Abstract: The present invention provides a novel combination therapy with PD-1 blockade therapy. A pharmaceutical composition which comprises a substance capable of enhancing T cell receptor (TCR) signaling and is administered before, after or simultaneously with the administration of a PD-1 signaling inhibitor. A drug which enhances PD-1 signaling inhibitory activity, comprising a CD45 inhibitor and/or a cell. A TCR signaling enhancer comprising a CD45 inhibitor and/or a cell.

Abstract: A novel therapeutic strategy for the anti-PD-1 antibody therapy is provided. A pharmaceutical composition which comprises at least one substance selected from the group consisting of the following (i) to (iii) and is administered before, after or simultaneously with the administration of a PD-1 signal inhibitor: (i) ROS generators and substances that regulate downstream signaling pathways thereof, (ii) substances exhibiting an uncoupling effect and substances that regulate downstream signaling pathways thereof, and (iii) amino acids.

Abstract: A novel therapeutic strategy for the anti-PD-1 antibody therapy is provided. A pharmaceutical composition which comprises at least one substance selected from the group consisting of the following (i) to (iii) and is administered before, after or simultaneously with the administration of a PD-1 signal inhibitor: (i) ROS generators and substances that regulate downstream signaling pathways thereof, (ii) substances exhibiting an uncoupling effect and substances that regulate downstream signaling pathways thereof, and (iii) amino acids.

Abstract: The present invention provides markers for judging the efficacy of therapy with a PD-1 signal inhibitor before or at an early stage of the therapy. As biomarkers for predicting or judging the efficacy of therapy with a PD-1 signal inhibitor, surrogate indicators of metabolic changes relating to mitochondrial activity in T cells and/or T cell activation in a subject are used. As such indicators, intestinal flora-related metabolites in the serum or plasma, energy metabolism-related metabolites in the serum or plasma, amino acid metabolism-related metabolites and/or derivatives thereof in the serum of plasma, oxygen consumption rate and/or ATP turnover in peripheral blood CD8+ cells, amino acids in T cells, and T-bet in peripheral blood CD8+ cells may be used.

Abstract: The present invention provides a novel therapeutic strategy for anti-PD-1 antibody therapy. The present invention relates to a pharmaceutical composition which increases the function of oxidative phosphorylation in T cells; and a pharmaceutical composition which has an action for increasing the function of oxidative phosphorylation in T cells and is administered before, after or simultaneously with the administration of a PD-1 signaling inhibitor.

Abstract: A marker for judging the efficacy of therapy with a PD-1 signal inhibitor-containing drug before or at an early stage of the therapy is provided.

Abstract: Disclosed is a method for assisting a determination of an efficacy of an immune checkpoint inhibitor, the method comprising: measuring a free protein marker in a liquid sample collected from a subject; and determining the efficacy of the immune checkpoint inhibitor in the subject based on a result of the measurement, wherein the free protein marker is at least one selected from free Cytotoxic T lymphocyte antigen-4 (CTLA-4), free Programmed cell death-1 (PD-1) and free Programmed cell death-ligand 1 (PD-L1).

Abstract: A novel therapeutic strategy for the anti-PD-1 antibody therapy is provided. A pharmaceutical composition which comprises at least one substance selected from the group consisting of the following (i) to (iii) and is administered before, after or simultaneously with the administration of a PD-1 signal inhibitor: (i) ROS generators and substances that regulate downstream signaling pathways thereof, (ii) substances exhibiting an uncoupling effect and substances that regulate downstream signaling pathways thereof, and (iii) amino acids.

Abstract: The present invention relates to a method for determining cancer, the method comprising the steps of: measuring free PD-L1 (Programmed cell death-ligand 1) and free PD-1 (Programmed cell death-1) as free protein markers in a liquid sample collected from a subject, and determining whether or not the liquid sample is a sample collected from a subject suffering from cancer, based on measurement results.