{
    "info": {
        "nct_id": "NCT04943627",
        "official_title": "A Phase 3 Trial of Balstilimab Versus Investigator Choice Chemotherapy in Patients With Recurrent Cervical Cancer After Platinum-Based Chemotherapy (BRAVA)",
        "inclusion_criteria": "1. Voluntarily agree to participate by giving written informed consent.\n2. ≥ 18 years of age.\n3. Diagnosis and prior systemic treatment:\n\n   1. Has recurrent or metastatic cervical cancer (SCC, AC, or ASC histology) and has experienced disease progression during or after treatment with a standard platinum based therapy with or without bevacizumab.\n   2. Has received at least 1 prior systemic therapy regimen for recurrent, persistent, and/or metastatic cervical cancer.\n\n   Note: Chemotherapy administered in the adjuvant or neoadjuvant setting, or in combination with radiation therapy, should not be counted as a prior systemic therapy regimen for recurrent, persistent, and/or metastatic cervical cancer.\n4. Measurable disease - based on Investigator assessment.\n\n   a. Radiological evidence of measurable disease on imaging based on RECIST v1.1 Note: Patients must have at least 1 \"target lesion\" to be used to assess response, as defined by RECIST v1.1. Tumors within a previously irradiated field will be designated as \"non target\" lesions unless progression is documented, or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.\n5. Has a life expectancy of at least 3 months and an ECOG performance status of 0 or 1.\n6. Patients must have sufficient and adequate formalin-fixed tumor tissue sample available that is not older than 3 years; otherwise, a fresh biopsy is required. Archival tissue or fresh biopsy must be from a site not previously irradiated.\n7. Has adequate organ function as indicated by the following laboratory values:\n\n   1. Adequate hematological function defined by absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, and stable hemoglobin ≥ 8 g/dL (without transfusions within 1 week before first dose).\n   2. Adequate hepatic function based by a total bilirubin level ≤ 1.5 × the upper limit of normal (ULN), aspartate aminotransferase (AST) level ≤ 2.5 × ULN, alanine aminotransferase (ALT) level ≤ 2.5 × ULN, alkaline phosphatase (ALP) ≤ 2.5 × ULN, and albumin ≥ 3.0 mg/dL. In the case of hepatic metastases, < 5 × ULN for AST/ALT and ALP.\n   3. Adequate renal function defined as calculated creatinine clearance > 40 mL/min or a serum creatinine < 1.5 × ULN, per institutional standards (creatinine clearance should be calculated per institutional standards).\n   4. Adequate coagulation defined by international normalized ratio or prothrombin time ≤ 1.5 × institutional upper limit of normal IULN unless the patient is receiving anticoagulant therapy) and activated partial thromboplastin time ≤ 1.5 × IULN (unless the patient is receiving anticoagulant therapy).\n   5. Normal thyroid function (thyroid stimulating hormone) whether or not the patient is on supplemental thyroid hormone.\n8. Has no history of another primary malignancy except:\n\n   1. Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of study drug and of low potential risk for recurrence.\n   2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.\n   3. Adequately treated carcinoma in situ without evidence of disease.\n9. Women of childbearing potential (WOCP) must have a negative serum pregnancy test at Screening (within 72 hours before first dose of study drug). Non-childbearing potential is defined as (by other than medical reasons):\n\n   1. ≥ 45 years of age and has not menstruated for greater than 1 year.\n   2. Definitive pelvic radiation for the treatment of cervical cancer.\n   3. Whose status is post hysterectomy, bilateral oophorectomy, or tubal ligation.\n   4. WOCP must be willing to use 2 highly effective methods of contraception (defined in the informed consent form) throughout the trial, starting with the Screening Visit through 90 days after the last dose of study drug Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.\n10. Is willing and able to comply with the requirements of the protocol.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Is currently participating and receiving study therapy or has participated in a trial of an investigational agent and received study therapy or used an investigational device within 4 weeks before the first dose of treatment.\n2. Has an inadequate period of time prior to first dose of study treatment that is defined as:\n\n   1. Received systemic cytotoxic chemotherapy or biological therapy within 28 days before initiation of study treatment\n   2. Received radiation therapy within 28 days before initiation of study treatment, except for palliative bone therapy, which can be received 2 weeks prior to initiation of study treatment\n   3. Had major surgery within 4 weeks before initiation of study treatment\n3. Has received prior therapy with:\n\n   a. Any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints) such as anti-programmed cell death protein 1 and anti-PD-L1 antibodies.\n4. Has persisting toxicity related to prior therapy of NCI-CTCAE v5.0 Grade ≥ 1 severity, with the exceptions noted below:\n\n   1. Peripheral neuropathy Grade ≤ 2.\n   2. Alopecia Grade ≤ 2.\n5. Is expected to require any other form of systemic or localized antineoplastic therapy while on trial (including maintenance therapy with another agent, radiation therapy, and/or surgical resection).\n6. Has known severe hypersensitivity reactions to fully human monoclonal antibodies (NCI CTCAE v5.0 Grade ≥ 3), any history of anaphylaxis, or uncontrolled asthma.\n7. Is receiving systemic corticosteroids ≤ 7 days prior to the first dose of trial treatment or receiving any other form of systemic immunosuppressive medication (corticosteroid use on trial for management of immune-related adverse events and/or as a premedication for intravenous [IV] contrast allergies/reactions is allowed). Patients who are receiving daily corticosteroid replacement therapy are an exception to this rule. Examples of permitted therapy are daily prednisone at doses of 5 to 7.5 mg or equivalent hydrocortisone dose and steroid therapy administered by topical, intraocular, intranasal, and/or inhalation routes.\n8. History of central nervous system tumor, metastasis(es), and/or carcinomatous meningitis identified either on the baseline brain imaging obtained during the Screening period or identified prior to consent.