{
    "info": {
        "nct_id": "NCT03062358",
        "official_title": "A Phase III Randomized Double-blind Study of Pembrolizumab Plus Best Supportive Care vs. Placebo Plus Best Supportive Care as Second-Line Therapy in Asian Subjects With Previously Systemically Treated Advanced Hepatocellular Carcinoma (KEYNOTE-394)",
        "inclusion_criteria": "* Has a HCC diagnosis confirmed by radiology, histology, or cytology (fibrolamellar, and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible)\n* Has Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy and not amenable to a curative treatment approach.\n* Has a Child-Pugh A liver score within 7 days prior to first dose of study medication\n* Has a life expectancy of >3 months\n* Has at least one measurable lesion based on RECIST version 1.1 as determined by investigator.\n* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 7 days prior to receiving the first dose of study medication.\n* Has documented objective radiographic progression during or after treatment with sorafenib or oxaliplatin-based chemotherapy, or else intolerance to sorafenib or oxaliplatin-based chemotherapy\n* Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study therapy\n* Female and male participants of reproductive potential must agree to use adequate contraception starting from the first dose of study medication, throughout the study period, and for up to 120 days after the last dose of study medication\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Is currently participating or has participated in a study with an investigational agent or using an investigational device within 4 weeks of the first dose of study medication\n* Has received sorafenib or oxaliplatin-based chemotherapy within 14 days of first dose of study medication\n* Has had esophageal or gastric variceal bleeding within the last 6 months\n* Has clinically apparent ascites on physical examination\n* Has portal vein invasion at the main portal branch (Vp4), inferior vena cava, or cardiac involvement of HCC based on imaging\n* Has had clinically diagnosed hepatic encephalopathy in the last 6 months\n* Has had a solid organ or hematologic transplant\n* Has had prior systemic therapy for HCC in the advanced (incurable) setting other than sorafenib or oxaliplatin-based chemotherapy, prior to start of study medication\n* Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic treatment.\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication\n* Has received locoregional therapy to liver (transcatheter chemoembolization [TACE], transcatheter embolization [TAE], hepatic arterial infusion [HAI], radiation, radioembolization, or ablation) within 4 weeks prior to the first dose of study medication\n* Has had major surgery to liver or other site within 4 weeks prior to the first dose of study medication\n* Has had a minor surgery ≤7 days prior to the first dose of study medication\n* Has not recovered adequately (i.e., Grade ≤1 or baseline) from the toxicity and/or complications from any intervention prior to study start\n* Has a diagnosed additional malignancy within 3 years prior to first dose of study medication with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cancers\n* Has a known history of, or any evidence of, central nervous system (CNS) metastases and/or carcinomatous meningitis\n* Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis\n* Has an active infection requiring systemic therapy\n* Is pregnant or breast feeding or expecting to conceive or father starting from the first dose of study medication, throughout the study period, and for up to 120 days after the last dose of study medication\n* Has received prior immunotherapy with an anti-Programmed Cell Death Receptor 1 (PD-1), Programmed Cell Death Receptor Ligand 1 (anti-PD-L1), or anti-Programmed Cell Death Receptor Ligand 2 (PD-L2) or has previously participated in clinical studies with pembrolizumab\n* Has a known history of human immunodeficiency virus (HIV)\n* Has untreated active Hepatitis B\n* Has Hepatitis C in which participants received therapy for HCV <4 weeks prior to receiving pembrolizumab\n* Has received a live vaccine within 30 days prior to the first dose of study therapy",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Has a HCC diagnosis confirmed by radiology, histology, or cytology (fibrolamellar, and mixed hepatocellular/cholangiocarcinoma subtypes are not eligible)",
            "criterions": [
                {
                    "exact_snippets": [
                        "HCC diagnosis"
                    ],
                    "criterion": "HCC diagnosis",
                    "requirement_type": "confirmation",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "fibrolamellar, and mixed hepatocellular/cholangiocarcinoma subtypes"
                    ],
                    "criterion": "HCC subtype",
                    "requirement_type": "exclusion",
                    "expected_value": [
                        "fibrolamellar",
                        "mixed hepatocellular/cholangiocarcinoma"
                    ]
                }
            ]
        },
        {
            "line": "* Has Barcelona Clinic Liver Cancer (BCLC) Stage C disease or BCLC Stage B disease not amenable to locoregional therapy or refractory to locoregional therapy and not amenable to a curative treatment approach.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Barcelona Clinic Liver Cancer (BCLC) Stage C disease"
                    ],
                    "criterion": "BCLC stage",
                    "requirement_type": "specific stage",
                    "expected_value": "C"
                },
                {
                    "exact_snippets": [
                        "BCLC Stage B disease not amenable to locoregional therapy"
                    ],
