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Study of Nivolumab and Ipilimumab or Drug Combination for Patients with Metastatic Kidney Cancer

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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 kidney cancer, which is a type of cancer that has spread from the kidney to other parts of the body. The study will explore the effectiveness of two medications, nivolumab and ipilimumab, either used alone or in combination, as well as a group of drugs known as VEGFR tyrosine kinase inhibitors (tKi), which includes medications like sunitinib and pazopanib. These treatments are given to patients who have not received prior systemic therapy for their cancer.

The purpose of the study is to evaluate how well these treatments work in different molecular subgroups of kidney cancer. Participants will receive one of the treatments based on their specific molecular group, which is determined by analyzing tumor samples. The study will monitor the response to treatment, including whether the cancer shrinks or disappears, and how long patients live without the cancer getting worse. The treatments are administered through an intravenous route, meaning they are given directly into a vein.

Throughout the study, participants will be regularly assessed by investigators to track their response to the treatment. This includes checking for any changes in the size of the cancer and monitoring overall health. The study aims to provide valuable information on the effectiveness of these treatments for metastatic kidney cancer, potentially leading to improved treatment options for patients in the future.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the trial

    Upon joining the trial, the patient will be assigned to a treatment group based on their specific molecular group. This assignment is determined by analyzing tumor samples provided by the patient.

  2. Step 2

    Treatment initiation

    The patient will begin treatment with either nivolumab alone, nivolumab combined with ipilimumab, or a different type of medication known as a tyrosine kinase inhibitor (TKI), which could be sunitinib or pazopanib. The specific treatment will depend on the patient's molecular group.

  3. Step 3

    Medication administration

    The medications nivolumab and ipilimumab are administered through an intravenous (IV) infusion. This means the medication is given directly into a vein. The frequency and dosage will be determined by the healthcare team based on the treatment plan.

  4. Step 4

    Monitoring and assessments

    Throughout the trial, the patient's response to the treatment will be closely monitored. This includes regular medical assessments and imaging tests, such as CT or MRI scans, to evaluate the size of the tumors and check for any changes.

  5. Step 5

    Evaluation of response

    The main goal is to assess the patient's overall response to the treatment. This involves determining whether the tumors have shrunk or disappeared, which is referred to as a complete or partial response.

  6. Step 6

    End of treatment

    The duration of the treatment will vary depending on the patient's response and any side effects experienced. The treatment may continue until the end of the study or until it is no longer beneficial for the patient.

  7. Step 7

    Follow-up

    After the treatment ends, the patient will have follow-up visits to monitor their health and any long-term effects of the treatment. These visits are important to ensure the patient's well-being and to gather additional data for the study.

Who can join the trial?

10 criteria

  • Must have a confirmed diagnosis of **kidney cancer** with a clear-cell component. This means the cancer cells have a specific appearance under a microscope.
  • Must have **metastatic kidney cancer**, which means the cancer has spread to other parts of the body.
  • Must not have received any previous treatment for metastatic kidney cancer. However, if you had treatment more than one year ago and the cancer returned, you may still be eligible.
  • Must have an **ECOG performance status** of 0, 1, or 2. This is a scale used to assess how well you can perform daily activities. A score of 0 means fully active, while 2 means you are up and about more than half the day.
  • Must have a **measurable disease** according to specific criteria used by doctors to assess cancer size and spread.
  • Must provide **frozen or fresh tumor samples** for laboratory analysis. These samples help determine the specific type of kidney cancer. Note: Samples from fine needle aspiration or bone metastases are not acceptable.
  • Must have **formalin-fixed, paraffin-embedded (FFPE) tumor tissue** available for further analysis. This is a method of preserving tissue samples for study.
  • The specific **molecular group** of your cancer must be identified before you can be randomly assigned to a treatment group in the study.
  • Must be aged 18 years or older.
  • Both **male and female** participants are eligible.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer besides kidney cancer cannot participate.
  • Patients who have had another cancer in the past, unless it was successfully treated and has not come back for at least 5 years, cannot participate.
  • Patients with serious heart problems, such as a recent heart attack or heart failure, cannot participate.
  • Patients with uncontrolled high blood pressure cannot participate.
  • Patients with active infections that require treatment with antibiotics cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have received another experimental treatment within the last 4 weeks cannot participate.
  • Patients with known allergies to the study drugs cannot participate.
  • Patients with autoimmune diseases, which are conditions where the immune system attacks the body, cannot participate.
  • Patients with brain metastases, which are cancer cells that have spread to the brain, cannot participate unless they have been treated and are stable.
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Investigated drugs

