Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Not recruiting

Study of Pembrolizumab, Belzutifan, and Lenvatinib for Patients with Advanced Clear Cell Renal Cell Carcinoma

Fast replyRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

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

This clinical trial is focused on studying treatments for advanced clear cell renal cell carcinoma, a type of kidney cancer. The study will explore the effectiveness and safety of different combinations of medications. The medications being tested include Pembrolizumab (also known by its code name MK-3475), Belzutifan (MK-6482), Lenvatinib (MK-7902), and a combination of Pembrolizumab and Quavonlimab (MK-1308A). These treatments are being compared to see which combination works best as a first-line treatment, meaning it is the first treatment given for this type of cancer.

The purpose of the study is to determine which combination of these medications can help patients live longer without their cancer getting worse. Participants will be randomly assigned to receive one of the treatment combinations. Some participants will receive Pembrolizumab with Belzutifan and Lenvatinib, others will receive MK-1308A with Lenvatinib, and another group will receive Pembrolizumab with Lenvatinib. There is also a possibility of receiving a placebo, which is a substance with no active medication, to compare the effects of the actual treatments.

The study will monitor participants over a period to assess how well the treatments work and to check for any side effects. The goal is to find the most effective treatment combination that can help manage the disease and improve the quality of life for those with advanced clear cell renal cell carcinoma. Participants will receive regular check-ups and assessments to track their progress throughout the study.

The research process

The trial runs in 7 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, you will be randomly assigned to one of the treatment groups. This means you will receive a specific combination of medications as part of the trial.

  2. Step 2

    Treatment group assignment

    You may be placed in one of the following groups: Arm A, Arm B, or Arm C. Each group receives different combinations of medications.

  3. Step 3

    Medication administration

    If you are in Arm A, you will receive pembrolizumab through an intravenous infusion, belzutifan as an oral tablet, and lenvatinib as an oral capsule.

    If you are in Arm B, you will receive MK-1308A through an intravenous infusion and lenvatinib as an oral capsule.

    If you are in Arm C, you will receive pembrolizumab through an intravenous infusion and lenvatinib as an oral capsule.

  4. Step 4

    Medication schedule

    The intravenous infusion of pembrolizumab or MK-1308A will be administered at the study site. The frequency and duration of these infusions will be explained to you by the study team.

    The oral medications, belzutifan and lenvatinib, will be taken at home. The study team will provide instructions on how often and how long you need to take these medications.

  5. Step 5

    Regular check-ups

    You will have regular check-ups with the study team to monitor your health and the effects of the treatment. These check-ups may include physical exams, blood tests, and imaging tests.

  6. Step 6

    Reporting side effects

    It is important to report any side effects or changes in your health to the study team immediately. This helps ensure your safety and the success of the study.

  7. Step 7

    End of treatment

    At the end of the treatment period, you will have a final evaluation to assess your response to the treatment. The study team will discuss the results with you and provide any necessary follow-up care.

Who can join the trial?

7 criteria

  • The patient must have a confirmed diagnosis of **clear cell renal cancer**. This means that a doctor has determined the patient has this specific type of kidney cancer.
  • The patient must not have received any previous treatment for advanced **clear cell renal cancer**. This means they have not been treated with drugs or therapies for this advanced stage of cancer.
  • Male patients must either not engage in sexual intercourse with women or agree to use birth control during the study and for at least 7 days after the last dose of the study drugs **belzutifan** and **lenvatinib**.
  • Female patients must not be pregnant or breastfeeding. They must either be unable to become pregnant or agree to use a highly effective birth control method or not engage in sexual intercourse with men during the study and for a certain period after the last dose of the study drugs. This period is at least 120 days after receiving **pembrolizumab** or **pembrolizumab/quavonlimab**, or at least 30 days after the last dose of **lenvatinib** or **belzutifan**, whichever is longer.
  • The patient must have **adequately controlled blood pressure**. This means their blood pressure is at a safe level, with or without medication.
  • The patient must have **adequate organ function**. This means their organs, like the liver and kidneys, are working well enough to participate in the study.
  • If the patient is receiving treatment to prevent bone loss, this treatment must have started at least 2 weeks before joining the study.

