Abstract A1: Clinical outcomes in patients with chronic hepatitis C and metastatic renal cell carcinoma (mRCC) after treatment with nivolumab

Clinical trials of immune checkpoint inhibitors have historically excluded patients with chronic hepatitis C (HCV) infection. The safety and efficacy profile of nivolumab is unknown in this under-represented population. Data were collected in a retrospective fashion on 36 patients with metastatic clear-cell mRCC. Patients were required to have a chronic HCV infection, no evidence of other malignancy or cirrhosis, and to have received nivolumab (3 mg/kg every 2 weeks) as second- or third-line therapy. Clinical outcomes included overall survival (OS), progression-free survival (PFS), and objective response rate (ORR). Safety was evaluated. Median follow-up was 17.5 months. Nivolumab was well tolerated in all HCV-infected patients (grade 3-4 toxicity was found in 6 of 36 cases [17%]). No unexpected toxicity was observed. Exposure to nivolumab was not associated with increased risk for hepatocellular carcinoma and cirrhosis (N=0). Medians OS and PFS were 23.9 (95% CI 20.7-26.5) and 6.8 (95% CI 4.9-8.7) months, respectively. 23% of patients had partial responses. The efficacy and safety profile observed in this study supports the administration of nivolumab in mRCC patients infected with HCV and warrants further investigation. Citation Format: Ilya Tsimafeyeu, Rustem Gafanov, Anna Semenova, Ani Oganesyan, Anastasia Bondarenko, Sufia Safina, Kristina Zakurdaeva, Svetlana Protsenko. Clinical outcomes in patients with chronic hepatitis C and metastatic renal cell carcinoma (mRCC) after treatment with nivolumab [abstract]. In: Proceedings of the AACR Special Conference on Tumor Immunology and Immunotherapy; 2019 Nov 17-20; Boston, MA. Philadelphia (PA): AACR; Cancer Immunol Res 2020;8(3 Suppl):Abstract nr A1.