2026-525267-40-00RecruitingPhase 4
Intensified Monitoring of PhArmacology of Cabozantinib as a tool for Toxicity management in patients with renal cell carcinoma
Source: EU CTIS (euclinicaltrials.eu) · Last updated 21 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 216 (estimated)
- First submitted
- 6 Feb 2026
- Start date
- 30 Jul 2026
- Lead sponsor
- Centro Di Riferimento Oncologico Di Aviano
- Diseases
- Kidney cancer
- EU CT number
- 2026-525267-40-00
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 216
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.
AI-kivonat: who the study is looking for
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
Read by machine on 9 Nov 2026.
Who cannot take part
Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Any condition that, in the investigator’s judgment, could compromise appropriate participation in the study.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centro di Riferimento Oncologico di Aviano | Aviano | Italy | Recruiting |
| Azienda Sanitaria Dell'Alto Adige | Bolzano | Italy | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.