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Cabozantinib Monitoring for Toxicity Management in Patients with Renal Cell Carcinoma

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is studying renal cell carcinoma, a type of kidney cancer. The treatment used in the study includes nivolumab given by vein and cabozantinib taken as tablets by mouth. The purpose of the study is to see whether closer medicine monitoring and advice on treatment use can help reduce treatment stops caused by side effects from cabozantinib in people with this cancer.

During the study, treatment is given in the usual way, while doctors also review how the medicine is processed in the body, possible inherited differences that may affect treatment, and other medicines that may interact with cabozantinib. Based on this review, treatment suggestions are provided to the cancer doctors. The study then looks at how often treatment has to be interrupted because of side effects. The study is expected to continue for several years.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Start of study treatment
You start the study treatment for renal cell carcinoma, which is a type of kidney cancer.
You receive cabozantinib by mouth as 60 mg tablets. The tablets may be supplied as 20 mg, 40 mg, or 60 mg film-coated tablets, but the total dose is 60 mg each time it is taken.
You also receive nivolumab as an intravenous infusion, which means it is given through a vein, at a dose of 480 mg.
The study uses these medicines during the treatment period, and the trial is planned to run from 2026-05-06 to 2030-05-06.
Step 2
Monitoring during treatment
During the trial, your treatment is monitored with pharmacological counseling, which means medicine-related advice based on test results and review of your treatment.
This monitoring includes TDM, which means measuring the amount of cabozantinib in your blood, pharmacogenetics, which means checking how your genes may affect how the medicine works, and analysis of possible drug interactions, which means checking whether other medicines may affect cabozantinib.
The purpose of this stage is to support treatment management and help reduce treatment interruptions caused by side effects related to cabozantinib.
Step 3
Treatment review and adjustment
Your treatment is reviewed using the monitoring results, and treatment-management suggestions are provided to the doctor who prescribes your cancer treatment.
The study evaluates whether these suggestions are followed and whether treatment interruptions due to clinically relevant side effects happen less often than in historical data, which means older previously collected information.
Step 4
Study assessments over time
During the trial, blood-related measurements may be checked over time to assess cabozantinib levels and related safety information.
The study also evaluates how cabozantinib levels may differ according to gene variants, inflammation markers, and treatment-related side effects.
The study may also compare different ways of estimating medicine levels and may examine changes in ctdna, which means small pieces of tumor dna found in the blood, in relation to disease response or progression.

Who can join the trial?

15 criteria

Adults aged 18 years or older.
Diagnosed with advanced or metastatic renal cell carcinoma with mainly clear-cell subtype. Advanced means the cancer cannot be treated with surgery or radiation aimed at cure. Metastatic means it has spread to other parts of the body.
The cancer must be confirmed by histology, which means the diagnosis was made by examining tissue under a microscope.
Must be a candidate to receive either nivolumab plus cabozantinib or cabozantinib alone as part of usual medical care.
Must have signed written informed consent, meaning the person has agreed in writing to take part after being informed about the study.
May have started cabozantinib at any time before joining the study.
May have other medical conditions and may be taking other medicines.
Previous nephrectomy is allowed, which means prior surgical removal of a kidney.
May be in any IMDC risk group: good, intermediate, or poor. IMDC is a system used to estimate risk in metastatic kidney cancer.
Must have an ECOG performance status of 0 or 1. ECOG is a scale that shows how well a person can carry out daily activities; 0 means fully active, and 1 means able to do light work.
Must be able to understand the study requirements and follow them.
Women who can become pregnant must avoid pregnancy while taking cabozantinib.
Male patients taking cabozantinib must avoid causing pregnancy in their female partners during treatment.
Effective contraception, meaning reliable birth control, must be used by male and female patients and their partners during treatment and for at least 4 months after treatment ends.
If oral contraceptives are used, they should be combined with another method, such as a barrier method, which is a method like condoms that helps prevent pregnancy.

Who cannot join the trial?

8 criteria

Patients with a kidney cancer that is not renal cell carcinoma, such as urothelial cancer (cancer of the lining of the urinary tract), sarcoma (a cancer that starts in support tissues), or lymphoma (a cancer of the lymph system).
Any other cancer diagnosed within the last 2 years before treatment starts, except for:
- Basal cell skin cancer or squamous cell skin cancer that was treated properly.
- Carcinoma in situ of the breast or cervix, which means very early cancer cells that have not spread.
- Low-risk prostate cancer with no planned treatment, meaning early prostate cancer with a low chance of spreading.
- Pregnancy.
- Not agreeing to give informed consent, meaning the patient does not sign the form saying they understand the study and agree to take part.
- Being unable to attend the required regular check-ups during the study.
- Any other medical condition or situation that, in the study doctor’s judgment, could make it hard to take part safely or correctly in the study.

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Verified sites

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Central Hospital Of Bolzano
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Bolzano, Italy

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Investigated drugs

nivolumab
This is an antibody medicine given through a vein. In this trial, it is being used as a cancer treatment to help the immune system recognize and attack cancer cells.
cabozantinib
This is an oral cancer medicine taken as tablets. In this trial, it is being used to slow or stop the growth of kidney cancer by blocking signals that help cancer cells grow and by reducing the blood supply that feeds the tumor.

What is already known about the treatment

Nivolumab
Nivolumab is given as a liquid infusion into a vein by a healthcare professional, usually in a clinic or hospital. It is a well-established cancer medicine and is widely described in medical literature for treating several cancers, including renal cell carcinoma. It belongs to a group called immune checkpoint inhibitors, and it works by blocking the PD-1 protein on immune cells, which helps the body’s own immune system recognize and attack cancer cells more strongly.
Cabozantinib
Cabozantinib is taken by mouth as a film-coated tablet, usually once daily, and the dose can be adjusted based on tolerance and treatment goals. It is an approved and well-known cancer medicine in medical practice and literature, especially for renal cell carcinoma and some other cancers. It is a type of targeted therapy called a kinase inhibitor, and it works by blocking several signals that cancer cells use to grow, survive, and build new blood vessels.

Investigated diseases

Renal cell carcinoma - A cancer that begins in the kidney, most often in the cells lining the small tubes that filter blood. It usually grows slowly at first, but over time it can enlarge within the kidney and spread to nearby tissues or other parts of the body.