\n\n   Note: Patients with a history of brain metastases that have been treated may participate provided they show evidence of stable supra-tentorial lesions at screening (based on 2 sets of brain images, performed ≥ 4 weeks apart, and obtained after the brain metastases treatment). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be minimal and be expected as sequelae from treated lesions. For individuals who received steroids as part of brain metastases treatment, steroids must be discontinued ≥ 7 days prior to the first dose of study drug.\n9. Has active or history of autoimmune disease that requires systemic treatment within 2 years of the start of study drug (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) Note: Patients with autoimmune conditions requiring hormone replacement therapy or topical treatments are eligible.\n10. Has had an allogeneic tissue/solid organ transplant requiring ongoing immunosuppressive treatment.\n11. Has or had known drug-induced interstitial lung disease, not fully resolved, or has had a history of pneumonitis that has required oral or IV corticosteroids.\n12. Has an active infection requiring IV systemic treatment.\n13. Has known history of HIV (HIV 1/2 antibodies).\n14. Has known untreated hepatitis B/hepatitis C virus (HBV/HCV) or tuberculosis. Active HBV is defined as a known positive hepatitis B surface antigen result. Active HCV is defined as a known positive hepatitis C antibody result and known quantitative HCV RNA results greater than the lower limits of detection of the assay.\n15. Has clinically significant (ie, active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months before enrollment, unstable angina, congestive heart failure (New York Heart Association Class ≥ II), or serious uncontrolled cardiac arrhythmia requiring medication.\n16. Has other systemic conditions or organ abnormalities that in the opinion of the Investigator may interfere with the conduct and/or interpretation of the current trial.\n17. Has known psychiatric or substance use disorders that would interfere with cooperation or compromise participation with the requirements of the trial.\n18. Is legally incapacitated or has limited legal capacity.\n19. Is pregnant or breastfeeding.\n20. Has received a live/attenuated vaccine within 14 days of first dose of study treatment and other vaccines within 48 hours of first dose of study treatment.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Voluntarily agree to participate by giving written informed consent.",
            "criterions": [
                {
                    "exact_snippets": "Voluntarily agree to participate by giving written informed consent.",
                    "criterion": "informed consent",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. ≥ 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "≥ 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Diagnosis and prior systemic treatment:",
            "criterions": [
                {
                    "exact_snippets": "Diagnosis",
                    "criterion": "diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior systemic treatment",
                    "criterion": "prior systemic treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Has recurrent or metastatic cervical cancer (SCC, AC, or ASC histology) and has experienced disease progression during or after treatment with a standard platinum based therapy with or without bevacizumab.",
            "criterions": [
                {
                    "exact_snippets": "Has recurrent or metastatic cervical cancer",
                    "criterion": "cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "recurrence or metastasis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "(SCC, AC, or ASC histology)",
                    "criterion": "cervical cancer histology",
                    "requirements": [
                        {
                            "requirement_type": "types",
                            "expected_value": [
                                "SCC",
                                "AC",
                                "ASC"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "has experienced disease progression during or after treatment with a standard platinum based therapy",
                    "criterion": "disease progression",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": "standard platinum based therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "with or without bevacizumab",
                    "criterion": "bevacizumab treatment",
                    "requirements": [
                        {
                            "requirement_type": "inclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Has received at least 1 prior systemic therapy regimen for recurrent, persistent, and/or metastatic cervical cancer.",
            "criterions": [
                {
                    "exact_snippets": "Has received at least 1 prior systemic therapy regimen",
                    "criterion": "prior systemic therapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "regimen"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "recurrent, persistent, and/or metastatic cervical cancer",
                    "criterion": "cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": [
                                "recurrent",
                                "persistent",
                                "metastatic"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note: Chemotherapy administered in the adjuvant or neoadjuvant setting, or in combination with radiation therapy, should not be counted as a prior systemic therapy regimen for recurrent, persistent, and/or metastatic cervical cancer.",
            "criterions": [
                {
                    "exact_snippets": "Chemotherapy administered in the adjuvant or neoadjuvant setting",
                    "criterion": "chemotherapy setting",
                    "requirements": [
                        {
                            "requirement_type": "setting",
                            "expected_value": [
                                "adjuvant",
                                "neoadjuvant"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "in combination with radiation therapy",
                    "criterion": "chemotherapy combination",
                    "requirements": [
                        {
                            "requirement_type": "combination",
                            "expected_value": "radiation therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "should not be counted as a prior systemic therapy regimen for recurrent, persistent, and/or metastatic cervical cancer",
