TPS570 Background: Cabozantinib plus nivolumab is a first-line standard treatment for advanced clear-cell renal cell carcinoma (RCC) based on the pivotal CheckMate 9ER trial (Motzer, Lancet Oncol 2022). However, clinical trial populations usually differ from real-life settings, and physician-reported adverse events (AEs) often underestimate symptom burden. Remote Patient Monitoring (RPM) of self-reported outcomes (PROs) can improve management of treatment-related toxicities and adherence. Methods: CANIQOL is a French prospective, multicenter, real-life, single-arm phase IV study evaluating the impact of RPM of self-reported symptoms on treatment management in patients (pts) receiving cabozantinib (40 mg PO daily) and nivolumab (240 mg IV q2w or 480 mg IV q4w) for advanced clear-cell RCC. Pts will report weekly PRO-CTCAE data using the RPM Cureety platform up to 6 months after start of the combined treatment. The RPM solution automatically generates alerts for the healthcare team, allowing adjustments for unplanned clinical actions and optimizing treatments management. This trial aims to assess the impact of RPM of self-reported symptoms on treatment management adjustments in pts receiving cabozantinib plus nivolumab for advanced RCC in real-life settings. The primary endpoint is the rate of pts with adjustment in treatment management (unplanned consultation, phone follow-up, advice, treatment discontinuation, hospitalization) within 3 months after combination initiation. Secondary endpoints include the evolution of self-reported side effects (PRO-CTCAE), fatigue (FACIT-F), quality of life (FKSI-10), anxiety/depression (HADS), the satisfaction regarding RPM (F-SUS), and the characterization of alerts. Duration of treatment, adherence to the oral treatment at 3 and 6 months (Girerd), and clinical outcomes (RECIST 1.1, objective response rate at 3 and 6 months, IMDC subgroup analysis) will also be assessed. Assuming the rate of adjustment of treatment management within 3 months after the combination start is around 25%, 70 assessable pts are required to estimate this rate with a 95% confidence interval (CI) of width 20%. We plan to enroll 83 pts to anticipate 15% of non-assessable pts, over 36 months of inclusion. The first patient was enrolled in October 2025. Follow-up is 6 months per patient. CANIQOL will provide real-world evidence on feasibility and clinical utility of RPM of PRO (side effects and quality of life) in pts receiving cabozantinib plus nivolumab for advanced RCC, assessing its impact on toxicity management, adherence, and quality of life. Trial registration: NCT07028125. Sponsor: Centre François Baclesse, Caen, France. Funding: IPSEN; logistical support – Cureety. Clinical trial information: NCT07028125 .
Levard et al. (Sun,) studied this question.