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Intensified Monitoring of PhArmacology of Cabozantinib as a tool for Toxicity management in patients with renal cell carcinoma
EU CTIS ID: 2026-525267-40-00
What this study is testing
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.
- Therapeutic use (Phase IV)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- Patients with non-renal cell neoplasms of the kidney (e.g. urothelial, sarcoma, lymphoma).
- 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.
- Pregnancy status.
- Refusal of informed consent.
- Patients who could not attend periodic clinical check-ups.
- Any condition that, in the investigator’s judgment, could compromise appropriate participation in the study.
See the full eligibility criteria
- 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.
- Patients with non-renal cell neoplasms of the kidney (e.g. urothelial, sarcoma, lymphoma).
- 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.
- Pregnancy status.
- Refusal of informed consent.
- Patients who could not attend periodic clinical check-ups.
- Any condition that, in the investigator’s judgment, could compromise appropriate participation in the study.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.