{
    "info": {
        "nct_id": "NCT02301039",
        "official_title": "SARC028: A Phase II Study of the Anti-PD1 Antibody Pembrolizumab (MK-3475) in Patients With Advanced Sarcomas",
        "inclusion_criteria": "* Age ≥ 18 years (Age ≥ 12 years for patients with bone sarcomas).\n* Histologically confirmed diagnosis of unresectable, recurrent, and/or metastatic high grade soft-tissue or bone sarcoma of one of the following subtypes: soft tissue sarcomas (leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH and synovial sarcoma), and bone sarcomas (Ewing sarcoma, osteosarcoma, and chondrosarcoma [de-differentiated or mesenchymal]).\n* ECOG Performance Status of 0 or 1.\n* At least one site of measurable disease on CT/MRI scans as defined by RECIST 1.1. Baseline imaging must be performed within 30 days of dosing.\n* At least one site of accessible disease for pre- and post-treatment core biopsies for at least 20 patients per arm on the expansion cohorts.\n* Patients may have received 1-3 prior systemic therapies in the metastatic setting.\n* Adequate organ function within 14 days of dosing\n* Must be willing to provide and have available archival tissue for PD-L1 testing.\n* Written, voluntary informed consent.\n* Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 120 days after last study drug administration. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative pregnancy test ≤ 72 hours prior to Day 1 of study.\n* Effective methods of birth control include: surgically sterile, barrier device (condom, diaphragm), contraceptive coil, intrauterine device (IUD), and abstinence.\n* Life expectancy of >12 weeks.\n* Patients with central nervous system disease are eligible for enrollment if they have received prior radiotherapy or surgery to sites of CNS metastatic disease and are without evidence of clinical progression for at least 4 weeks prior to screening, have no evidence of new or enlarging brain metastases, and are off steroids for at least 7 days before first dose of pembrolizumab.\nHealthy volunteers allowed\nMust have minimum age of 12 Years",
        "exclusion_criteria": "* Prior systemic therapy targeting PD-1: PD-L1 axis.\n* Patients who are curable by conventional multidisciplinary management.\n* Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol.\n* Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation < 2 weeks prior to screening or who have not recovered adequately from side effects of such therapy.\n* Patients who have active infections requiring therapy.\n* Patients that are known to be positive for Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active Hepatitis B (HBsAg reactive), or Hepatitis C (HCV RNA [qualitative] is detected); patients with negative Hepatitis C antibody testing may not need RNA testing.\n* Patients that have a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial.\n* Patients who received systemic anti-cancer treatment prior to the first dose of study drug within the following time frames:\n* Patients with active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo or resolved childhood asthma/atopy would be exception to this rule. Patients that require inhaled steroids or local steroid injections would not be excluded from the study. Patients with hypothyroidism not from autoimmune disease that is stable on hormone replacement will not be excluded from the study.\n* Women who are pregnant or nursing/breastfeeding.\n* Known hypersensitivity to pembrolizumab or another mAb.\n* Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.\n* Patients with untreated central nervous system disease. Patients with controlled treated CNS lesions who have undergone surgery or stereotactic radiosurgery and stable for 4 weeks are eligible.\n* Inability to comply with protocol required procedures.\n* Patients with medical conditions that require chronic systemic corticosteroid therapy or require any other form of immunosuppressive medication. However, patients using physiologic replacement doses of hydrocortisone, or its equivalent, will be considered eligible for this study: up to 20 mg hydrocortisone (or 5 mg of prednisone) in the morning and 10 mg hydrocortisone (or 2.5 mg prednisone) in the evening.\n* Patients with the risk factors for bowel obstruction or bowel perforation (examples include but not limited to a history of acute diverticulitis, intra-abdominal abscess, abdominal carcinomatosis).\n* Patients who have received a live vaccine within 30 days prior to the first dose of trial treatment.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Age ≥ 18 years (Age ≥ 12 years for patients with bone sarcomas).",
            "criterions": [
                {
                    "exact_snippets": [
                        "Age ≥ 18 years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 18
                    }
                },
                {
                    "exact_snippets": [
                        "Age ≥ 12 years",
                        "patients with bone sarcomas"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 12
                    }
                }
            ]
        },
        {
            "line": "* Histologically confirmed diagnosis of unresectable, recurrent, and/or metastatic high grade soft-tissue or bone sarcoma of one of the following subtypes: soft tissue sarcomas (leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH and synovial sarcoma), and bone sarcomas (Ewing sarcoma, osteosarcoma, and chondrosarcoma [de-differentiated or mesenchymal]).",
            "criterions": [
                {
                    "exact_snippets": [
                        "Histologically confirmed diagnosis"
                    ],
                    "criterion": "diagnosis",
                    "requirement_type": "confirmation",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "unresectable"
                    ],
                    "criterion": "sarcoma",
                    "requirement_type": "resectability",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "recurrent"
                    ],
                    "criterion": "sarcoma",
