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Study Comparing Savolitinib and Durvalumab with Sunitinib and Durvalumab for Patients with Advanced Papillary Renal Cell Carcinoma

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 a type of kidney cancer called papillary renal cell carcinoma (PRCC), which is driven by a specific factor known as MET. The study is looking at patients whose cancer cannot be removed by surgery and has spread to other parts of the body. The trial will test the effectiveness of a combination of two treatments, savolitinib and durvalumab, compared to another treatment called sunitinib and durvalumab given alone. Savolitinib is a medication that targets the MET factor, while durvalumab is an immunotherapy that helps the immune system fight cancer. Sunitinib is a medication that blocks certain proteins that help cancer cells grow.

The purpose of the study is to see how well these treatments work in stopping the cancer from getting worse. Participants will be randomly assigned to one of three groups: one group will receive savolitinib and durvalumab, another group will receive sunitinib, and the third group will receive durvalumab alone. The study will monitor the participants over time to see how long they live without the cancer getting worse and to check for any side effects from the treatments.

The trial will last for several years, and participants will have regular check-ups and tests to monitor their health and the progress of the cancer. The study aims to provide more information about the best treatment options for people with MET-driven PRCC, helping to improve future care for patients with this type of cancer.

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

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria, including a diagnosis of MET-driven, unresectable, and locally advanced or metastatic papillary renal cell carcinoma.

    A tumor sample is required to assess the condition.

  2. Step 2

    Randomization

    Participants are randomly assigned to one of three groups: savolitinib plus durvalumab, sunitinib, or durvalumab monotherapy.

  3. Step 3

    Treatment administration

    For those receiving savolitinib plus durvalumab:

    Savolitinib is taken orally in the form of tablets.

    Durvalumab is administered intravenously as a solution for infusion.

    For those receiving sunitinib:

    Sunitinib is taken orally in the form of capsules.

    For those receiving durvalumab monotherapy:

    Durvalumab is administered intravenously as a solution for infusion.

  4. Step 4

    Monitoring and assessments

    Regular monitoring is conducted to assess the effectiveness of the treatment.

    Progression-free survival (PFS) is evaluated to determine the time from randomization until disease progression or death.

    Additional assessments include overall survival (OS), objective response rate (ORR), duration of response (DoR), and disease control rate (DCR).

  5. Step 5

    End of study

    The study is estimated to conclude by June 29, 2026.

    Final evaluations are conducted to assess the outcomes of the treatment.

Who can join the trial?

11 criteria

  • The patient must have a type of kidney cancer called **Papillary Renal Cell Carcinoma (PRCC)** that cannot be removed by surgery and has spread to nearby areas or other parts of the body.
  • The cancer must be confirmed as **MET-driven**, which means it has a specific genetic change, using a special test done by the study's laboratory.
  • The patient should not have received any previous treatments for cancer that has spread, and should not have used certain drugs like **MET inhibitors**, **Durvalumab**, or **Sunitinib** before.
  • The patient must have a **Karnofsky Score** of 70 or higher, which is a way to measure their ability to carry out daily activities.
  • There must be at least one cancer area that has not been treated with radiation and can be measured accurately at the start of the study.
  • The patient must have organs and bone marrow that are working well enough.
  • The patient should have a life expectancy of at least 12 weeks.
  • The patient must have normal blood clotting abilities.
  • The patient must provide a sample of their tumor, preserved in a special way called **FFPE**, to check if the cancer is MET-driven.
  • Both male and female patients can participate.
  • Patients from vulnerable populations can also be included.

Who cannot join the trial?

10 criteria

  • Patients who have a different type of cancer that is not related to the study.
  • Patients who have had previous treatment with the same or similar medications being tested in the study.
  • Patients with severe or uncontrolled medical conditions that could interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who have participated in another clinical trial recently.
  • Patients with known allergies to the study medications.
  • Patients with a history of certain heart conditions.
  • Patients with active infections that require treatment.
  • Patients with a history of drug or alcohol abuse.
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Investigated drugs

  • Savolitinib

    is a medication being studied for its potential to treat certain types of kidney cancer. It works by targeting specific pathways in cancer cells that help them grow and spread. In this trial, it is being tested in combination with another medication to see if it can improve outcomes for patients with advanced kidney cancer.

  • Durvalumab

    is an immunotherapy drug that helps the body's immune system recognize and attack cancer cells. It is used in this trial to see if it can enhance the effects of other treatments in patients with advanced kidney cancer.

  • Sunitinib

    is a medication that is already used to treat kidney cancer. It works by blocking certain proteins that cancer cells need to grow. In this trial, it is being used as a comparison to see how well the new combination of treatments works against advanced kidney cancer.

What is already known about the treatment

  • Savolitinib

    Savolitinib is administered orally and is currently being studied in clinical trials for its effectiveness in treating MET-driven, unresectable, and locally advanced or metastatic papillary renal cell carcinoma. It is a selective MET inhibitor, which means it targets and blocks the MET receptor, a protein that can promote cancer cell growth when overactive. By inhibiting this receptor, savolitinib aims to slow down or stop the progression of cancer. It is classified as a tyrosine kinase inhibitor, a type of medication that interferes with specific enzymes involved in cancer cell signaling.

  • Durvalumab

    Durvalumab is given as an intravenous infusion and is being evaluated in clinical trials for its role in treating MET-driven, unresectable, and locally advanced or metastatic papillary renal cell carcinoma. It is an immune checkpoint inhibitor that works by blocking the PD-L1 protein on cancer cells, which can help the immune system recognize and attack these cells more effectively. This mechanism enhances the body's natural defenses against cancer. Durvalumab is classified as a monoclonal antibody, a type of drug designed to target specific proteins on cancer cells.

  • Sunitinib

    Sunitinib is taken orally and is part of ongoing clinical trials for its use in treating MET-driven, unresectable, and locally advanced or metastatic papillary renal cell carcinoma. It functions as a multi-targeted receptor tyrosine kinase inhibitor, which means it blocks several enzymes that promote tumor growth and blood vessel formation. By inhibiting these pathways, sunitinib aims to reduce tumor size and slow disease progression. It is classified under tyrosine kinase inhibitors, a group of drugs that target specific enzymes involved in cancer cell proliferation.

Investigated diseases

Papillary 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 formation of small, finger-like projections, or papillae, in the tumor. The disease can be classified into two types: Type 1, which tends to grow slowly, and Type 2, which is more aggressive. When the cancer is described as "MET-driven," it means that genetic changes in the MET gene are driving the growth of the cancer cells. The condition can become unresectable, meaning it cannot be removed surgically, and may progress to a locally advanced or metastatic stage, where it spreads beyond the kidney to other parts of the body.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2022-503105-38-00Protocol codeD5086C00001Estimated enrolment144 patientsSponsorAstraZeneca AB

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