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INTRODUCTION AND OBJECTIVE:To investigate the predictive impact of a change in serum CRP levels during the early phase of nivolumab therapy for metastatic renal cell carcinoma (mRCC).METHODS: Seventy mRCC patients treated with nivolumab after molecular-targeted therapy failure were retrospectively evaluated. Based on the CRP change, patients were classified as (i) normal: if pretreatment levels were <1 mg/dl; (ii) normalized: if pretreatment levels were !1.0 mg/dl and nadir levels within the initial three months of nivolumab therapy declined to <1.0 mg/dl; and ( iii) non-normalized: if pretreatment levels were !1 mg/dl and nadir levels remained !1.0 mg/dl. The predictive association between the CRP change and progression-free survival (PFS) and overall survival (OS) after nivolumab initiation was evaluated. RESULTS: The PFS was significantly lower in the nonnormalized group (n[25, 35.7%) than in the normal (n[29, 41.4%) (median: 2.33 vs. 6.28 months, p[0.0009) and normalized (n[16, 22.9%) (2.33 vs. 8.38 months, p[0.0006) groups, while no differences were observed between normal and normalized groups (p[0.610) (Figure 1a). The OS was significantly lower in the nonnormalized group than in the normal (8.02 months vs. not reached, p<0.0001) and normalized groups (8.02 vs. 26.0 months, p[0.0047); further, the OS of the normalized group was lower than that of the normal group (p[0.0454) (Figure 1b). Multivariate analyses showed that the CRP change was an independent factor for PFS (p[0.0025) and OS (p[0.0009).CONCLUSIONS: The CRP change during the early phase of nivolumab therapy was significantly associated with mRCC patient survival, and can thus be used for outcome prediction.