Cabozantinib and Nivolumab Among Older Patients With Renal Cell Carcinoma
Cabozantinib and Nivolumab Among Older Patients With Renal-cell Carcinoma, a Prospective Cohort With Geriatric, Pharmacologic and Patient-reported-outcome Evaluation
Gustave Roussy, Cancer Campus, Grand Paris
50 participants
May 16, 2025
INTERVENTIONAL
Conditions
Summary
The goal of the study is to describe real-life use and exposition to nivolumab-cabozantinib among older patients with metastatic clear-cell renal cell cancer
Eligibility
Inclusion Criteria7
- Patients ≥ 70 years-old
- Confirmed advanced or metastatic renal-cell carcinoma
- Patients not previously treated in metastatic setting
- Performance Status 0 to 2
- Sexually active male patients must agree to use condom during the study and for at least 5 months after the last study treatment administration. Also, it is recommended their women of childbearing potential partner use a highly effective method of contraception.
- Patient should understand, sign, and date the written informed consent form prior to any protocol-specific procedures performed. Patient should be able and willing to comply with study visits and procedures as per protocol.
- Patients must be affiliated to a social security system or beneficiary of the same
Exclusion Criteria5
- Participation in another clinical study with an investigational product during the last four weeks and while on study treatment (Patients may be included in CABOLD if they are included in the arm B of CARE1 study EUCT N° 2023-503317-29-00)
- Performance Status \> 2
- Any severe cardiovascular or thrombo-embolic event in the last three months
- Any situation for which exclusive palliative care intervention is recommended
- Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent
Interventions
Briefly, nivolumab is administered as an approximately 30-minute (240mg every 2 weeks) or 60-minute (480mg every 4 weeks) IV infusion.
Cabozantinib is a medication that is taken orally every day, once a day away from meals at the initial dose of 40 mg/day.
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT06934057