                    "criterion": "BCLC stage B",
                    "requirement_type": "amenability to locoregional therapy",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "BCLC Stage B disease",
                        "refractory to locoregional therapy"
                    ],
                    "criterion": "BCLC stage B",
                    "requirement_type": "refractoriness to locoregional therapy",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "BCLC Stage B disease",
                        "not amenable to a curative treatment approach"
                    ],
                    "criterion": "BCLC stage B",
                    "requirement_type": "amenability to curative treatment",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Has a Child-Pugh A liver score within 7 days prior to first dose of study medication",
            "criterions": [
                {
                    "exact_snippets": [
                        "Child-Pugh A liver score"
                    ],
                    "criterion": "Child-Pugh liver score",
                    "requirement_type": "category",
                    "expected_value": "A"
                },
                {
                    "exact_snippets": [
                        "within 7 days prior to first dose of study medication"
                    ],
                    "criterion": "timing of Child-Pugh liver score assessment",
                    "requirement_type": "timing",
                    "expected_value": "within 7 days prior to first dose of study medication"
                }
            ]
        },
        {
            "line": "* Has a life expectancy of >3 months",
            "criterions": [
                {
                    "exact_snippets": [
                        "life expectancy of >3 months"
                    ],
                    "criterion": "life expectancy",
                    "requirement_type": "duration",
                    "expected_value": {
                        "operator": ">",
                        "value": 3
                    }
                }
            ]
        },
        {
            "line": "* Has at least one measurable lesion based on RECIST version 1.1 as determined by investigator.",
            "criterions": [
                {
                    "exact_snippets": [
                        "at least one measurable lesion"
                    ],
                    "criterion": "measurable lesion",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "operator": ">=",
                        "value": 1
                    }
                },
                {
                    "exact_snippets": [
                        "based on RECIST version 1.1"
                    ],
                    "criterion": "RECIST version",
                    "requirement_type": "version",
                    "expected_value": "1.1"
                },
                {
                    "exact_snippets": [
                        "as determined by investigator"
                    ],
                    "criterion": "investigator determination",
                    "requirement_type": "responsibility",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 7 days prior to receiving the first dose of study medication.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Eastern Cooperative Oncology Group (ECOG) performance status"
                    ],
                    "criterion": "ECOG performance status",
                    "requirement_type": "value",
                    "expected_value": [
                        "0",
                        "1"
                    ]
                },
                {
                    "exact_snippets": [
                        "performed within 7 days prior to receiving the first dose of study medication"
                    ],
                    "criterion": "ECOG performance status assessment",
                    "requirement_type": "timing",
                    "expected_value": "within 7 days prior to first dose"
                }
            ]
        },
        {
            "line": "* Has documented objective radiographic progression during or after treatment with sorafenib or oxaliplatin-based chemotherapy, or else intolerance to sorafenib or oxaliplatin-based chemotherapy",
            "criterions": [
                {
                    "exact_snippets": [
                        "documented objective radiographic progression"
                    ],
                    "criterion": "radiographic progression",
                    "requirement_type": "documentation",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "treatment with sorafenib or oxaliplatin-based chemotherapy"
                    ],
                    "criterion": "treatment",
                    "requirement_type": "type",
                    "expected_value": [
                        "sorafenib",
                        "oxaliplatin-based chemotherapy"
                    ]
                },
                {
                    "exact_snippets": [
                        "intolerance to sorafenib or oxaliplatin-based chemotherapy"
                    ],
                    "criterion": "intolerance",
                    "requirement_type": "treatment",
                    "expected_value": [
                        "sorafenib",
                        "oxaliplatin-based chemotherapy"
                    ]
                }
            ]
        },
        {
            "line": "* Female participants of childbearing potential must have a negative urine or serum pregnancy test within 72 hours prior to receiving the first dose of study therapy",
            "criterions": [
                {
                    "exact_snippets": [
                        "Female participants of childbearing potential"
                    ],
