{
    "info": {
        "nct_id": "NCT03107182",
        "official_title": "A Phase II Trial of Nivolumab/Nab-paclitaxel/Carboplatin Induction Chemotherapy Followed by Response-stratified Locoregional Therapy for Patients With Locoregionally Advanced HPV-related Oropharyngeal Cancer- the OPTIMA II Trial",
        "inclusion_criteria": "* Patients must have pathologically confirmed HPV-positive head and neck squamous cell carcinoma of the oropharynx. Confirmed HPV-positive disease of other subsites are uncommon but also eligible.\n* HPV testing must be compliant with the following criteria:\n* p16 IHC positivity is sufficient to enroll and initiate treatment (p16 IHC interpretation to follow guidelines by Jordan and Lingen et al89).\n* p16 IHC positivity is to be validated using an HPV PCR during the induction phase. This is essential as HPV genotype influences treatment arm allocation, with non-HPV16 HPV strains being considered high risk.\n* Availability of ≥10 unstained 5 micron slides (to be provided to HTRC at the University of Chicago). Patients who cannot fulfill this requirement will need to undergo a new biopsy prior to enrollment on study.\n* Patients must be at least 18 years of age.\n* Patients with AJCC (7th edition, 2010) N2-N3 nodal disease or T3-T4 primary tumor.\n* Measurable disease (either primary site and/or nodal disease) by RECIST 1.1 criteria.\n* No previous radiation or chemotherapy for a head and neck cancer.\n* No complete surgical resection for a head and neck cancer within 8 weeks of enrollment (although lymph node biopsy including excision of an individual node with presence of residual nodal disease, or surgical biopsy/excision of the tumor with residual disease is acceptable).\n* ECOG performance status 0-1 (Karnofsky greater than or equal to 80%).\n* Normal Organ Function\n* Leukocytes ≥3000/mm3,\n* platelets ≥100,000/mm3,\n* absolute neutrophil count ≥1,500,\n* hemoglobin >9.0 gm/dL,\n* AST and ALT <2.5 X ULN\n* alkaline phosphatase <2.5 X ULN\n* albumin >2.9 gm/dL, 29 Version Date: 12/28/2016\n* total bilirubin ≤1.5 mg/dl,\n* creatinine clearance >45 mL/min (or SCr <1.5 mg/dL), normal within 2 weeks prior to start of treatment.\n* The standard Cockcroft and Gault formula or the measured glomerular filtration rate must be used to calculate CrCl for enrollment or dosing\n* Patients must sign a study-specific informed consent form prior to study entry. Patients should have the ability to understand and the willingness to sign a written informed consent document.\n* Age, Sex, and Reproductive Status:\n\n  1. Men and women, ages > 18.\n  2. Women of childbearing potential (WOCBP=premenopausal woman capable of becoming pregnant) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.\n  3. Women must not be breastfeeding.\n  4. WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of study drug(s) plus 30 days (duration of ovulatory cycle) for a total of 23 weeks post-treatment completion.\n  5. Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of study drug(s) plus 90 days (duration of sperm turnover) for a total of 31 weeks post treatment completion.\n  6. Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, they must still undergo pregnancy testing as described in this section.\n* Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of <1% when used consistently and correctly.\n* At a minimum subjects must agree to the use of one method of highly effective contraception as listed below:\n\nHIGHLY EFFECTIVE METHODS OF CONTRACEPTION\n\n* Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants and intrauterine devices (IUDs) such as Mirena® by WOCBP subject or male subject's WOCBP partner\n* IUDs, such as ParaGard®\n* Tubal ligation\n* Vasectomy 30 Version Date: 12/28/2016\n* Complete Abstinence*\n\n  * *Complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs. Female subjects must continue to have pregnancy tests. Acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence.\n\nSubjects are encouraged to use two methods of contraception, with one method being highly effective and the other method being either highly effective or less effective as listed below:\n\nLESS EFFECTIVE METHODS OF CONTRACEPTION\n\n* Diaphragm with spermicide\n* Cervical cap with spermicide\n* Vaginal sponge\n* Male condoms and spermicide\n* Male condom without spermicide\n* Progestin only pills by WOCBP subject or male subject's WOCBP partner\n* Female condom*\n\n  * *A male and female condom must not be used together\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Unequivocal demonstration of distant metastases (M1 disease).\n* Unidentifiable primary site.\n* Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival. Including but not limited to ongoing or active infection, immunodeficiency, symptomatic congestive heart failure, pulmonary dysfunction, cardiomyopathy, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance.\n* Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns (please see above paragraph under inclusion criteria regarding WOCBP) 31 Version Date: 12/28/2016\n* Prior surgical therapy other than incisional/excisional biopsy or organ-sparing procedures such as debulking of airway-compromising tumors. Residual measurable tumor is required for enrollment on study as outlined above\n* Patients receiving other investigational agents.\n* Peripheral neuropathy >grade 1\n* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy in excess of physiologic dose or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.\n* Has a known history of active tuberculosis (Bacillus Tuberculosis infection)\n* Has hypersensitivity to nivolumab or any other drug used in this protocol.\n* Has had a prior systemic anti-cancer treatment within the last 8 weeks\n* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer or any tumors that are not likely to influence live expectancy in the subsequent 3 years without active treatment (e.g. low grade prostate cancer in absence of therapy).