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Study on the Safety and Effects of XL092 with Nivolumab, Ipilimumab, and Relatlimab for Patients with Advanced Solid Tumors

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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 a new treatment for various types of advanced or metastatic solid tumors, which are cancers that have spread to other parts of the body and cannot be removed by surgery. The diseases being studied include clear cell renal cell carcinoma, metastatic castration-resistant prostate cancer, urothelial carcinoma, non-clear cell renal cell carcinoma, colorectal cancer, hepatocellular cancer, non-small cell lung cancer, and head and neck squamous cell carcinoma. The study will test a combination of medications, including zanzalintinib, nivolumab, ipilimumab, and relatlimab. These medications are designed to work together to help the immune system fight cancer.

The purpose of the study is to find the best dose of these medications and to see how safe and effective they are when used together. Participants will receive the medications in different combinations, either as a single treatment or in pairs or triplets. The study will also look at how the body processes these medications and how they affect cancer cells. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of the actual treatment.

During the study, participants will receive the treatment over a period of time, and their health will be closely monitored by the research team. The study will help determine the safety and potential benefits of these treatments for people with advanced cancers. The information gathered will contribute to understanding how these medications can be used to treat different types of cancer effectively.

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

    Joining the study

    Upon joining the study, participation begins with a thorough review of the study protocol and signing of the informed consent form. This ensures understanding of the study's purpose and procedures.

  2. Step 2

    Dose-escalation stage

    During this stage, the focus is on determining the recommended dose of the medication zanzalintinib when used in combination with other treatments. The safety and tolerability of these combinations are closely monitored.

    The medications used include nivolumab and ipilimumab, both administered intravenously as solutions for infusion. The specific dosage and frequency are adjusted based on individual response and tolerance.

  3. Step 3

    Expansion stage

    In this stage, the effectiveness of zanzalintinib alone and in combination with other treatments is assessed. This involves monitoring the response of specific tumor types to the treatment.

    The combination therapies may include nivolumab and relatlimab as a fixed-dose combination, administered intravenously. The goal is to evaluate the preliminary efficacy and further assess safety.

  4. Step 4

    Medication administration

    The study involves the administration of several medications. Relatlimab + Nivolumab is given as a fixed-dose combination intravenously. XL092 is provided in tablet form for oral consumption.

    Ipilimumab and OPDIVO (nivolumab) are administered as solutions for infusion intravenously. The frequency and duration of administration depend on the specific treatment regimen assigned.

  5. Step 5

    Monitoring and assessments

    Throughout the trial, regular monitoring and assessments are conducted to evaluate the safety and effectiveness of the treatment. This includes tracking any adverse events and measuring the response of the tumor to the treatment.

    Blood tests and imaging studies may be performed to assess the concentration of the medications in the body and the impact on tumor and blood biomarkers.

  6. Step 6

    Completion of the trial

    The trial is expected to continue until December 31, 2030. Upon completion, the data collected will be analyzed to determine the overall safety and efficacy of the treatment combinations.

Who can join the trial?

10 criteria

  • The patient must have a solid tumor that cannot be removed by surgery, is locally advanced, or has spread to other parts of the body. This means the cancer is in a stage where it cannot be easily treated with surgery.
  • For most groups in the study, the patient must have a tumor that can be measured using a specific method called RECIST 1.1, except for a type of prostate cancer called mCRPC.
  • The patient should provide a sample of their tumor tissue, either from a previous test or a new sample if it can be safely taken.
  • The patient must have recovered from any side effects of previous treatments to a level that is considered safe or not significant by the doctor.
  • The patient must be 18 years or older.
  • The patient must have a **Karnofsky Performance Status** of 70% or higher. This is a score that measures the patient's ability to perform daily activities.
  • The patient must have organs and bone marrow that are working well enough to handle the treatment.
  • 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 partner must agree to use effective birth control during the study and for a certain time after the last treatment.
  • Female patients who can have children must not be pregnant at the start of the study.

Who cannot join the trial?

18 criteria

  • Patients who have a different type of cancer than those specified in the study.
  • Patients who have not received the required previous treatments for their specific type of cancer.
  • Patients who have certain health conditions that might interfere with the study treatment.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial recently.
  • Patients who have allergies to the study medications or their components.
  • Patients who have certain infections that are not well controlled.
  • Patients who have a history of certain heart conditions.
  • Patients who have a history of certain lung conditions.
  • Patients who have a history of certain liver conditions.
  • Patients who have a history of certain kidney conditions.
  • Patients who have a history of certain blood disorders.
  • Patients who have a history of certain immune system disorders.
  • Patients who have a history of certain neurological conditions.
  • Patients who have a history of certain psychiatric conditions.
  • Patients who have a history of substance abuse.
  • Patients who are unable to provide informed consent.
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Investigated drugs

  • XL092

    is an experimental medication being studied for its potential to treat advanced or metastatic solid tumors. It is being tested in combination with other cancer-fighting drugs to determine the best dose and to understand how it works in the body. Researchers are looking at how safe it is and how well it can help fight cancer.

  • Nivolumab

    is a type of immunotherapy used to help the body's immune system recognize and attack cancer cells. It is being tested in combination with other drugs to see if it can improve treatment outcomes for people with advanced cancers.

  • Ipilimumab

    is another immunotherapy drug that works by helping the immune system to better target and destroy cancer cells. In this study, it is used together with nivolumab to see if the combination can be more effective in treating cancer.

  • Relatlimab FDC

    is a fixed-dose combination of drugs that is being tested alongside nivolumab. This combination aims to enhance the immune system's ability to fight cancer by using two different mechanisms to target the disease.

What is already known about the treatment

Zanzalintinib – Zanzalintinib is administered orally and is currently being studied in clinical trials for its safety and effectiveness in treating various advanced or metastatic solid tumors. It is primarily being investigated for use in conditions such as clear cell renal cell carcinoma, metastatic castration-resistant prostate cancer, urothelial carcinoma, non-clear cell renal cell carcinoma, colorectal cancer, hepatocellular cancer, non-small cell lung cancer, and head and neck squamous cell carcinoma. The medication works by inhibiting specific molecular pathways that promote tumor growth and survival, classifying it as a targeted cancer therapy. Its development is focused on determining the optimal dosage and understanding its interactions with other immuno-oncology agents like nivolumab, ipilimumab, and relatlimab.

Investigated diseases

  • Clear Cell Renal Cell Carcinoma

    This 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. The disease can progress to advanced stages where it spreads to other parts of the body.

  • Metastatic Castration-Resistant Prostate Cancer

    This form of prostate cancer continues to grow and spread even when the amount of testosterone in the body is reduced to very low levels. It often spreads to bones and other organs, making it more challenging to manage.

  • Urothelial Carcinoma

    This cancer affects the lining of the urinary system, including the bladder, ureters, and part of the kidneys. It can be aggressive and may spread to other parts of the body if not detected early.

  • Non-Clear Cell Renal Cell Carcinoma

    Unlike clear cell renal cell carcinoma, this type includes various subtypes of kidney cancer that do not have clear cells. It can behave differently and may require different management strategies.

  • Colorectal Cancer

    This cancer starts in the colon or rectum and is often detected through screening tests. It can grow slowly over time and may spread to other parts of the body if not treated.

  • Hepatocellular Cancer

    This is the most common type of liver cancer, often associated with chronic liver diseases. It can develop as a single tumor or multiple small cancer nodules in the liver.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase ITrial ID2023-510061-10-00Protocol codeXL092-002Estimated enrolment862 patientsSponsorExelixis Inc.

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