{
    "info": {
        "nct_id": "NCT03026062",
        "official_title": "Randomized Phase II Trial of Durvalumab (MEDI4736) and Tremelimumab Administered in Combination Versus Sequentially in Recurrent Platinum-Resistant Epithelial Ovarian Cancer",
        "inclusion_criteria": "1. Written informed consent and any locally-required authorization (e.g., HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.\n2. Age >/= 18 years at time of study entry.\n3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n4. Adequate normal organ and marrow function as defined by: Hemoglobin >/= 9.0 g/dL (transfusion is allowed to correct anemia); Absolute neutrophil count (ANC) >/= 1.5 x 10^9/L (> 1500 per mm^3); Platelet count >/= 100 x 10^9/L (>100,000 per mm^3); Serum bilirubin </= 1.5 x institutional upper limit of normal (ULN) unless diagnosed with Gilbert's syndrome; AST and ALT </= 2.5 x ULN unless liver metastases are present, in which case it must be </= 5x ULN; Serum creatinine CL >40 mL/min by the Cockcroft-Gault formula ( Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance: Creatinine CL (mL/min) = [Weight (kg) x (140 - Age) x 0.85]/[72 x serum creatinine (mg/dL)].\n5. Subjects must either be of non-reproductive potential (i.e., post-menopausal by history: >/= 60 years old and no menses for >/= 1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.\n6. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including biopsies and follow up.\n7. Histology (reviewed at MDACC) showing recurrent high grade epithelial ovarian, peritoneal, or fallopian tube cancer of clear cell histology or mixed carcinoma with a clear cell component. In addition, subjects for the molecularly defined expansion cohort will also include patients with recurrent uterine serous carcinoma (who have received at least one prior line of platinum-based chemotherapy), and must have somatic mutations testing (performed by MD Anderson or a CLIA certified test offered by a commercial vendor such as Foundation One or Caris) that demonstrates a nonsynonymous PPP2R1A mutation (other protein phosphatase 2A or related pathway mutations/alterations may be eligible if approved by the PI). Synonymous mutations and variants of uncertain significance do not qualify.\n8. Platinum resistant or refractory disease as defined by progression of disease on a platinum-containing regimen or recurrence of disease within 180 days of previous platinum treatment (not applicable to the uterine serous carcinoma molecularly defined expansion cohort, however, subjects with uterine serous must have received at least one prior line of platinum-based therapy).\n9. Have measurable disease based on modified RECIST 1.1. For the purposes of this study measurable disease is defined at least one \"target\" lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each target lesion must be >20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or >10 mm when measured by spiral CT. The target lesion must be distinct from other tumor areas selected for pre-treatment biopsies. Pre-treatment imaging must be performed within 4 weeks of starting therapy.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).\n2. Previous enrollment or randomization in the present study.\n3. Participation in another clinical study with an investigational product administered during the last 28 days.\n4. Any previous treatment with adoptive T cells therapy, a PD1 or PDL1 inhibitor, including Durvalumab or any anti-CTLA4 therapy, including Tremelimumab.\n5. History of another primary malignancy except for: 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; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; or adequately treated carcinoma in situ without evidence of disease, e.g., cervical cancer in situ.\n6. Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) </= 28 days prior to the first dose of study drug (</= 21 days prior to the first dose of study drug for subjects who have received prior TKIs [e.g., erlotinib, gefitinib and crizotinib] and </= 6 weeks for nitrosourea, mitomycin C, or bevacizumab). (If sufficient wash-out time has not occurred due to the schedule or PK properties of an agent, a longer wash-out period may be required.)\n7. Mean QT interval corrected for heart rate (QTc) >/= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction.\n8. Current or prior use of immunosuppressive medication within 28 days before the first dose of Durvalumab OR Tremelimumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Steroid premedication for the prevention of radiologic contrast hypersensitivity is allowed.\n9. Any unresolved toxicity (> CTCAE grade 1) from previous anti-cancer therapy, excluding alopecia. Subjects with irreversible toxicity greater than grade 1 that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy).\n10. Any prior Grade >/= 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE > Grade 1.\n11. Active or prior documented autoimmune disease within the past 2 years. NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.\n12. Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).\n13. History of primary immunodeficiency.\n14. History of allogeneic organ transplant.\n15. History of hypersensitivity to Durvalumab, Tremelimumab, or any excipient.\n16. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent.\n17. Known history of previous clinical diagnosis of tuberculosis.\n18. History of leptomeningeal carcinomatosis or brain metastasis.\n19. Unresolved partial or complete small or large bowel obstruction.\n20. Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving Durvalumab OR Tremelimumab.\n21. Subjects who are pregnant, breast-feeding or of reproductive potential who are not employing an effective method of birth control or are not willing to employ effective birth control from screening to 180 days after the last dose of Durvalumab + Tremelimumab combination therapy or 90 days after the last dose of Durvalumab monotherapy, whichever is the longer time period.\n22. Any medical, social, or psychological condition that would interfere with evaluation of study treatment or interpretation of patient safety or study results.\n23. Subjects with uncontrolled seizures.\n24. Non-English speakers will be excluded from participating in the patient-reported outcomes component of the study.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. Written informed consent and any locally-required authorization (e.g., HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject prior to performing any protocol-related procedures, including screening evaluations.",
                "criterions": [
                    {
                        "exact_snippets": "Written informed consent ... obtained from the subject",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "any locally-required authorization (e.g., HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject",
                        "criterion": "locally-required authorization",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Written informed consent ... obtained from the subject",
                        "criterion": "informed consent",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "any locally-required authorization (e.g., HIPAA in the USA, EU Data Privacy Directive in the EU) obtained from the subject",
                        "criterion": "locally-required authorization",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Age >/= 18 years at time of study entry.",
                "criterions": [
                    {
