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Study of Pembrolizumab and Axitinib Combination Versus Sunitinib for Patients with Advanced or Metastatic Kidney Cancer

Fast replyRegistered drugNo placebo
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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 a type of kidney cancer known as metastatic renal cell carcinoma. The study is investigating the effectiveness and safety of a combination treatment using two medications, pembrolizumab and axitinib, compared to a single medication called sunitinib. Pembrolizumab, also known by its code name MK-3475, is a medication that helps the immune system fight cancer cells. Axitinib and sunitinib are both medications that work by blocking certain proteins that help cancer cells grow.

The purpose of this study is to compare how well patients with advanced kidney cancer respond to the combination of pembrolizumab and axitinib versus those who receive only sunitinib. Participants in the study will be randomly assigned to receive either the combination treatment or the single medication. The study will monitor the participants over a period to see how the cancer responds to the treatments and to check for any side effects.

Throughout the study, participants will receive regular check-ups and assessments to track their health and the progress of their cancer. The study aims to provide valuable information on which treatment option might be more effective for patients with this type of kidney cancer. The trial is expected to continue until the end of 2025, allowing researchers to gather comprehensive data on the treatments' long-term effects.

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, you will be randomly assigned to one of two groups. One group will receive a combination of pembrolizumab and axitinib, while the other group will receive sunitinib alone.

    This assignment is random, meaning it is like flipping a coin to decide which treatment you will receive.

  2. Step 2

    Treatment with pembrolizumab and axitinib

    If you are in the group receiving pembrolizumab and axitinib, you will receive pembrolizumab through an intravenous infusion. This means the medication will be given to you directly into a vein through a needle.

    You will also take axitinib by mouth in the form of a pill. The specific dosage and frequency will be explained to you by the study team.

  3. Step 3

    Treatment with sunitinib

    If you are in the group receiving sunitinib, you will take this medication by mouth in the form of a pill.

    The specific dosage and frequency will be explained to you by the study team.

  4. Step 4

    Regular check-ups

    Throughout the study, you will have regular check-ups to monitor your health and the effects of the treatment.

    These check-ups will include physical exams, blood tests, and imaging tests to see how the treatment is working.

  5. Step 5

    Reporting side effects

    It is important to report any side effects or changes in your health to the study team immediately.

    The study team will provide guidance on how to manage any side effects you may experience.

  6. Step 6

    End of treatment

    The treatment will continue until the study ends or until it is no longer beneficial for you.

    The study team will discuss the next steps with you as the study comes to an end.

Who can join the trial?

10 criteria

  • Has a confirmed diagnosis of renal cell carcinoma (RCC) with a clear cell component, which may or may not have sarcomatoid features.
  • Has locally advanced or metastatic disease (meaning the cancer has spread to other parts of the body) or has recurrent disease.
  • Has measurable disease according to specific medical guidelines assessed by a doctor or radiologist.
  • Has not received any prior systemic therapy for advanced RCC.
  • Has provided a sample of tumor tissue, either from a previous sample or a new biopsy of a tumor that has not been treated with radiation.
  • Has a Karnofsky performance status (KPS) of 70% or higher, which is a measure of the ability to carry out daily activities.
  • If receiving treatment to prevent bone loss, such as bisphosphonates or RANK-L inhibitors, the treatment must have started at least 2 weeks before joining the study.
  • Demonstrates adequate organ function, meaning the organs are working well enough to participate in the study.
  • Male participants who can father children must agree to use a reliable method of birth control from the first dose of the study drug until 120 days after the last dose.
  • Female participants who can become pregnant must agree to use a reliable method of birth control during the study and for 120 days after the last dose of the study drug.

Who cannot join the trial?