                    "criterion": "gender",
                    "requirement_type": "specific",
                    "expected_value": "female"
                },
                {
                    "exact_snippets": [
                        "Female participants of childbearing potential"
                    ],
                    "criterion": "childbearing potential",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "must have a negative urine or serum pregnancy test"
                    ],
                    "criterion": "pregnancy test",
                    "requirement_type": "result",
                    "expected_value": "negative"
                },
                {
                    "exact_snippets": [
                        "within 72 hours prior to receiving the first dose of study therapy"
                    ],
                    "criterion": "pregnancy test timing",
                    "requirement_type": "timing",
                    "expected_value": "within 72 hours prior to first dose"
                }
            ]
        },
        {
            "line": "* Female and male participants of reproductive potential must agree to use adequate contraception starting from the first dose of study medication, throughout the study period, and for up to 120 days after the last dose of study medication",
            "criterions": [
                {
                    "exact_snippets": [
                        "Female and male participants of reproductive potential"
                    ],
                    "criterion": "reproductive potential",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "must agree to use adequate contraception"
                    ],
                    "criterion": "contraception",
                    "requirement_type": "agreement to use",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "starting from the first dose of study medication, throughout the study period, and for up to 120 days after the last dose of study medication"
                    ],
                    "criterion": "contraception",
                    "requirement_type": "duration",
                    "expected_value": "starting from the first dose of study medication, throughout the study period, and for up to 120 days after the last dose of study medication"
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": [
                        "Healthy volunteers allowed"
                    ],
                    "criterion": "healthy volunteers",
                    "requirement_type": "participation",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 18 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Is currently participating or has participated in a study with an investigational agent or using an investigational device within 4 weeks of the first dose of study medication",
            "criterions": [
                {
                    "exact_snippets": [
                        "currently participating",
                        "in a study"
                    ],
                    "criterion": "study participation",
                    "requirement_type": "current status",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "has participated",
                        "in a study"
                    ],
                    "criterion": "study participation",
                    "requirement_type": "past status",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "investigational agent"
                    ],
                    "criterion": "investigational agent",
                    "requirement_type": "use",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "investigational device"
                    ],
                    "criterion": "investigational device",
                    "requirement_type": "use",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "within 4 weeks of the first dose of study medication"
                    ],
                    "criterion": "time since last investigational study",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 4
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Has received sorafenib or oxaliplatin-based chemotherapy within 14 days of first dose of study medication",
            "criterions": [
                {
                    "exact_snippets": [
                        "Has received sorafenib"
                    ],
                    "criterion": "sorafenib",
                    "requirement_type": "prior treatment",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "oxaliplatin-based chemotherapy"
                    ],
                    "criterion": "oxaliplatin-based chemotherapy",
                    "requirement_type": "prior treatment",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "within 14 days of first dose of study medication"
                    ],
                    "criterion": "time since last treatment",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 14
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Has had esophageal or gastric variceal bleeding within the last 6 months",
            "criterions": [
                {
                    "exact_snippets": [
                        "esophageal or gastric variceal bleeding"
                    ],
                    "criterion": "esophageal or gastric variceal bleeding",
                    "requirement_type": "occurrence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "within the last 6 months"
                    ],
                    "criterion": "esophageal or gastric variceal bleeding",
                    "requirement_type": "time frame",
                    "expected_value": "last 6 months"
                }
            ]
        },
        {
            "line": "* Has clinically apparent ascites on physical examination",
            "criterions": [
                {