Who cannot join the trial?

10 criteria

  • Patients with any other type of cancer besides clear cell renal cancer cannot participate.
  • Patients who have had another cancer within the last 5 years, except for skin cancer that is not melanoma, cannot participate.
  • Patients who have had a major surgery within the last 4 weeks cannot participate.
  • Patients who have an active infection that requires treatment with antibiotics cannot participate.
  • Patients who have a known allergy to the study medication or its ingredients cannot participate.
  • Patients who are pregnant or breastfeeding cannot participate.
  • Patients who have a history of heart problems, such as heart attack or heart failure, cannot participate.
  • Patients who have uncontrolled high blood pressure cannot participate.
  • Patients who have a history of bleeding disorders cannot participate.
  • Patients who are currently participating in another clinical trial cannot participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

  • Pembrolizumab

    is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. This medication is often used to treat various types of cancer, including advanced kidney cancer, by blocking a specific protein that prevents the immune system from doing its job effectively.

  • Belzutifan

    is a medication that targets a specific pathway in cancer cells, which is important for their growth and survival. By blocking this pathway, Belzutifan can help slow down or stop the growth of cancer cells. It is used in combination with other treatments to enhance their effectiveness in treating advanced kidney cancer.

  • Lenvatinib

    is a medication that works by blocking certain proteins that help cancer cells grow and spread. It is used to treat various types of cancer, including advanced kidney cancer. By interfering with these proteins, Lenvatinib can help slow down the progression of the disease.

  • MK-1308A

    is an investigational medication being studied for its potential to treat advanced kidney cancer. It is designed to work with the immune system to help it better recognize and attack cancer cells. This medication is being tested in combination with other treatments to see if it can improve outcomes for patients with this type of cancer.

What is already known about the treatment

  • Pembrolizumab

    Pembrolizumab is administered as an intravenous infusion, meaning it is given directly into the bloodstream through a vein. It is currently a well-established medication in the treatment of various cancers, including advanced clear cell renal cell carcinoma. The main therapeutic use of pembrolizumab is to help the immune system recognize and attack cancer cells. At the molecular level, it works by blocking a protein called PD-1 on immune cells, which helps the immune system to better detect and destroy cancer cells. Pembrolizumab is classified as an immune checkpoint inhibitor.

  • Belzutifan

    Belzutifan is taken orally in the form of tablets. It is a newer medication being studied for its effectiveness in treating advanced clear cell renal cell carcinoma. The primary therapeutic indication for belzutifan is to inhibit the growth of cancer cells. It works at the molecular level by blocking a protein called HIF-2α, which is involved in the growth and survival of cancer cells. Belzutifan is classified as a HIF-2α inhibitor.

  • Lenvatinib

    Lenvatinib is administered orally as a capsule. It is an established treatment for certain types of cancer, including advanced clear cell renal cell carcinoma. The main therapeutic use of lenvatinib is to slow down or stop the growth of cancer cells. It works by blocking certain proteins called tyrosine kinases, which are involved in the growth of cancer cells and the formation of blood vessels that supply tumors. Lenvatinib is classified as a tyrosine kinase inhibitor.

  • MK-1308A

    MK-1308A is administered as an intravenous infusion. It is currently being studied in clinical trials for its potential use in treating advanced clear cell renal cell carcinoma. The main therapeutic goal of MK-1308A is to enhance the immune system's ability to fight cancer. It works by targeting specific proteins that can suppress the immune response against cancer cells. MK-1308A is classified as an immune checkpoint inhibitor.

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 often begins as a small mass in the kidney and can grow over time. As it progresses, it may invade nearby tissues and spread to other parts of the body, such as the lungs, bones, or liver. The growth and spread of the cancer can lead to symptoms such as blood in the urine, pain in the side or back, and a lump in the abdomen. The progression of the disease can vary greatly among individuals.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-502122-41-00Protocol codeMK-6482-012Estimated enrolment1 682 patientsSponsorMerck Sharp & Dohme LLC

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.