                    "requirement_type": "recurrence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "metastatic"
                    ],
                    "criterion": "sarcoma",
                    "requirement_type": "metastasis",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "high grade"
                    ],
                    "criterion": "sarcoma",
                    "requirement_type": "grade",
                    "expected_value": "high"
                },
                {
                    "exact_snippets": [
                        "soft-tissue or bone sarcoma"
                    ],
                    "criterion": "sarcoma",
                    "requirement_type": "type",
                    "expected_value": [
                        "soft-tissue",
                        "bone"
                    ]
                },
                {
                    "exact_snippets": [
                        "soft tissue sarcomas (leiomyosarcoma, poorly differentiated/de-differentiated liposarcoma, high grade pleomorphic undifferentiated sarcoma/MFH and synovial sarcoma)"
                    ],
                    "criterion": "soft tissue sarcoma subtype",
                    "requirement_type": "type",
                    "expected_value": [
                        "leiomyosarcoma",
                        "poorly differentiated/de-differentiated liposarcoma",
                        "high grade pleomorphic undifferentiated sarcoma/MFH",
                        "synovial sarcoma"
                    ]
                },
                {
                    "exact_snippets": [
                        "bone sarcomas (Ewing sarcoma, osteosarcoma, and chondrosarcoma [de-differentiated or mesenchymal])"
                    ],
                    "criterion": "bone sarcoma subtype",
                    "requirement_type": "type",
                    "expected_value": [
                        "Ewing sarcoma",
                        "osteosarcoma",
                        "chondrosarcoma [de-differentiated or mesenchymal]"
                    ]
                }
            ]
        },
        {
            "line": "* ECOG Performance Status of 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": [
                        "ECOG Performance Status"
                    ],
                    "criterion": "ECOG Performance Status",
                    "requirement_type": "value",
                    "expected_value": [
                        "0",
                        "1"
                    ]
                }
            ]
        },
        {
            "line": "* At least one site of measurable disease on CT/MRI scans as defined by RECIST 1.1. Baseline imaging must be performed within 30 days of dosing.",
            "criterions": [
                {
                    "exact_snippets": [
                        "At least one site of measurable disease",
                        "on CT/MRI scans"
                    ],
                    "criterion": "measurable disease",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Baseline imaging must be performed",
                        "within 30 days of dosing"
                    ],
                    "criterion": "baseline imaging",
                    "requirement_type": "timing",
                    "expected_value": "within 30 days of dosing"
                }
            ]
        },
        {
            "line": "* At least one site of accessible disease for pre- and post-treatment core biopsies for at least 20 patients per arm on the expansion cohorts.",
            "criterions": [
                {
                    "exact_snippets": [
                        "At least one site of accessible disease"
                    ],
                    "criterion": "accessible disease site",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "operator": ">=",
                        "value": 1
                    }
                },
                {
                    "exact_snippets": [
                        "pre- and post-treatment core biopsies"
                    ],
                    "criterion": "core biopsies",
                    "requirement_type": "timing",
                    "expected_value": [
                        "pre-treatment",
                        "post-treatment"
                    ]
                },
                {
                    "exact_snippets": [
                        "at least 20 patients per arm"
                    ],
                    "criterion": "patients per arm",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "operator": ">=",
                        "value": 20
                    }
                }
            ]
        },
        {
            "line": "* Patients may have received 1-3 prior systemic therapies in the metastatic setting.",
            "criterions": [
                {
                    "exact_snippets": [
                        "1-3 prior systemic therapies"
                    ],
                    "criterion": "prior systemic therapies",
                    "requirement_type": "quantity",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 1
                            },
                            {
                                "operator": "<=",
                                "value": 3
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "metastatic setting"
                    ],
                    "criterion": "metastatic setting",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Adequate organ function within 14 days of dosing",
            "criterions": [
                {
                    "exact_snippets": [
                        "Adequate organ function"
                    ],
                    "criterion": "organ function",
                    "requirement_type": "adequacy",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "within 14 days of dosing"
                    ],
                    "criterion": "time frame for organ function assessment",
                    "requirement_type": "time frame",
                    "expected_value": "within 14 days of dosing"
