All studies
Active not recruitingPHASE3INTERVENTIONAL

Savolitinib Plus Durvalumab Versus Sunitinib and Durvalumab Monotherapy in MET-Driven, Unresectable and Locally Advanced or Metastatic PRCC

This research is looking into better ways to treat a specific type of advanced kidney cancer called Papillary Renal Cell Carcinoma (PRCC). This particular cancer is linked to a genetic change called "MET-driven." The study is comparing two different drug combinations: savolitinib plus durvalumab, or durvalumab on its own, against a standard treatment, sunitinib. It aims to see which treatment is most effective and safest for people who haven't had other treatments for their advanced cancer. Doctors hope to find out if these newer combinations are better than current options for helping patients with this challenging condition.

At a glance

Status
Active not recruiting
Phase
PHASE3
Sponsor
AstraZeneca
Enrolment target
148
Start
28 Oct 2021
Estimated completion
01 Feb 2027

What is this study about?

This study is a Phase III clinical trial, which means it's a very important step to see if new treatments are better than existing ones. It's designed for people with a specific type of kidney cancer called Papillary Renal Cell Carcinoma (PRCC). This cancer is described as "unresectable and locally advanced or metastatic," which means it has spread or cannot be removed by surgery. Crucially, the cancer must be linked to a certain genetic change called "MET-driven."

The main goal of this study is to compare the effectiveness and safety of a new combination of two drugs, savolitinib and durvalumab, against a standard treatment called sunitinib. The study will also look at whether durvalumab on its own could be a helpful treatment. This is important because finding more effective treatments can make a real difference in people's lives when dealing with advanced cancer.

Participants in the study will be randomly assigned to receive one of three treatments: savolitinib combined with durvalumab, sunitinib, or durvalumab on its own. This allows doctors to fairly compare the different treatments. The study is "open label," meaning both the patients and their doctors will know which treatment they are receiving. This new research aims to provide clearer answers about the best treatment options for this specific type of advanced kidney cancer.

Key takeaways

  • This study is for a specific type of advanced kidney cancer (PRCC) with a genetic change.
  • It compares new drug combinations against a standard treatment.
  • Participation involves being randomly assigned to one of three treatment groups.
  • Regular health checks and scans will be part of the study.
  • The aim is to find more effective treatments for this challenging cancer.
  • You can stop participating at any time.

Who may be eligible?

To be able to join this study, people must have a confirmed diagnosis of Papillary Renal Cell Carcinoma (PRCC) that has spread or can't be removed by surgery. It's essential that their cancer has a specific genetic change called "MET-driven." Participants should not have had any previous drug treatments for their advanced cancer, nor have ever received savolitinib, durvalumab, or sunitinib in the past.

There are also some general health requirements, such as having good overall health, measuring at least 70 on a general health score (Karnofsky Score), and having healthy organ and bone marrow function. You'll also need to have at least one area of cancer that can be measured by doctors and be expected to live for at least 12 weeks.

Some conditions might prevent someone from joining, such as serious liver or heart problems, HIV or hepatitis infections, or certain autoimmune diseases. If you've had recent radiation to your spinal cord or brain tumours that are causing symptoms, or have had certain vaccinations recently, you might not be able to take part. The research team will carefully check all these details to make sure the study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. Do I have a type of kidney cancer called Papillary Renal Cell Carcinoma (PRCC)?
  2. Has my cancer spread or can it not be completely removed by surgery?
  3. Has my doctor confirmed my cancer is "MET-driven"?
  4. Have I received any previous drug treatment for my advanced cancer?
  5. Do I have any serious heart or liver conditions?
  6. Am I generally well enough to participate in a study?
Answer every question to see your result.

What does participation involve?

If you join this study, you'll be randomly assigned to one of three treatment groups. This means you have an equal chance of receiving one of the study treatments: savolitinib plus durvalumab, sunitinib, or durvalumab on its own. The treatments are given in different ways: savolitinib and sunitinib are taken as tablets by mouth once a day, while durvalumab is given as a drip into a vein every four weeks.

You will continue to receive the assigned treatment for as long as it is working for you, and you are not experiencing severe side effects. Doctors will regularly check your cancer using scans (like X-rays or CTs) to see how the treatment is working. They will also monitor your health closely through blood tests and other examinations to check for any side effects. If the cancer starts to grow, or if side effects become too severe, or if you decide you no longer wish to continue, the treatment will be stopped. Some patients in the durvalumab-only group might have the option to switch to the savolitinib and durvalumab combination if their cancer progresses.

Potential risks and benefits

Taking part in a clinical trial might offer the chance to receive new treatments that are not yet widely available, and these could be more effective than current options for your specific cancer. You'll also receive very close medical monitoring. However, there are potential risks, as new drugs can have side effects that aren't fully known, or they might not work as well as expected. All medications carry potential side effects, and some may be serious. The study team will explain all known risks to you. You have the right to withdraw from the study at any time and for any reason, without it affecting your usual medical care.

Locations (137)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Research Site
    Verified postcode
    Boston, United States
  • Research Site
    Verified postcode
    New York, United States
  • Research Site
    Unverified
    CABA, Argentina
  • Research Site
    Unverified
    Ciudad Autónoma Buenos Aires, Argentina
  • Research Site
    Unverified
    Ciudad de Buenos Aires, Argentina
  • Research Site
    Unverified
    Ciudad de Buenos Aires, Argentina
  • Research Site
    Verified postcode
    La Plata, Argentina
  • Research Site
    Verified postcode
    Rosario, Argentina
  • Research Site
    Verified postcode
    San Miguel de Tucumán, Argentina
  • Research Site
    Verified postcode
    Box Hill, Australia
  • Research Site
    Unverified
    Macquarie University, Australia
  • Research Site
    Verified postcode
    Belo Horizonte, Brazil

Common questions

What is 'MET-driven' PRCC?

It means your kidney cancer has a specific genetic change that doctors think could make it respond to certain treatments.

What is a 'Phase III' study?

It's a big study where new treatments are compared to existing ones to see if they're better and safer before they become widely available.

Will I know which treatment I'm getting?

Yes, this is an 'open label' study, so both you and your doctor will know which treatment you are receiving.

What happens if the treatment isn't working?

Your doctors will regularly check your cancer with scans. If it starts to grow, or if you have severe side effects, your treatment will be stopped, and other options will be discussed.

Can I leave the study at any time?

Yes, you are free to leave the study at any point without it affecting your future medical care.

How to find out more

Always speak to your GP or specialist before deciding to take part in a study.

Discussion

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