                    "exact_snippets": [
                        "clinically apparent ascites on physical examination"
                    ],
                    "criterion": "ascites",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Has portal vein invasion at the main portal branch (Vp4), inferior vena cava, or cardiac involvement of HCC based on imaging",
            "criterions": [
                {
                    "exact_snippets": [
                        "portal vein invasion"
                    ],
                    "criterion": "portal vein",
                    "requirement_type": "invasion",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "inferior vena cava",
                        "involvement"
                    ],
                    "criterion": "inferior vena cava",
                    "requirement_type": "involvement",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "cardiac involvement"
                    ],
                    "criterion": "cardiac",
                    "requirement_type": "involvement",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "HCC based on imaging"
                    ],
                    "criterion": "HCC",
                    "requirement_type": "diagnosis",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Has had clinically diagnosed hepatic encephalopathy in the last 6 months",
            "criterions": [
                {
                    "exact_snippets": [
                        "clinically diagnosed hepatic encephalopathy"
                    ],
                    "criterion": "hepatic encephalopathy",
                    "requirement_type": "diagnosis",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "in the last 6 months"
                    ],
                    "criterion": "hepatic encephalopathy",
                    "requirement_type": "timeframe",
                    "expected_value": "last 6 months"
                }
            ]
        },
        {
            "line": "* Has had a solid organ or hematologic transplant",
            "criterions": [
                {
                    "exact_snippets": [
                        "solid organ or hematologic transplant"
                    ],
                    "criterion": "solid organ transplant",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "solid organ or hematologic transplant"
                    ],
                    "criterion": "hematologic transplant",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Has had prior systemic therapy for HCC in the advanced (incurable) setting other than sorafenib or oxaliplatin-based chemotherapy, prior to start of study medication",
            "criterions": [
                {
                    "exact_snippets": [
                        "prior systemic therapy for HCC in the advanced (incurable) setting"
                    ],
                    "criterion": "prior systemic therapy for HCC",
                    "requirement_type": "setting",
                    "expected_value": "advanced (incurable)"
                },
                {
                    "exact_snippets": [
                        "prior systemic therapy for HCC",
                        "other than sorafenib or oxaliplatin-based chemotherapy"
                    ],
                    "criterion": "prior systemic therapy for HCC",
                    "requirement_type": "exclusion",
                    "expected_value": [
                        "sorafenib",
                        "oxaliplatin-based chemotherapy"
                    ]
                }
            ]
        },
        {
            "line": "* Has an active autoimmune disease that has required systemic treatment in the past 2 years. Replacement therapy is not considered a form of systemic treatment.",
            "criterions": [
                {
                    "exact_snippets": [
                        "active autoimmune disease"
                    ],
                    "criterion": "autoimmune disease",
                    "requirement_type": "activity",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "has required systemic treatment in the past 2 years"
                    ],
                    "criterion": "systemic treatment for autoimmune disease",
                    "requirement_type": "requirement",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Replacement therapy is not considered a form of systemic treatment"
                    ],
                    "criterion": "replacement therapy",
                    "requirement_type": "classification",
                    "expected_value": "not systemic treatment"
                }
            ]
        },
        {
            "line": "* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication",
            "criterions": [
                {
                    "exact_snippets": [
                        "Has a diagnosis of immunodeficiency"
                    ],
                    "criterion": "immunodeficiency",
                    "requirement_type": "diagnosis",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "is receiving systemic steroid therapy"
                    ],
                    "criterion": "systemic steroid therapy",
                    "requirement_type": "receiving",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "any other form of immunosuppressive therapy within 7 days prior to the first dose of study medication"
                    ],
                    "criterion": "immunosuppressive therapy",
                    "requirement_type": "receiving",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Has received locoregional therapy to liver (transcatheter chemoembolization [TACE], transcatheter embolization [TAE], hepatic arterial infusion [HAI], radiation, radioembolization, or ablation) within 4 weeks prior to the first dose of study medication",
