{
    "info": {
        "nct_id": "NCT03858582",
        "official_title": "A Phase II, Neo-adjuvant Pembrolizumab, Docetaxel, Cisplatin Therapy Followed by Surgery and Pembrolizumab Consolidation Therapy in Locally Advanced Thymic Epithelial Tumor (TET)",
        "inclusion_criteria": "1. Male/female participants who are at least 19 years of age on the day of signing informed consent with histologically confirmed diagnosis of TETs will be enrolled in this study.\n2. Locally advanced stage (Modified Masaoka stage III or IVa)\n3. No previous chemotherapy treatment history\n4. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.\n5. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.\n6. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.\n7. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.\n8. Have measurable disease based on RECIST 1.1.\n9. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously treated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.\n10. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the date of allocation/randomization.\nHealthy volunteers allowed\nMust have minimum age of 19 Years",
        "exclusion_criteria": "1. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).\n2. Has received prior systemic anti-cancer therapy including investigational agents except patient had no active treatment for past 5 years.\n3. Has received prior radiotherapy.\n4. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.\n5. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.\n6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n7. Has a known additional malignancy that is progressing or has required active treatment. Exception include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.\n8. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n9. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.\n10. Has an active infection requiring systemic therapy.\n11. Has a known history of Human Immunodeficiency Virus (HIV).\n12. Has an active Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] positive) infection or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.\n13. Has a known history of active TB (Bacillus Tuberculosis). Old TB patient can be participated by investigator's decision.\n14. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.\n15. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n16. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.\n17. Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia\n18. Has a treatment history wih mAb within 4 weeks prior to the first dose of trial treatment\n19. Has a known history of psychosis or substance abuse",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Male/female participants who are at least 19 years of age on the day of signing informed consent with histologically confirmed diagnosis of TETs will be enrolled in this study.",
            "criterions": [
                {
                    "exact_snippets": "Male/female participants",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "at least 19 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 19,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "histologically confirmed diagnosis of TETs",
                    "criterion": "TETs diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Locally advanced stage (Modified Masaoka stage III or IVa)",
            "criterions": [
                {
                    "exact_snippets": "Locally advanced stage (Modified Masaoka stage III or IVa)",
                    "criterion": "disease stage",
                    "requirements": [
                        {
                            "requirement_type": "classification",
                            "expected_value": [
                                "Modified Masaoka stage III",
                                "Modified Masaoka stage IVa"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. No previous chemotherapy treatment history",
            "criterions": [
                {
                    "exact_snippets": "No previous chemotherapy treatment history",
                    "criterion": "chemotherapy treatment history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Male subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 120 days after the last dose of study therapy.",
            "criterions": [
                {
                    "exact_snippets": "Male subjects",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "agree to use an adequate method of contraception",
                    "criterion": "contraception use",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "starting with the first dose of study therapy through 120 days after the last dose of study therapy",
                    "criterion": "contraception use duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "starting with the first dose of study therapy through 120 days after the last dose of study therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Female subject of childbearing potential should have a negative urine or serum pregnancy within 72 hours prior to receiving the first dose of study medication. If the urine test is positive or cannot be confirmed as negative, a serum pregnancy test will be required.",
            "criterions": [
                {
                    "exact_snippets": "Female subject of childbearing potential",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female of childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "negative urine or serum pregnancy",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "within 72 hours prior to receiving the first dose of study medication",
                    "criterion": "timing of pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "within 72 hours prior to first dose"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Female subjects of childbearing potential should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study through 120 days after the last dose of study medication. Subjects of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year.",
            "criterions": [
                {
                    "exact_snippets": "Female subjects of childbearing potential",
                    "criterion": "gender and reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "gender",
                            "expected_value": "female"
                        },
                        {
                            "requirement_type": "reproductive status",
                            "expected_value": "childbearing potential"
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to use 2 methods of birth control",
                    "criterion": "birth control methods",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "methods"
                            }
                        },
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "be surgically sterile",
                    "criterion": "surgical sterility",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "abstain from heterosexual activity",
                    "criterion": "sexual activity",
                    "requirements": [
                        {
                            "requirement_type": "abstinence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "for the course of the study through 120 days after the last dose of study medication",