\n* Has active autoimmune disease that has required systemic treatment in the past year (i.e. with use of steroids or immunosuppressive drugs). Replacement therapy e.g. levothyroxine, insulin, or physiologic corticosteroid doses for adrenal or pituitary insufficiency, etc. are not considered a form of systemic treatment.\n* Has known history of, or any evidence of active, non-infectious pneumonitis.\n* Has a history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).\n* Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). However, if eradicated patient is eligible.\n* Has received a live vaccine within 28 days of planned start of study therapy. o Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed within 28 days prior to initiation of treatment.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patients must have pathologically confirmed HPV-positive head and neck squamous cell carcinoma of the oropharynx. Confirmed HPV-positive disease of other subsites are uncommon but also eligible.",
            "criterions": [
                {
                    "exact_snippets": "pathologically confirmed HPV-positive head and neck squamous cell carcinoma of the oropharynx",
                    "criterion": "HPV-positive head and neck squamous cell carcinoma of the oropharynx",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Confirmed HPV-positive disease of other subsites",
                    "criterion": "HPV-positive disease of other subsites",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HPV testing must be compliant with the following criteria:",
            "criterions": [
                {
                    "exact_snippets": "HPV testing must be compliant",
                    "criterion": "HPV testing",
                    "requirements": [
                        {
                            "requirement_type": "compliance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* p16 IHC positivity is sufficient to enroll and initiate treatment (p16 IHC interpretation to follow guidelines by Jordan and Lingen et al89).",
            "criterions": [
                {
                    "exact_snippets": "p16 IHC positivity is sufficient to enroll",
                    "criterion": "p16 IHC positivity",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* p16 IHC positivity is to be validated using an HPV PCR during the induction phase. This is essential as HPV genotype influences treatment arm allocation, with non-HPV16 HPV strains being considered high risk.",
            "criterions": [
                {
                    "exact_snippets": "p16 IHC positivity is to be validated using an HPV PCR",
                    "criterion": "p16 IHC positivity",
                    "requirements": [
                        {
                            "requirement_type": "validation",
                            "expected_value": "HPV PCR"
                        }
                    ]
                },
                {
                    "exact_snippets": "HPV genotype influences treatment arm allocation",
                    "criterion": "HPV genotype",
                    "requirements": [
                        {
                            "requirement_type": "influence on treatment arm allocation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "non-HPV16 HPV strains being considered high risk",
                    "criterion": "HPV strain",
                    "requirements": [
                        {
                            "requirement_type": "risk level",
                            "expected_value": "high risk for non-HPV16"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Availability of ≥10 unstained 5 micron slides (to be provided to HTRC at the University of Chicago). Patients who cannot fulfill this requirement will need to undergo a new biopsy prior to enrollment on study.",
            "criterions": [
                {
                    "exact_snippets": "Availability of ≥10 unstained 5 micron slides",
                    "criterion": "unstained slides",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 10,
                                "unit": "slides"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must be at least 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be at least 18 years of age.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with AJCC (7th edition, 2010) N2-N3 nodal disease or T3-T4 primary tumor.",
            "criterions": [
                {
                    "exact_snippets": "AJCC (7th edition, 2010) N2-N3 nodal disease",
                    "criterion": "nodal disease",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 2,
                                        "unit": "N"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "T3-T4 primary tumor",
                    "criterion": "primary tumor",
                    "requirements": [
                        {
                            "requirement_type": "stage",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "T"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Measurable disease (either primary site and/or nodal disease) by RECIST 1.1 criteria.",
            "criterions": [
                {
                    "exact_snippets": "Measurable disease ... by RECIST 1.1 criteria.",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "criteria",
                            "expected_value": "RECIST 1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No previous radiation or chemotherapy for a head and neck cancer.",
            "criterions": [
                {
                    "exact_snippets": "No previous radiation ... for a head and neck cancer.",
                    "criterion": "previous radiation for head and neck cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "No previous ... chemotherapy for a head and neck cancer.",