                        "exact_snippets": "Age >/= 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age >/= 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 18,
                                        "unit": "years"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Subjects must either be of non-reproductive potential (i.e., post-menopausal by history: >/= 60 years old and no menses for >/= 1 year without an alternative medical cause; OR history of hysterectomy, OR history of bilateral tubal ligation, OR history of bilateral oophorectomy) or must have a negative serum pregnancy test upon study entry.",
                "criterions": [
                    {
                        "exact_snippets": "non-reproductive potential ... post-menopausal by history: >/= 60 years old",
                        "criterion": "post-menopausal status",
                        "requirement": {
                            "requirement_type": "age",
                            "expected_value": {
                                "operator": ">=",
                                "value": 60,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "non-reproductive potential ... post-menopausal by history: >/= 60 years old",
                        "criterion": "post-menopausal status",
                        "requirement": {
                            "requirement_type": "menstrual history",
                            "expected_value": "no menses for >/= 1 year without an alternative medical cause"
                        }
                    },
                    {
                        "exact_snippets": "non-reproductive potential ... history of hysterectomy",
                        "criterion": "hysterectomy history",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "non-reproductive potential ... history of bilateral tubal ligation",
                        "criterion": "bilateral tubal ligation history",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "non-reproductive potential ... history of bilateral oophorectomy",
                        "criterion": "bilateral oophorectomy history",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "negative serum pregnancy test upon study entry",
                        "criterion": "serum pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "non-reproductive potential ... post-menopausal by history: >/= 60 years old",
                                        "criterion": "post-menopausal status",
                                        "requirement": {
                                            "requirement_type": "age",
                                            "expected_value": {
                                                "operator": ">=",
                                                "value": 60,
                                                "unit": "years"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "non-reproductive potential ... post-menopausal by history: >/= 60 years old",
                                        "criterion": "post-menopausal status",
                                        "requirement": {
                                            "requirement_type": "menstrual history",
                                            "expected_value": "no menses for >/= 1 year without an alternative medical cause"
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "non-reproductive potential ... history of hysterectomy",
                                "criterion": "hysterectomy history",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "non-reproductive potential ... history of bilateral tubal ligation",
                        "criterion": "bilateral tubal ligation history",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "non-reproductive potential ... history of bilateral oophorectomy",
                        "criterion": "bilateral oophorectomy history",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "negative serum pregnancy test upon study entry",
                        "criterion": "serum pregnancy test",
                        "requirement": {
                            "requirement_type": "result",
                            "expected_value": "negative"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Subject is willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including biopsies and follow up.",
                "criterions": [
                    {
                        "exact_snippets": "Subject is willing and able to comply with the protocol for the duration of the study",
                        "criterion": "compliance with protocol",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Subject is willing and able to comply with the protocol for the duration of the study",
                        "criterion": "compliance with protocol",
                        "requirement": {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "undergoing treatment",
                        "criterion": "undergoing treatment",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "scheduled visits and examinations including biopsies and follow up",
                        "criterion": "scheduled visits and examinations",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Subject is willing and able to comply with the protocol for the duration of the study",
                                "criterion": "compliance with protocol",
                                "requirement": {
                                    "requirement_type": "willingness",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "Subject is willing and able to comply with the protocol for the duration of the study",
                                "criterion": "compliance with protocol",
                                "requirement": {
                                    "requirement_type": "ability",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "undergoing treatment",
                        "criterion": "undergoing treatment",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "scheduled visits and examinations including biopsies and follow up",
                        "criterion": "scheduled visits and examinations",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Platinum resistant or refractory disease as defined by progression of disease on a platinum-containing regimen or recurrence of disease within 180 days of previous platinum treatment (not applicable to the uterine serous carcinoma molecularly defined expansion cohort, however, subjects with uterine serous must have received at least one prior line of platinum-based therapy).",
                "criterions": [
                    {
                        "exact_snippets": "Platinum resistant or refractory disease as defined by progression of disease on a platinum-containing regimen",
                        "criterion": "platinum resistance or refractoriness",
                        "requirement": {
                            "requirement_type": "definition",
                            "expected_value": "progression of disease on a platinum-containing regimen"
                        }
                    },
                    {
                        "exact_snippets": "recurrence of disease within 180 days of previous platinum treatment",
                        "criterion": "platinum resistance or refractoriness",
                        "requirement": {
                            "requirement_type": "definition",
                            "expected_value": "recurrence of disease within 180 days of previous platinum treatment"