                }
            ]
        },
        {
            "line": "* Must be willing to provide and have available archival tissue for PD-L1 testing.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Must be willing to provide",
                        "archival tissue"
                    ],
                    "criterion": "archival tissue",
                    "requirement_type": "willingness to provide",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "have available archival tissue"
                    ],
                    "criterion": "archival tissue",
                    "requirement_type": "availability",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "PD-L1 testing"
                    ],
                    "criterion": "PD-L1 testing",
                    "requirement_type": "purpose",
                    "expected_value": "archival tissue"
                }
            ]
        },
        {
            "line": "* Written, voluntary informed consent.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Written, voluntary informed consent"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "type",
                    "expected_value": "written"
                },
                {
                    "exact_snippets": [
                        "Written, voluntary informed consent"
                    ],
                    "criterion": "informed consent",
                    "requirement_type": "voluntariness",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Fertile men and women of childbearing potential must agree to use an effective method of birth control from providing signed consent and for 120 days after last study drug administration. Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause. Women of childbearing potential must have a negative pregnancy test ≤ 72 hours prior to Day 1 of study.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Fertile men and women of childbearing potential"
                    ],
                    "criterion": "fertility",
                    "requirement_type": "status",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "must agree to use an effective method of birth control"
                    ],
                    "criterion": "birth control",
                    "requirement_type": "agreement to use",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Women of childbearing potential include pre-menopausal women and women within the first 2 years of the onset of menopause"
                    ],
                    "criterion": "women of childbearing potential",
                    "requirement_type": "definition",
                    "expected_value": [
                        "pre-menopausal women",
                        "women within the first 2 years of the onset of menopause"
                    ]
                },
                {
                    "exact_snippets": [
                        "Women of childbearing potential must have a negative pregnancy test",
                        "≤ 72 hours prior to Day 1 of study"
                    ],
                    "criterion": "pregnancy test",
                    "requirement_type": "result",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "=",
                                "value": 0
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "Women of childbearing potential must have a negative pregnancy test",
                        "≤ 72 hours prior to Day 1 of study"
                    ],
                    "criterion": "pregnancy test timing",
                    "requirement_type": "timing",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 72
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Effective methods of birth control include: surgically sterile, barrier device (condom, diaphragm), contraceptive coil, intrauterine device (IUD), and abstinence.",
            "criterions": [
                {
                    "exact_snippets": [
                        "surgically sterile"
                    ],
                    "criterion": "birth control method",
                    "requirement_type": "effectiveness",
                    "expected_value": "surgically sterile"
                },
                {
                    "exact_snippets": [
                        "barrier device (condom, diaphragm)"
                    ],
                    "criterion": "birth control method",
                    "requirement_type": "effectiveness",
                    "expected_value": [
                        "condom",
                        "diaphragm"
                    ]
                },
                {
                    "exact_snippets": [
                        "contraceptive coil"
                    ],
                    "criterion": "birth control method",
                    "requirement_type": "effectiveness",
                    "expected_value": "contraceptive coil"
                },
                {
                    "exact_snippets": [
                        "intrauterine device (IUD)"
                    ],
                    "criterion": "birth control method",
                    "requirement_type": "effectiveness",
                    "expected_value": "intrauterine device (IUD)"
                },
                {
                    "exact_snippets": [
                        "abstinence"
                    ],
                    "criterion": "birth control method",
                    "requirement_type": "effectiveness",
                    "expected_value": "abstinence"
                }
            ]
        },
        {
            "line": "* Life expectancy of >12 weeks.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Life expectancy of >12 weeks"
                    ],
                    "criterion": "life expectancy",
                    "requirement_type": "duration",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">",
                                "value": 12
