Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A PHASE II, MULTICENTRE, OPEN-LABEL STUDY OF CABOZANTINIB AS 2ND LINE TREATMENT IN SUBJECTS WITH UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC RENAL CELL CARCINOMA WITH A CLEAR-CELL COMPONENT WHO PROGRESSED AFTER 1ST LINE TREATMENT WITH CHECKPOINT INHIBITORS

This research study is looking at a new way to treat an advanced type of kidney cancer. The specific condition is called 'unresectable, locally advanced or metastatic renal cell carcinoma with a clear-cell component', which means the cancer has spread or can't be removed by surgery. This study is for people whose cancer has unfortunately continued to grow after their first course of treatment, which was a type of medicine called a 'checkpoint inhibitor'. The study is testing a drug called Cabometyx, given as a tablet. The main aim is to see how many people experience their cancer shrinking or disappearing after taking Cabometyx. Researchers will also look at how long the cancer stays under control and how long people live, as well as checking for changes in symptoms.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Ipsen Pharma

Enrolment target

Start

01 Aug 2024

Unresectable Locally Advanced or Metastatic Renal Cell Carcinoma with a Clear-Cell Component Who Progressed After 1st Line Treatment with Checkpoint Inhibitors

What is this study about?

This study is a medical research project designed to learn more about a particular medicine called Cabometyx (also known by its scientific name, cabozantinib). It's a 'Phase II' study, which means it's a step further than very early tests, but still aims to gather more information before possibly becoming a widely used treatment. The study is open-label, meaning both you and your doctor will know you're taking Cabometyx, unlike some studies where a placebo (dummy drug) might be used or you might get another standard treatment.

The main goal is to understand how well Cabometyx works for people with a specific type of advanced kidney cancer. This includes cancer that has spread to other parts of the body (metastatic), has grown locally and can't be removed by surgery (locally advanced), or can't be fully taken out through an operation (unresectable). Importantly, this study is for those whose kidney cancer has a 'clear-cell component' – a common type of kidney cancer – and has grown even after they've already had a different kind of treatment called a 'checkpoint inhibitor'.

Doctors are particularly interested in seeing if Cabometyx can shrink the cancer (called the 'objective response rate'). They will measure this carefully using scans. They will also look at other important things, like how long it takes for the treatment to start working, how long the cancer stays under control, and how long people live overall. Another key aspect is how people feel; the study will use questionnaires to see if the treatment helps with symptoms related to the cancer.

Key takeaways

This study is for people with advanced clear-cell kidney cancer.
It's for those whose cancer has progressed after a previous treatment (checkpoint inhibitor).
The study is testing a tablet medicine called Cabometyx.
Doctors want to see if Cabometyx can shrink the cancer and improve symptoms.
You would have regular clinic visits for checks, scans, and to discuss your health.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To be considered for this study, you would need to be an adult, at least 18 years old. Both men and women can take part.

The study is specifically for people who have advanced kidney cancer that doctors can't remove with surgery, or cancer that has grown quite a lot locally, or has spread to other parts of the body. Your kidney cancer also needs to be the 'clear-cell' type.

Crucially, you would have already received one type of cancer treatment called a 'checkpoint inhibitor', and unfortunately, your cancer would have grown or worsened since that treatment.

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 advanced kidney cancer that doctors can't remove by surgery, or has it spread?
Is your kidney cancer the 'clear-cell' type?
Has your cancer grown even after you've already had a first treatment (a checkpoint inhibitor)?
Are you able to take tablets by mouth?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be taking Cabometyx tablets. There are different strengths (60 mg, 40 mg, or 20 mg), and your study doctor would decide which dose is right for you. You would have regular visits to the clinic for check-ups, blood tests, and scans to monitor your health and how the treatment is working. These scans would help doctors measure the size of your cancer to see if it's shrinking or growing. You would also fill out questionnaires occasionally to describe how you are feeling and if your symptoms are changing.

The study treatment continues as long as it is helping you and you are tolerating it well. After you stop taking the study medicine, you would still have follow-up appointments to track your long-term health and survival. The total duration of your involvement could vary depending on how long you take the medicine and the follow-up period, but it's important to understand it's an ongoing commitment that involves regular interaction with the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study could be that Cabometyx helps to shrink your cancer or stop it from growing, potentially improving your symptoms or quality of life compared to other available options. However, there's no guarantee it will work for everyone, and it might not work for you. Medicines can also have side effects, and Cabometyx is known to have some. Your study team will discuss all known side effects with you in detail. Remember, taking part is completely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your future medical care.

Locations (2)

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

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Unverified
Germany
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Unverified
France

Common questions

What kind of kidney cancer is this study for?

This study is specifically for a type of advanced kidney cancer called 'renal cell carcinoma with a clear-cell component' that has spread or can't be removed by surgery.

What does 'unresectable, locally advanced or metastatic' mean?

It means the cancer can't be fully removed by surgery, or it's grown quite a lot in the area where it started, or it has spread to other parts of the body.

I've already had cancer treatment. Can I still join?

Yes, this study is designed for people whose cancer has unfortunately progressed (grown) after they've already had a 'checkpoint inhibitor' type of treatment.

What is Cabometyx?

Cabometyx is the name of the medicine being tested in this study. It's given as a tablet that you take by mouth.

How will doctors know if the treatment is working?

They will use regular scans to measure the size of your cancer and see if it is shrinking. They will also look at how you feel and measure how long the cancer stays under control.