                    "criterion": "duration of birth control or abstinence",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "course of the study through 120 days after the last dose of study medication"
                        }
                    ]
                },
                {
                    "exact_snippets": "Subjects of childbearing potential are those who have not been surgically sterilized",
                    "criterion": "surgical sterilization",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "have not been free from menses for > 1 year",
                    "criterion": "menstrual status",
                    "requirements": [
                        {
                            "requirement_type": "duration without menses",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. The participant (or legally acceptable representative if applicable) provides written informed consent for the trial.",
            "criterions": [
                {
                    "exact_snippets": "The participant (or legally acceptable representative if applicable) provides written informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Have measurable disease based on RECIST 1.1.",
            "criterions": [
                {
                    "exact_snippets": "measurable disease based on RECIST 1.1",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Have provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion not previously treated. Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides. Newly obtained biopsies are preferred to archived tissue.",
            "criterions": [
                {
                    "exact_snippets": "provided archival tumor tissue sample or newly obtained core or excisional biopsy of a tumor lesion",
                    "criterion": "tumor tissue sample",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Formalin-fixed, paraffin embedded (FFPE) tissue blocks are preferred to slides",
                    "criterion": "tissue preparation method",
                    "requirements": [
                        {
                            "requirement_type": "preference",
                            "expected_value": "FFPE tissue blocks"
                        }
                    ]
                },
                {
                    "exact_snippets": "Newly obtained biopsies are preferred to archived tissue",
                    "criterion": "biopsy recency",
                    "requirements": [
                        {
                            "requirement_type": "preference",
                            "expected_value": "newly obtained biopsies"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1. Evaluation of ECOG is to be performed within 7 days prior to the date of allocation/randomization.",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Evaluation of ECOG is to be performed within 7 days prior to the date of allocation/randomization",
                    "criterion": "ECOG evaluation timing",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days prior to allocation/randomization"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 19 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 19 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 19,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "2. Has received prior systemic anti-cancer therapy including investigational agents except patient had no active treatment for past 5 years.",
            "criterions": [
                {
                    "exact_snippets": "Has received prior systemic anti-cancer therapy including investigational agents",
                    "criterion": "prior systemic anti-cancer therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "except patient had no active treatment for past 5 years",
                    "criterion": "active treatment in past 5 years",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Has received prior radiotherapy.",
            "criterions": [
                {
                    "exact_snippets": "Has received prior radiotherapy.",
                    "criterion": "prior radiotherapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Has received a live vaccine within 30 days prior to the first dose of study drug. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.",
            "criterions": [
                {
                    "exact_snippets": "Has received a live vaccine within 30 days prior to the first dose of study drug.",
                    "criterion": "live vaccine",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 30,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed.",
                    "criterion": "intranasal influenza vaccine",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "currently participating in ... study of an investigational agent",
                    "criterion": "participation in study of investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "has participated in a study of an investigational agent",
                    "criterion": "past participation in study of investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "time since participation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "has used an investigational device within 4 weeks prior to the first dose of study treatment",
                    "criterion": "use of investigational device",
                    "requirements": [
                        {
                            "requirement_type": "time since use",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "Has a diagnosis of immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent)",
                    "criterion": "chronic systemic steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "dosing",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg daily of prednisone equivalent"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug",
                    "criterion": "immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 7 days prior to the first dose of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Has a known additional malignancy that is progressing or has required active treatment. Exception include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.",
            "criterions": [
                {
                    "exact_snippets": "Has a known additional malignancy that is progressing or has required active treatment.",
                    "criterion": "additional malignancy",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "active treatment",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Exception include basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or in situ cervical cancer that has undergone potentially curative therapy.",
                    "criterion": "exceptional malignancies",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "basal cell carcinoma of the skin",
                                "squamous cell carcinoma of the skin",
                                "in situ cervical cancer"
                            ]
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "potentially curative therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.",
            "criterions": [
                {
                    "exact_snippets": "Has active autoimmune disease",
