{
    "info": {
        "nct_id": "NCT04754191",
        "official_title": "A Phase 2 Umbrella Protocol of Enfortumab Vedotin As Monotherapy and Combined with Other Agents in Patients with Metastatic Castration-Resistant Prostate Cancer",
        "inclusion_criteria": "* Male subject aged ≥ 18 years.\n* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology.\n* Diagnosis of metastatic or locally advanced, inoperable disease that cannot be treated with definitive intent\n* Castrate levels of testosterone as defined as < 50 ng/dL (1.73 nmol/L).\n* Prior treatment with at least three or more cycles of taxane therapy (docetaxel or cabazitaxel).\n\nNote: Docetaxel in the newly diagnosed metastatic setting and docetaxel rechallenge allowed.\n\n* Prior treatment with at least one prior Novel Hormone Therapy (NHT), defined as second-generation antiandrogen therapies that include but are not limited to abiraterone acetate, enzalutamide, apalutamide, and darolutamide.\n* Subject has received or refused therapies which have shown to improve overall survival and are recommended per NCCN guidelines prior to enrollment in trial. Such agents include but are not limited to docetaxel, cabazitaxel, sipuleucel-T, olaparib, rucaparib, radium-223 and lutetium (177Lu) vipivotide tetraxetan depending on patient eligibility.\n* Had disease progression on or after NHT prior to enrolling in the study.\n* ECOG Performance Status ≤ 2.\n* Adequate organ function as defined as:\n\n  * Hematologic:\n\n    * White blood cell count (WBC) ≥ 2000/mm3\n    * Absolute neutrophil count (ANC) ≥ 1500/mm3\n    * Platelet count ≥ 100,000/mm3\n    * Hemoglobin ≥ 9g/dL\n  * Hepatic:\n\n    * Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN) unless there is a known history of Gilbert's syndrome.\n    * AST(SGOT)/ALT(SGPT) ≤ 5 × institutional ULN\n  * Renal:\n\n    * Estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula:\n* Highly effective contraception throughout the study as described in Section 7.4.\n* Discontinued all previous treatments for cancer (except androgen-deprivation therapy and bone loss prevention treatment) 28 days prior to starting study therapy.\n* Recovery to baseline or ≤ Grade 1 CTCAE v 5.0 from toxicities related to any prior treatments, unless AE(s) are clinically non-significant and/or stable on supportive therapy as determined by the treating physician.\n* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.\nHealthy volunteers allowed\nMust be MALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Prior or concurrent malignancy (other than adenocarcinoma of the prostate). Note: Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial as approved by the Principal Investigator.\n* The subject has an uncontrolled, significant intercurrent or recent illness that would preclude safe study participation.\n* Clinically significant cardiovascular disease: myocardial infarction (<6 months prior to enrollment), unstable angina, congestive heart failure (> New York Heart Association Classification Class IIB) or a serious cardiac arrhythmia requiring medication.\n* Known HIV infection with a detectable viral load at the time of screening. Note: Patients on effective antiretroviral therapy with an undetectable viral load at the time of screening are eligible for this trial.\n* Known chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection with a detectable viral load.\n\nNote: Patients with an undetectable HBV viral load are eligible. Patients with an undetectable HCV viral load are eligible.\n\n* Live attenuated vaccinations within ≤ 4 weeks of the first study therapy and while on trial is prohibited.\n* Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v5.0 Grade ≥ 3).\n* Subjects taking prohibited medications as described in Section 6.3. A washout period of prohibited medications for a period of at least 5 half-lives or as clinically indicated should occur prior to the start of treatment.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Male subject aged ≥ 18 years.",
            "criterions": [
                {
                    "exact_snippets": "Male subject",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "aged ≥ 18 years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell histology.",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed adenocarcinoma of the prostate",
                    "criterion": "adenocarcinoma of the prostate",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "without small cell histology",
                    "criterion": "small cell histology",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diagnosis of metastatic or locally advanced, inoperable disease that cannot be treated with definitive intent",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis of metastatic or locally advanced, inoperable disease",
                    "criterion": "disease status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "metastatic",
                                "locally advanced",
                                "inoperable"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "disease that cannot be treated with definitive intent",
                    "criterion": "treatment intent",
                    "requirements": [
                        {
                            "requirement_type": "capability",
                            "expected_value": "cannot be treated with definitive intent"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with at least three or more cycles of taxane therapy (docetaxel or cabazitaxel).",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with at least three or more cycles of taxane therapy (docetaxel or cabazitaxel)",
                    "criterion": "taxane therapy",
                    "requirements": [
                        {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "cycles",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "cycles"
                            }
                        },
                        {
                            "requirement_type": "specific drugs",
                            "expected_value": [
                                "docetaxel",
