Personalized dosing could tame kidney cancer Drug's side effects
NCT ID NCT07805122
First seen Sep 04, 2026 · Last updated Sep 04, 2026
Summary
This trial tests whether personalized pharmacological counselling can help manage side effects of the kidney cancer drug cabozantinib. The approach combines blood level monitoring, genetic testing, and drug interaction checks to tailor dosing. Researchers will compare treatment interruption rates in patients receiving this counselling against historical data. The goal is to keep patients on effective treatment longer with fewer disruptions.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- individualized pharmacological counselling integrating therapeutic drug monitoring, pharmacogenetic testing, and drug interaction evaluation
- What this could lead to
- If successful, this approach could help kidney cancer patients stay on cabozantinib longer with fewer side effects, potentially improving treatment outcomes.
- What could go wrong
- This is an early-stage study comparing against historical data, so results may not hold in larger or more diverse groups. The counselling approach may not reduce toxicity as hoped.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 216 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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May 2030
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria for the intervention group: * Patients diagnosed with histologically confirmed advanced/metastatic RCC with predominantly clear cell subtype. * 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", due to factors such as missed doses, gastrointestinal disturbances, or potential drug interactions that could reduce their effectiveness, 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 will be included in the study regardless of their time of treatment start with Cabozantinib and regardless of their concomitant diseases or co-medication. Exclusion Criteria for intervention group: * 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. Inclusion criteria for the historical control group: * Patients diagnosed with histologically confirmed advanced/metastatic RCC with predominantly clear cell subtype. * 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). Exclusion criteria for the historical control group: * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Centro di Riferimento Oncologico, CRO-IRCCS
RECRUITINGAviano, Pordenone, 33081, Italy
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Other studies related to the condition(s) this trial covers.
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- Can a year of sunitinib delay kidney Cancer's return after lung surgery?
- Can a drug duo outperform standard care for advanced kidney cancer?
- Can we predict who needs extra therapy after kidney cancer surgery?
- Can a Two-Drug combo outsmart advanced cancers?