            "criterions": [
                {
                    "exact_snippets": [
                        "Has received locoregional therapy to liver"
                    ],
                    "criterion": "locoregional therapy to liver",
                    "requirement_type": "receipt",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "within 4 weeks prior to the first dose of study medication"
                    ],
                    "criterion": "time since locoregional therapy",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 4
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Has had major surgery to liver or other site within 4 weeks prior to the first dose of study medication",
            "criterions": [
                {
                    "exact_snippets": [
                        "major surgery to liver or other site"
                    ],
                    "criterion": "major surgery",
                    "requirement_type": "recency",
                    "expected_value": {
                        "operator": "<=",
                        "value": 4
                    }
                }
            ]
        },
        {
            "line": "* Has had a minor surgery ≤7 days prior to the first dose of study medication",
            "criterions": [
                {
                    "exact_snippets": [
                        "Has had a minor surgery ≤7 days prior to the first dose of study medication"
                    ],
                    "criterion": "minor surgery",
                    "requirement_type": "time since",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 7
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Has not recovered adequately (i.e., Grade ≤1 or baseline) from the toxicity and/or complications from any intervention prior to study start",
            "criterions": [
                {
                    "exact_snippets": [
                        "Has not recovered adequately",
                        "Grade ≤1 or baseline",
                        "toxicity"
                    ],
                    "criterion": "toxicity",
                    "requirement_type": "recovery",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Has not recovered adequately",
                        "Grade ≤1 or baseline",
                        "complications"
                    ],
                    "criterion": "complications",
                    "requirement_type": "recovery",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Has a diagnosed additional malignancy within 3 years prior to first dose of study medication with the exception of curatively treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin and/or curatively resected in situ cancers",
            "criterions": [
                {
                    "exact_snippets": [
                        "diagnosed additional malignancy within 3 years prior to first dose of study medication"
                    ],
                    "criterion": "additional malignancy",
                    "requirement_type": "diagnosis time frame",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 3
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "curatively treated basal cell carcinoma of the skin"
                    ],
                    "criterion": "basal cell carcinoma of the skin",
                    "requirement_type": "treatment outcome",
                    "expected_value": "curatively treated"
                },
                {
                    "exact_snippets": [
                        "curatively treated",
                        "squamous cell carcinoma of the skin"
                    ],
                    "criterion": "squamous cell carcinoma of the skin",
                    "requirement_type": "treatment outcome",
                    "expected_value": "curatively treated"
                },
                {
                    "exact_snippets": [
                        "curatively resected in situ cancers"
                    ],
                    "criterion": "in situ cancers",
                    "requirement_type": "treatment outcome",
                    "expected_value": "curatively resected"
                }
            ]
        },
        {
            "line": "* Has a known history of, or any evidence of, central nervous system (CNS) metastases and/or carcinomatous meningitis",
            "criterions": [
                {
                    "exact_snippets": [
                        "known history of",
                        "central nervous system (CNS) metastases"
                    ],
                    "criterion": "central nervous system (CNS) metastases",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "evidence of",
                        "central nervous system (CNS) metastases"
                    ],
                    "criterion": "central nervous system (CNS) metastases",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "known history of",
                        "carcinomatous meningitis"
                    ],
                    "criterion": "carcinomatous meningitis",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "evidence of",
                        "carcinomatous meningitis"
                    ],
                    "criterion": "carcinomatous meningitis",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis",
            "criterions": [
                {
                    "exact_snippets": [
                        "history of (non-infectious) pneumonitis"
                    ],
                    "criterion": "non-infectious pneumonitis",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "required steroids"
                    ],
                    "criterion": "steroid treatment",