                    "criterion": "prior systemic therapy regimen",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Measurable disease - based on Investigator assessment.",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "a. Radiological evidence of measurable disease on imaging based on RECIST v1.1 Note: Patients must have at least 1 \"target lesion\" to be used to assess response, as defined by RECIST v1.1. Tumors within a previously irradiated field will be designated as \"non target\" lesions unless progression is documented, or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy.",
            "criterions": [
                {
                    "exact_snippets": "Radiological evidence of measurable disease on imaging based on RECIST v1.1",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "evidence",
                            "expected_value": "radiological"
                        },
                        {
                            "requirement_type": "measurement standard",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients must have at least 1 \"target lesion\" ... as defined by RECIST v1.1",
                    "criterion": "target lesion",
                    "requirements": [
                        {
                            "requirement_type": "minimum count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        },
                        {
                            "requirement_type": "definition standard",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                },
                {
                    "exact_snippets": "Tumors within a previously irradiated field will be designated as \"non target\" lesions unless progression is documented",
                    "criterion": "tumors within a previously irradiated field",
                    "requirements": [
                        {
                            "requirement_type": "designation",
                            "expected_value": "non target lesions"
                        },
                        {
                            "requirement_type": "condition for change",
                            "expected_value": "progression is documented"
                        }
                    ]
                },
                {
                    "exact_snippets": "Tumors within a previously irradiated field will be designated as \"non target\" lesions unless ... a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy",
                    "criterion": "tumors within a previously irradiated field",
                    "requirements": [
                        {
                            "requirement_type": "designation",
                            "expected_value": "non target lesions"
                        },
                        {
                            "requirement_type": "condition for change",
                            "expected_value": "biopsy is obtained to confirm persistence"
                        }
                    ]
                },
                {
                    "exact_snippets": "a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy",
                    "criterion": "biopsy to confirm persistence",
                    "requirements": [
                        {
                            "requirement_type": "time since radiation therapy",
                            "expected_value": {
                                "operator": ">=",
                                "value": 90,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Has a life expectancy of at least 3 months and an ECOG performance status of 0 or 1.",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of at least 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ECOG performance status of 0 or 1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Patients must have sufficient and adequate formalin-fixed tumor tissue sample available that is not older than 3 years; otherwise, a fresh biopsy is required. Archival tissue or fresh biopsy must be from a site not previously irradiated.",
            "criterions": [
                {
                    "exact_snippets": "sufficient and adequate formalin-fixed tumor tissue sample available",
                    "criterion": "formalin-fixed tumor tissue sample",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "sufficiency",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "formalin-fixed tumor tissue sample ... not older than 3 years",
                    "criterion": "formalin-fixed tumor tissue sample age",
                    "requirements": [
                        {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "fresh biopsy is required",
                    "criterion": "fresh biopsy",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Archival tissue or fresh biopsy ... from a site not previously irradiated",
                    "criterion": "tissue or biopsy site irradiation status",
                    "requirements": [
                        {
                            "requirement_type": "irradiation status",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Has adequate organ function as indicated by the following laboratory values:",
            "criterions": [
                {
                    "exact_snippets": "adequate organ function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Adequate hepatic function based by a total bilirubin level ≤ 1.5 × the upper limit of normal (ULN), aspartate aminotransferase (AST) level ≤ 2.5 × ULN, alanine aminotransferase (ALT) level ≤ 2.5 × ULN, alkaline phosphatase (ALP) ≤ 2.5 × ULN, and albumin ≥ 3.0 mg/dL. In the case of hepatic metastases, < 5 × ULN for AST/ALT and ALP.",
            "criterions": [
                {
                    "exact_snippets": "total bilirubin level ≤ 1.5 × the upper limit of normal (ULN)",
                    "criterion": "total bilirubin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aspartate aminotransferase (AST) level ≤ 2.5 × ULN",
                    "criterion": "aspartate aminotransferase (AST) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alanine aminotransferase (ALT) level ≤ 2.5 × ULN",
                    "criterion": "alanine aminotransferase (ALT) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "alkaline phosphatase (ALP) ≤ 2.5 × ULN",
                    "criterion": "alkaline phosphatase (ALP) level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "albumin ≥ 3.0 mg/dL",
                    "criterion": "albumin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3.0,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "hepatic metastases, < 5 × ULN for AST/ALT and ALP",