                    "criterion": "previous chemotherapy for head and neck cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* No complete surgical resection for a head and neck cancer within 8 weeks of enrollment (although lymph node biopsy including excision of an individual node with presence of residual nodal disease, or surgical biopsy/excision of the tumor with residual disease is acceptable).",
            "criterions": [
                {
                    "exact_snippets": "No complete surgical resection for a head and neck cancer within 8 weeks of enrollment",
                    "criterion": "complete surgical resection for a head and neck cancer",
                    "requirements": [
                        {
                            "requirement_type": "time since procedure",
                            "expected_value": {
                                "operator": "<",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "lymph node biopsy including excision of an individual node with presence of residual nodal disease",
                    "criterion": "lymph node biopsy",
                    "requirements": [
                        {
                            "requirement_type": "presence of residual nodal disease",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "surgical biopsy/excision of the tumor with residual disease",
                    "criterion": "surgical biopsy/excision of the tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence of residual disease",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ECOG performance status 0-1 (Karnofsky greater than or equal to 80%).",
            "criterions": [
                {
                    "exact_snippets": "ECOG performance status 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Karnofsky greater than or equal to 80%",
                    "criterion": "Karnofsky performance status",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">=",
                                "value": 80,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Normal Organ Function",
            "criterions": [
                {
                    "exact_snippets": "Normal Organ Function",
                    "criterion": "organ function",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "normal"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Leukocytes ≥3000/mm3,",
            "criterions": [
                {
                    "exact_snippets": "Leukocytes ≥3000/mm3",
                    "criterion": "leukocytes",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3000,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* platelets ≥100,000/mm3,",
            "criterions": [
                {
                    "exact_snippets": "platelets ≥100,000/mm3",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "mm3"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* absolute neutrophil count ≥1,500,",
            "criterions": [
                {
                    "exact_snippets": "absolute neutrophil count ≥1,500",
                    "criterion": "absolute neutrophil count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "N/A"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* hemoglobin >9.0 gm/dL,",
            "criterions": [
                {
                    "exact_snippets": "hemoglobin >9.0 gm/dL",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 9.0,
                                "unit": "gm/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST and ALT <2.5 X ULN",
            "criterions": [
                {
                    "exact_snippets": "AST and ALT <2.5 X ULN",
                    "criterion": "AST",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "X ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "AST and ALT <2.5 X ULN",
                    "criterion": "ALT",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "X ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* alkaline phosphatase <2.5 X ULN",
            "criterions": [
                {
                    "exact_snippets": "alkaline phosphatase <2.5 X ULN",
                    "criterion": "alkaline phosphatase",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<",
                                "value": 2.5,
                                "unit": "X ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* albumin >2.9 gm/dL, 29 Version Date: 12/28/2016",
            "criterions": [
                {
                    "exact_snippets": "albumin >2.9 gm/dL",
                    "criterion": "albumin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">",
                                "value": 2.9,
                                "unit": "gm/dL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* total bilirubin ≤1.5 mg/dl,",
            "criterions": [
                {
                    "exact_snippets": "total bilirubin ≤1.5 mg/dl",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "mg/dl"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* creatinine clearance >45 mL/min (or SCr <1.5 mg/dL), normal within 2 weeks prior to start of treatment.",
            "criterions": [
                {
                    "exact_snippets": "creatinine clearance >45 mL/min",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">",
                                "value": 45,
                                "unit": "mL/min"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "SCr <1.5 mg/dL",
                    "criterion": "serum creatinine (SCr)",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": "<",
                                "value": 1.5,
                                "unit": "mg/dL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "normal within 2 weeks prior to start of treatment",
                    "criterion": "timeframe for normal values",
                    "requirements": [
                        {
