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Study of Nivolumab and Ipilimumab for Patients with Advanced Kidney Cancer and Intermediate or Poor Risk Factors

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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 Advanced Renal Cell Carcinoma, a type of kidney cancer that has spread and is not suitable for surgery or radiation. The study involves two treatments: Nivolumab and Ipilimumab. Nivolumab is a medication that helps the immune system fight cancer, and Ipilimumab is another drug that boosts the immune system's response to cancer cells. The trial will compare the effects of using Nivolumab alone versus using it in combination with Ipilimumab.

The purpose of the study is to understand how well these treatments work in patients who have not received any previous treatment for their advanced kidney cancer and have certain risk factors. Participants will receive either the combination of Nivolumab and Ipilimumab or Nivolumab alone. Some participants may receive a placebo. The study will monitor the progress of the disease and the response to the treatment over time.

Throughout the study, participants will receive the treatments through an intravenous infusion, which means the medication is given directly into a vein. The study will last for a period of time, during which the health and response of the participants will be closely observed. The goal is to determine which treatment option is more effective in managing the cancer and improving the patients' health outcomes.

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 verifying a diagnosis of advanced kidney cancer with specific risk factors.

    Imaging tests such as CT or MRI are used to measure the disease according to specific criteria.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of two groups: one receiving a combination of nivolumab and ipilimumab, and the other receiving nivolumab alone.

  3. Step 3

    Treatment administration

    The treatment involves intravenous administration. Nivolumab is given as a solution for infusion, and ipilimumab is provided as a concentrate for solution for infusion.

    The frequency and dosage are determined by the study protocol and are administered under medical supervision.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment. This includes imaging tests and laboratory evaluations.

    The study aims to evaluate progression-free survival and overall response rate, among other outcomes.

  5. Step 5

    Completion of study

    The study is expected to conclude by March 2025. Participants will continue to be monitored for outcomes such as overall survival and any adverse effects.

Who can join the trial?

7 criteria

  • The patient must have a confirmed diagnosis of **renal carcinoma**. This is a type of kidney cancer, and it should have a **clear cell component**, which is a specific type of cell found in this cancer. It may 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 must have a **measurable disease**. This means the cancer can be measured using imaging tests like a **CT scan** or **MRI**. These are special types of scans that take detailed pictures of the inside of the body.
  • The patient should not have received any **systemic therapy** for renal cell carcinoma before. Systemic therapy is treatment that travels through the bloodstream to reach cancer cells all over the body.
  • The patient must be considered **intermediate or poor risk** according to the **International Metastatic RCC Database Consortium (IMDC)**. This is a way to classify how serious the cancer is based on certain factors.
  • Both **male and female** patients can participate.
  • The study includes patients who may be considered part of a **vulnerable population**. This means they might need extra protection or care during the study.

Who cannot join the trial?

9 criteria

  • Patients with other types of cancer besides Advanced Renal Cell Carcinoma cannot participate. This is a type of kidney cancer.
  • Patients who have had previous treatments that might interfere with the study drugs are not eligible.
  • Patients with certain health conditions that could make the study unsafe for them are excluded.
  • Patients who are pregnant or breastfeeding cannot take part in the study.
  • Patients who are unable to follow the study procedures or attend the required visits are not eligible.
  • Patients with a history of severe allergic reactions to similar drugs are excluded.
  • Patients with active infections that require treatment are not eligible.
  • Patients with certain heart conditions that could be worsened by the study drugs are excluded.
  • Patients who are participating in another clinical trial at the same time are not eligible.
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Investigated drugs

  • Nivolumab

    is a medication used in this trial to treat advanced renal cell carcinoma. It works by helping the immune system recognize and attack cancer cells more effectively. Nivolumab is often used in patients who have not received prior treatment for their cancer.

  • Ipilimumab

    is another medication used in combination with Nivolumab in this trial. It also helps the immune system fight cancer by targeting a different pathway than Nivolumab. When used together, these medications aim to enhance the body's ability to combat cancer cells in patients with advanced 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 advanced renal cell carcinoma, and is well-documented in medical literature. The main therapeutic indication for nivolumab in this trial is advanced renal cell carcinoma with intermediate- or poor-risk factors. 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 administered as an intravenous infusion. It is approved for use in treating certain types of cancer and is widely recognized in medical literature. In this trial, ipilimumab is used in combination with nivolumab for advanced renal cell carcinoma with intermediate- or poor-risk factors. Its mechanism of action involves blocking the CTLA-4 protein on T-cells, which boosts the immune system's ability to fight cancer. Ipilimumab is classified as an immune checkpoint inhibitor.

Investigated diseases

Advanced Renal Cell Carcinoma with Intermediate- or Poor-Risk Factors – This is a type of kidney cancer that has progressed to an advanced stage, meaning it has spread beyond the kidney to other parts of the body. It is characterized by the presence of intermediate or poor-risk factors, which can include specific clinical features or laboratory findings that suggest a more aggressive disease course. The cancer cells in renal cell carcinoma originate in the lining of the small tubes in the kidney. As the disease advances, it can lead to symptoms such as blood in the urine, pain in the side or back, and unexplained weight loss. The progression of the disease can vary, with some cases growing slowly while others may spread more rapidly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-508264-29-00Protocol codeCA209-8Y8Estimated enrolment448 patientsSponsorBristol-Myers Squibb Services Unlimited Company

sourced from the EU Clinical Trials Register and site verification

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