                    "criterion": "hepatic metastases",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "AST/ALT level",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "× ULN"
                            }
                        },
                        {
                            "requirement_type": "ALP level",
                            "expected_value": {
                                "operator": "<",
                                "value": 5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Adequate renal function defined as calculated creatinine clearance > 40 mL/min or a serum creatinine < 1.5 × ULN, per institutional standards (creatinine clearance should be calculated per institutional standards).",
            "criterions": [
                {
                    "exact_snippets": "Adequate renal function defined as calculated creatinine clearance > 40 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": ">",
                                "value": 40,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serum creatinine < 1.5 × ULN",
                    "criterion": "serum creatinine",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Normal thyroid function (thyroid stimulating hormone) whether or not the patient is on supplemental thyroid hormone.",
            "criterions": [
                {
                    "exact_snippets": "Normal thyroid function (thyroid stimulating hormone)",
                    "criterion": "thyroid function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. Has no history of another primary malignancy except:",
            "criterions": [
                {
                    "exact_snippets": "no history of another primary malignancy",
                    "criterion": "history of another primary malignancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Malignancy treated with curative intent and with no known active disease ≥ 5 years before the first dose of study drug and of low potential risk for recurrence.",
            "criterions": [
                {
                    "exact_snippets": "Malignancy treated with curative intent",
                    "criterion": "malignancy treatment intent",
                    "requirements": [
                        {
                            "requirement_type": "intent",
                            "expected_value": "curative"
                        }
                    ]
                },
                {
                    "exact_snippets": "no known active disease ≥ 5 years before the first dose of study drug",
                    "criterion": "active disease status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "low potential risk for recurrence",
                    "criterion": "recurrence risk",
                    "requirements": [
                        {
                            "requirement_type": "risk level",
                            "expected_value": "low"
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease.",
            "criterions": [
                {
                    "exact_snippets": "Adequately treated non-melanoma skin cancer",
                    "criterion": "non-melanoma skin cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "lentigo maligna without evidence of disease",
                    "criterion": "lentigo maligna",
                    "requirements": [
                        {
                            "requirement_type": "disease evidence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Adequately treated carcinoma in situ without evidence of disease.",
            "criterions": [
                {
                    "exact_snippets": "Adequately treated carcinoma in situ",
                    "criterion": "carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "adequately treated"
                        }
                    ]
                },
                {
                    "exact_snippets": "without evidence of disease",
                    "criterion": "evidence of disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Women of childbearing potential (WOCP) must have a negative serum pregnancy test at Screening (within 72 hours before first dose of study drug). Non-childbearing potential is defined as (by other than medical reasons):",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential (WOCP)",
                    "criterion": "childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have a negative serum pregnancy test",
                    "criterion": "serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "at Screening (within 72 hours before first dose of study drug)",
                    "criterion": "timing of serum pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 72 hours before first dose of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. ≥ 45 years of age and has not menstruated for greater than 1 year.",
            "criterions": [
                {
                    "exact_snippets": "≥ 45 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 45,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "has not menstruated for greater than 1 year",
                    "criterion": "menstruation status",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Definitive pelvic radiation for the treatment of cervical cancer.",
            "criterions": [
                {
                    "exact_snippets": "Definitive pelvic radiation",
                    "criterion": "pelvic radiation",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": "definitive"
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment of cervical cancer",
                    "criterion": "cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Whose status is post hysterectomy, bilateral oophorectomy, or tubal ligation.",
            "criterions": [
                {
                    "exact_snippets": "post hysterectomy",
                    "criterion": "hysterectomy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "post"
                        }
                    ]
                },
                {
                    "exact_snippets": "post ... bilateral oophorectomy",
                    "criterion": "bilateral oophorectomy status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "post"
                        }
                    ]
                },
                {
                    "exact_snippets": "post ... tubal ligation",
                    "criterion": "tubal ligation status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "post"