                            "requirement_type": "timeframe",
                            "expected_value": "within 2 weeks prior to start of treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* The standard Cockcroft and Gault formula or the measured glomerular filtration rate must be used to calculate CrCl for enrollment or dosing",
            "criterions": [
                {
                    "exact_snippets": "The standard Cockcroft and Gault formula or the measured glomerular filtration rate must be used to calculate CrCl",
                    "criterion": "CrCl calculation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "standard Cockcroft and Gault formula",
                                "measured glomerular filtration rate"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must sign a study-specific informed consent form prior to study entry. Patients should have the ability to understand and the willingness to sign a written informed consent document.",
            "criterions": [
                {
                    "exact_snippets": "Patients must sign a study-specific informed consent form",
                    "criterion": "informed consent form",
                    "requirements": [
                        {
                            "requirement_type": "signature",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients should have the ability to understand",
                    "criterion": "ability to understand",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willingness to sign a written informed consent document",
                    "criterion": "willingness to sign",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Age, Sex, and Reproductive Status:",
            "criterions": [
                {
                    "exact_snippets": "Age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                },
                {
                    "exact_snippets": "Sex",
                    "criterion": "sex",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                },
                {
                    "exact_snippets": "Reproductive Status",
                    "criterion": "reproductive status",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": "N/A"
                        }
                    ]
                }
            ]
        },
        {
            "line": "1. Men and women, ages > 18.",
            "criterions": [
                {
                    "exact_snippets": "Men and women",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": [
                                "male",
                                "female"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "ages > 18",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum age",
                            "expected_value": {
                                "operator": ">",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Women of childbearing potential (WOCBP=premenopausal woman capable of becoming pregnant) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 24 hours prior to the start of study drug.",
            "criterions": [
                {
                    "exact_snippets": "Women of childbearing potential (WOCBP=premenopausal woman capable of becoming pregnant)",
                    "criterion": "women of childbearing potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "must have a negative serum or urine pregnancy test",
                    "criterion": "pregnancy test result",
                    "requirements": [
                        {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    ]
                },
                {
                    "exact_snippets": "minimum sensitivity 25 IU/L or equivalent units of HCG",
                    "criterion": "pregnancy test sensitivity",
                    "requirements": [
                        {
                            "requirement_type": "sensitivity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 25,
                                "unit": "IU/L"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 24 hours prior to the start of study drug",
                    "criterion": "timing of pregnancy test",
                    "requirements": [
                        {
                            "requirement_type": "timing",
                            "expected_value": "within 24 hours prior to the start of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Women must not be breastfeeding.",
            "criterions": [
                {
                    "exact_snippets": "Women must not be breastfeeding.",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of study drug(s) plus 30 days (duration of ovulatory cycle) for a total of 23 weeks post-treatment completion.",
            "criterions": [
                {
                    "exact_snippets": "WOCBP must agree to follow instructions for method(s) of contraception",
                    "criterion": "WOCBP contraception agreement",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of study drug(s) plus 90 days (duration of sperm turnover) for a total of 31 weeks post treatment completion.",
            "criterions": [
                {
                    "exact_snippets": "Men who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception",
                    "criterion": "contraception agreement",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Azoospermic males and WOCBP who are continuously not heterosexually active are exempt from contraceptive requirements. However, they must still undergo pregnancy testing as described in this section.",
            "criterions": [
                {
                    "exact_snippets": "Azoospermic males",
                    "criterion": "azoospermia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "WOCBP who are continuously not heterosexually active",