                    "requirement_type": "necessity",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "current pneumonitis"
                    ],
                    "criterion": "pneumonitis",
                    "requirement_type": "current presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Has an active infection requiring systemic therapy",
            "criterions": [
                {
                    "exact_snippets": [
                        "active infection"
                    ],
                    "criterion": "infection",
                    "requirement_type": "status",
                    "expected_value": "active"
                },
                {
                    "exact_snippets": [
                        "requiring systemic therapy"
                    ],
                    "criterion": "systemic therapy",
                    "requirement_type": "necessity",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Is pregnant or breast feeding or expecting to conceive or father starting from the first dose of study medication, throughout the study period, and for up to 120 days after the last dose of study medication",
            "criterions": [
                {
                    "exact_snippets": [
                        "Is pregnant"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "breast feeding"
                    ],
                    "criterion": "breastfeeding",
                    "requirement_type": "status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "expecting to conceive"
                    ],
                    "criterion": "expectation to conceive",
                    "requirement_type": "status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "expecting to",
                        "father"
                    ],
                    "criterion": "expectation to father",
                    "requirement_type": "status",
                    "expected_value": false
                }
            ]
        },
        {
            "line": "* Has a known history of human immunodeficiency virus (HIV)",
            "criterions": [
                {
                    "exact_snippets": [
                        "known history of human immunodeficiency virus (HIV)"
                    ],
                    "criterion": "human immunodeficiency virus (HIV)",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Has untreated active Hepatitis B",
            "criterions": [
                {
                    "exact_snippets": [
                        "untreated active Hepatitis B"
                    ],
                    "criterion": "Hepatitis B",
                    "requirement_type": "treatment status",
                    "expected_value": "untreated"
                },
                {
                    "exact_snippets": [
                        "untreated active Hepatitis B"
                    ],
                    "criterion": "Hepatitis B",
                    "requirement_type": "activity status",
                    "expected_value": "active"
                }
            ]
        },
        {
            "line": "* Has Hepatitis C in which participants received therapy for HCV <4 weeks prior to receiving pembrolizumab",
            "criterions": [
                {
                    "exact_snippets": [
                        "Hepatitis C"
                    ],
                    "criterion": "Hepatitis C",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "therapy for HCV <4 weeks prior to receiving pembrolizumab"
                    ],
                    "criterion": "therapy for HCV",
                    "requirement_type": "time since last treatment",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 4
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Has received a live vaccine within 30 days prior to the first dose of study therapy",
            "criterions": [
                {
                    "exact_snippets": [
                        "received a live vaccine within 30 days prior to the first dose of study therapy"
                    ],
                    "criterion": "live vaccine",
                    "requirement_type": "receipt",
                    "expected_value": false
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Has received prior immunotherapy with an anti-Programmed Cell Death Receptor 1 (PD-1), Programmed Cell Death Receptor Ligand 1 (anti-PD-L1), or anti-Programmed Cell Death Receptor Ligand 2 (PD-L2) or has previously participated in clinical studies with pembrolizumab",
            "criterions": [
                {
                    "exact_snippets": [
                        "Has received prior immunotherapy with an anti-Programmed Cell Death Receptor 1 (PD-1)"
                    ],
                    "criterion": "prior immunotherapy with anti-PD-1",
                    "requirement_type": "receipt",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Has received prior immunotherapy with an anti-Programmed Cell Death Receptor Ligand 1 (anti-PD-L1)"
                    ],
                    "criterion": "prior immunotherapy with anti-PD-L1",
                    "requirement_type": "receipt",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Has received prior immunotherapy with an anti-Programmed Cell Death Receptor Ligand 2 (PD-L2)"
                    ],
                    "criterion": "prior immunotherapy with anti-PD-L2",
                    "requirement_type": "receipt",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "has previously participated in clinical studies with pembrolizumab"
                    ],
                    "criterion": "participation in clinical studies with pembrolizumab",
                    "requirement_type": "history",
                    "expected_value": true
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}