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. WOCP must be willing to use 2 highly effective methods of contraception (defined in the informed consent form) throughout the trial, starting with the Screening Visit through 90 days after the last dose of study drug Note: Abstinence is acceptable if this is the established and preferred contraception for the patient.",
            "criterions": [
                {
                    "exact_snippets": "WOCP must be willing to use 2 highly effective methods of contraception",
                    "criterion": "contraception methods",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "methods"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "starting with the Screening Visit through 90 days after the last dose of study drug",
                    "criterion": "contraception duration",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "from Screening Visit through 90 days after the last dose of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Is willing and able to comply with the requirements of the protocol.",
            "criterions": [
                {
                    "exact_snippets": "Is willing and able to comply with the requirements of the protocol.",
                    "criterion": "compliance with protocol requirements",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "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": "1. Is currently participating and receiving study therapy or has participated in a trial of an investigational agent and received study therapy or used an investigational device within 4 weeks before the first dose of treatment.",
            "criterions": [
                {
                    "exact_snippets": "Is currently participating and receiving study therapy",
                    "criterion": "current participation in a study",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has participated in a trial of an investigational agent and received study therapy",
                    "criterion": "past participation in a trial of an investigational agent",
                    "requirements": [
                        {
                            "requirement_type": "participation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "used an investigational device within 4 weeks before the first dose of treatment",
                    "criterion": "use of an investigational device",
                    "requirements": [
                        {
                            "requirement_type": "time since use",
                            "expected_value": {
                                "operator": "<",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Has an inadequate period of time prior to first dose of study treatment that is defined as:",
            "criterions": [
                {
                    "exact_snippets": "inadequate period of time prior to first dose of study treatment",
                    "criterion": "period of time prior to first dose of study treatment",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Received systemic cytotoxic chemotherapy or biological therapy within 28 days before initiation of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Received systemic cytotoxic chemotherapy ... within 28 days before initiation of study treatment",
                    "criterion": "systemic cytotoxic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Received ... biological therapy within 28 days before initiation of study treatment",
                    "criterion": "biological therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Received radiation therapy within 28 days before initiation of study treatment, except for palliative bone therapy, which can be received 2 weeks prior to initiation of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Received radiation therapy within 28 days before initiation of study treatment",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "palliative bone therapy, which can be received 2 weeks prior to initiation of study treatment",
                    "criterion": "palliative bone therapy",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Had major surgery within 4 weeks before initiation of study treatment",
            "criterions": [
                {
                    "exact_snippets": "Had major surgery within 4 weeks before initiation of study treatment",
                    "criterion": "major surgery",
                    "requirements": [
                        {
                            "requirement_type": "time since surgery",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Has received prior therapy with:",
            "criterions": [
                {
                    "exact_snippets": "Has received prior therapy",
                    "criterion": "prior therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "a. Any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints) such as anti-programmed cell death protein 1 and anti-PD-L1 antibodies.",
            "criterions": [
                {
                    "exact_snippets": "Any antibody/drug targeting T-cell co-regulatory proteins (immune checkpoints)",
                    "criterion": "antibody/drug targeting T-cell co-regulatory proteins",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "anti-programmed cell death protein 1",
                    "criterion": "anti-programmed cell death protein 1",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "anti-PD-L1 antibodies",
                    "criterion": "anti-PD-L1 antibodies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Has persisting toxicity related to prior therapy of NCI-CTCAE v5.0 Grade ≥ 1 severity, with the exceptions noted below:",
            "criterions": [
                {
                    "exact_snippets": "persisting toxicity related to prior therapy of NCI-CTCAE v5.0 Grade ≥ 1 severity",
                    "criterion": "persisting toxicity",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "NCI-CTCAE v5.0 Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Peripheral neuropathy Grade ≤ 2.",
            "criterions": [
                {
                    "exact_snippets": "Peripheral neuropathy Grade ≤ 2",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "Grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Alopecia Grade ≤ 2.",
            "criterions": [
                {
                    "exact_snippets": "Alopecia Grade ≤ 2",