                        }
                    },
                    {
                        "exact_snippets": "subjects with uterine serous must have received at least one prior line of platinum-based therapy",
                        "criterion": "prior platinum-based therapy for uterine serous carcinoma",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "line"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "or_criteria": [
                                {
                                    "exact_snippets": "Platinum resistant or refractory disease as defined by progression of disease on a platinum-containing regimen",
                                    "criterion": "platinum resistance or refractoriness",
                                    "requirement": {
                                        "requirement_type": "definition",
                                        "expected_value": "progression of disease on a platinum-containing regimen"
                                    }
                                },
                                {
                                    "exact_snippets": "recurrence of disease within 180 days of previous platinum treatment",
                                    "criterion": "platinum resistance or refractoriness",
                                    "requirement": {
                                        "requirement_type": "definition",
                                        "expected_value": "recurrence of disease within 180 days of previous platinum treatment"
                                    }
                                }
                            ]
                        }
                    ]
                },
                "then_criteria": null,
                "else_criteria": {
                    "exact_snippets": "subjects with uterine serous must have received at least one prior line of platinum-based therapy",
                    "criterion": "prior platinum-based therapy for uterine serous carcinoma",
                    "requirement": {
                        "requirement_type": "quantity",
                        "expected_value": {
                            "operator": ">=",
                            "value": 1,
                            "unit": "line"
                        }
                    }
                }
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "4. Any previous treatment with adoptive T cells therapy, a PD1 or PDL1 inhibitor, including Durvalumab or any anti-CTLA4 therapy, including Tremelimumab.",
                "criterions": [
                    {
                        "exact_snippets": "Any previous treatment with adoptive T cells therapy",
                        "criterion": "previous treatment with adoptive T cells therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Any previous treatment with ... a PD1 or PDL1 inhibitor",
                        "criterion": "previous treatment with PD1 or PDL1 inhibitor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Any previous treatment with ... Durvalumab",
                        "criterion": "previous treatment with Durvalumab",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Any previous treatment with ... any anti-CTLA4 therapy",
                        "criterion": "previous treatment with anti-CTLA4 therapy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Any previous treatment with ... Tremelimumab",
                        "criterion": "previous treatment with Tremelimumab",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any previous treatment with adoptive T cells therapy",
                                "criterion": "previous treatment with adoptive T cells therapy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any previous treatment with ... a PD1 or PDL1 inhibitor",
                                "criterion": "previous treatment with PD1 or PDL1 inhibitor",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any previous treatment with ... Durvalumab",
                                "criterion": "previous treatment with Durvalumab",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any previous treatment with ... any anti-CTLA4 therapy",
                                "criterion": "previous treatment with anti-CTLA4 therapy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any previous treatment with ... Tremelimumab",
                                "criterion": "previous treatment with Tremelimumab",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. History of another primary malignancy except for: 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; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; or adequately treated carcinoma in situ without evidence of disease, e.g., cervical cancer in situ.",
                "criterions": [
                    {
                        "exact_snippets": "History of another primary malignancy",
                        "criterion": "history of another primary malignancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "malignancy treated with curative intent and with no known active disease >/= 5 years before the first dose of study drug",
                        "criterion": "malignancy treated with curative intent",
                        "requirement": {
                            "requirement_type": "active disease status",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "malignancy treated with curative intent and with no known active disease >/= 5 years before the first dose of study drug",
                        "criterion": "malignancy treated with curative intent",
                        "requirement": {
                            "requirement_type": "time since treatment",
                            "expected_value": {
                                "operator": ">=",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    },
                    {
                        "exact_snippets": "low potential risk for recurrence",
                        "criterion": "risk for recurrence",
                        "requirement": {
                            "requirement_type": "potential risk",
                            "expected_value": "low"
                        }
                    },
                    {
                        "exact_snippets": "adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease",
                        "criterion": "adequately treated non-melanoma skin cancer or lentigo maligna",
                        "requirement": {
                            "requirement_type": "evidence of disease",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "adequately treated carcinoma in situ without evidence of disease",
                        "criterion": "adequately treated carcinoma in situ",
                        "requirement": {
                            "requirement_type": "evidence of disease",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "and_criteria": [
                                            {
                                                "and_criteria": [
                                                    {
                                                        "not_criteria": {
                                                            "exact_snippets": "History of another primary malignancy",
                                                            "criterion": "history of another primary malignancy",
