The CABOLD study: A real life prospective cohort evaluating the combination of cabozantinib and nivolumab among older patients with renal-cell carcinoma.

TPS607 Background: In the era of combination therapy, and due to age-related physiological changes, management of older patients with Clear-cell renal cell carcinoma (ccRCC) is a challenge. The combination of cabozantinib and nivolumab is one of the recommended treatments in untreated metastatic or locally advanced ccRCC. However, data regarding the use of this treatment among 70 years old or more (70+) patients are scarce. The CABOLD study seeks to address these gaps by assessing the real-life use of this combination in older patients. Methods: The CABOLD study is a prospective, multicentric, single-arm cohort trial conducted across 10 centers in France. It aims to enroll 50 patients aged 70 years and above with advanced or metastatic ccRCC, who are treatment-naïve in this setting. Eligible participants must have a Performance Status (PS) of 0 to 2. Patients will receive standard-of-care treatment consisting of cabozantinib at 40 mg daily and nivolumab on a 28-day cycle (240 mg on Days 1 and 15 for the first two cycles, followed by 480 mg on Day 1 for subsequent cycles). The starting dose of cabozantinib may be reduced to 20 mg daily at the investigator’s discretion. Patients will benefit of a multi-modal follow-up including medical oncologists, geriatricians and trained nurses to monitor safety closely. Abbreviated geriatric assessment, using G-CODE, will be performed at inclusion, under treatment, and during follow-up, along with quality of life (QoL) evaluation. Optional pharmacological monitoring for cabozantinib will be conducted to assess potential associations with clinical outcomes. Patients will be followed for 12 months in the study, followed by a long-term follow-up after one year. Primary objective is to describe real-life treatment patterns of nivolumab-cabozantinib, including dose modifications and interruptions due to toxicity. Main secondary objectives include efficacy, survival, tolerance, QoL. Enrollment for the study has not yet begun at the time of submission. The CABOLD study is designed to provide insights into the real-world use of cabozantinib and nivolumab in 70+ patients with metastatic ccRCC. By incorporating geriatric assessments and pharmacological monitoring, the trial aims to improve our understanding of treatment tolerability, efficacy, and quality of life in this vulnerable population, potentially guiding tailored therapeutic strategies for older adults with RCC.