tumors, effectively starving the cancer of nutrients and slowing its growth. It is classified as a tyrosine kinase inhibitor, a type of drug that interferes with specific enzymes involved in cancer cell growth.

Investigated diseases

Advanced or metastatic renal cell carcinoma – This is a type of kidney cancer that has spread beyond the kidney to other parts of the body. It originates in the lining of the small tubes in the kidney. As the disease progresses, cancer cells can invade nearby tissues and organs. The cancer may spread to lymph nodes, bones, lungs, or other organs. Symptoms can include blood in the urine, pain in the side or back, and a lump in the abdomen. Over time, the disease can lead to more severe symptoms as it affects additional body systems.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-504761-23-00Protocol codeCA209-214Estimated enrolment1 355 patientsSponsorBristol Myers Squibb International Corporation

sourced from the EU Clinical Trials Register and site verification

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