                    "criterion": "WOCBP heterosexual activity",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "not heterosexually active"
                        }
                    ]
                },
                {
                    "exact_snippets": "undergo pregnancy testing",
                    "criterion": "pregnancy testing",
                    "requirements": [
                        {
                            "requirement_type": "requirement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Investigators shall counsel WOCBP and male subjects who are sexually active with WOCBP on the importance of pregnancy prevention and the implications of an unexpected pregnancy. Investigators shall advise WOCBP and male subjects who are sexually active with WOCBP on the use of highly effective methods of contraception. Highly effective methods of contraception have a failure rate of <1% when used consistently and correctly.",
            "criterions": [
                {
                    "exact_snippets": "WOCBP and male subjects who are sexually active with WOCBP ... importance of pregnancy prevention",
                    "criterion": "pregnancy prevention counseling",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "WOCBP and male subjects who are sexually active with WOCBP ... use of highly effective methods of contraception",
                    "criterion": "contraception counseling",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Highly effective methods of contraception have a failure rate of <1%",
                    "criterion": "contraception failure rate",
                    "requirements": [
                        {
                            "requirement_type": "failure rate",
                            "expected_value": {
                                "operator": "<",
                                "value": 1,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* At a minimum subjects must agree to the use of one method of highly effective contraception as listed below:",
            "criterions": [
                {
                    "exact_snippets": "subjects must agree to the use of one method of highly effective contraception",
                    "criterion": "use of highly effective contraception",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "HIGHLY EFFECTIVE METHODS OF CONTRACEPTION",
            "criterions": [
                {
                    "exact_snippets": "HIGHLY EFFECTIVE METHODS OF CONTRACEPTION",
                    "criterion": "contraception",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "high"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants and intrauterine devices (IUDs) such as Mirena® by WOCBP subject or male subject's WOCBP partner",
            "criterions": [
                {
                    "exact_snippets": "Hormonal methods of contraception including combined oral contraceptive pills, vaginal ring, injectables, implants and intrauterine devices (IUDs) such as Mirena®",
                    "criterion": "hormonal contraception method",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "WOCBP subject or male subject's WOCBP partner",
                    "criterion": "WOCBP status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "WOCBP"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* IUDs, such as ParaGard®",
            "criterions": [
                {
                    "exact_snippets": "IUDs, such as ParaGard®",
                    "criterion": "IUD usage",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Tubal ligation",
            "criterions": [
                {
                    "exact_snippets": "Tubal ligation",
                    "criterion": "tubal ligation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Vasectomy 30 Version Date: 12/28/2016",
            "criterions": [
                {
                    "exact_snippets": "Vasectomy",
                    "criterion": "vasectomy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Complete Abstinence*",
            "criterions": [
                {
                    "exact_snippets": "Complete Abstinence",
                    "criterion": "abstinence",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* *Complete abstinence is defined as complete avoidance of heterosexual intercourse and is an acceptable form of contraception for all study drugs. Female subjects must continue to have pregnancy tests. Acceptable alternate methods of highly effective contraception must be discussed in the event that the subject chooses to forego complete abstinence.",
            "criterions": [
                {
                    "exact_snippets": "Complete abstinence is defined as complete avoidance of heterosexual intercourse",
                    "criterion": "abstinence",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "complete avoidance of heterosexual intercourse"
                        }
                    ]
                },
                {
                    "exact_snippets": "abstinence ... is an acceptable form of contraception for all study drugs",
                    "criterion": "abstinence",
                    "requirements": [
                        {
                            "requirement_type": "acceptability",
                            "expected_value": "acceptable form of contraception for all study drugs"
                        }
                    ]
                },
                {
                    "exact_snippets": "Female subjects must continue to have pregnancy tests",
                    "criterion": "pregnancy tests",
                    "requirements": [
                        {
                            "requirement_type": "continuation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Acceptable alternate methods of highly effective contraception must be discussed",
                    "criterion": "alternate methods of contraception",
                    "requirements": [