                                                            "requirement": {
                                                                "requirement_type": "presence",
                                                                "expected_value": false
                                                            }
                                                        }
                                                    },
                                                    {
                                                        "not_criteria": {
                                                            "exact_snippets": "malignancy treated with curative intent and with no known active disease >/= 5 years before the first dose of study drug",
                                                            "criterion": "malignancy treated with curative intent",
                                                            "requirement": {
                                                                "requirement_type": "active disease status",
                                                                "expected_value": false
                                                            }
                                                        }
                                                    }
                                                ]
                                            },
                                            {
                                                "exact_snippets": "malignancy treated with curative intent and with no known active disease >/= 5 years before the first dose of study drug",
                                                "criterion": "malignancy treated with curative intent",
                                                "requirement": {
                                                    "requirement_type": "time since treatment",
                                                    "expected_value": {
                                                        "operator": ">=",
                                                        "value": 5,
                                                        "unit": "years"
                                                    }
                                                }
                                            }
                                        ]
                                    },
                                    {
                                        "exact_snippets": "low potential risk for recurrence",
                                        "criterion": "risk for recurrence",
                                        "requirement": {
                                            "requirement_type": "potential risk",
                                            "expected_value": "low"
                                        }
                                    }
                                ]
                            },
                            {
                                "not_criteria": {
                                    "exact_snippets": "adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease",
                                    "criterion": "adequately treated non-melanoma skin cancer or lentigo maligna",
                                    "requirement": {
                                        "requirement_type": "evidence of disease",
                                        "expected_value": false
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "not_criteria": {
                            "exact_snippets": "adequately treated carcinoma in situ without evidence of disease",
                            "criterion": "adequately treated carcinoma in situ",
                            "requirement": {
                                "requirement_type": "evidence of disease",
                                "expected_value": false
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Mean QT interval corrected for heart rate (QTc) >/= 470 ms calculated from 3 electrocardiograms (ECGs) using Fridericia's Correction.",
                "criterions": [
                    {
                        "exact_snippets": "Mean QT interval corrected for heart rate (QTc) >/= 470 ms",
                        "criterion": "QTc interval",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 470,
                                "unit": "ms"
                            }
                        }
                    },
                    {
                        "exact_snippets": "calculated from 3 electrocardiograms (ECGs)",
                        "criterion": "number of ECGs",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "=",
                                "value": 3,
                                "unit": "ECGs"
                            }
                        }
                    },
                    {
                        "exact_snippets": "using Fridericia's Correction",
                        "criterion": "correction method",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "Fridericia's Correction"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Mean QT interval corrected for heart rate (QTc) >/= 470 ms",
                                "criterion": "QTc interval",
                                "requirement": {
                                    "requirement_type": "value",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 470,
                                        "unit": "ms"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "calculated from 3 electrocardiograms (ECGs)",
                                "criterion": "number of ECGs",
                                "requirement": {
                                    "requirement_type": "quantity",
                                    "expected_value": {
                                        "operator": "=",
                                        "value": 3,
                                        "unit": "ECGs"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "using Fridericia's Correction",
                        "criterion": "correction method",
                        "requirement": {
                            "requirement_type": "method",
                            "expected_value": "Fridericia's Correction"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Current or prior use of immunosuppressive medication within 28 days before the first dose of Durvalumab OR Tremelimumab, with the exceptions of intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid. Steroid premedication for the prevention of radiologic contrast hypersensitivity is allowed.",
                "criterions": [
                    {
                        "exact_snippets": "Current or prior use of immunosuppressive medication within 28 days before the first dose of Durvalumab OR Tremelimumab",
                        "criterion": "use of immunosuppressive medication",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within 28 days before the first dose of Durvalumab OR Tremelimumab"
                        }
                    },
                    {
                        "exact_snippets": "exceptions of intranasal and inhaled corticosteroids",
                        "criterion": "use of intranasal and inhaled corticosteroids",
                        "requirement": {
                            "requirement_type": "exception",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid",
