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Study of Axitinib and Nivolumab for Patients with Metastatic Renal Cell Carcinoma Not Responding Completely to Initial Treatment

Verified siteRegistered drugNo placebo
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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 metastatic renal cell carcinoma (mRCC). The study is investigating the effects of two medications, axitinib and nivolumab. Axitinib is a medication that helps to block certain proteins that promote cancer growth, while nivolumab is an immunotherapy drug that helps the immune system recognize and attack cancer cells. The trial will compare the combination of axitinib and nivolumab to nivolumab alone, following an initial treatment phase with nivolumab and another drug called ipilimumab.

The purpose of the study is to explore how effective the combination of axitinib and nivolumab is compared to nivolumab alone in treating patients with mRCC who have not had a complete response to the initial treatment. Participants will receive either the combination of axitinib and nivolumab or nivolumab alone. The study will last for a period of up to 12 months, during which the effects of the treatments will be monitored.

Throughout the study, researchers will evaluate various outcomes, such as how well the cancer responds to the treatments, the length of time patients live without the cancer getting worse, and the overall survival of the patients. Additionally, the study will assess the safety of the treatments and their impact on the quality of life of the participants. The findings from this study aim to provide valuable insights into the treatment of metastatic renal cell carcinoma.

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

    Induction phase

    The initial phase involves treatment with nivolumab and ipilimumab. This phase is designed to prepare the body for further treatment.

    During this phase, the patient receives nivolumab through an intravenous infusion. The frequency and dosage are determined by the healthcare provider based on individual needs and responses.

  2. Step 2

    Evaluation after induction

    After completing the induction phase, an evaluation is conducted to assess the response to the treatment.

    The evaluation checks for any side effects and determines if there is a complete response or progressive disease.

  3. Step 3

    Treatment phase with nivolumab alone or with axitinib

    If the evaluation shows no complete response or progressive disease, the patient continues with nivolumab alone or in combination with axitinib.

    Nivolumab is administered through intravenous infusion, while axitinib is taken orally. The dosage and frequency are tailored to the patient's condition and response to the treatment.

  4. Step 4

    Ongoing monitoring and assessment

    Throughout the trial, regular monitoring and assessments are conducted to evaluate the effectiveness and safety of the treatment.

    These assessments include measuring the overall response rate, progression-free survival, and overall survival, as well as monitoring the depth and duration of response and quality of life.

  5. Step 5

    End of trial

    The trial is estimated to conclude by June 30, 2026. At the end of the trial, a final evaluation is conducted to assess the overall outcomes and any long-term effects of the treatment.

Who can join the trial?

16 criteria

  • The patient must have a confirmed diagnosis of advanced renal cell carcinoma (RCC) with a clear-cell subtype. This means the cancer has spread beyond the kidney.
  • The patient should have completed treatment with nivolumab and ipilimumab without severe side effects and should not have a complete response or worsening of the disease.
  • The patient must be 18 years or older.
  • A sample of the patient's tumor tissue must be available for testing.
  • The patient must have at least one tumor that can be measured according to specific medical guidelines.
  • The patient should have a good general health status, as determined by a specific performance scale used by doctors.
  • The patient must have proper functioning of organs and bone marrow, as shown by specific blood tests:
  • Enough white blood cells, specifically neutrophils, which help fight infection.
  • A sufficient number of platelets, which help with blood clotting.
  • Adequate levels of hemoglobin, which carries oxygen in the blood.
  • Liver enzymes (ALT and AST) should be within a certain range.
  • Bilirubin levels, which indicate liver function, should be within a certain range.
  • Kidney function should be within a certain range, as shown by creatinine levels or clearance.
  • The patient must understand the study requirements and agree to participate by signing a consent form.
  • If the patient is sexually active and can have children, they and their partners must agree to use reliable birth control methods during the study and for 5 months after the last treatment.
  • Female patients who can become pregnant must not be pregnant at the start of the study. This includes women who have had menstrual periods in the past year, unless they have had a hysterectomy.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer other than metastatic renal cell carcinoma (mRCC). This is a type of kidney cancer that has spread to other parts of the body.
  • Patients who are not within the specified age range for the study.
  • Patients who are not able to follow the study procedures or take the study medications as required.
  • Patients who have other serious health conditions that might interfere with the study or make it unsafe for them to participate.
  • Patients who are pregnant or breastfeeding, as the study medications might affect the baby.
  • Patients who are participating in another clinical trial at the same time.
  • Patients who have had a recent major surgery or are planning to have surgery during the study period.
  • Patients who have a history of severe allergic reactions to any of the study medications.
  • Patients who have an active infection that requires treatment.
  • Patients who have a history of drug or alcohol abuse that might interfere with their ability to participate in the study.
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Investigated drugs

  • Axitinib

    is a medication used in this trial to see if it can improve treatment outcomes when added to another drug. It works by blocking certain proteins that help cancer cells grow, which may slow down or stop the growth of the cancer.

  • Nivolumab

    is an immunotherapy drug used in this trial. It helps the immune system recognize and attack cancer cells more effectively. It is being tested both alone and in combination with other medications to see how well it works in treating cancer.

  • Ipilimumab

    is another immunotherapy drug used during the initial phase of the trial. It works by activating the immune system to help it fight cancer cells. It is used in combination with nivolumab to see if this combination can improve treatment outcomes.

What is already known about the treatment

  • Axitinib

    Axitinib is administered orally in tablet form. It is currently being studied in clinical trials for its effectiveness in treating metastatic renal cell carcinoma (mRCC). The medication works by inhibiting certain proteins that promote blood vessel growth in tumors, thereby slowing or stopping cancer progression. Axitinib is classified as a tyrosine kinase inhibitor, which targets specific enzymes involved in cancer cell growth.

  • Nivolumab

    Nivolumab is given as an intravenous infusion. It is an established treatment in the medical field for various cancers, including metastatic renal cell carcinoma (mRCC). The drug functions by blocking a protein called PD-1 on immune cells, enhancing the body's immune response against cancer cells. Nivolumab is classified as an immune checkpoint inhibitor, which helps the immune system recognize and attack cancer cells.

  • Ipilimumab

    Ipilimumab is administered through intravenous infusion. It is widely used in the treatment of certain cancers, including metastatic renal cell carcinoma (mRCC). The medication works by targeting CTLA-4, a protein receptor that downregulates the immune system, thereby boosting the immune response against cancer cells. Ipilimumab is classified as an immune checkpoint inhibitor, which aids in enhancing the body's natural defense against tumors.

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 and can metastasize to areas such as the lungs, bones, or liver. The disease often progresses silently in its early stages, making it difficult to detect until it has advanced. As it progresses, symptoms may include blood in the urine, persistent pain in the side or back, and unexplained weight loss. The spread of cancer cells can lead to the formation of new tumors in other organs, complicating the condition. The progression and symptoms can vary significantly from person to person.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511397-70-00Protocol codeAxInEstimated enrolment178 patientsSponsorConsorzio Oncotech

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