Gou M, et al. - Researchers tested nivolumab for metastatic biliary tract cancer (MBTC) in 30 MBTC patients who were administered a median of 4 cycles of nivolumab 200 mg or 180 mg according to patient tolerance. Complete response (CR) and partial response (PR) were noted in 1 case and 5 cases, respectively, 12 cases were stable (SD). Objective response rate (ORR) was 20%, disease control rate (DCR) was 60%. Progression free survival (PFS) was 3.1m. Fatigue (3 cases), fever (2 cases), hypothyroidism (1 case), skin reaction (1 case) were documented as adverse events (AEs) of nivolumab monothrapy. Leukopenia (5 cases), thrombocytopenia (2 cases), and grade 3-4 were leukopenia (3 cases) were identified as hematologic toxicity related to nivolumab combined with chemotherapy. Statistically significant PFS was noted in association with nivolumab combined with chemotherapy vs nivolumab monothrapy (4.1 m vs 2.3 m). A shorter PFS was observed among patients with metastatic number > 2 vs those < 2 (1.4 m vs 4.1 m). The only independent factor for longer PFS was nivolumab combined with chemotherapy. Overall, the safety of nivolumab in MBTC was controllable.