Background and Importance Nivolumab is indicated for advanced renal cell carcinoma (RCC) both as monotherapy (second-line) and in combination with ipilimumab (first-line). It is not known the benefit to add ipilimumab to nivolumab, also it must been taken the possible worse security profile.

Aim and Objectives The aim of this study is to determine the efficacy and security of nivolumab plus ipilimumab vs nivolumab monotherapy in the clinical practice.

Material and Methods This is a descriptive, observational and retrospective study (January 2016 to September 2023) of 30 patients treated with nivolumab or nivolumab plus ipilimumab in a third-level hospital. The data were obtained from the electronic medical records of the patients and the FarmaTools Management programme. Data were processed by Microsoft Excel and SPSS software.

Results In this study 30 patients were included in total, 11 treated with dual therapy and 19 with monotherapy. Patient demographics and disease characteristics are described in table 1. Median progression-free survival was 4.9 months (95% CI: 0–10.8) for nivolumab and 10.7 months (95% CI: 0–26.5) for the combination therapy. However, when we compared the two treatments using the log-rank test, the p-value was 0.799. The median overall survival was 43.4 months (95% CI: 0–97.4) for nivolumab, but it was not reached for the combination treatment. The most prevalent adverse reactions in the monotherapy vs dual therapy group, respectively, were hepatic (5.3% vs 45.5%), endocrine (36.8 vs 63.6) and skin (57.9 vs 36.4). It should be noted that one patient with the combination therapy had myositis, myocarditis, and hepatitis. This patient ultimately died.

Conclusion and Relevance No differences were observed in efficacy, but there were differences in safety. However, our study is limited since it involves few patients.

Conflict of Interest No conflict of interest.