All studies
Active not recruitingOBSERVATIONAL

Study of Cabozantinib as Monotherapy or in Combination With Nivolumab in Patients With Advanced or Metastatic Renal Cell Carcinoma Under Real-life Clinical Setting in 1st Line Treatment.

This study is for adults in the UK who have advanced or metastatic kidney cancer and are starting their first treatment. It focuses on a medicine called cabozantinib, which can be given on its own or together with another drug, nivolumab. The main goal is to understand how these treatments are used in real-life healthcare settings. Researchers will track things like how many patients need to change their dose, pause their treatment, or stop it completely because of side effects. This helps doctors learn more about the practical use and safety of these important treatments when given to patients as part of their regular care.

At a glance

Status
Active not recruiting
Sponsor
Ipsen
Enrolment target
224
Start
24 Sep 2018
Estimated completion
30 Sep 2027

What is this study about?

This study is looking at how a specific treatment, called cabozantinib, is used for people in the UK who have advanced kidney cancer. This type of cancer has either spread to other parts of the body (metastatic) or is at an advanced stage. The study aims to understand how patients actually receive this medicine in their everyday clinic visits, rather than in a highly controlled research setting.

Cabozantinib can be given by itself or in combination with another medicine called nivolumab. This is often the first treatment people receive for their kidney cancer. Researchers want to observe how doctors prescribe these drugs, how patients take them, and what happens during the treatment journey. This includes noting any dose changes, treatment breaks, or if treatment needs to stop due to side effects, which can sometimes be serious.

By observing patients in this 'real-life' way, doctors can gain valuable insights into the practical use, effectiveness, and general safety of these treatments when they are part of standard patient care across the UK. This information helps healthcare professionals make better decisions and improve care for others with advanced kidney cancer in the future.

Key takeaways

  • The study looks at standard kidney cancer treatment, not new drugs.
  • It helps doctors understand how cabozantinib and nivolumab work in real life.
  • You must have advanced or metastatic kidney cancer and be starting these treatments.
  • Participation means your regular treatment will be observed and recorded.
  • You won't have extra appointments or tests beyond your usual care.
  • Your decision to join or leave the study won't affect your treatment.

Who may be eligible?

To join this study, you must be 18 years or older and able to give your clear agreement to take part. You must also have advanced or metastatic kidney cancer and be about to start treatment with cabozantinib, either on its own or combined with nivolumab. This would be your first treatment for this type of cancer, and the decision to use these medicines must have already been made by your doctor based on standard NHS guidelines.

There are also some reasons why you might not be able to join. For example, if you are currently taking part in another medical study where new treatments are being tested, or if you have been in such a study within the last three months, you wouldn't be able to participate. You also can't join if you've been part of this specific study before.

Both men and women can take part, as long as they meet the age and health requirements.

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 18 years old or older?
  2. Do you have advanced or metastatic kidney cancer?
  3. Are you about to start cabozantinib (alone or with nivolumab) as your first treatment for this cancer?
  4. Are you not currently in another medical research study testing new treatments?
  5. Have you not been in another medical research study testing new treatments in the last 3 months?
  6. Have you not taken part in this specific study before?
Answer every question to see your result.

What does participation involve?

If you join this study, you won't be given a new or experimental treatment. Instead, your doctors will simply observe and record information about your standard treatment with cabozantinib (alone or with nivolumab) as you receive it during your regular clinic visits. This means your appointments, tests, and medications will be exactly what your doctor would normally recommend for your condition. The researchers will collect details on how well the treatment is working for you and any side effects you might experience. There are no additional study visits or extra procedures beyond what is already planned for your care. The total duration of your participation will depend on how long your doctor determines you should continue with this treatment.

Potential risks and benefits

The potential benefits of taking part in this study are that your treatment will be carefully monitored, which might offer you reassurance. While you won't receive any new or experimental treatment, the information gathered from your journey will help doctors understand how these medicines work in many patients and improve care for others in the future. As this is an observational study of standard care, there are no extra risks beyond those already associated with your prescribed treatment. You are free to withdraw from the study at any time without affecting your medical care.

Locations (82)

  • Landeskrankenhaus Hochsteiermark
    Verified postcode
    Leoben, Austria
  • Kepler Universitätsklinikum GmbH
    Verified postcode
    Linz, Austria
  • Uniklinikum Salzburg
    Verified postcode
    Salzburg, Austria
  • Salzkammergutklinikum Vöcklabruck
    Verified postcode
    Vöcklabruck, Austria
  • Klinikum Wels-Grieskirchen GmbH
    Verified postcode
    Wels, Austria
  • Universitätsklinikum Aachen
    Verified postcode
    Aachen, Germany
  • Urologisches Zentrum Euregio
    Verified postcode
    Aachen, Germany
  • Onkologie aschaffenburg
    Verified postcode
    Aschaffenburg, Germany
  • Universitätsklinikum Augsburg A.ö.R
    Verified postcode
    Augsburg, Germany
  • MVZ Taunus GmbH
    Verified postcode
    Bad Homburg, Germany
  • Hämatologisch-Onkologische Schwerpunktpraxis
    Verified postcode
    Bad Liebenwerda, Germany
  • Urologische Praxis Bad Schlema
    Verified postcode
    Bad Schlema, Germany

Common questions

What is advanced or metastatic kidney cancer?

This means kidney cancer that has grown beyond the kidney or has spread to other parts of your body.

What are cabozantinib and nivolumab?

These are medicines used to treat advanced kidney cancer. Cabozantinib is a tablet, and nivolumab is given as an injection.

Will I get different treatment if I join this study?

No, you will receive the exact same treatment and care your doctor would normally plan for you. The study just observes this standard treatment.

What kind of information will be collected about me?

Researchers will note details about your treatment, like your dosage, any changes to it, and any side effects you experience, all as part of your normal care.

How long will I be in the study?

Your participation will last as long as you are receiving the cabozantinib treatment under your doctor's 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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