                        {
                            "requirement_type": "discussion",
                            "expected_value": "must be discussed"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Subjects are encouraged to use two methods of contraception, with one method being highly effective and the other method being either highly effective or less effective as listed below:",
            "criterions": [
                {
                    "exact_snippets": "Subjects are encouraged to use two methods of contraception",
                    "criterion": "contraception methods",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "methods"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "one method being highly effective",
                    "criterion": "contraception method effectiveness",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "highly effective"
                        }
                    ]
                },
                {
                    "exact_snippets": "the other method being either highly effective or less effective",
                    "criterion": "contraception method effectiveness",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": [
                                "highly effective",
                                "less effective"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "LESS EFFECTIVE METHODS OF CONTRACEPTION",
            "criterions": [
                {
                    "exact_snippets": "LESS EFFECTIVE METHODS OF CONTRACEPTION",
                    "criterion": "contraception methods",
                    "requirements": [
                        {
                            "requirement_type": "effectiveness",
                            "expected_value": "less effective"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Diaphragm with spermicide",
            "criterions": [
                {
                    "exact_snippets": "Diaphragm with spermicide",
                    "criterion": "contraceptive method",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "diaphragm with spermicide"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Cervical cap with spermicide",
            "criterions": [
                {
                    "exact_snippets": "Cervical cap with spermicide",
                    "criterion": "contraceptive method",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "cervical cap with spermicide"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Vaginal sponge",
            "criterions": [
                {
                    "exact_snippets": "Vaginal sponge",
                    "criterion": "vaginal sponge",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Male condoms and spermicide",
            "criterions": [
                {
                    "exact_snippets": "Male condoms",
                    "criterion": "male condoms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "spermicide",
                    "criterion": "spermicide",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Male condom without spermicide",
            "criterions": [
                {
                    "exact_snippets": "Male condom without spermicide",
                    "criterion": "male condom",
                    "requirements": [
                        {
                            "requirement_type": "spermicide",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Progestin only pills by WOCBP subject or male subject's WOCBP partner",
            "criterions": [
                {
                    "exact_snippets": "Progestin only pills by WOCBP subject",
                    "criterion": "WOCBP subject",
                    "requirements": [
                        {
                            "requirement_type": "medication",
                            "expected_value": "Progestin only pills"
                        }
                    ]
                },
                {
                    "exact_snippets": "Progestin only pills by ... male subject's WOCBP partner",
                    "criterion": "male subject's WOCBP partner",
                    "requirements": [
                        {
                            "requirement_type": "medication",
                            "expected_value": "Progestin only pills"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Female condom*",
            "criterions": [
                {
                    "exact_snippets": "Female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* *A male and female condom must not be used together",
            "criterions": [
                {
                    "exact_snippets": "A male and female condom must not be used together",
                    "criterion": "condom usage",
                    "requirements": [
                        {
                            "requirement_type": "combination",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 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": "* Unequivocal demonstration of distant metastases (M1 disease).",
            "criterions": [
                {
                    "exact_snippets": "Unequivocal demonstration of distant metastases (M1 disease)",
                    "criterion": "distant metastases",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unidentifiable primary site.",
            "criterions": [
                {
                    "exact_snippets": "Unidentifiable primary site.",
                    "criterion": "primary site",
                    "requirements": [
                        {
                            "requirement_type": "identifiability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival. Including but not limited to ongoing or active infection, immunodeficiency, symptomatic congestive heart failure, pulmonary dysfunction, cardiomyopathy, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance.",
