Cabozantinib and Nivolumab Among Older Patients With Renal-cell Carcinoma, a Prospective Cohort With Geriatric, Pharmacologic and Patient-reported-outcome Evaluation

What this Trial Is About

Researchers are evaluating the use and exposure to the combination of Nivolumab and Cabozantinib in older patients with metastatic clear-cell renal cell cancer. This prospective, multicenter, single-arm Phase 4 study aims to understand how these treatments are applied in real-life settings among patients aged 70 and older. The study includes a detailed geriatric evaluation and focuses on patients not previously treated in the metastatic setting. Participants will receive the standard care treatment of Nivolumab and Cabozantinib. Nivolumab is given as an intravenous infusion either every 2 weeks or every 4 weeks, while Cabozantinib is taken orally once daily at an initial dose of 40 mg away from meals. The study features a multimodal follow-up involving oncologists, geriatricians, nursing staff, phone calls, and optional pharmacological monitoring specific to Cabozantinib. During the trial, patients will undergo evaluations including geriatric assessments, monitoring of dosing and any dose interruptions or modifications at 24 weeks, and radiological assessments at 12 months. Researchers will also track overall survival, progression-free survival, quality of life through patient-reported outcomes, and the frequency of adverse events using both clinical and patient-reported criteria up to 12 months. Participation involves regular visits and assessments over at least one year to collect comprehensive data on treatment effects and patient well-being.

Cabozantinib and Nivolumab Among Older Patients With Renal Cell Carcinoma