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A Phase II Open Label Single Arm Study of Adjuvant Nivolumab following Chemo-Radiation in localized Muscle-Invasive Bladder Cancer (NEXT)
This is a phase 2, single arm, open label trial to evaluate the rate of failure free survival at 2 years after start of chemoradiation with adjuvant nivolumab in adult subjects who undergo chemoradiation for localized bladder cancer.
The primary purpose of this study is to evaluate the ability of checkpoint inhibition with nivolumab to enhance the efficacy of chemoradiation in localized bladder cancer to reduce the rates of loco regional and distant recurrence without added toxicity. - Primary Objectives and Endpoint The primary objective is to evaluate the two-year rate of failure-free survival (FFS). The definition of failure will include loco-regional recurrence, and distant recurrence. The primary endpoint of the FFS will be determined based on disease recurrence date defined as the time between the start date of study treatment (nivolumab) and the date of first recurrence or non-cancer related death. Secondary Objectives and Endpoint - Evaluate the rate of failure-free survival at two years in subjects with intact bladder (FFSIB). This will be measured only in subjects who do not have local recurrence requiring radical cystectomy. The endpoint of FFSIB will be determined based on disease recurrence date defined as the time between the start date of study treatment (nivolumab) and the date of first recurrence or non-cancer related death. - Evaluate the rate of acute and late grade 2 or higher treatment-related GU, GI, hematologic, and immune related toxicity. The incidence of adverse events will be collected and tabulated through treatment and follow up. - Evaluate the effect of treatment on Quality of Life. The endpoint will include the completion of quality of life questionnaires as per study calendar. - Evaluate cystoscopic local control at 6 months, 1 year and 2 years post start of study treatment with nivolumab after censoring for distant recurrence. The endpoint will be measurement of local recurrence at 6 months, 1 year and 2 years as determined by cystoscopy. - Evaluate the rate of salvage cystectomy. This will be measured by the endpoint of radical cystectomy for local recurrence during study treatment. - Evaluate the rate of distant failure-free survival at two years in subjects with intact bladder and those who discontinue study to undergo salvage cystectomy. This will be measured in subjects who do and do not have local recurrence requiring radical cystectomy during study treatment. The endpoint FFS will be determined based on disease recurrence date defined as the time between the start date of study treatment (nivolumab) and the date of first distant recurrence or non-cancer related death. - Evaluate overall survival up to 5 years. This will be measured by the rate of death for up to 5 years from start of study treatment. Exploratory Objectives: - To asses immunological monitoring on peripheral blood mononuclear cells and other humoral factors collected prior to the initiation of chemoradiation, study therapy, and throughout the study drug administration, to characterize changes in immune cell and immune factor subsets that can be correlated with clinical outcome. - To assess the correlation of response to PD-L1 expression in pretreatment tumor tissue in the study subjects
BMS-936558 (Nivolumab); Nivolumab (Opdivo)