Frontlight ResearchEarly access
Taking people in ItalyPhase 4
Drug-level monitoring to help manage cabozantinib side effects in kidney cancer
Tests whether drug-level monitoring reduces cabozantinib treatment interruptions from side effects in kidney cancer.
Key facts
- Who runs it
- Centro Di Riferimento Oncologico Di Aviano
- Where
- Aviano and Bolzano, ItalySee the 2 sites
- Trial code
- Registry title
- Intensified Monitoring of PhArmacology of Cabozantinib as a tool for Toxicity management in patients with renal cell carcinoma
- Status
- Recruiting
- Phase
- Phase 4
- People taking part
- 216 people, planned
- Started
- 30 Jul 2026
- Expected to end
- 6 May 2030
- Type of study
- Interventional
- Record updated
- 21 May 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults with advanced or metastatic renal cell carcinoma, mainly clear-cell type, who are about to receive cabozantinib alone or with nivolumab.
- Age
- 18 years or older
- Sex
- Men and women can join.
- Disease stage
- Advanced (cannot be treated by surgery or radiation to remove all the disease) or metastatic (stage IV) renal cell carcinoma, mostly clear-cell type, confirmed by tissue examination. All IMDC risk groups (good, intermediate, poor) can join.
- Earlier treatment
- Not stated for time of cabozantinib start; people who had a kidney removed can join.
Main reasons for not taking part
- Kidney tumours that are not renal cell carcinoma (for example urothelial, sarcoma, lymphoma)
- Another cancer within the 2 years before treatment start, with a few listed exceptions
- Pregnancy
- Cannot attend regular check-ups
- Refusal to sign informed consent
The registry criteria, word for word
Show all 16 criteriaShow less
Who can take part
- Patients diagnosed with histologically confirmed advanced/metastatic RCC with predominantly clear-cell subtype
- Patients will be included in the study regardless of their time of treatment start with cabozantinib and regardless of their concomitant diseases or co-medication
- Advanced (not amenable to curative surgery or radiation therapy) or metastatic (AJCC Stage IV) RCC, candidate to receive systemic treatment with Nivolumab + Cabozantinib or Cabozantinib monotherapy as per clinical practice (investigators choice)
- Signed Written Informed Consent
- Male or female subjects aged ≥18 years old
- Women of childbearing potential must avoid pregnancy while on Cabozantinib. Female partners of male patients taking cabozantinib must also avoid pregnancy. Effective methods of contraception should be used by male and female patients and their partners during therapy, and for at least 4 months after completing therapy. Because oral contraceptives might possibly not be considered as “effective methods of contraception”, they should be used together with another method, such as a barrier method
- Previous nephrectomy is permitted
- All IMDC (International Metastatic RCC Database Consortium) risk (good, intermediate, poor)
- Eastern Cooperative Oncology Group performance status 0 or 1
- Capable of understanding and complying with the protocol requirements
Who cannot take part
- Diagnosis of any non-RCC malignancy occurring within 2 years prior to the date of the start of treatment except for adequately treated basal cell or squamous cell skin cancer, or carcinoma in situ of the breast or of the cervix or low-grade prostate cancer (≤pT2, N0; Gleason 6) with no plans for treatment intervention
- Any condition that, in the investigator’s judgment, could compromise appropriate participation in the study
- Patients with non-renal cell neoplasms of the kidney (e.g. urothelial, sarcoma, lymphoma)
- Pregnancy status
- Refusal of informed consent
- Patients who could not attend periodic clinical check-ups
Where in Italy
- Centro di Riferimento Oncologico di AvianoAviano, ItalyTaking people
- Azienda Sanitaria Dell'Alto AdigeBolzano, ItalyTaking people
About the trial
What the trial wants to find out
To evaluate whether the implementation of a systematic pharmacological counseling activity based on TDM, pharmacogenetics and pharmacological interaction analysis, providing cabozantinib treatment-management suggestions to prescribing oncologists, results in a reduced frequency of treatment interruptions due to clinically relevant Cabozantinib-related toxicity in RCC patients compared with historical data.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record
Print a page for my doctorData and sources
- Registry record
- Listed on the EU's official list of trials (CTIS).
- Official title
- Intensified Monitoring of PhArmacology of Cabozantinib as a tool for Toxicity management in patients with renal cell carcinoma
- Plain-language title
- Drug-level monitoring to help manage cabozantinib side effects in kidney cancerGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 9 November 2026.
- Record updated
- 21 May 2026