Intensified monitoring to personalize cabozantinib dosing in advanced kidney cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on patients with advanced or metastatic renal cell carcinoma treated with cabozantinib, with or without nivolumab, to see if intensified pharmacology monitoring and pharmacogenetic testing can reduce toxicity. The approach combines therapeutic drug monitoring, genetic testing, and careful review of drug interactions to tailor cabozantinib exposure. By personalizing dosing, the trial aims to keep patients on effective treatment while minimizing adverse events. The study builds on real-world data suggesting a link between drug exposure and tolerability for cabozantinib.

Why it matters

Who can join: the full rules

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.

Where it's running

• Centro di Riferimento Oncologico, CRO-IRCCS
  Aviano, Pordenone, Italy Recruiting

Study contacts

• Study coordinator: Erika Cecchin, PhD, PharmD
• Email: ececchin@cro.it
• Phone: 0434659667

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Belzutifan plus zanzalintinib versus cabozantinib for recurrent advanced kidney cancer after adjuvant PD-1/L1 therapy

  This study will test whether taking belzutifan together with zanzalintinib helps people with recurrent advanced kidney cancer live longer and keep the cancer from getting worse compared with cabozantinib after prior adjuvant PD-1/L1 therapy.

  Recruiting at 127 sites Phase 3 Merck Sharp & Dohme LLC · Anchorage, Alaska and 126 other locations · NCT07227402

• Higher dose of cabozantinib for advanced kidney cancer

  This study is testing whether a higher dose of cabozantinib can help people with advanced kidney cancer who didn’t respond to previous treatment with the same drug.

  Recruiting Phase 2 University of Texas Southwestern Medical Center · Dallas, Texas · NCT05931393

• Combining nivolumab, ipilimumab, and cabozantinib for untreated kidney cancer that has spread to the brain

  This trial tests whether adding the oral drug cabozantinib to two immunotherapy medicines (nivolumab and ipilimumab) helps people with untreated renal cell carcinoma brain metastases live longer or have their brain tumors shrink.

  Recruiting Phase 2 M.D. Anderson Cancer Center · Houston, Texas · NCT05048212

• Plasma DNA Methylation to Classify Kidney Masses Before Surgery

  This study tests a blood-based DNA methylation test to help distinguish malignant kidney cancers from benign kidney masses in adults who are planned for kidney surgery.

  Recruiting RenJi Hospital · Shanghai, Shanghai Municipality · NCT07874542

• Your Kidney Cancer Immunotherapy: How You Get It and If Labs Can Be At Home

  This study tests whether people with kidney cancer prefer intravenous or subcutaneous immunotherapy and whether at‑home lab draws plus telehealth visits before treatment are practical.

  Recruiting at 7 sites Phase 4 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07872553

• Who’s at high risk after RCC surgery? Real-world clues from French registry

  This study looks at real-world data from French RCC patients who had local or high-risk locally advanced disease to see how they do after surgery and how doctors decide on adjuvant treatment.

  Recruiting University Hospital, Bordeaux · Bordeaux · NCT07753343

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.