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Patients with central nervous system disease are eligible for enrollment if they have received prior radiotherapy or surgery to sites of CNS metastatic disease and are without evidence of clinical progression for at least 4 weeks prior to screening, have no evidence of new or enlarging brain metastases, and are off steroids for at least 7 days before first dose of pembrolizumab.",
            "criterions": [
                {
                    "exact_snippets": [
                        "central nervous system disease"
                    ],
                    "criterion": "central nervous system disease",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "received prior radiotherapy or surgery to sites of CNS metastatic disease"
                    ],
                    "criterion": "prior radiotherapy or surgery to CNS metastatic disease",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "without evidence of clinical progression",
                        "at least 4 weeks prior to screening"
                    ],
                    "criterion": "clinical progression",
                    "requirement_type": "absence",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 4
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "no evidence of new or enlarging brain metastases"
                    ],
                    "criterion": "new or enlarging brain metastases",
                    "requirement_type": "absence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "off steroids",
                        "at least 7 days before first dose of pembrolizumab"
                    ],
                    "criterion": "steroid use",
                    "requirement_type": "absence",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": ">=",
                                "value": 7
                            }
                        ]
                    }
                }
            ]
        },
        {
            "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 12 Years",
            "criterions": [
                {
                    "exact_snippets": [
                        "minimum age of 12 Years"
                    ],
                    "criterion": "age",
                    "requirement_type": "minimum",
                    "expected_value": {
                        "operator": ">=",
                        "value": 12
                    }
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Prior systemic therapy targeting PD-1: PD-L1 axis.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Prior systemic therapy targeting PD-1"
                    ],
                    "criterion": "systemic therapy",
                    "requirement_type": "prior targeting",
                    "expected_value": "PD-1"
                },
                {
                    "exact_snippets": [
                        "Prior systemic therapy targeting",
                        "PD-L1 axis"
                    ],
                    "criterion": "systemic therapy",
                    "requirement_type": "prior targeting",
                    "expected_value": "PD-L1 axis"
                }
            ]
        },
        {
            "line": "* Patients who are curable by conventional multidisciplinary management.",
            "criterions": [
                {
                    "exact_snippets": [
                        "curable by conventional multidisciplinary management"
                    ],
                    "criterion": "curability",
                    "requirement_type": "method",
                    "expected_value": "conventional multidisciplinary management"
                }
            ]
        },
        {
            "line": "* Patients with severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol.",
            "criterions": [
                {
                    "exact_snippets": [
                        "severe and/or uncontrolled concurrent medical disease"
                    ],
                    "criterion": "concurrent medical disease",
                    "requirement_type": "severity/control",
                    "expected_value": "severe and/or uncontrolled"
                },
                {
                    "exact_snippets": [
                        "in the opinion of the investigator could cause unacceptable safety risks"
                    ],
                    "criterion": "safety risks",
                    "requirement_type": "acceptability",
                    "expected_value": "unacceptable"
                },
                {
                    "exact_snippets": [
                        "compromise compliance with the protocol"
                    ],
                    "criterion": "compliance with the protocol",
                    "requirement_type": "compromise",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients who have received wide field radiotherapy ≤ 4 weeks or limited field radiation for palliation < 2 weeks prior to screening or who have not recovered adequately from side effects of such therapy.",
            "criterions": [
                {
                    "exact_snippets": [
                        "wide field radiotherapy ≤ 4 weeks"
                    ],
                    "criterion": "wide field radiotherapy",
                    "requirement_type": "time since treatment",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 4
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "limited field radiation for palliation < 2 weeks"
                    ],
                    "criterion": "limited field radiation for palliation",
                    "requirement_type": "time since treatment",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<",
                                "value": 2
                            }
                        ]
                    }
                },
                {
                    "exact_snippets": [
                        "have not recovered adequately from side effects of such therapy"
                    ],
                    "criterion": "recovery from side effects of radiotherapy",
                    "requirement_type": "adequacy",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients who have active infections requiring therapy.",