            "criterions": [
                {
                    "exact_snippets": "Intercurrent medical illnesses which would impair patient tolerance to therapy or limit survival",
                    "criterion": "intercurrent medical illnesses",
                    "requirements": [
                        {
                            "requirement_type": "impact on therapy tolerance",
                            "expected_value": "impair"
                        },
                        {
                            "requirement_type": "impact on survival",
                            "expected_value": "limit"
                        }
                    ]
                },
                {
                    "exact_snippets": "ongoing or active infection",
                    "criterion": "infection",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "ongoing",
                                "active"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic congestive heart failure",
                    "criterion": "congestive heart failure",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pulmonary dysfunction",
                    "criterion": "pulmonary dysfunction",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiomyopathy",
                    "criterion": "cardiomyopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "unstable angina pectoris",
                    "criterion": "angina pectoris",
                    "requirements": [
                        {
                            "requirement_type": "stability",
                            "expected_value": "unstable"
                        }
                    ]
                },
                {
                    "exact_snippets": "cardiac arrhythmia",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "psychiatric illness/social situations that would limit compliance",
                    "criterion": "psychiatric illness/social situations",
                    "requirements": [
                        {
                            "requirement_type": "impact on compliance",
                            "expected_value": "limit"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant and nursing women are excluded because of the potential teratogenic effects and potential unknown effects on nursing newborns (please see above paragraph under inclusion criteria regarding WOCBP) 31 Version Date: 12/28/2016",
            "criterions": [
                {
                    "exact_snippets": "Pregnant and nursing women are excluded",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Pregnant and nursing women are excluded",
                    "criterion": "nursing",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior surgical therapy other than incisional/excisional biopsy or organ-sparing procedures such as debulking of airway-compromising tumors. Residual measurable tumor is required for enrollment on study as outlined above",
            "criterions": [
                {
                    "exact_snippets": "Prior surgical therapy other than incisional/excisional biopsy or organ-sparing procedures such as debulking of airway-compromising tumors",
                    "criterion": "prior surgical therapy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "other than incisional/excisional biopsy or organ-sparing procedures such as debulking of airway-compromising tumors"
                        }
                    ]
                },
                {
                    "exact_snippets": "Residual measurable tumor is required for enrollment",
                    "criterion": "residual measurable tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients receiving other investigational agents.",
            "criterions": [
                {
                    "exact_snippets": "Patients receiving other investigational agents",
                    "criterion": "use of investigational agents",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Peripheral neuropathy >grade 1",
            "criterions": [
                {
                    "exact_snippets": "Peripheral neuropathy >grade 1",
                    "criterion": "peripheral neuropathy",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy in excess of physiologic dose or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment.",
            "criterions": [
                {
                    "exact_snippets": "Has a diagnosis of immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "is receiving systemic steroid therapy in excess of physiologic dose",
                    "criterion": "systemic steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "dose",
                            "expected_value": "in excess of physiologic dose"
                        }
                    ]
                },
                {
                    "exact_snippets": "any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment",
                    "criterion": "immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 7 days prior to the first dose of trial treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a known history of active tuberculosis (Bacillus Tuberculosis infection)",
            "criterions": [
                {
                    "exact_snippets": "known history of active tuberculosis (Bacillus Tuberculosis infection)",
                    "criterion": "active tuberculosis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has hypersensitivity to nivolumab or any other drug used in this protocol.",
            "criterions": [
                {
                    "exact_snippets": "hypersensitivity to nivolumab",
                    "criterion": "hypersensitivity to nivolumab",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "hypersensitivity to ... any other drug used in this protocol",
