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Cabozantinib Monitoring for Toxicity Management in Patients with Renal Cell Carcinoma

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What is this study about?

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.

Who Can Join the Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Central Hospital Of Bolzano Bolzano Italy
Centro Di Riferimento Oncologico Di Aviano Aviano Italy

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Italy Italy
Not yet recruiting
06.05.2026

Trial locations

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.

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.

Trial ID:
2026-525267-40-00
Trial Phase:
Therapeutic confirmatory (Phase III)

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