Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study on Cabozantinib, Nivolumab, and Ipilimumab for Patients with Advanced or Metastatic Kidney Cancer Who Have Not Received Prior Treatment

Fast replyRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

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 Metastatic Renal Cell Carcinoma (RCC), which is an advanced form of cancer that has spread beyond the kidney. The study is investigating the effectiveness and safety of a combination of medications in patients who have not received prior treatment for this condition. The medications being tested include Cabozantinib, Nivolumab, and Ipilimumab. Cabozantinib is taken as a tablet, while Nivolumab and Ipilimumab are given as infusions, which means they are administered directly into the bloodstream through a vein.

The purpose of the study is to compare the combination of Cabozantinib, Nivolumab, and Ipilimumab against the combination of Nivolumab and Ipilimumab alone. Participants will be randomly assigned to receive either the three-drug combination or the two-drug combination. The study is designed to be "double-blind," meaning neither the participants nor the researchers will know which treatment each participant is receiving, to ensure unbiased results. Some participants may receive a placebo, which looks like the real medication but does not contain any active ingredients.

The study will take place over a period of time, with regular visits to monitor the participants' health and the effects of the treatment. The main goal is to see how long the participants live without the cancer getting worse, known as Progression-Free Survival (PFS). The study will also look at overall survival, which is the length of time participants live after starting the treatment. Participants will be closely monitored for any side effects or changes in their condition throughout the study.

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. This process is called randomization and ensures that each participant has an equal chance of being placed in either group.

  2. Step 2

    Treatment group assignment

    If you are placed in the first group, you will receive a combination of cabozantinib, nivolumab, and ipilimumab. Cabozantinib is taken orally as a 20 mg film-coated tablet. Nivolumab and ipilimumab are administered intravenously, which means they are given through a vein.

    If you are placed in the second group, you will receive nivolumab and ipilimumab only, both administered intravenously.

  3. Step 3

    Medication administration

    Nivolumab is given as a 10 mg/mL solution for infusion. Ipilimumab is given as a 5 mg/mL solution for infusion. The frequency and duration of these infusions will be explained to you by the study team.

    The oral cabozantinib tablet is taken as directed by the study team, typically once daily.

  4. Step 4

    Monitoring and follow-up

    Throughout the study, your health and response to the treatment will be closely monitored. This includes regular visits to the study site for assessments and tests.

    The study team will evaluate your progress using specific criteria to measure the effectiveness of the treatment.

  5. Step 5

    End of study participation

    The study is expected to continue until December 31, 2025. Your participation may end earlier if you choose to withdraw or if the study team determines it is in your best interest.

    At the end of your participation, you will have a final visit to assess your health and discuss any further steps.

Who can join the trial?

7 criteria

  • Must have a diagnosis of advanced or metastatic renal cell carcinoma with a clear-cell component. This means the kidney cancer has spread and cannot be treated with surgery or radiation.
  • Must be classified as having intermediate- or poor-risk renal cell carcinoma according to specific criteria used by doctors.
  • Must have measurable disease as determined by the study doctor, which means the cancer can be measured using specific guidelines.
  • Must have a Karnofsky Performance Status (KPS) of 70% or higher. This is a scale that measures the ability to perform daily activities, with higher numbers indicating better function.
  • Must have adequate organ and marrow function, meaning the organs and bone marrow are working well enough to participate in the study.
  • Open to both male and female participants.
  • Participants must be within the specified age range for the study.

Who cannot join the trial?

9 criteria

  • Patients who have received any prior treatment for their metastatic renal cell carcinoma cannot participate. This means if you have already been treated for this type of cancer, you are not eligible.
  • Patients with other types of cancer that are not stable or are being actively treated are excluded. This means if you have another cancer that is not under control, you cannot join the study.
  • Patients with serious heart problems are not eligible. This includes conditions like heart failure or recent heart attacks.
  • Patients with uncontrolled high blood pressure cannot participate. This means if your blood pressure is not well-managed, you are not eligible.
  • Patients with active infections that require treatment are excluded. This means if you have an infection that needs medication, you cannot join the study.
  • Patients with autoimmune diseases that are not stable are not eligible. Autoimmune diseases are conditions where the immune system attacks the body, like lupus or rheumatoid arthritis.
  • Patients who are pregnant or breastfeeding cannot participate. This means if you are expecting a baby or nursing, you are not eligible.
  • Patients who have had a major surgery within the last 4 weeks are excluded. This means if you have recently had a significant operation, you cannot join the study.
  • Patients with known allergies to the study drugs are not eligible. This means if you are allergic to any of the medications being tested, you cannot participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Cabozantinib

    is a medication used in this trial to help treat advanced kidney cancer. It works by blocking certain proteins that promote cancer cell growth, which may help slow down or stop the progression of the disease.

  • Nivolumab

    is an immunotherapy drug that helps your immune system fight cancer. It works by blocking a protein that prevents your immune system from attacking cancer cells, allowing your body to better target and destroy them.

  • Ipilimumab

    is another immunotherapy medication used in this trial. It helps activate your immune system to recognize and attack cancer cells more effectively. By enhancing the immune response, it can help slow down the growth of cancer.

What is already known about the treatment

  • Cabozantinib

    Cabozantinib is administered orally in the form of a tablet. It is currently being studied in clinical trials for its effectiveness in treating advanced or metastatic renal cell carcinoma, particularly in patients who have not received prior treatment and are considered to be at intermediate or poor risk. The medication works by inhibiting certain proteins that promote cancer cell growth and blood vessel formation, thereby slowing down the progression of the disease. It is classified as a tyrosine kinase inhibitor, which is a type of targeted cancer therapy.

  • Nivolumab

    Nivolumab is given as an intravenous infusion, meaning it is administered directly into the bloodstream through a vein. It is an established treatment in the medical field for various cancers, including renal cell carcinoma, and is being evaluated in combination with other drugs for enhanced effectiveness. Nivolumab helps the immune system recognize and attack cancer cells by blocking a protein that prevents immune cells from doing their job. It belongs to a class of drugs known as immune checkpoint inhibitors.

  • Ipilimumab

    Ipilimumab is also administered via intravenous infusion. It is a well-known medication used in cancer treatment, particularly for melanoma and renal cell carcinoma, and is being tested in combination with other therapies to improve outcomes. Ipilimumab works by activating the immune system to fight cancer cells, specifically by targeting a protein that normally keeps immune responses in check. It is classified as an immune checkpoint inhibitor, similar to nivolumab.

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 originates in the lining of the small tubes in the kidney. As the disease progresses, cancer cells can travel through the bloodstream or lymphatic system to form tumors in other organs, such as the lungs, bones, or liver. The spread of cancer to other parts of the body is known as metastasis. Symptoms may include blood in the urine, pain in the side or back, and unexplained weight loss. The progression of the disease can vary, with some tumors growing slowly while others may spread more rapidly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515616-47-00Protocol codeXL184-313Estimated enrolment855 patientsSponsorExelixis Inc.

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

ClinicalTrials.eu

Every clinical trial in Europe, in plain language.

Explore the full ecosystem of clinical research in Europe.

Search trials

Legal notice · Published by CTIN POLAND sp. z o.o., ul. rtm. Witolda Pileckiego 67/109, 02-781 Warsaw, Poland · KRS 0001111334 · REGON 528919042 · NIP 9512598637

© 2026 Clinical Trials EU – European Clinical Trials Information Network

GDPR compliance, ISO 9001 and ISO 27001 certified (LL-C Certification)

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).