Cabozantinib and Nivolumab Among Older Patients With Renal Cell Carcinoma

Launched by GUSTAVE ROUSSY, CANCER CAMPUS, GRAND PARIS · Apr 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of two medications, Cabozantinib and Nivolumab, in older patients with a specific type of kidney cancer called metastatic clear-cell renal cell carcinoma. The aim is to understand how these treatments work in real-life situations for patients aged 70 and older who have not received previous treatment for their cancer.

To be eligible for the study, patients need to be at least 70 years old and have a confirmed diagnosis of advanced kidney cancer. They should be in good enough health to participate, meaning their overall condition is rated between 0 and 2 on a scale where lower numbers indicate better health. Participants will need to agree to follow the study guidelines and understand the information provided about the trial. It's important to note that the study will not be recruiting participants just yet, so interested individuals should keep an eye out for when it begins.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients ≥ 70 years-old
• • 2. Confirmed advanced or metastatic renal-cell carcinoma
• • 3. Patients not previously treated in metastatic setting
• • 4. Performance Status 0 to 2
• • 5. 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.
• • 6. 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.
• • 7. Patients must be affiliated to a social security system or beneficiary of the same
• Exclusion Criteria:
• • 1. 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)
• • 2. Performance Status \> 2
• • 3. 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)
• • 4. Any severe cardiovascular or thrombo-embolic event in the last three months
• • 5. Any situation for which exclusive palliative care intervention is recommended
• • 6. Patient under guardianship or deprived of his liberty by a judicial or administrative decision or incapable of giving its consent