            "criterions": [
                {
                    "exact_snippets": [
                        "active infections"
                    ],
                    "criterion": "infections",
                    "requirement_type": "activity",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "requiring therapy"
                    ],
                    "criterion": "infections",
                    "requirement_type": "treatment necessity",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients that are known to be positive for Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies), active Hepatitis B (HBsAg reactive), or Hepatitis C (HCV RNA [qualitative] is detected); patients with negative Hepatitis C antibody testing may not need RNA testing.",
            "criterions": [
                {
                    "exact_snippets": [
                        "positive for Human Immunodeficiency Virus (HIV)"
                    ],
                    "criterion": "HIV status",
                    "requirement_type": "positivity",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "active Hepatitis B (HBsAg reactive)"
                    ],
                    "criterion": "Hepatitis B status",
                    "requirement_type": "activity",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Hepatitis C (HCV RNA [qualitative] is detected)"
                    ],
                    "criterion": "Hepatitis C status",
                    "requirement_type": "RNA detection",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "negative Hepatitis C antibody testing"
                    ],
                    "criterion": "Hepatitis C antibody testing",
                    "requirement_type": "result",
                    "expected_value": "negative"
                }
            ]
        },
        {
            "line": "* Patients that have a known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial.",
            "criterions": [
                {
                    "exact_snippets": [
                        "known psychiatric",
                        "disorder"
                    ],
                    "criterion": "psychiatric disorder",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "known",
                        "substance abuse",
                        "disorder"
                    ],
                    "criterion": "substance abuse disorder",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients who received systemic anti-cancer treatment prior to the first dose of study drug within the following time frames:",
            "criterions": [
                {
                    "exact_snippets": [
                        "Patients who received systemic anti-cancer treatment"
                    ],
                    "criterion": "systemic anti-cancer treatment",
                    "requirement_type": "prior treatment",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients with active autoimmune disease or a documented history of autoimmune disease or syndrome that requires systemic steroids or immunosuppressive agents. Patients with vitiligo or resolved childhood asthma/atopy would be exception to this rule. Patients that require inhaled steroids or local steroid injections would not be excluded from the study. Patients with hypothyroidism not from autoimmune disease that is stable on hormone replacement will not be excluded from the study.",
            "criterions": [
                {
                    "exact_snippets": [
                        "active autoimmune disease"
                    ],
                    "criterion": "autoimmune disease",
                    "requirement_type": "activity",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "documented history of autoimmune disease"
                    ],
                    "criterion": "autoimmune disease",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "syndrome that requires systemic steroids or immunosuppressive agents"
                    ],
                    "criterion": "syndrome",
                    "requirement_type": "treatment requirement",
                    "expected_value": [
                        "systemic steroids",
                        "immunosuppressive agents"
                    ]
                },
                {
                    "exact_snippets": [
                        "Patients with vitiligo or resolved childhood asthma/atopy would be exception"
                    ],
                    "criterion": "vitiligo",
                    "requirement_type": "exception",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "resolved childhood asthma/atopy would be exception"
                    ],
                    "criterion": "childhood asthma/atopy",
                    "requirement_type": "resolution",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "Patients that require inhaled steroids or local steroid injections would not be excluded"
                    ],
                    "criterion": "steroid requirement",
                    "requirement_type": "type",
                    "expected_value": [
                        "inhaled",
                        "local injections"
                    ]
                },
                {
                    "exact_snippets": [
                        "Patients with hypothyroidism not from autoimmune disease that is stable on hormone replacement will not be excluded"
                    ],
                    "criterion": "hypothyroidism",
                    "requirement_type": "stability",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Women who are pregnant or nursing/breastfeeding.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Women who are pregnant"
                    ],
                    "criterion": "pregnancy",
                    "requirement_type": "status",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "nursing/breastfeeding"
                    ],
                    "criterion": "breastfeeding",