                                "cabazitaxel"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note: Docetaxel in the newly diagnosed metastatic setting and docetaxel rechallenge allowed.",
            "criterions": [
                {
                    "exact_snippets": "Docetaxel in the newly diagnosed metastatic setting",
                    "criterion": "docetaxel treatment",
                    "requirements": [
                        {
                            "requirement_type": "setting",
                            "expected_value": "newly diagnosed metastatic"
                        }
                    ]
                },
                {
                    "exact_snippets": "docetaxel rechallenge allowed",
                    "criterion": "docetaxel rechallenge",
                    "requirements": [
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior treatment with at least one prior Novel Hormone Therapy (NHT), defined as second-generation antiandrogen therapies that include but are not limited to abiraterone acetate, enzalutamide, apalutamide, and darolutamide.",
            "criterions": [
                {
                    "exact_snippets": "Prior treatment with at least one prior Novel Hormone Therapy (NHT) ... abiraterone acetate, enzalutamide, apalutamide, and darolutamide.",
                    "criterion": "prior treatment with Novel Hormone Therapy (NHT)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        },
                        {
                            "requirement_type": "examples",
                            "expected_value": [
                                "abiraterone acetate",
                                "enzalutamide",
                                "apalutamide",
                                "darolutamide"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subject has received or refused therapies which have shown to improve overall survival and are recommended per NCCN guidelines prior to enrollment in trial. Such agents include but are not limited to docetaxel, cabazitaxel, sipuleucel-T, olaparib, rucaparib, radium-223 and lutetium (177Lu) vipivotide tetraxetan depending on patient eligibility.",
            "criterions": [
                {
                    "exact_snippets": "Subject has received or refused therapies",
                    "criterion": "therapies received or refused",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "therapies which have shown to improve overall survival",
                    "criterion": "therapies improving overall survival",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "improve overall survival"
                        }
                    ]
                },
                {
                    "exact_snippets": "therapies ... are recommended per NCCN guidelines",
                    "criterion": "therapies recommended per NCCN guidelines",
                    "requirements": [
                        {
                            "requirement_type": "recommendation",
                            "expected_value": "per NCCN guidelines"
                        }
                    ]
                },
                {
                    "exact_snippets": "Such agents include ... docetaxel, cabazitaxel, sipuleucel-T, olaparib, rucaparib, radium-223 and lutetium (177Lu) vipivotide tetraxetan",
                    "criterion": "specific therapies",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": [
                                "docetaxel",
                                "cabazitaxel",
                                "sipuleucel-T",
                                "olaparib",
                                "rucaparib",
                                "radium-223",
                                "lutetium (177Lu) vipivotide tetraxetan"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Had disease progression on or after NHT prior to enrolling in the study.",
            "criterions": [
                {
                    "exact_snippets": "disease progression",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "on or after NHT prior to enrolling in the study"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG Performance Status ≤ 2.",
            "criterions": [
                {
                    "exact_snippets": "ECOG Performance Status ≤ 2",
                    "criterion": "ECOG Performance Status",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Adequate organ function as defined as:",
            "criterions": [
                {
                    "exact_snippets": "Adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hematologic:",
            "criterions": [
                {
                    "exact_snippets": "Hematologic",
                    "criterion": "hematologic",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* White blood cell count (WBC) ≥ 2000/mm3",
            "criterions": [
                {
                    "exact_snippets": "White blood cell count (WBC) ≥ 2000/mm3",
                    "criterion": "white blood cell count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2000,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count (ANC) ≥ 1500/mm3",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) ≥ 1500/mm3",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelet count ≥ 100,000/mm3",
            "criterions": [
                {
                    "exact_snippets": "Platelet count ≥ 100,000/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin ≥ 9g/dL",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥ 9g/dL",
                    "criterion": "hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9,
                                "unit": "g/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hepatic:",
            "criterions": [
                {
                    "exact_snippets": "Hepatic",
                    "criterion": "hepatic function",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN) unless there is a known history of Gilbert's syndrome.",
            "criterions": [
                {
