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Phase Ib Feasibility Trial of Neoadjuvant Nivolumab/Lirilumab in Cisplatin-Ineligible Muscle-Invasive Bladder Cancer
Primary Objective: To assess safety of treatment according to Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0) manifested as the rate of Grade 3 or higher treatment related adverse events in patients treated with nivolumab (Cohort 1) or combination of nivolumab/lirilumab (Cohort 2). Secondary Objectives: To assess the change in CD8+ TIL density from pre-treatment Transurethral Resection of Bladder Tumor (TURBT) to post-treatment Radical Cystectomy (RC) tissues separately in patients treated with nivolumab or combination of nivolumab/lirilumab.
To assess percentage (%) change in CD8+ TIL density from pre-treatment TURBT to post-treatment RC tissues separately in patients treated with nivolumab and combination of nivolumab/lirilumab.
To describe the rate of patients in each cohort who do not get RC within 6 weeks after completion of neoadjuvant treatment specifically and directly related to treatment-related adverse events (AEs).
To assess the antitumor efficacy of nivolumab and combination of nivolumab/lirilumab as measured by pathologic complete (pT0N0) and partial (