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Study comparing XL092 plus nivolumab versus sunitinib for patients with advanced or metastatic non-clear cell kidney cancer

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Non-Clear Cell Renal Cell Carcinoma that has spread to other parts of the body (advanced or metastatic). The study compares two different treatment approaches. The first approach combines two medications: XL092 (taken as tablets) and Nivolumab (given through an infusion into a vein). The second approach uses Sunitinib (taken as capsules) alone. The purpose is to determine if the combination treatment works better than sunitinib in treating this type of kidney cancer.

During the study, participants will be randomly assigned to receive either the combination of XL092 and nivolumab, or sunitinib alone. The treatment may continue for up to 252 weeks (about 5 years). Regular medical examinations and scans will be performed to monitor how well the treatment is working and check for any side effects. The study will measure how long participants live without their cancer getting worse and track their overall survival time.

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 screening and assignment

    You will undergo initial medical tests to confirm eligibility for the study

    If eligible, you will be randomly assigned to one of two treatment groups

  2. Step 2

    Treatment Group A: XL092 with Nivolumab

    If assigned to Group A, you will receive two medications:

    XL092 tablets taken by mouth

    Nivolumab (OPDIVO) given through an intravenous infusion (delivered into a vein)

  3. Step 3

    Treatment Group B: Sunitinib

    If assigned to Group B, you will receive:

    Sunitinib capsules taken by mouth

    Available doses are 12.5 mg or 25 mg hard capsules

  4. Step 4

    Regular monitoring

    Your condition will be regularly monitored using imaging scans

    Blood tests will be performed to check organ function and blood cell counts

    Your response to treatment will be evaluated using specialized criteria (RECIST 1.1)

  5. Step 5

    Follow-up period

    After completing treatment, you will need to continue using birth control methods:

    For XL092: 186 days for women, 96 days for men

    For Nivolumab: 5 months for women

    For Sunitinib: 4 weeks for women, 7 weeks for men

  6. Step 6

    Study completion

    The study is expected to continue until June 2028

    Your participation duration will depend on how your body responds to the treatment

Who can join the trial?

18 criteria

  • Must be 18 years or older
  • Must have confirmed non-clear cell renal cell carcinoma (a type of kidney cancer) that is advanced or has spread to other parts of the body
  • Must have measurable disease that can be evaluated using specific medical criteria (RECIST 1.1)
  • Must provide either stored tumor tissue sample or agree to a new tumor biopsy
  • Must have recovered from side effects of any previous treatments
  • Must have good physical functioning ability (Karnofsky Performance Score of 70% or higher)
  • Must have adequate blood cell counts and organ function, including:
    • Sufficient white blood cells, red blood cells, and platelets
    • Normal blood clotting function
    • Adequate liver function
    • Adequate kidney function
    • Normal protein levels in urine
    • Must test negative for hepatitis B and hepatitis C
    • Must be able to understand and follow study requirements
    • Must sign an informed consent document
    • For women who can become pregnant:
      • Must not be pregnant when starting the study
      • Must use effective birth control during the study and for 186 days after
      • For men participating in the study:
        • Must use effective birth control during the study and for 96 days after
        • Must not donate sperm during this period

Who cannot join the trial?

13 criteria

  • Prior treatment with any systemic therapy for advanced or metastatic renal cell carcinoma (a type of kidney cancer)
  • Active brain or spinal cord metastases (cancer that has spread to brain or spine) that are untreated or unstable
  • History of severe or uncontrolled autoimmune disease (condition where immune system attacks healthy cells)
  • Active or chronic infections including hepatitis B, hepatitis C, or HIV
  • Significant heart conditions in the past 6 months, including heart attack, unstable angina, or heart failure
  • Uncontrolled high blood pressure
  • Major surgery within 4 weeks before starting the study treatment
  • Current participation in other clinical trials
  • Known allergy or sensitivity to components of the study drugs
  • Pregnant or breastfeeding women
  • Any condition that, in the opinion of the study doctor, would interfere with safe participation in the study
  • Unable to swallow oral medications
  • History of other cancers within 3 years before study entry, except for adequately treated non-melanoma skin cancer or carcinoma in situ
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Investigated drugs

  • XL092

    is an experimental medication being studied for treating advanced kidney cancer. It belongs to a class of drugs that work by blocking specific proteins involved in cancer growth and spread.

  • Nivolumab

    is an immunotherapy medication that helps the body's immune system fight cancer cells. It works by blocking a protein that prevents T-cells (immune system cells) from attacking cancer cells.

  • Sunitinib

    is a targeted therapy medication used to treat several types of cancer, including kidney cancer. It works by blocking specific proteins that help cancer cells grow and survive, and it can also prevent the formation of new blood vessels that feed tumors.

What is already known about the treatment

  • XL092

    An investigational oral tyrosine kinase inhibitor being studied in clinical trials for the treatment of advanced or metastatic non-clear cell renal cell carcinoma. This medication is administered orally and works by blocking specific proteins involved in cancer cell growth and survival. It is currently being evaluated in combination with nivolumab as a potential first-line treatment option, comparing its efficacy against the established medication sunitinib.

  • Nivolumab

    An FDA-approved immunotherapy medication administered through intravenous infusion that works by blocking the PD-1 protein on immune cells, helping the body's immune system recognize and attack cancer cells. This medication belongs to the class of drugs called checkpoint inhibitors and has shown effectiveness in treating various types of cancer, including renal cell carcinoma, by enhancing the body's natural immune response against cancer cells.

  • Sunitinib

    An oral medication belonging to the class of tyrosine kinase inhibitors that is currently approved for the treatment of various cancers, including renal cell carcinoma. This medication works by blocking multiple proteins that promote cancer cell growth and blood vessel formation, effectively starving tumors of their blood supply and inhibiting their growth. It is typically taken once daily on a specific schedule determined by the treating physician.

Investigated diseases

Non-Clear Cell Renal Cell Carcinoma - A type of kidney cancer that develops in the cells lining the small tubes within kidneys, specifically characterized by cells that don't have the typical clear appearance under a microscope. This cancer begins in the kidney tissue and can spread to nearby structures. The disease can progress from being localized in the kidney to becoming advanced, where it extends beyond the kidney's outer tissue. In its metastatic form, the cancer spreads to distant parts of the body through the bloodstream or lymphatic system. The cancer cells can form new tumors in other organs, most commonly in the lungs, bones, liver, or brain.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-501703-27-00Protocol codeXL092-304Estimated enrolment379 patientsSponsorExelixis 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).