AuthorisedTherapeutic use (Phase IV)Interventional

Intensified Monitoring of PhArmacology of Cabozantinib as a tool for Toxicity management in patients with renal cell carcinoma

This study, called Intensified Monitoring of Pharmacology of Cabozantinib, focuses on improving how we manage side effects when treating kidney cancer with a medicine called Cabozantinib. We want to see if very close monitoring of the medicine in your system, along with good advice, can help reduce unpleasant side effects and stop you from needing to pause your treatment. By comparing this new way of monitoring to what we've done in the past, we hope to find a better way to keep kidney cancer patients on their treatment for longer and with fewer problems. This is a "Phase IV" study, meaning the treatment is already in use, and we are looking at ways to improve its effectiveness and make it more manageable for patients.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Centro Di Riferimento Oncologico Di Aviano

Enrolment target

216

Start

21 May 2026

Renal cell carcinoma

What is this study about?

This study is all about helping people with a type of kidney cancer called renal cell carcinoma. The main treatment medicine we're looking at is called Cabozantinib. While this medicine is very helpful, it can sometimes cause side effects, which might lead to patients needing to stop or pause their treatment. This study is designed to find better ways to manage these side effects.

Imagine you're taking a medicine, and doctors want to make sure you're getting just the right amount – enough to work, but not too much to cause problems. This study will involve very careful monitoring of how Cabozantinib works in your body. They'll also be giving patients advice and support on how to best manage their treatment.

The real goal is to see if this closer monitoring and advice can lead to fewer interruptions in treatment due to side effects. If we can keep patients on their treatment more consistently, it's generally better for fighting the cancer. By comparing this new approach to past records, the researchers hope to show that this method makes a real difference in patient well-being and treatment success.

Key takeaways

Focuses on improving side effect management for kidney cancer patients.
Uses Cabozantinib and OPDIVO treatments.
Aims to reduce treatment interruptions by close monitoring and advice.
Compares new monitoring methods to previous experience.
Open to adults aged 18 and over, both men and women.

Who may be eligible?

To be part of this study, you need to be an adult, 18 years old or older. The study is open to both men and women.

More specific details about your health and medical history would be discussed with you by the study team to make sure this is the right study for you. It's important that joining a study is safe and suitable for your individual situation.

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.

Are you 18 years old or older?
Do you have renal cell carcinoma (a type of kidney cancer)?
Are you able to take Cabozantinib medicine?
Are you able to attend regular check-ups and follow advice?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be receiving Cabozantinib tablets as part of your kidney cancer treatment, along with potentially OPDIVO infusions. The main focus will be on closely monitoring how your body uses and responds to the Cabozantinib. This means regular check-ups, which might include blood tests to measure the amount of medicine in your system and to check for any signs of side effects. You'll also be given advice and support on how to manage any side effects you experience.

The study is looking at how well patients follow this advice and how that affects their treatment. There will be ongoing assessments to track any side effects and how your cancer is responding. The total duration of your participation would depend on your individual treatment plan and how long you are on the medication, but it would involve regular follow-up during your treatment period.

Potential risks and benefits

Participating in this study might offer the benefit of more intensive monitoring and support for managing potential side effects of your Cabozantinib treatment, which could lead to fewer treatment interruptions. However, all medical treatments carry risks, and side effects from Cabozantinib can occur. There might also be additional appointments or tests required for the study. You will be fully informed of all potential risks and benefits before deciding to join, and you have the right to withdraw from the study at any time without affecting your standard care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy

Common questions

What is Cabozantinib?

Cabozantinib is a medicine used to treat a type of kidney cancer called renal cell carcinoma. It works by targeting specific things in cancer cells to stop their growth.

What does 'intensified monitoring' mean?

It means the study will keep a very close eye on how your body reacts to the Cabozantinib medicine, including measuring how much of it is in your system and watching for any side effects, to help manage your treatment better.

Why is this study important for kidney cancer patients?

This study aims to make Cabozantinib treatment more manageable for patients by reducing side effects and interruptions, which could help deliver more consistent and effective treatment against kidney cancer.

Will I get different medication in this study?

You will receive Cabozantinib and potentially OPDIVO as part of your treatment. The study is mostly about how these medicines are monitored and managed, not about new drugs.

How long would I be in the study?

The length of your participation would depend on your individual treatment plan and how long your doctor recommends you stay on the medication, with regular check-ups throughout that period.