Personalized dosing could tame kidney cancer Drug's side effects

NCT ID NCT07805122

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

About 216 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2026

Expected to finish

May 2030

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Advanced/metastatic renal cell carcinoma with predominantly clear cell subtype are added.

Our safety recommendation!

By submitting, you agree to our Terms of use

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Centro di Riferimento Oncologico, CRO-IRCCS

    RECRUITING

    Aviano, Pordenone, 33081, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.