Cabozantinib and Nivolumab Among Older Patients With Renal Cell Carcinoma

Prior treatment

• 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)

Other illness

• Any condition that represent a contraindication to Cabozantinib and/or Nivolumab, as described in summaries of products characteristics, including symptomatic untreated brain metastasis or active auto-immune disease requiring systemic immunosuppressant/modulator (thyroid or adrenal disorder are not an exclusion criteria)

Other

• 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

• 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