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RecruitingPHASE4INTERVENTIONAL

Cabozantinib and Nivolumab Among Older Patients With Renal Cell Carcinoma

This research study is for older patients, aged 70 and above, who have a type of advanced kidney cancer that has spread. The main goal is to understand how a combination of two anti-cancer medicines, called nivolumab and cabozantinib, is used and how patients experience it in a real-world setting. This isn't a comparison study; all patients will receive this specific combination. Researchers want to see how older patients respond to this treatment and how their general health is supported throughout. This includes regular checks by cancer specialists and a team focusing on older people's health, offering extra support and follow-up.

At a glance

Status
Recruiting
Phase
PHASE4
Sponsor
Gustave Roussy, Cancer Campus, Grand Paris
Enrolment target
50
Start
16 May 2025
Estimated completion
01 Apr 2028

What is this study about?

This study is focusing on kidney cancer that has spread, often called advanced or metastatic kidney cancer, specifically in older adults aged 70 and above. Doctors are interested in understanding the real-life experiences of these patients when treated with a combination of two medicines: nivolumab and cabozantinib. These drugs work in different ways to fight cancer, and combining them is a common approach in modern cancer treatment. The researchers want to see how these medicines are used and what impact they have on patients in everyday clinical practice, rather than in a highly controlled trial setting.

The main aim is to gather information on how effective and tolerable this treatment combination is for older patients. It's not designed to compare it against other treatments, but rather to observe how this specific treatment regimen works for this particular group of patients. All participants will receive the nivolumab and cabozantinib combination as part of their standard care.

A special part of this study is the focus on the overall health of older patients. Each participant will have a thorough health check-up by a team specialising in older people's health. They will also receive extra support and regular follow-up during their treatment from cancer doctors, nurses, or other healthcare professionals. This could also include phone calls and an option for closer monitoring of the cabozantinib drug levels in the body if needed.

Key takeaways

  • Study for older patients (70+) with advanced kidney cancer.
  • Investigating a combination of two drugs: nivolumab and cabozantinib.
  • Focus on real-life use and patient experience.
  • Includes special health checks and extra support for older patients.
  • Not comparing to other treatments; everyone gets the study drugs.
  • Close follow-up by cancer and older adult health specialists.

Who may be eligible?

To join this study, you need to be at least 70 years old and have been diagnosed with advanced kidney cancer that has spread. This treatment should be the first you've received for your advanced cancer. You also need to be able to carry out most of your daily activities with little to no difficulty.

There are also some conditions that would mean you couldn't take part. For example, if you've recently been in another study testing a new drug, or if you have certain serious heart problems or blood clots in the last three months. Some existing health conditions that might react badly with the study drugs, such as untreated brain tumours or active auto-immune diseases that need strong medication, would also prevent you from joining. However, manageable thyroid or adrenal conditions are usually okay.

It's important that you understand and agree to participate by signing a consent form. You must also be covered by a social security system and be willing and able to attend all necessary appointments.

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. Are you 70 years old or older?
  2. Do you have kidney cancer that has spread?
  3. Is this your first treatment for advanced kidney cancer?
  4. Can you carry out most of your daily activities without much trouble?
  5. Do you have a social security system in place?
  6. Have you not had a serious heart problem or blood clot in the last three months?
Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive two medications: nivolumab and cabozantinib, as standard treatment. Before starting, you will have a detailed health assessment, including a special check-up focused on your overall health as an older adult. Throughout the study, you will have regular check-ups with your cancer doctor, and also with a nurse or doctor from a team that specialises in older people's health. This might involve phone calls between your clinic visits. For some patients, there might also be an optional extra check to see how the cabozantinib medicine is working in their body. The total duration of your participation will depend on how you respond to the treatment, but you will be closely monitored throughout.

Potential risks and benefits

Participating in this study might offer the potential benefit of access to a specific combination of treatments for your kidney cancer, with additional support and monitoring from a team focused on older people's health. Like all medications, nivolumab and cabozantinib can have side effects, which your doctor will discuss with you. These could include tiredness, changes in appetite, or other effects on your body. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (7)

  • Institut de Cancérologie de l'Ouest - Angers
    Verified postcode
    Angers, France· Not yet recruiting
  • Centre Georges François Leclerc
    Verified postcode
    Dijon, France· Not yet recruiting
  • Centre Léon Bérard
    Verified postcode
    Lyon, France· Not yet recruiting
  • Hôpital Tenon
    Verified postcode
    Paris, France· Not yet recruiting
  • Institut Universitaire Du Cancer Toulouse- Oncopole Claudius Regaud
    Verified postcode
    Toulouse, France· Not yet recruiting
  • CHU Tours - Hôpital Bretonneau
    Verified postcode
    Tours, France· Not yet recruiting
  • Gustave Roussy
    Verified postcode
    Villejuif, France· Recruiting

Common questions

What exactly is 'advanced kidney cancer'?

It means the cancer has grown outside of the kidney or has spread to other parts of your body. This is also called metastatic kidney cancer.

What are nivolumab and cabozantinib?

Nivolumab is an immunotherapy drug that helps your body’s immune system fight cancer. Cabozantinib is a targeted therapy drug that blocks signals the cancer needs to grow.

What does 'geriatric evaluation' mean?

This is a special health check-up done by a healthcare professional with expertise in older adults. It looks at your overall health, not just your cancer, to provide the best support.

Will I have to pay to be in this study?

No, you will not have to pay for the study treatments or the extra assessments directly related to the research.

Can I continue to take my other medications?

You should discuss all your current medications with the study doctor, as some might interact with the study drugs, but many common medications may be continued under medical guidance.

How to find out more

Maxime Frelaut, MD

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

Interested in taking part?

Register your interest

Share your details and the research team for "Cabozantinib and Nivolumab Among Older Patients With Renal C…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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