12 criteria

  • Patients with other types of cancer that have spread to other parts of the body cannot participate.
  • Patients who have had another cancer within the last 5 years, except for certain skin cancers or in situ cancers (cancers that have not spread), are excluded.
  • Patients with active infections that require treatment with antibiotics, antivirals, or antifungals are not eligible.
  • Patients with a history of severe allergic reactions to similar drugs used in the study cannot join.
  • Patients with uncontrolled high blood pressure, which means blood pressure that is not managed by medication, are excluded.
  • Patients with significant heart problems, such as heart failure or recent heart attacks, cannot participate.
  • Patients with brain metastases, which means cancer that has spread to the brain, are not eligible unless treated and stable.
  • Patients who are pregnant or breastfeeding cannot join the study.
  • Patients who have received another investigational drug within the last 4 weeks are excluded.
  • Patients with autoimmune diseases, which are conditions where the immune system attacks the body, are not eligible.
  • Patients with a history of organ transplant cannot participate.
  • Patients with known HIV, hepatitis B, or hepatitis C infections are excluded.
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Investigated drugs

  • Pembrolizumab

    is a type of medication known as an immunotherapy. It works by helping your immune system recognize and attack cancer cells. In this trial, pembrolizumab is used in combination with another medication to see if it can help treat kidney cancer that has spread to other parts of the body or is locally advanced.

  • Axitinib

    is a medication that targets specific proteins in cancer cells, which can help stop the cancer from growing and spreading. It is used in this trial alongside pembrolizumab to see if the combination is more effective than using another treatment alone for kidney cancer.

  • Sunitinib

    is a medication that is used on its own in this trial. It works by blocking certain proteins that cancer cells need to grow. The trial is comparing the effectiveness of sunitinib alone to the combination of pembrolizumab and axitinib in treating kidney 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 field of oncology, particularly in the treatment of various cancers, and is widely discussed in medical literature. The main therapeutic indication for pembrolizumab in this trial is metastatic renal cell carcinoma, a type of kidney cancer that has spread to other parts of the body. At the molecular level, pembrolizumab works by blocking a specific protein called PD-1 on immune cells, which helps the immune system recognize and attack cancer cells more effectively. It is classified as an immune checkpoint inhibitor, a type of drug that helps the body's immune system fight cancer.

  • Axitinib

    Axitinib is taken orally in the form of a tablet, which means it is swallowed and absorbed through the digestive system. It is an established treatment option in oncology, particularly for kidney cancer, and is frequently mentioned in medical research and literature. In this clinical trial, axitinib is used to treat metastatic renal cell carcinoma, a form of kidney cancer that has spread beyond the kidney. Axitinib works by inhibiting certain proteins called tyrosine kinases, which are involved in the growth of blood vessels that supply nutrients to tumors, effectively starving the cancer cells. It is classified as a tyrosine kinase inhibitor, a type of medication that blocks signals needed for tumors to grow.

  • Sunitinib

    Sunitinib is administered orally as a capsule, which is taken by mouth and absorbed through the digestive tract. It is a well-known medication in the treatment of various cancers, including kidney cancer, and is extensively covered in medical literature. The primary use of sunitinib in this trial is for treating metastatic renal cell carcinoma, a type of kidney cancer that has spread to other areas of the body. Sunitinib works by blocking multiple proteins, including tyrosine kinases, that are involved in the growth and spread of cancer cells and the formation of blood vessels that supply tumors. It is classified as a multi-targeted tyrosine kinase inhibitor, a type of drug that interferes with cancer cell growth and blood supply.

Investigated diseases

Metastatic renal cell carcinoma – Metastatic renal cell carcinoma is a type of kidney cancer that has spread beyond the kidney to other parts of the body. It originates in the renal cortex, where the kidney's filtering units are located. The disease progresses as cancer cells travel through the bloodstream or lymphatic system to form secondary tumors in other organs, such as the lungs, bones, or liver. As the cancer spreads, it can cause symptoms like pain, fatigue, and weight loss. The progression of the disease can vary, with some patients experiencing rapid spread while others may have a slower progression. The spread of cancer cells can lead to complications depending on the organs affected.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-507294-18-00Protocol codeMK-3475-426Estimated enrolment861 patientsSponsorMerck Sharp & Dohme LLC

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