  • Nivolumab

    is a type of medication known as an immune checkpoint inhibitor. It works by helping your immune system recognize and attack cancer cells more effectively. In this trial, it is used to treat patients with metastatic kidney cancer, either on its own or in combination with another medication.

  • Ipilimumab

    is another immune checkpoint inhibitor. It helps boost the immune system's response against cancer cells. In this trial, it is used in combination with nivolumab to enhance the treatment's effectiveness for patients with metastatic kidney cancer.

  • Sunitinib

    is a medication that targets specific proteins in cancer cells, which helps stop the cancer from growing and spreading. It is used in this trial as an alternative treatment option for patients with metastatic kidney cancer.

  • Pazopanib

    is a medication that works by blocking certain proteins that cancer cells need to grow. It is used in this trial as another treatment option for patients with metastatic kidney cancer, similar to sunitinib.

What is already known about the treatment

  • Nivolumab

    Nivolumab is administered as an intravenous infusion, meaning it is given directly into a vein through a needle. It is currently used in medicine to treat various types of cancer, including kidney cancer, and is well-documented in medical literature. The main therapeutic indication for Nivolumab in this trial is metastatic kidney cancer. At the molecular level, Nivolumab works by blocking a protein called PD-1 on immune cells, which helps the immune system recognize and attack cancer cells. It is classified as an immune checkpoint inhibitor.

  • Ipilimumab

    Ipilimumab is also given as an intravenous infusion. It is used in combination with other medications to treat certain cancers, including kidney cancer, and is supported by extensive medical research. In this trial, it is used for metastatic kidney cancer. Ipilimumab works by targeting a protein called CTLA-4 on immune cells, enhancing the body's immune response against cancer cells. It belongs to the class of immune checkpoint inhibitors.

  • Sunitinib

    Sunitinib is taken orally in the form of a capsule. It is a well-established treatment for kidney cancer and is widely referenced in medical literature. The main therapeutic use in this trial is for metastatic kidney cancer. Sunitinib works by blocking certain proteins that promote cancer cell growth and blood vessel formation, effectively starving the tumor. It is classified as a tyrosine kinase inhibitor.

  • Pazopanib

    Pazopanib is administered orally as a tablet. It is commonly used in the treatment of kidney cancer and is well-documented in medical studies. In this trial, it is indicated for metastatic kidney cancer. Pazopanib functions by inhibiting proteins that are involved in the growth of cancer cells and the formation of new blood vessels, thereby slowing tumor growth. It is also classified as a tyrosine kinase inhibitor.

Investigated diseases

Kidney Cancer – Kidney cancer is a type of cancer that begins in the kidneys, which are two bean-shaped organs located behind the abdominal organs. The most common type of kidney cancer in adults is renal cell carcinoma, which usually starts in the lining of tiny tubes in the kidney. As the disease progresses, cancer cells can grow and form a mass or tumor, potentially spreading to other parts of the body. Symptoms may not appear in the early stages, but as the tumor grows, it can cause blood in the urine, persistent pain in the back or side, and unexplained weight loss. The progression of kidney cancer can vary, with some tumors growing slowly over time, while others may be more aggressive.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-520045-23-00Estimated enrolment200 patientsSponsorARTIC

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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).