                    "criterion": "alopecia grade",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Is expected to require any other form of systemic or localized antineoplastic therapy while on trial (including maintenance therapy with another agent, radiation therapy, and/or surgical resection).",
            "criterions": [
                {
                    "exact_snippets": "require any other form of systemic or localized antineoplastic therapy",
                    "criterion": "requirement for antineoplastic therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "maintenance therapy with another agent",
                    "criterion": "maintenance therapy with another agent",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "radiation therapy",
                    "criterion": "radiation therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "surgical resection",
                    "criterion": "surgical resection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Has known severe hypersensitivity reactions to fully human monoclonal antibodies (NCI CTCAE v5.0 Grade ≥ 3), any history of anaphylaxis, or uncontrolled asthma.",
            "criterions": [
                {
                    "exact_snippets": "known severe hypersensitivity reactions to fully human monoclonal antibodies (NCI CTCAE v5.0 Grade ≥ 3)",
                    "criterion": "hypersensitivity reactions to fully human monoclonal antibodies",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "NCI CTCAE v5.0 Grade"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "any history of anaphylaxis",
                    "criterion": "history of anaphylaxis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "uncontrolled asthma",
                    "criterion": "asthma",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Is receiving systemic corticosteroids ≤ 7 days prior to the first dose of trial treatment or receiving any other form of systemic immunosuppressive medication (corticosteroid use on trial for management of immune-related adverse events and/or as a premedication for intravenous [IV] contrast allergies/reactions is allowed). Patients who are receiving daily corticosteroid replacement therapy are an exception to this rule. Examples of permitted therapy are daily prednisone at doses of 5 to 7.5 mg or equivalent hydrocortisone dose and steroid therapy administered by topical, intraocular, intranasal, and/or inhalation routes.",
            "criterions": [
                {
                    "exact_snippets": "receiving systemic corticosteroids ≤ 7 days prior to the first dose of trial treatment",
                    "criterion": "systemic corticosteroid use",
                    "requirements": [
                        {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "receiving any other form of systemic immunosuppressive medication",
                    "criterion": "systemic immunosuppressive medication use",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "corticosteroid use on trial for management of immune-related adverse events and/or as a premedication for intravenous [IV] contrast allergies/reactions is allowed",
                    "criterion": "corticosteroid use for specific purposes",
                    "requirements": [
                        {
                            "requirement_type": "purpose",
                            "expected_value": [
                                "management of immune-related adverse events",
                                "premedication for IV contrast allergies/reactions"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients who are receiving daily corticosteroid replacement therapy are an exception to this rule",
                    "criterion": "daily corticosteroid replacement therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Examples of permitted therapy are daily prednisone at doses of 5 to 7.5 mg or equivalent hydrocortisone dose",
                    "criterion": "prednisone or hydrocortisone dose",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 5,
                                        "unit": "mg"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 7.5,
                                        "unit": "mg"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "steroid therapy administered by topical, intraocular, intranasal, and/or inhalation routes",
                    "criterion": "steroid therapy route",
                    "requirements": [
                        {
                            "requirement_type": "route",
                            "expected_value": [
                                "topical",
                                "intraocular",
                                "intranasal",
                                "inhalation"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. History of central nervous system tumor, metastasis(es), and/or carcinomatous meningitis identified either on the baseline brain imaging obtained during the Screening period or identified prior to consent.",
            "criterions": [
                {
                    "exact_snippets": "History of central nervous system tumor",
                    "criterion": "central nervous system tumor",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "metastasis(es)",
                    "criterion": "metastasis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "carcinomatous meningitis",
                    "criterion": "carcinomatous meningitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Note: Patients with a history of brain metastases that have been treated may participate provided they show evidence of stable supra-tentorial lesions at screening (based on 2 sets of brain images, performed ≥ 4 weeks apart, and obtained after the brain metastases treatment). In addition, any neurologic symptoms that developed either as a result of the brain metastases or their treatment must have resolved or be minimal and be expected as sequelae from treated lesions. For individuals who received steroids as part of brain metastases treatment, steroids must be discontinued ≥ 7 days prior to the first dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "history of brain metastases",
                    "criterion": "history of brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of stable supra-tentorial lesions at screening",
                    "criterion": "stable supra-tentorial lesions",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "2 sets of brain images, performed ≥ 4 weeks apart",