                    "exact_snippets": "Total Bilirubin ≤ 1.5x institutional upper limit of normal (ULN)",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x institutional ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless there is a known history of Gilbert's syndrome",
                    "criterion": "Gilbert's syndrome",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST(SGOT)/ALT(SGPT) ≤ 5 × institutional ULN",
            "criterions": [
                {
                    "exact_snippets": "AST(SGOT)/ALT(SGPT) ≤ 5 × institutional ULN",
                    "criterion": "AST(SGOT)/ALT(SGPT) levels",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "institutional ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Renal:",
            "criterions": [
                {
                    "exact_snippets": "Renal",
                    "criterion": "renal function",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula:",
            "criterions": [
                {
                    "exact_snippets": "Estimated creatinine clearance ≥ 30 mL/min by Cockcroft-Gault formula",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "estimation method",
                            "expected_value": "Cockcroft-Gault formula"
                        },
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Highly effective contraception throughout the study as described in Section 7.4.",
            "criterions": [
                {
                    "exact_snippets": "Highly effective contraception",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "high"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Discontinued all previous treatments for cancer (except androgen-deprivation therapy and bone loss prevention treatment) 28 days prior to starting study therapy.",
            "criterions": [
                {
                    "exact_snippets": "Discontinued all previous treatments for cancer (except androgen-deprivation therapy and bone loss prevention treatment) 28 days prior to starting study therapy.",
                    "criterion": "previous cancer treatments",
                    "requirements": [
                        {
                            "requirement_type": "discontinuation",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time since discontinuation",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Recovery to baseline or ≤ Grade 1 CTCAE v 5.0 from toxicities related to any prior treatments, unless AE(s) are clinically non-significant and/or stable on supportive therapy as determined by the treating physician.",
            "criterions": [
                {
                    "exact_snippets": "Recovery to baseline or ≤ Grade 1 CTCAE v 5.0 from toxicities related to any prior treatments",
                    "criterion": "toxicity from prior treatments",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "CTCAE v 5.0"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless AE(s) are clinically non-significant",
                    "criterion": "adverse events (AEs)",
                    "requirements": [
                        {
                            "requirement_type": "clinical significance",
                            "expected_value": "non-significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "stable on supportive therapy as determined by the treating physician",
                    "criterion": "adverse events (AEs)",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "stable on supportive therapy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines.",
            "criterions": [
                {
                    "exact_snippets": "Able to provide informed consent",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to sign an approved consent form",
                    "criterion": "consent form signing",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "conforms to federal and institutional guidelines",
                    "criterion": "consent form guidelines",
                    "requirements": [
                        {
                            "requirement_type": "conformance",
                            "expected_value": [
                                "federal guidelines",
                                "institutional guidelines"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be MALE",
            "criterions": [
                {
                    "exact_snippets": "Must be MALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Prior or concurrent malignancy (other than adenocarcinoma of the prostate). Note: Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial as approved by the Principal Investigator.",
            "criterions": [
                {
                    "exact_snippets": "Prior or concurrent malignancy (other than adenocarcinoma of the prostate)",
                    "criterion": "prior or concurrent malignancy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "other than adenocarcinoma of the prostate"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients with prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen",
                    "criterion": "interference with safety or efficacy assessment",
                    "requirements": [
                        {
                            "requirement_type": "potential",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The subject has an uncontrolled, significant intercurrent or recent illness that would preclude safe study participation.",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled, significant intercurrent or recent illness",
                    "criterion": "illness",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "significance",
                            "expected_value": "significant"
                        },
                        {
                            "requirement_type": "recency",
                            "expected_value": "recent"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known HIV infection with a detectable viral load at the time of screening. Note: Patients on effective antiretroviral therapy with an undetectable viral load at the time of screening are eligible for this trial.",
            "criterions": [
                {