                    "requirement_type": "status",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Known hypersensitivity to pembrolizumab or another mAb.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Known hypersensitivity to pembrolizumab"
                    ],
                    "criterion": "hypersensitivity",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "hypersensitivity to",
                        "another mAb"
                    ],
                    "criterion": "hypersensitivity",
                    "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": "presence",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients with untreated central nervous system disease. Patients with controlled treated CNS lesions who have undergone surgery or stereotactic radiosurgery and stable for 4 weeks are eligible.",
            "criterions": [
                {
                    "exact_snippets": [
                        "untreated central nervous system disease"
                    ],
                    "criterion": "central nervous system disease",
                    "requirement_type": "treatment status",
                    "expected_value": false
                },
                {
                    "exact_snippets": [
                        "controlled treated CNS lesions",
                        "undergone surgery or stereotactic radiosurgery",
                        "stable for 4 weeks"
                    ],
                    "criterion": "CNS lesions",
                    "requirement_type": "treatment status",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Inability to comply with protocol required procedures.",
            "criterions": [
                {
                    "exact_snippets": [
                        "Inability to comply with protocol required procedures"
                    ],
                    "criterion": "protocol compliance",
                    "requirement_type": "ability",
                    "expected_value": true
                }
            ]
        },
        {
            "line": "* Patients with medical conditions that require chronic systemic corticosteroid therapy or require any other form of immunosuppressive medication. However, patients using physiologic replacement doses of hydrocortisone, or its equivalent, will be considered eligible for this study: up to 20 mg hydrocortisone (or 5 mg of prednisone) in the morning and 10 mg hydrocortisone (or 2.5 mg prednisone) in the evening.",
            "criterions": [
                {
                    "exact_snippets": [
                        "medical conditions that require chronic systemic corticosteroid therapy"
                    ],
                    "criterion": "chronic systemic corticosteroid therapy",
                    "requirement_type": "necessity",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "require any other form of immunosuppressive medication"
                    ],
                    "criterion": "immunosuppressive medication",
                    "requirement_type": "necessity",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "physiologic replacement doses of hydrocortisone, or its equivalent, will be considered eligible",
                        "up to 20 mg hydrocortisone (or 5 mg of prednisone) in the morning and 10 mg hydrocortisone (or 2.5 mg prednisone) in the evening"
                    ],
                    "criterion": "physiologic replacement doses of hydrocortisone",
                    "requirement_type": "dosage",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 20
                            },
                            {
                                "operator": "<=",
                                "value": 10
                            }
                        ]
                    }
                }
            ]
        },
        {
            "line": "* Patients who have received a live vaccine within 30 days prior to the first dose of trial treatment.",
            "criterions": [
                {
                    "exact_snippets": [
                        "received a live vaccine within 30 days prior to the first dose of trial treatment"
                    ],
                    "criterion": "live vaccine",
                    "requirement_type": "recency",
                    "expected_value": {
                        "comparisons": [
                            {
                                "operator": "<=",
                                "value": 30
                            }
                        ]
                    }
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "* Patients with the risk factors for bowel obstruction or bowel perforation (examples include but not limited to a history of acute diverticulitis, intra-abdominal abscess, abdominal carcinomatosis).",
            "criterions": [
                {
                    "exact_snippets": [
                        "risk factors for bowel obstruction"
                    ],
                    "criterion": "bowel obstruction",
                    "requirement_type": "risk factors",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "risk factors for bowel perforation"
                    ],
                    "criterion": "bowel perforation",
                    "requirement_type": "risk factors",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "history of acute diverticulitis"
                    ],
                    "criterion": "acute diverticulitis",
                    "requirement_type": "history",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "intra-abdominal abscess"
                    ],
                    "criterion": "intra-abdominal abscess",
                    "requirement_type": "presence",
                    "expected_value": true
                },
                {
                    "exact_snippets": [
                        "abdominal carcinomatosis"
                    ],
                    "criterion": "abdominal carcinomatosis",
                    "requirement_type": "presence",
                    "expected_value": true
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}