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Study Comparing Tivozanib and Nivolumab Combination to Tivozanib Alone in Patients with Renal Cell Carcinoma After Previous Immune Therapy

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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 Renal Cell Carcinoma. The study is investigating the effectiveness of a treatment using two medications: Tivozanib and Nivolumab. Tivozanib is taken orally in the form of a capsule, while Nivolumab, also known by its code name BMS936558, is given through an intravenous infusion, which means it is administered directly into a vein.

The purpose of the study is to compare the combination of Tivozanib and Nivolumab with Tivozanib alone in patients whose cancer has progressed after one or two previous treatments, including a type of treatment called an immune checkpoint inhibitor. This study will help determine if the combination of these medications can help patients live longer without their cancer getting worse.

Participants in the study will receive either the combination of Tivozanib and Nivolumab or Tivozanib alone. The study will monitor the participants over a period to see how their cancer responds to the treatment. The study will also assess the safety and any side effects of the treatments. The results will provide valuable information on the potential benefits of combining these medications for treating 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 assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

    Eligibility criteria include being 18 years or older, having a life expectancy of at least 3 months, and having a confirmed diagnosis of renal cell carcinoma with a clear cell component.

  2. Step 2

    Randomization

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

  3. Step 3

    Treatment administration

    For those receiving tivozanib alone, the medication is taken orally. The specific dosage and frequency are determined by the study protocol.

    For those receiving the combination treatment, tivozanib is taken orally, and nivolumab is administered through an intravenous infusion. The dosage and frequency are specified in the study protocol.

  4. Step 4

    Regular monitoring

    Participants undergo regular monitoring to assess the effectiveness of the treatment and to check for any side effects.

    This includes physical examinations, blood tests, and imaging studies to track the progression of the disease.

  5. Step 5

    Progress evaluation

    The primary goal is to evaluate progression-free survival, which means the length of time during and after treatment that the cancer does not get worse.

    Secondary evaluations include overall survival, response rate, and duration of response.

  6. Step 6

    Completion of study

    The study is estimated to end by July 31, 2025. Participants will be informed about the results and any further steps if necessary.

Who can join the trial?

7 criteria

  • Must be 18 years or older and have a life expectancy of at least 3 months.
  • Must have experienced disease progression (worsening of the disease) during or after at least 6 weeks of treatment with an immune checkpoint inhibitor (ICI) for advanced kidney cancer with a clear cell component, either as the first or second treatment option.
  • Must have recovered from side effects of previous treatments to a level that is considered mild or back to the original state.
  • Must have kidney cancer confirmed by a laboratory test, showing a clear cell component.
  • Must have measurable disease according to specific criteria used by doctors to assess cancer.
  • Must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, which means being fully active or having some symptoms but still able to carry out light work.
  • All participants must follow specific contraceptive measures as defined by the study protocol.

Who cannot join the trial?

3 criteria

  • Patients who have not been diagnosed with renal cell carcinoma (a type of kidney cancer) cannot participate.
  • Patients who have not received 1 or 2 previous treatments that included an immune checkpoint inhibitor (a type of drug that helps the immune system fight cancer) cannot participate.
  • Patients who are part of a vulnerable population (groups that may need special protection) cannot participate.
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Investigated drugs

  • Tivozanib

    is a medication used in this clinical trial to treat kidney cancer, specifically renal cell carcinoma. It works by blocking certain proteins that help cancer cells grow and spread. By doing this, tivozanib can help slow down or stop the progression of the cancer.

  • Nivolumab

    is another medication used in this trial, often in combination with tivozanib. It is an immune checkpoint inhibitor, which means it helps the body's immune system recognize and attack cancer cells more effectively. Nivolumab works by blocking a protein that prevents the immune system from attacking cancer cells, thereby boosting the body's natural defenses against the cancer.

What is already known about the treatment

  • Tivozanib

    Tivozanib is administered orally in the form of a capsule. It is currently being studied in clinical trials for its effectiveness in treating renal cell carcinoma, a type of kidney cancer. The main therapeutic use of Tivozanib is to slow down the progression of this cancer. At the molecular level, Tivozanib works by blocking certain proteins that promote the growth of blood vessels that supply the tumor, effectively starving the cancer cells. It is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.

  • Nivolumab

    Nivolumab is given as an intravenous infusion, meaning it is administered directly into the bloodstream through a vein. It is an established medication in the treatment of various cancers, including renal cell carcinoma, and is being evaluated in combination with Tivozanib in clinical trials. Nivolumab's primary therapeutic role is to enhance the body's immune response against cancer cells. It works by blocking a protein called PD-1 on immune cells, which helps the immune system recognize and attack cancer cells more effectively. Nivolumab is classified as an immune checkpoint inhibitor, a type of immunotherapy.

Investigated diseases

Renal cell carcinoma – Renal cell carcinoma is a type of kidney cancer that originates in the lining of the small tubes in the kidney. It typically begins as a single mass or tumor in one kidney, but it can also occur in both kidneys simultaneously. As the disease progresses, the tumor may grow larger and can spread to nearby tissues and organs, such as the lymph nodes, lungs, or bones. The cancer cells can invade the blood vessels, allowing the disease to metastasize to distant parts of the body. Symptoms may include blood in the urine, a lump in the abdomen, or persistent pain in the side. The progression of renal cell carcinoma can vary, with some tumors growing slowly over time while others may advance more rapidly.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-514570-43-00Protocol codeAV-951-20-304Estimated enrolment326 patientsSponsorAveo Pharmaceuticals Inc.

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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).