Background: Immune checkpoint inhibitors (ICIs) have transformed cancer therapy, yet their efficacy and safety in patients with chronic kidney disease (CKD) remain uncertain, as this population is frequently excluded from pivotal trials. We aimed to evaluate clinical outcomes of ICI therapy in patients with cancer and CKD. Methods: We conducted a systematic review and meta-analysis comparing outcomes of ICI therapy in patients with and without CKD. PubMed, Embase, and the Cochrane Library were systematically searched. Eligible studies included patients with CKD stages 3–5 reporting at least one efficacy or safety outcome; kidney transplant recipients were excluded. Subgroup analyses were performed for advanced CKD. Hazard ratios (HR) and risk ratios (RR) with 95% confidence intervals (CI) were pooled using random-effects models. Results: Fourteen studies ( n = 12,589 patients) were included. Patients with CKD had a significantly higher risk of nephritis (RR 2.43; 95% CI 1.11–5.33; I ² = 0%) compared with those without CKD. No significant differences were observed in acute kidney injury (RR 1.39; 95% CI 0.93–2.08), overall survival (HR 0.97; 95% CI 0.58–1.61), or progression-free survival (HR 1.05; 95% CI 0.76–1.44). The incidence of any-grade irAEs (RR 1.01; 95% CI 0.96–1.07) and grade ⩾3 irAEs (RR 1.07; 95% CI 0.92–1.25) was also similar between groups. However, advanced CKD was associated with worse overall survival (HR 1.42; 95% CI 1.14–1.76) and a higher incidence of any-grade irAEs (RR 1.17; 95% CI 1.01–1.34). Conclusions: Available observational evidence does not show a clear difference in ICI efficacy or major toxicity between patients with CKD and those without CKD, although the certainty of evidence is very low. However, advanced CKD was associated with worse overall survival and a higher incidence of any-grade irAEs compared with patients without advanced CKD. These findings underscore the need for close monitoring and stage-stratified management in this population.
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