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Study on the Effectiveness of Relatlimab, Ipilimumab, and Nivolumab in Patients with High-Risk Clear Cell Renal Cell 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 a type of kidney cancer known as clear cell renal cell carcinoma (RCC). This cancer is at risk of coming back or spreading to other parts of the body. The study is testing a combination of treatments to see how well they work before surgery. The treatments being tested include three medications: Relatlimab, Ipilimumab (also known as Yervoy), and Nivolumab (also known as Opdivo). These medications are given through a drip into a vein, which is called an infusion.

The purpose of the study is to find out how well these medications work together in treating high-risk non-metastatic clear cell RCC. Participants in the study will receive different combinations of these medications before they have surgery to remove the cancer. The study will look at how the cancer responds to the treatment and how safe the medications are for the patients. Some participants will receive a placebo, which is a treatment that looks like the real medication but does not contain any active ingredients.

The study will take place over several months, and participants will be closely monitored by the research team. They will have regular check-ups and tests to see how the treatment is affecting their cancer and overall health. The study aims to provide valuable information about the effectiveness of these treatments in preventing the cancer from coming back or spreading. This research could help improve future treatment options for people with clear cell RCC.

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 study

    Upon joining the study, eligibility is confirmed based on specific criteria, including age, health status, and previous treatments.

    A signed informed consent document is required, indicating understanding and agreement to participate.

  2. Step 2

    Initial assessments

    Initial assessments include a series of medical tests to establish baseline health status.

    These tests may involve blood tests, imaging, and biopsies to confirm the diagnosis of clear cell renal cell cancer.

  3. Step 3

    Treatment phase

    The treatment involves a combination of immunotherapy drugs administered intravenously.

    The medications used are relatlimab, ipilimumab (Yervoy 5 mg/ml), and nivolumab (Opdivo 10 mg/ml).

    The specific dosage and frequency of administration are determined by the study protocol and medical team.

  4. Step 4

    Monitoring and follow-up

    Regular monitoring is conducted to assess the response to treatment and any side effects.

    This includes follow-up appointments, additional blood tests, and imaging studies.

  5. Step 5

    Surgery

    Surgery is planned following the neoadjuvant immunotherapy phase to remove the tumor.

    The timing of surgery may be adjusted based on the patient's response to treatment and overall health.

  6. Step 6

    Post-surgery evaluation

    After surgery, further evaluations are conducted to determine the pathologic response to treatment.

    This includes analyzing the removed tissue to assess the effectiveness of the immunotherapy.

  7. Step 7

    Long-term follow-up

    Long-term follow-up is essential to monitor for any recurrence of cancer or distant metastases.

    Regular check-ups and imaging studies are part of this phase to ensure ongoing health and address any issues promptly.

Who can join the trial?

13 criteria

  • Must be an adult at least 18 years old.
  • Women who can have children must use a reliable method to prevent pregnancy during the study and for 23 weeks after the last dose of the study drug.
  • Women who can have children must have a negative pregnancy test within 24 hours before starting the study treatment.
  • Women who cannot have children (postmenopausal or surgically sterile) and men who cannot father children do not need to use contraception.
  • Must be able to understand and follow the study requirements and have signed the consent form.
  • Must have a **World Health Organization (WHO) Performance Status** of 0 or 1, which means being fully active or having some restrictions but able to carry out light work.
  • Must have a confirmed diagnosis of **resectable clear cell RCC** (a type of kidney cancer that can be surgically removed) that can be measured and biopsied, with no history of cancer spreading to distant parts of the body.
  • Must be at intermediate to high risk based on specific clinical and biopsy criteria.
  • Must not have any other cancers, unless they have been treated and the life expectancy related to cancer is more than 5 years.
  • Must be willing to have three tumor biopsies and extra blood tests during screening and if the cancer returns.
  • Must not have had previous treatments targeting specific immune system proteins like **CTLA-4, PD-1, PD-L1, or LAG-3**.
  • Must not have taken medications that suppress the immune system within 2 weeks before starting the study treatment.
  • Must have certain laboratory test results within normal ranges, including white blood cells, neutrophils, platelets, hemoglobin, creatinine, liver enzymes (AST and ALT), bilirubin, and normal levels of CK, Troponin T, and LDH.

Who cannot join the trial?

3 criteria

  • Patients with a history of **distant metastases** cannot participate. This means the cancer has spread to other parts of the body.
  • Patients who have previously received **CTLA-4/PD-1/PD-L1/LAG-3 directed immunotherapy** are not eligible. These are specific types of treatments that help the immune system fight cancer.
  • Patients under 18 years old are not allowed to join the study.
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Investigated drugs

  • Nivolumab

    is an immunotherapy medication used in this trial. It works by helping the immune system recognize and attack cancer cells more effectively. It is often used in the treatment of various types of cancer, including renal cell carcinoma.

  • Ipilimumab

    is another immunotherapy drug included in the trial. It helps to activate the immune system by targeting a specific protein on immune cells, which can enhance the body's ability to fight cancer. It is commonly used in combination with other treatments for better results.

  • M21NSC

    is a code name for an investigational drug being tested in this trial. Its role is to evaluate its effectiveness and safety when used in combination with other immunotherapy drugs for treating clear cell renal cell cancer.

What is already known about the treatment

Nivolumab – This medication is administered intravenously and is used in the treatment of certain types of cancer, including clear cell renal cell carcinoma (RCC). It is currently being studied in clinical trials for its effectiveness in combination with other immunotherapies. Nivolumab works by blocking the PD-1 protein on immune cells, which helps the immune system attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor and is primarily indicated for cancers that have not responded to other treatments.

Investigated diseases

Clear Cell Renal Cell Carcinoma (RCC) – Clear cell renal cell carcinoma is a type of kidney cancer that originates in the lining of the small tubes in the kidney. It is characterized by the presence of clear cells when viewed under a microscope. This cancer can be classified as intermediate to high-risk based on its potential to grow and spread. The disease progresses as the cancer cells multiply, potentially forming a mass or tumor in the kidney. If not contained, it may invade nearby tissues or spread to other parts of the body. The progression is often monitored using imaging techniques and specific criteria like RECIST 1.1 to assess changes in tumor size.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-515514-40-00Protocol codeCA209-6DJEstimated enrolment69 patientsSponsorHet Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting

sourced from the EU Clinical Trials Register and site verification

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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).