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Study of XL092 and belzutifan combination therapy in people with clear cell kidney cancer who had disease return during or after immunotherapy treatment

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What is this trial about?

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

This clinical trial focuses on treating clear cell renal cell carcinoma, a type of kidney cancer. The study will test a combination of medications including XL092 (also known as Zanzalintinib) and Belzutifan in patients whose cancer has returned during or after previous treatment. The purpose is to evaluate how well these medications work together and to determine their safety when used in combination.

The study is divided into two phases. The first phase will focus on finding the right dose of the medications and checking their safety. The second phase will look at how effective the treatment is in fighting the cancer. The medications are taken by mouth in the form of tablets. Patients will be monitored for any side effects and how their cancer responds to the treatment.

Throughout the study, doctors will track how the tumors respond to treatment, how long the response lasts, and how long patients survive without their cancer getting worse. They will also monitor the overall survival of patients and look for any benefits from the treatment. Regular medical check-ups and tests will be performed to ensure patient safety and evaluate the treatment's effectiveness.

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

    Initial medication phase

    You will receive two medications: Belzutifan (film-coated tablet) and XL092 (tablet). Both medications are taken orally.

    Your blood pressure must be controlled and not exceed 140/90 mm Hg before starting the treatment.

  2. Step 2

    Regular monitoring

    Your doctor will monitor for any side effects or unwanted reactions to the medications.

    Regular assessments will be performed to measure how your tumor responds to treatment using RECIST 1.1 criteria (a standardized way to measure changes in tumor size).

    Blood tests will be conducted to check your organ function throughout the study.

  3. Step 3

    Follow-up assessments

    Regular imaging scans will be performed to track any changes in your kidney cancer.

    Your doctor will monitor how long the treatment remains effective.

    The study will track how long you remain free from disease progression.

  4. Step 4

    Safety requirements

    Male participants must continue contraception for at least 7 days after the last dose of Belzutifan and 96 days after the last dose of XL092.

    Female participants must continue contraception for at least 30 days after the last dose of Belzutifan and 186 days after the last dose of XL092.

    Female participants must not breastfeed for 96 days after the last dose of study medications.

  5. Step 5

    Study completion

    The study is expected to continue until June 2030.

    Your participation may end earlier if your disease progresses or if you experience significant side effects.

    After completing the treatment, you will continue to be monitored for any lasting effects and overall survival.

Who can join the trial?

11 criteria

  • Must have confirmed diagnosis of clear cell renal cell carcinoma (a type of kidney cancer) that cannot be surgically removed or has spread to other parts of the body
  • Must be between 18 and 120 years of age
  • For male participants: - Must use contraception for at least 7 days after the last dose of Belzutifan and 96 days after the last dose of Zanzalintinib - Must not donate sperm during this period - Must use appropriate contraception methods or remain abstinent
  • For female participants: - Must not be breastfeeding - Must have a negative pregnancy test before starting treatment - Must use effective contraception for at least 30 days after the last dose of Belzutifan and 186 days after the last dose of Zanzalintinib
  • Must not have received any previous systemic treatment (medication that travels through the bloodstream) for advanced kidney cancer, except for certain immunotherapy treatments
  • Must have measurable disease that can be evaluated using specific medical criteria
  • Must be able to swallow oral medication
  • Must provide a tumor tissue sample, either from previous procedures or a new biopsy
  • If receiving bone treatments, must have started them at least 2 weeks before beginning the study
  • Must have controlled blood pressure (140/90 mm Hg or lower)
  • Must have adequate organ function

Who cannot join the trial?

15 criteria

  • History of autoimmune diseases (conditions where the body's immune system attacks its own tissues)
  • Active or untreated brain metastases (cancer that has spread to the brain)
  • Significant heart conditions including heart failure, uncontrolled high blood pressure, or irregular heart rhythm
  • Active infections requiring systemic treatment (medications that affect the whole body)
  • Previous organ transplant requiring ongoing immunosuppression (medications that weaken the immune system)
  • Other active cancers requiring treatment, except for certain skin cancers
  • Severe kidney or liver problems
  • Pregnancy or breastfeeding
  • Known allergies to study medications
  • Participation in other clinical trials within the past 30 days
  • Mental conditions that could interfere with study compliance
  • Use of medications that could interact with study drugs
  • HIV, active hepatitis B, or hepatitis C infection
  • History of severe reactions to similar treatments
  • Major surgery within 28 days before starting the study
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Investigated drugs

Based on the provided trial data, I cannot extract specific medications as the source data doesn't contain detailed information about the treatments. However, from the trial title, we can identify that this study involves: Anti-PD-(L)1 therapy, which is a type of immunotherapy that helps the immune system recognize and fight cancer cells. It's commonly used as an adjuvant (additional) treatment for renal cell carcinoma (RCC). This appears to be a study investigating combinations of immune and targeted therapies, but specific medication names are not provided in the source data. Since no other specific medications or therapies are mentioned in the provided data, I cannot provide additional medication descriptions.

What is already known about the treatment

Based on the provided trial data, this appears to be a study involving immunotherapy and targeted therapies for renal cell carcinoma, but specific medication names are not provided in the source data. Without explicit medication information, I cannot create detailed medication descriptions in the requested format. The trial mentions anti-PD-(L)1 therapy as a previous treatment category, but doesn't specify individual medications. If you would like medication descriptions, please provide specific medication names from the clinical trial, and I will create detailed descriptions following your requested format.

Investigated diseases

Clear Cell Renal Cell Carcinoma - A type of kidney cancer that begins in the cells lining the small tubes in the kidney that filter waste from the blood. It gets its name from the clear appearance of the cancer cells when viewed under a microscope due to their high lipid and glycogen content. The disease typically starts in one kidney but can potentially spread to other parts of the body. This cancer develops when healthy cells in the kidney undergo genetic changes that cause them to grow uncontrollably and form a mass. Clear cell renal cell carcinoma is the most common form of kidney cancer in adults.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-516437-12-00Protocol codeMK-3475-03CEstimated enrolment127 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

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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.

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