Nivolumab in previously treated metastatic renal cell carcinoma: real-world data from the Czech Republic and Slovakia

To describe the real-world clinical outcomes of nivolumab monotherapy in second- and later-line treatment of metastatic renal cell carcinoma (mRCC).

Study Design: Retrospective multicenter cohort study using data from the RENIS II registry, including 501 patients treated with nivolumab in the second or later line between 2013 and 2025.
Endpoints: Primary endpoints were overall survival (OS) and progression-free survival (PFS). Secondary endpoints included objective response rate (ORR), disease control rate (DCR), safety, and exploratory analyses of baseline inflammatory indices.

Median OS was 24.2 months and median PFS was 8.6 months.
The ORR was 28.8% and the DCR was 61.2% in the response-evaluable population.
Grade 3/4 adverse events were recorded in 11.4% of patients.
Higher baseline NLR, PLR, and SII were associated with inferior survival in univariable analyses.

Nivolumab monotherapy demonstrated clinical activity and manageable toxicity in previously treated mRCC.

The study is retrospective and may be subject to biases inherent in observational studies.
Data is limited to specific regions (Czech Republic and Slovakia), which may not be generalizable to other populations.

Baseline inflammatory indices, particularly NLR and PLR, showed potential prognostic value and warrant further investigation.