                    "criterion": "brain images",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": ">=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "neurologic symptoms ... must have resolved or be minimal",
                    "criterion": "neurologic symptoms",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "resolved or minimal"
                        }
                    ]
                },
                {
                    "exact_snippets": "steroids must be discontinued ≥ 7 days prior to the first dose of study drug",
                    "criterion": "steroid discontinuation",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": ">=",
                                "value": 7,
                                "unit": "days"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Has active or history of autoimmune disease that requires systemic treatment within 2 years of the start of study drug (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) Note: Patients with autoimmune conditions requiring hormone replacement therapy or topical treatments are eligible.",
            "criterions": [
                {
                    "exact_snippets": "active or history of autoimmune disease",
                    "criterion": "autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requires systemic treatment within 2 years of the start of study drug",
                    "criterion": "systemic treatment for autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 2 years of the start of study drug"
                        }
                    ]
                },
                {
                    "exact_snippets": "use of disease-modifying agents, corticosteroids, or immunosuppressive drugs",
                    "criterion": "systemic treatment for autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": [
                                "disease-modifying agents",
                                "corticosteroids",
                                "immunosuppressive drugs"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "autoimmune conditions requiring hormone replacement therapy or topical treatments are eligible",
                    "criterion": "autoimmune conditions requiring hormone replacement therapy or topical treatments",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Has had an allogeneic tissue/solid organ transplant requiring ongoing immunosuppressive treatment.",
            "criterions": [
                {
                    "exact_snippets": "Has had an allogeneic tissue/solid organ transplant",
                    "criterion": "allogeneic tissue/solid organ transplant",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring ongoing immunosuppressive treatment",
                    "criterion": "ongoing immunosuppressive treatment",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "11. Has or had known drug-induced interstitial lung disease, not fully resolved, or has had a history of pneumonitis that has required oral or IV corticosteroids.",
            "criterions": [
                {
                    "exact_snippets": "Has or had known drug-induced interstitial lung disease",
                    "criterion": "drug-induced interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "not fully resolved",
                    "criterion": "drug-induced interstitial lung disease resolution",
                    "requirements": [
                        {
                            "requirement_type": "resolution",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "has had a history of pneumonitis",
                    "criterion": "history of pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has required oral or IV corticosteroids",
                    "criterion": "pneumonitis treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": [
                                "oral corticosteroids",
                                "IV corticosteroids"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "12. Has an active infection requiring IV systemic treatment.",
            "criterions": [
                {
                    "exact_snippets": "active infection requiring IV systemic treatment",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "IV systemic"
                        }
                    ]
                }
            ]
        },
        {
            "line": "13. Has known history of HIV (HIV 1/2 antibodies).",
            "criterions": [
                {
                    "exact_snippets": "known history of HIV (HIV 1/2 antibodies)",
                    "criterion": "HIV history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "14. Has known untreated hepatitis B/hepatitis C virus (HBV/HCV) or tuberculosis. Active HBV is defined as a known positive hepatitis B surface antigen result. Active HCV is defined as a known positive hepatitis C antibody result and known quantitative HCV RNA results greater than the lower limits of detection of the assay.",
            "criterions": [
                {
                    "exact_snippets": "known untreated hepatitis B",
                    "criterion": "hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "known untreated ... hepatitis C virus (HBV/HCV)",
                    "criterion": "hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "known untreated ... tuberculosis",
                    "criterion": "tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "treatment status",
                            "expected_value": "untreated"
                        }
                    ]
                },
                {
                    "exact_snippets": "Active HBV is defined as a known positive hepatitis B surface antigen result",
                    "criterion": "active hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "hepatitis B surface antigen result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Active HCV is defined as a known positive hepatitis C antibody result",
                    "criterion": "active hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "hepatitis C antibody result",
                            "expected_value": "positive"
                        }
                    ]
                },
                {
                    "exact_snippets": "Active HCV is defined as ... known quantitative HCV RNA results greater than the lower limits of detection of the assay",
                    "criterion": "active hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "quantitative HCV RNA result",
                            "expected_value": {
                                "operator": ">",
