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Study of Axitinib and Immune Checkpoint Inhibitors for Patients with Untreated Advanced or Metastatic Kidney Cancer

Verified siteRegistered 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 treatments for renal cell carcinoma, a type of kidney cancer that is locally advanced, cannot be surgically removed, or has spread to other parts of the body. The study involves several medications, including RO7247669 (also known as Tobemstomig), Tiragolumab, Pembrolizumab (marketed as KEYTRUDA), and Axitinib. These medications are used in different combinations to explore their effectiveness and safety in treating this form of cancer.

The purpose of the study is to evaluate how well these combinations work and how safe they are for patients. Participants will receive these medications through an intravenous infusion, which means the medicine is given directly into a vein. The study will compare different groups of patients receiving different combinations of these drugs. One group will receive Tobemstomig and Axitinib, another will receive Tiragolumab, Tobemstomig, and Axitinib, and a control group will receive Pembrolizumab and Axitinib. Some participants may receive a placebo, which is a substance with no active medication, to help compare the effects of the actual drugs.

The study will take place over a period of up to 24 months, during which participants will be monitored for any changes in their condition and any side effects they may experience. The goal is to determine which combination of treatments is most effective in slowing down the progression of the cancer and to assess the overall safety of these treatments. Participants will be closely observed by medical professionals throughout the study to ensure their well-being and to gather important data on the treatments being tested.

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, eligibility is confirmed based on specific criteria, including the type of renal cell carcinoma and overall health status.

    Initial assessments are conducted to establish a baseline for your health and the extent of the disease.

  2. Step 2

    Randomization

    You are randomly assigned to one of the study groups. This could be Arm A, Arm B, or the Control Arm.

    The assignment determines the combination of medications you will receive during the trial.

  3. Step 3

    Treatment administration

    If assigned to Arm A, you will receive tobemstomig and axitinib. If assigned to Arm B, you will receive tiragolumab, tobemstomig, and axitinib. The Control Arm involves pembrolizumab and axitinib.

    Tobemstomig, tiragolumab, and pembrolizumab are administered intravenously, meaning they are given through a vein. Axitinib is taken orally, as a pill.

    The frequency and duration of each medication depend on the specific protocol of the study arm you are assigned to.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the effectiveness of the treatment and to check for any side effects.

    Assessments include imaging tests to measure the size of the tumor and blood tests to monitor your health.

  5. Step 5

    End of treatment

    The treatment phase continues until the study's end date or until it is determined that the treatment is no longer effective or safe for you.

    Final assessments are conducted to evaluate the overall impact of the treatment on your health and the progression of the disease.

  6. Step 6

    Follow-up

    After the treatment phase, follow-up visits are scheduled to monitor your health and any long-term effects of the treatment.

    These visits help in understanding the overall survival and response rate to the treatment.

Who can join the trial?

10 criteria

  • The patient must have **untreated** locally advanced or metastatic renal cell carcinoma, which means the cancer has not been treated and is either in a nearby area or has spread to other parts of the body.
  • The patient should have an **IMDC risk score** of intermediate (1 or 2) or poor (3 to 6). This score helps to understand the risk level of the cancer.
  • The patient must have a **measurable disease**, meaning there is at least one tumor that can be measured using specific criteria called RECIST v1.1.
  • The patient needs to have **adequate hematologic and end-organ function**, which means their blood and organs are working well enough to participate in the study. This will be checked within 14 days before starting the study treatment.
  • The cancer must be **clear-cell renal cell carcinoma (ccRCC)**, which is a specific type of kidney cancer. It can have sarcomatoid features, but other types like papillary, chromophobe, and unclassified are not allowed.
  • The patient must have a **negative hepatitis B surface antigen (HBsAg) test** and a **negative hepatitis C virus (HCV) antibody test** at screening. If the HCV antibody test is positive, a follow-up test must show negative HCV RNA.
  • The patient must have a **positive hepatitis B surface antibody (HBsAb) test** at screening, or if the HBsAb is negative, it should be confirmed at screening.
  • The patient must be within the age range of **18 to 64 years old**.
  • Both **male and female** patients can participate in the study.
  • The study may include **vulnerable populations**, which means it might involve people who need special protection or care.

Who cannot join the trial?

4 criteria

  • Patients who have not received treatment for their kidney cancer that has spread or cannot be removed by surgery.
  • Patients who are not within the specified age range for the study.
  • Patients who belong to a specific clinical trial group that is not included in this study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care.
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Investigated drugs

  • Tobemstomig

    is an immune checkpoint inhibitor being studied for its potential to help the body's immune system fight cancer cells. It is being tested in combination with other medications to see if it can improve outcomes for patients with advanced kidney cancer.

  • Axitinib

    is a medication that works by blocking certain proteins that help cancer cells grow. It is used in this trial to see if it can enhance the effects of other treatments in patients with advanced kidney cancer.

  • Pembrolizumab

    is another immune checkpoint inhibitor that helps the immune system recognize and attack cancer cells. It is being used as a comparison treatment in this study to evaluate the effectiveness of new drug combinations.

  • Tiragolumab

    is an experimental drug that is also an immune checkpoint inhibitor. It is being tested in combination with other medications to determine if it can provide additional benefits in treating advanced kidney cancer.

What is already known about the treatment

  • Tobemstomig

    This medication is administered intravenously and is currently being studied in clinical trials for its effectiveness in treating advanced renal cell carcinoma. It is an immune checkpoint inhibitor, which means it helps the immune system recognize and attack cancer cells. Tobemstomig works by blocking specific proteins that prevent immune cells from attacking cancer, thereby enhancing the body's natural immune response against tumors. It is classified as an immunotherapy agent.

  • Axitinib

    Axitinib is taken orally in the form of tablets and is approved for use in treating advanced renal cell carcinoma. It is a tyrosine kinase inhibitor, which means it blocks certain enzymes that promote cancer cell growth. By inhibiting these enzymes, axitinib helps to slow down or stop the growth of cancer cells. It is classified as a targeted therapy.

  • Pembrolizumab

    This medication is given through an intravenous infusion and is widely used in the treatment of various cancers, including renal cell carcinoma. Pembrolizumab is an immune checkpoint inhibitor that works by blocking a protein called PD-1, which helps the immune system detect and fight cancer cells more effectively. It is classified as an immunotherapy agent.

  • Tiragolumab

    Administered intravenously, tiragolumab is currently under investigation in clinical trials for its potential in treating renal cell carcinoma. It is an immune checkpoint inhibitor that targets specific proteins to enhance the immune system's ability to fight cancer. By blocking these proteins, tiragolumab aims to improve the immune response against cancer cells. It is classified as an immunotherapy agent.

Investigated diseases

Renal Cell Carcinoma – This is a type of kidney cancer that begins in the lining of the small tubes in the kidney. It is often detected at an advanced stage, where it may have spread beyond the kidney to other parts of the body. The disease can be locally advanced, meaning it has grown into nearby tissues, or metastatic, indicating it has spread to distant organs. As the cancer progresses, it can cause symptoms such as blood in the urine, pain in the side, and a lump in the abdomen. The progression of the disease can vary, with some cases remaining stable for a period, while others may advance more rapidly.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-505816-39-00Protocol codeBO43936Estimated enrolment217 patientsSponsorF. Hoffmann-La Roche AG

sourced from the EU Clinical Trials Register and site verification

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