This study aimed to evaluate the effectiveness and safety of
molecular-targeted therapies (
MTTs) after the discontinuation of
nivolumab and
ipilimumab (NIVO+IPI) combination
therapy in patients who had been diagnosed with advanced/metastatic
renal cell carcinoma as real-world outcomes. We enrolled patients treated with
MTTs following initial
therapy with NIVO+IPI at nine institutions in Japan. We evaluated the objective response rate (ORR) as the primary endpoint and disease control rate (DCR), best overall response, and oncological outcomes (overall survival (OS) and progression-free survival (PFS)) as the secondary endpoints. We also evaluated factors predictive of
disease progression after the administration of
MTTs. Patients were followed up for a median of 8 months. The ORR was 44.8%, and the DCR was 72.4%. The median OS and PFS of
MTTs after NIVO+IPI were 18 months and 8 months, respectively. A total of 31% of patients experienced grade 3/4 MTT-related adverse events. The median PFS in patients with bone
metastases was significantly shorter than that in those without bone
metastases (4 vs. 12 months, p = 0.012).
MTTs may be a useful secondary treatment option after the discontinuation of NIVO+IPI.