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Study on the Effects of Tumor Removal in Patients with Metastatic Kidney Cancer Treated with Nivolumab and Ipilimumab Combination

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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 the effects of different treatments for metastatic renal cell carcinoma, a type of kidney cancer that has spread to other parts of the body. The study will explore the impact of removing the primary tumor in patients who are already receiving standard care with immunotherapy. The treatments being tested include combinations of medications such as axitinib with pembrolizumab, cabozantinib with nivolumab, lenvatinib with pembrolizumab, and nivolumab alone after a combination of nivolumab and ipilimumab. These medications are known as antineoplastic agents, which help to stop the growth of cancer cells, and protein kinase inhibitors, which block certain proteins that promote cancer cell growth.

The purpose of the study is to evaluate how delaying the removal of the primary tumor affects the survival of patients who are receiving these treatments. Participants will be randomly assigned to either have the tumor removed or not, while continuing their current treatment. The study will last for a period of up to 36 months, during which the effects of the treatments on the patients' overall survival and progression-free survival will be monitored. Progression-free survival refers to the length of time during and after treatment that a patient lives with the disease without it getting worse.

Additionally, the study will assess the safety of the surgical procedure and its impact on the quality of life of the patients. Quality of life will be evaluated using specific questionnaires. The study will also look at how different treatment strategies affect the proteins in the body and how these changes relate to treatment outcomes. This research aims to provide valuable insights into the best treatment approaches for patients with metastatic renal cell carcinoma.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial treatment phase

    The initial treatment phase involves the administration of standard of care (SOC) therapies for metastatic renal cell carcinoma (mRCC).

    Patients will receive one of the following combinations: axitinib with pembrolizumab, cabozantinib with nivolumab, lenvatinib with pembrolizumab, or nivolumab alone after nivolumab with ipilimumab.

    The duration of this phase is between 24 to 52 weeks, depending on the patient's response and absence of disease progression.

  2. Step 2

    Evaluation for deferred surgery

    After the initial treatment phase, patients will be evaluated for the possibility of undergoing deferred cytoreductive nephrectomy (CN), which is a surgical procedure to remove part of the kidney.

    The decision to proceed with surgery will be based on the patient's overall health, response to treatment, and the absence of disease progression.

  3. Step 3

    Continued therapy

    Patients who do not undergo surgery will continue with their assigned SOC therapy.

    The continuation of therapy will be monitored regularly to assess the patient's response and manage any side effects.

  4. Step 4

    Radiotherapy consideration

    For patients with a primary tumor size of up to 4 cm, radiotherapy may be considered as an additional treatment option.

    The decision to include radiotherapy will depend on the patient's specific condition and treatment response.

  5. Step 5

    Safety and quality of life assessment

    Throughout the trial, the safety of treatments and the patient's quality of life will be evaluated.

    Adverse events will be monitored and graded according to established criteria, and quality of life will be assessed using specific questionnaires.

  6. Step 6

    End of trial

    The trial is expected to conclude by September 3, 2029.

    Final assessments will be conducted to evaluate the overall survival and progression-free survival of patients, as well as the impact of different treatment strategies on these outcomes.

Who can join the trial?

16 criteria

  • Must provide informed consent before any study-specific procedures. This means you understand the study and agree to participate by signing a document.
  • Women who can have children and men must agree to use adequate contraception from the time they sign the consent form until at least 3 months after the last study drug is given. This means using reliable birth control methods.
  • Must have adequate bone-marrow, liver, and kidney function as shown by specific lab tests done within 7 days before starting the study treatment. These tests include:
    • Creatinine level less than 2.5 mg/dl and creatinine clearance greater than 30 ml/min, which checks kidney function.
    • Total bilirubin level no more than 1.5 times the normal limit, which checks liver function.
    • Alanine aminotransferase and aspartate aminotransferase levels no more than 2 times the normal limit (or 5 times if the liver is involved), which also check liver function.
    • International normalized ratio (INR) and partial thromboplastin time (PTT) no more than 1.5 times the normal limit, which check blood clotting. If you are on blood thinners like warfarin or heparin, you can still participate if your blood clotting is stable.
    • Platelet count of at least 100,000/mm3, hemoglobin level greater than 9 g/dl, and absolute neutrophil count greater than 1,500/mm3, which check blood health.
    • Alkaline phosphatase level no more than 2.5 times the normal limit (or 5 times if the liver is involved), which checks liver and bone health.
    • Must be a male or female patient who is at least 18 years old.
    • Must have a confirmed diagnosis of renal cell carcinoma with mostly clear cell type, which is a type of kidney cancer.
    • Must have evidence of primary kidney cancer.
    • Must have either measurable or non-measurable metastatic disease according to specific criteria, which means cancer that has spread to other parts of the body.
    • Must have an Eastern Cooperative Oncology Group performance status of 0 or 1, which means you are fully active or have some symptoms but can still do light work.
    • Must have a life expectancy of at least 9 months.
    • Must be under treatment with a standard of care therapy that includes one anti-PD1 based treatment, such as axitinib + pembrolizumab, cabozantinib + nivolumab, lenvatinib + pembrolizumab, or nivolumab alone after nivolumab + ipilimumab, for at least 24 but not more than 52 weeks at the time of signing the consent form, and without signs of cancer progression.
    • Must be eligible to continue the combination of therapies for metastatic renal cell carcinoma (or nivolumab alone if previously treated with nivolumab + ipilimumab).

Who cannot join the trial?

5 criteria

  • Patients with other types of cancer besides **metastatic or locally advanced renal cell carcinoma** cannot participate. This means if the cancer has spread to other parts of the body or is advanced in the kidney area, they may be eligible, but not if they have different cancers.
  • Patients who are not receiving **standard of care (SOC)** with **anti-PD1-based therapies** for their kidney cancer cannot participate. **Standard of care** refers to the usual treatment given for a condition, and **anti-PD1-based therapies** are a type of treatment that helps the immune system fight cancer.
  • Patients who are not within the specified age range cannot participate. The age range includes adults and older adults.
  • Both male and female patients are eligible, so gender is not a reason for exclusion.
  • Patients who are considered part of a **vulnerable population** are not excluded. **Vulnerable population** refers to groups who might need special protection, like children or those unable to give consent, but this study does not exclude them based on this criterion.
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Investigated drugs

Anti-PD1-based therapies are a type of immunotherapy used in this trial. These therapies help the body's immune system recognize and attack cancer cells more effectively. They work by blocking a specific protein on the surface of immune cells, which can otherwise prevent the immune system from attacking cancer cells. This type of treatment is commonly used for various cancers, including metastatic renal cell carcinoma, to improve patient survival.

What is already known about the treatment

Nivolumab – Nivolumab is administered as an intravenous infusion, typically given in a clinical setting under the supervision of healthcare professionals. It is currently approved and widely used in the treatment of various cancers, including metastatic or locally advanced renal cell carcinoma. The main therapeutic indication for Nivolumab is to enhance the body's immune response against cancer cells. At the molecular level, it works by blocking the PD-1 protein on immune cells, preventing cancer cells from evading the immune system. Nivolumab is classified as an immune checkpoint inhibitor, a type of immunotherapy that helps the immune system recognize and attack cancer cells more effectively.

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 often begins in the cells lining the small tubes within the kidneys. As the disease progresses, cancer cells can travel through the bloodstream or lymphatic system to form new tumors in other organs. Symptoms may include blood in the urine, pain in the side or back, and unexplained weight loss. The disease can affect various organs, including the lungs, bones, and liver. The progression and symptoms can vary widely among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-517789-41-00Protocol codeITALIC-RCCEstimated enrolment409 patientsSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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