                                "value": 0,
                                "unit": "lower limits of detection of the assay"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "15. Has clinically significant (ie, active) cardiovascular disease: cerebral vascular accident/stroke or myocardial infarction within 6 months before enrollment, unstable angina, congestive heart failure (New York Heart Association Class ≥ II), or serious uncontrolled cardiac arrhythmia requiring medication.",
            "criterions": [
                {
                    "exact_snippets": "clinically significant (ie, active) cardiovascular disease",
                    "criterion": "cardiovascular disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cerebral vascular accident/stroke",
                    "criterion": "cerebral vascular accident/stroke",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myocardial infarction within 6 months before enrollment",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "congestive heart failure (New York Heart Association Class ≥ II)",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "New York Heart Association Class"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "serious uncontrolled cardiac arrhythmia requiring medication",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        },
                        {
                            "requirement_type": "medication requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "16. Has other systemic conditions or organ abnormalities that in the opinion of the Investigator may interfere with the conduct and/or interpretation of the current trial.",
            "criterions": [
                {
                    "exact_snippets": "Has other systemic conditions",
                    "criterion": "systemic conditions",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "organ abnormalities",
                    "criterion": "organ abnormalities",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "17. Has known psychiatric or substance use disorders that would interfere with cooperation or compromise participation with the requirements of the trial.",
            "criterions": [
                {
                    "exact_snippets": "known psychiatric ... interfere with cooperation or compromise participation",
                    "criterion": "psychiatric disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "substance use disorders ... interfere with cooperation or compromise participation",
                    "criterion": "substance use disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "18. Is legally incapacitated or has limited legal capacity.",
            "criterions": [
                {
                    "exact_snippets": "Is legally incapacitated",
                    "criterion": "legal capacity",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "legally incapacitated"
                        }
                    ]
                },
                {
                    "exact_snippets": "has limited legal capacity",
                    "criterion": "legal capacity",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "limited legal capacity"
                        }
                    ]
                }
            ]
        },
        {
            "line": "19. Is pregnant or breastfeeding.",
            "criterions": [
                {
                    "exact_snippets": "Is pregnant",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "20. Has received a live/attenuated vaccine within 14 days of first dose of study treatment and other vaccines within 48 hours of first dose of study treatment.",
            "criterions": [
                {
                    "exact_snippets": "Has received a live/attenuated vaccine within 14 days of first dose of study treatment",
                    "criterion": "live/attenuated vaccine",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 14,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other vaccines within 48 hours of first dose of study treatment",
                    "criterion": "other vaccines",
                    "requirements": [
                        {
                            "requirement_type": "time since administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 48,
                                "unit": "hours"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "line": "1. Adequate hematological function defined by absolute neutrophil count ≥ 1.5 × 109/L, platelet count ≥ 100 × 109/L, and stable hemoglobin ≥ 8 g/dL (without transfusions within 1 week before first dose).",
            "criterions": [
                {
                    "exact_snippets": "adequate hematological function ... absolute neutrophil count ≥ 1.5 × 109/L",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "× 10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate hematological function ... platelet count ≥ 100 × 109/L",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "× 10^9/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate hematological function ... stable hemoglobin ≥ 8 g/dL (without transfusions within 1 week before first dose)",
                    "criterion": "stable hemoglobin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 8,
                                "unit": "g/dL"
                            }
                        },
                        {
                            "requirement_type": "transfusion",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Adequate coagulation defined by international normalized ratio or prothrombin time ≤ 1.5 × institutional upper limit of normal IULN unless the patient is receiving anticoagulant therapy) and activated partial thromboplastin time ≤ 1.5 × IULN (unless the patient is receiving anticoagulant therapy).",
            "criterions": [
                {
                    "exact_snippets": "Adequate coagulation defined by international normalized ratio or prothrombin time ≤ 1.5 × institutional upper limit of normal IULN (unless the patient is receiving anticoagulant therapy)",
                    "criterion": "international normalized ratio or prothrombin time",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× IULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "activated partial thromboplastin time ≤ 1.5 × IULN (unless the patient is receiving anticoagulant therapy)",
                    "criterion": "activated partial thromboplastin time",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× IULN"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}