                    "criterion": "hypersensitivity to any other drug used in this protocol",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has had a prior systemic anti-cancer treatment within the last 8 weeks",
            "criterions": [
                {
                    "exact_snippets": "Has had a prior systemic anti-cancer treatment within the last 8 weeks",
                    "criterion": "prior systemic anti-cancer treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 8,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a known additional malignancy that is progressing or requires active treatment. Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy or in situ cervical cancer or any tumors that are not likely to influence live expectancy in the subsequent 3 years without active treatment (e.g. low grade prostate cancer in absence of therapy).",
            "criterions": [
                {
                    "exact_snippets": "Has a known additional malignancy that is progressing or requires active treatment.",
                    "criterion": "additional malignancy",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "active treatment requirement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Exceptions include basal cell carcinoma of the skin or squamous cell carcinoma of the skin that has undergone potentially curative therapy",
                    "criterion": "basal cell carcinoma of the skin or squamous cell carcinoma of the skin",
                    "requirements": [
                        {
                            "requirement_type": "curative therapy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Exceptions include ... in situ cervical cancer",
                    "criterion": "in situ cervical cancer",
                    "requirements": [
                        {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Exceptions include ... any tumors that are not likely to influence live expectancy in the subsequent 3 years without active treatment",
                    "criterion": "tumors not likely to influence life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "life expectancy influence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "Exceptions include ... low grade prostate cancer in absence of therapy",
                    "criterion": "low grade prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "therapy absence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has active autoimmune disease that has required systemic treatment in the past year (i.e. with use of steroids or immunosuppressive drugs). Replacement therapy e.g. levothyroxine, insulin, or physiologic corticosteroid doses for adrenal or pituitary insufficiency, etc. are not considered a form of systemic treatment.",
            "criterions": [
                {
                    "exact_snippets": "Has active autoimmune disease",
                    "criterion": "active autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has required systemic treatment in the past year",
                    "criterion": "systemic treatment for autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "past year"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has known history of, or any evidence of active, non-infectious pneumonitis.",
            "criterions": [
                {
                    "exact_snippets": "known history of, or any evidence of active, non-infectious pneumonitis",
                    "criterion": "non-infectious pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "evidence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a history of Human Immunodeficiency Virus (HIV) (HIV 1/2 antibodies).",
            "criterions": [
                {
                    "exact_snippets": "Has a history of Human Immunodeficiency Virus (HIV)",
                    "criterion": "Human Immunodeficiency Virus (HIV)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has known active Hepatitis B (e.g., HBsAg reactive) or Hepatitis C (e.g., HCV RNA [qualitative] is detected). However, if eradicated patient is eligible.",
            "criterions": [
                {
                    "exact_snippets": "Has known active Hepatitis B (e.g., HBsAg reactive)",
                    "criterion": "Hepatitis B",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "Has known active ... Hepatitis C (e.g., HCV RNA [qualitative] is detected)",
                    "criterion": "Hepatitis C",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received a live vaccine within 28 days of planned start of study therapy. o Note: Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed; however intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed within 28 days prior to initiation of treatment.",
            "criterions": [
                {
                    "exact_snippets": "Has received a live vaccine within 28 days of planned start of study therapy",
                    "criterion": "live vaccine",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Seasonal influenza vaccines for injection are generally inactivated flu vaccines and are allowed",
                    "criterion": "seasonal influenza vaccine for injection",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "inactivated"
                        },
                        {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "intranasal influenza vaccines (e.g., Flu-Mist®) are live attenuated vaccines, and are not allowed within 28 days prior to initiation of treatment",
                    "criterion": "intranasal influenza vaccine",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "live attenuated"
                        },
                        {
                            "requirement_type": "allowance",
                            "expected_value": false
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 28,
                                        "unit": "days"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}