Abstract A008: Neoadjuvant nivolumab, gemcitabine and cisplatin in muscle-invasive bladder cancer: Study update

Background: Cisplatin-based neoadjuvant chemotherapy in muscle-invasive bladder cancer (MIBC) improves survival which correlates with pathologic response (PaR) at radical cystectomy (RC). Immunotherapy with checkpoint inhibitors has improved outcomes in advanced bladder cancer and immunotherapy is synergistic with chemotherapy. Our ongoing trial is aimed at studying the efficacy and safety of nivolumab (N)with gemcitabine-cisplatin (GC) as neoadjuvant therapy for MIBC (NCT03294304). Methods: This is a single-arm, multicenter phase II study for patients with MIBC eligible for neoadjuvant GC and planned for RC. Forty-one patients will be treated with N+ GC every 21 days for 4 treatment cycles over 12 weeks followed by RC. The primary endpoint is PaR. Key inclusion criteria are presence of MIBC (predominantly urothelial carcinoma) with clinical stage T2-T4a and N≤1 disease (solitary lymph node measuring Citation Format: Shilpa Gupta, Christopher J. Weight, Neeraj Agarwal, Sumati Gupta, Badrinath Konety, Ewan Gibb, Elai Davicioni, Bharat Thyagarajan, Guru Sonpavde. Neoadjuvant nivolumab, gemcitabine and cisplatin in muscle-invasive bladder cancer: Study update [abstract]. In: Proceedings of the Fourth CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference: Translating Science into Survival; Sept 30-Oct 3, 2018; New York, NY. Philadelphia (PA): AACR; Cancer Immunol Res 2019;7(2 Suppl):Abstract nr A008.