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Study of Belzutifan with Lenvatinib versus Cabozantinib in Adults with Advanced Renal Cell Carcinoma Who Have Previously Received Anti-PD-1/L1 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 advanced renal cell carcinoma (a type of kidney cancer) that has clear cell features and has gotten worse after previous treatment. The study tests two different treatment approaches. The first approach combines two medications: belzutifan and lenvatinib. The second approach uses a single medication called cabozantinib. These medications are taken by mouth in the form of tablets or capsules.

The purpose of this study is to compare how well these two treatment approaches work in people whose cancer has progressed after receiving a specific type of immunotherapy (anti-PD-1/L1 therapy). The study will measure which treatment is better at stopping the cancer from growing and helping patients live longer.

During the study, participants will be randomly assigned to receive either the combination of belzutifan and lenvatinib or cabozantinib alone. The treatment will continue for up to 46 months, as long as it is working and the side effects are manageable. Throughout the study, doctors will regularly check the participants' health and monitor how their cancer responds to the treatment.

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 evaluation

    Your eligibility for the study will be assessed based on having advanced renal cell carcinoma (kidney cancer) with clear cell component

    Your medical history will be reviewed, particularly previous treatments with anti-PD-1/L1 therapy

    Your blood pressure and overall physical condition will be evaluated

    Your organ function will be assessed through medical tests

  2. Step 2

    Treatment assignment

    You will be randomly assigned to one of two treatment groups:

    Group 1: Combination of belzutifan (tablets) and lenvatinib (capsules) taken by mouth

    Group 2: Cabozantinib taken by mouth

  3. Step 3

    Treatment period

    You will take the assigned medication orally according to the prescribed schedule

    Regular assessments will be conducted to monitor your tumor response using imaging scans

    Your health status and any side effects will be monitored throughout the treatment

    Treatment will continue until disease progression or other stopping criteria are met

  4. Step 4

    Safety monitoring

    Regular medical check-ups will be performed to monitor your health

    Any side effects or adverse events will be recorded and assessed

    Blood pressure and organ function will be monitored regularly

    You may need to use appropriate birth control methods during treatment and for a specified period afterward (30-120 days depending on treatment group)

  5. Step 5

    Follow-up period

    Your health status will continue to be monitored after treatment completion

    Regular assessments will track your cancer progression status

    The study is expected to continue until February 2026

Who can join the trial?

11 criteria

  • You must have advanced kidney cancer (specifically clear cell renal cell carcinoma) that cannot be surgically removed or has spread to other parts of the body
  • Your organs must be functioning properly
  • You must have had your cancer progress during or after treatment with immunotherapy (anti-PD-1/L1 therapy), either as initial treatment or after surgery
  • Your cancer must be measurable using special imaging techniques
  • You must have good physical function, with a Karnofsky performance score of at least 70% (able to care for yourself but unable to carry out normal activities)
  • You must have received no more than 2 previous cancer treatments
  • You must have received only 1 previous immunotherapy treatment
  • Your blood pressure must be well controlled
  • If you are a male participant, you must agree to use contraception during treatment and for at least 7 days after the last dose
  • If you are a female participant, you must not be pregnant or breastfeeding, and either:
    • Be unable to have children, or
    • Agree to use contraception during treatment and for at least 30-120 days after the last dose, depending on treatment group

Who cannot join the trial?

14 criteria

  • Prior treatment with belzutifan (a medication that targets cancer cells) or cabozantinib (a type of targeted therapy)
  • Active brain metastases (cancer that has spread to the brain)
  • Severe heart conditions, including:
    • Uncontrolled high blood pressure
    • Heart attack within the last 6 months
    • Unstable heart rhythm problems
    • Severe liver problems or abnormal liver function tests
    • Known HIV infection
    • Active hepatitis B or C infection
    • Other active cancers requiring treatment (except for certain skin cancers or early-stage cancers that have been successfully treated)
    • Major surgery within 3 weeks before starting the study treatment
    • Pregnancy or breastfeeding
    • Unable to swallow oral medications
    • Any serious medical condition that could interfere with study participation or make it unsafe
    • Participation in another clinical trial within 4 weeks before starting this study
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Investigated drugs

Belzutifan (also known as MK-6482) is a medication that works by blocking a protein involved in cancer growth. It is being studied as a treatment for advanced kidney cancer in patients whose cancer has progressed after previous immunotherapy treatments. Lenvatinib (also known as MK-7902) is a medication that helps stop cancer cells from growing and forming new blood vessels. It works by blocking specific proteins that cancer cells need to grow and spread. It is already approved for treating several types of cancer, including kidney cancer. Cabozantinib is a medication that targets multiple proteins involved in cancer growth and spread. It works by blocking signals that cancer cells use to grow and create new blood vessels. It is currently used to treat advanced kidney cancer and has shown effectiveness in patients who have tried other treatments. The trial studies the combination of belzutifan and lenvatinib compared to cabozantinib alone in treating advanced kidney cancer (renal cell carcinoma) in patients whose cancer has progressed after receiving a specific type of immunotherapy.

What is already known about the treatment

  • Belzutifan

    An oral medication used in advanced renal cell carcinoma (kidney cancer) treatment that works by blocking HIF-2α, a protein involved in cancer growth when oxygen levels are low. This novel drug belongs to the class of HIF-2α inhibitors and is typically administered in tablet form as part of combination therapy with other cancer medications.

  • Lenvatinib

    A targeted oral therapy that belongs to the class of tyrosine kinase inhibitors, used in the treatment of various cancers including advanced kidney cancer. It works by blocking specific proteins that promote blood vessel growth in cancer cells, effectively cutting off their blood supply and inhibiting tumor growth.

  • Cabozantinib

    An oral medication from the tyrosine kinase inhibitor class used to treat advanced kidney cancer that has progressed after other treatments. It works by blocking multiple proteins involved in cancer growth and blood vessel development, helping to slow or stop cancer progression while taken as a daily tablet.

Investigated diseases

Renal Cell Carcinoma (RCC) - A type of kidney cancer that begins in the lining of small tubes within the kidneys. The clear cell variant is the most common form of RCC, characterized by cells that appear clear or pale when viewed under a microscope. The disease typically develops in the kidney's outer layer and can grow into a tumor over time. As it advances, the cancer may spread beyond the kidney to nearby lymph nodes or other organs. The clear cell component refers to the specific appearance of the cancer cells when examined in a laboratory.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-510620-39-00Protocol codeMK-6482-011Estimated enrolment708 patientsSponsorMerck Sharp & Dohme LLC

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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).