                    "exact_snippets": "Known HIV infection",
                    "criterion": "HIV infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "detectable viral load at the time of screening",
                    "criterion": "viral load",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients on effective antiretroviral therapy with an undetectable viral load at the time of screening are eligible",
                    "criterion": "antiretroviral therapy",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "undetectable viral load at the time of screening",
                    "criterion": "viral load",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known chronic hepatitis B virus (HBV) or hepatitis C virus (HCV) infection with a detectable viral load.",
            "criterions": [
                {
                    "exact_snippets": "Known chronic hepatitis B virus (HBV) ... detectable viral load.",
                    "criterion": "chronic hepatitis B virus (HBV) infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "viral load",
                            "expected_value": "detectable"
                        }
                    ]
                },
                {
                    "exact_snippets": "Known chronic ... hepatitis C virus (HCV) infection with a detectable viral load.",
                    "criterion": "chronic hepatitis C virus (HCV) infection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "viral load",
                            "expected_value": "detectable"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note: Patients with an undetectable HBV viral load are eligible. Patients with an undetectable HCV viral load are eligible.",
            "criterions": [
                {
                    "exact_snippets": "undetectable HBV viral load",
                    "criterion": "HBV viral load",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "undetectable HCV viral load",
                    "criterion": "HCV viral load",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Live attenuated vaccinations within ≤ 4 weeks of the first study therapy and while on trial is prohibited.",
            "criterions": [
                {
                    "exact_snippets": "Live attenuated vaccinations within ≤ 4 weeks of the first study therapy and while on trial is prohibited.",
                    "criterion": "live attenuated vaccinations",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": "prohibited"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Known prior severe hypersensitivity to investigational product or any component in its formulations, including known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v5.0 Grade ≥ 3).",
            "criterions": [
                {
                    "exact_snippets": "Known prior severe hypersensitivity to investigational product",
                    "criterion": "hypersensitivity to investigational product",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... any component in its formulations",
                    "criterion": "hypersensitivity to components in formulations",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        },
                        {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "known severe hypersensitivity reactions to monoclonal antibodies (NCI CTCAE v5.0 Grade ≥ 3)",
                    "criterion": "hypersensitivity to monoclonal antibodies",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "NCI CTCAE v5.0 Grade"
                            }
                        },
                        {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Subjects taking prohibited medications as described in Section 6.3. A washout period of prohibited medications for a period of at least 5 half-lives or as clinically indicated should occur prior to the start of treatment.",
            "criterions": [
                {
                    "exact_snippets": "Subjects taking prohibited medications",
                    "criterion": "prohibited medications",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "A washout period of prohibited medications for a period of at least 5 half-lives or as clinically indicated should occur prior to the start of treatment.",
                    "criterion": "washout period of prohibited medications",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "half-lives"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "* Castrate levels of testosterone as defined as &lt; 50 ng/dL (1.73 nmol/L).",
            "criterions": [
                {
                    "exact_snippets": "Castrate levels of testosterone ... < 50 ng/dL (1.73 nmol/L)",
                    "criterion": "testosterone level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 50,
                                "unit": "ng/dL"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [
        {
            "line": "* Clinically significant cardiovascular disease: myocardial infarction (&lt;6 months prior to enrollment), unstable angina, congestive heart failure (&gt; New York Heart Association Classification Class IIB) or a serious cardiac arrhythmia requiring medication.",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant cardiovascular disease: myocardial infarction (<6 months prior to enrollment)",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant cardiovascular disease: ... unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant cardiovascular disease: ... congestive heart failure (> New York Heart Association Classification Class IIB)",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.5,
                                "unit": "New York Heart Association Classification"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Clinically significant cardiovascular disease: ... serious cardiac arrhythmia requiring medication",
                    "criterion": "serious cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "treatment requirement",
                            "expected_value": "medication"
                        }
                    ]
                }
            ]
        }
    ],
    "failed_miscellaneous": []
}