                    "criterion": "active autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has required systemic treatment in the past 2 years",
                    "criterion": "systemic treatment for autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "past 2 years"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.",
            "criterions": [
                {
                    "exact_snippets": "history of (non-infectious) pneumonitis that required steroids",
                    "criterion": "history of non-infectious pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "steroids"
                        }
                    ]
                },
                {
                    "exact_snippets": "current pneumonitis",
                    "criterion": "current pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Has an active infection requiring systemic therapy.",
            "criterions": [
                {
                    "exact_snippets": "active infection requiring systemic therapy",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Has a known history of Human Immunodeficiency Virus (HIV).",
            "criterions": [
                {
                    "exact_snippets": "known history of Human Immunodeficiency Virus (HIV)",
                    "criterion": "Human Immunodeficiency Virus (HIV)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Has an active Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] positive) infection or known active Hepatitis C virus (defined as HCV RNA [qualitative] is detected) infection.",
            "criterions": [
                {
                    "exact_snippets": "active Hepatitis B (defined as Hepatitis B surface antigen [HBsAg] positive)",
                    "criterion": "Hepatitis B infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "HBsAg",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "active Hepatitis C virus (defined as HCV RNA [qualitative] is detected)",
                    "criterion": "Hepatitis C virus infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "HCV RNA [qualitative]",
                            "expected_value": "detected"
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Has a known history of active TB (Bacillus Tuberculosis). Old TB patient can be participated by investigator's decision.",
            "criterions": [
                {
                    "exact_snippets": "known history of active TB (Bacillus Tuberculosis)",
                    "criterion": "active TB history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Old TB patient can be participated by investigator's decision",
                    "criterion": "old TB history",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": "investigator's decision"
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator.",
            "criterions": [
                {
                    "exact_snippets": "Has a history or current evidence of any condition",
                    "criterion": "condition",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "therapy",
                    "criterion": "therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "laboratory abnormality",
                    "criterion": "laboratory abnormality",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.",
            "criterions": [
                {
                    "exact_snippets": "known psychiatric ... disorders",
                    "criterion": "psychiatric disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "substance abuse disorders",
                    "criterion": "substance abuse disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Is pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of trial treatment.",
            "criterions": [
                {
                    "exact_snippets": "Is pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "expecting to conceive",
                    "criterion": "intention to conceive",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "father children",
                    "criterion": "intention to father children",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Uncontrolled systemic illness such as DM, CHF, unstable angina, hypertension or arrhythmia",
            "criterions": [
                {
                    "exact_snippets": "Uncontrolled systemic illness such as DM",
                    "criterion": "diabetes mellitus (DM)",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled systemic illness such as ... CHF",
                    "criterion": "congestive heart failure (CHF)",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled systemic illness such as ... unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled systemic illness such as ... hypertension",
                    "criterion": "hypertension",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                },
                {
                    "exact_snippets": "Uncontrolled systemic illness such as ... arrhythmia",
                    "criterion": "arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Has a treatment history wih mAb within 4 weeks prior to the first dose of trial treatment",
            "criterions": [
                {
                    "exact_snippets": "treatment history wih mAb within 4 weeks prior to the first dose of trial treatment",
                    "criterion": "treatment history with mAb",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Has a known history of psychosis or substance abuse",
            "criterions": [
                {
                    "exact_snippets": "known history of psychosis",
                    "criterion": "psychosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known history of ... substance abuse",
                    "criterion": "substance abuse",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "line": "1. Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, CTLA-4, OX 40, CD137).",
            "criterions": [
                {
                    "exact_snippets": "Has received prior therapy with an anti-PD-1",
                    "criterion": "prior therapy with anti-PD-1",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received prior therapy with an anti-PD-L1",
                    "criterion": "prior therapy with anti-PD-L1",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received prior therapy with ... anti PD L2",
                    "criterion": "prior therapy with anti-PD-L2",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received prior therapy ... with an agent directed to another stimulatory or co-inhibitory T-cell receptor",
                    "criterion": "prior therapy with agent directed to stimulatory or co-inhibitory T-cell receptor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received prior therapy ... (eg, CTLA-4",
                    "criterion": "prior therapy with agent directed to CTLA-4",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received prior therapy ... OX 40",
                    "criterion": "prior therapy with agent directed to OX 40",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received prior therapy ... CD137",
                    "criterion": "prior therapy with agent directed to CD137",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}