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Randomized Phase II Study To Assess The Role Of Nivolumab As Single Agent To Eliminate Minimal Residual Disease And Maintain Remission In Acute Myelogenous Leukemia (AML) Patients After Chemotherapy (REMAIN TRIAL)
This randomized phase II trial studies how well nivolumab works in eliminating any remaining cancer cells and preventing cancer from returning in patients with acute myeloid leukemia that had a decrease in or disappearance of signs and symptoms of cancer after receiving chemotherapy. Monoclonal antibodies, such as nivolumab, may block cancer growth in different ways by targeting certain cells.
Primary Objectives: To evaluate and compare the progression free survival rate after randomization in the two treatment arms (Nivolumab vs. observation). Secondary Objectives: - To determine and compare the overall survival rates in the two arms. - To determine and compare the incidence of non-relapse mortality in the two arms. - To evaluate the toxicities of Nivolumab as maintenance. Exploratory Objectives: - To analyze PD-LI expression on AML cells from peripheral blood and/or bone marrow samples at diagnosis if available and at the time of study enrollment. - To monitor AML MRD by WT1 PCR at enrollment and at subsequent defined time points in the Nivolumab-treated and control groups. - To perform an exploratory analysis on the frequencies, absolute numbers and subsets of T cells (including regulatory T cells) in the Nivolumab-treated and control groups with an emphasis on activation markers. - To perform deep sequencing of T cell receptor (TCR)-alpha and TCR-beta chains on polyclonal T cells at baseline and at subsequent time points in the Nivolumab and control groups.