                        "criterion": "use of systemic corticosteroids",
                        "requirement": {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "mg/day of prednisone"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Steroid premedication for the prevention of radiologic contrast hypersensitivity is allowed",
                        "criterion": "steroid premedication for radiologic contrast hypersensitivity",
                        "requirement": {
                            "requirement_type": "allowance",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Current or prior use of immunosuppressive medication within 28 days before the first dose of Durvalumab OR Tremelimumab",
                                "criterion": "use of immunosuppressive medication",
                                "requirement": {
                                    "requirement_type": "time frame",
                                    "expected_value": "within 28 days before the first dose of Durvalumab OR Tremelimumab"
                                }
                            },
                            {
                                "not_criteria": {
                                    "or_criteria": [
                                        {
                                            "exact_snippets": "exceptions of intranasal and inhaled corticosteroids",
                                            "criterion": "use of intranasal and inhaled corticosteroids",
                                            "requirement": {
                                                "requirement_type": "exception",
                                                "expected_value": true
                                            }
                                        },
                                        {
                                            "exact_snippets": "systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone, or an equivalent corticosteroid",
                                            "criterion": "use of systemic corticosteroids",
                                            "requirement": {
                                                "requirement_type": "dose",
                                                "expected_value": {
                                                    "operator": "<=",
                                                    "value": 10,
                                                    "unit": "mg/day of prednisone"
                                                }
                                            }
                                        },
                                        {
                                            "exact_snippets": "Steroid premedication for the prevention of radiologic contrast hypersensitivity is allowed",
                                            "criterion": "steroid premedication for radiologic contrast hypersensitivity",
                                            "requirement": {
                                                "requirement_type": "allowance",
                                                "expected_value": true
                                            }
                                        }
                                    ]
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "10. Any prior Grade >/= 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent, or any unresolved irAE > Grade 1.",
                "criterions": [
                    {
                        "exact_snippets": "Any prior Grade >/= 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent",
                        "criterion": "prior immune-related adverse event",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "Grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Any prior Grade >/= 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent",
                        "criterion": "prior immune-related adverse event",
                        "requirement": {
                            "requirement_type": "treatment context",
                            "expected_value": "while receiving any previous immunotherapy agent"
                        }
                    },
                    {
                        "exact_snippets": "any unresolved irAE > Grade 1",
                        "criterion": "unresolved immune-related adverse event",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any prior Grade >/= 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent",
                                "criterion": "prior immune-related adverse event",
                                "requirement": {
                                    "requirement_type": "grade",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 3,
                                        "unit": "Grade"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Any prior Grade >/= 3 immune-related adverse event (irAE) while receiving any previous immunotherapy agent",
                                "criterion": "prior immune-related adverse event",
                                "requirement": {
                                    "requirement_type": "treatment context",
                                    "expected_value": "while receiving any previous immunotherapy agent"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "any unresolved irAE > Grade 1",
                        "criterion": "unresolved immune-related adverse event",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "Grade"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "11. Active or prior documented autoimmune disease within the past 2 years. NOTE: Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded.",
                "criterions": [
                    {
                        "exact_snippets": "Active or prior documented autoimmune disease within the past 2 years",
                        "criterion": "autoimmune disease",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": [
                                "active",
                                "prior"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Active or prior documented autoimmune disease within the past 2 years",
                        "criterion": "autoimmune disease",
                        "requirement": {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Active or prior documented autoimmune disease within the past 2 years",
                        "criterion": "autoimmune disease",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within the past 2 years"
                        }
                    },
                    {
                        "exact_snippets": "Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded",
                        "criterion": "autoimmune disease exceptions",
                        "requirement": {
                            "requirement_type": "condition",
                            "expected_value": [
                                "vitiligo",
                                "Grave's disease",
                                "psoriasis"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded",
                        "criterion": "autoimmune disease exceptions",
                        "requirement": {
                            "requirement_type": "treatment requirement",
                            "expected_value": "not requiring systemic treatment"
                        }
                    },
                    {
                        "exact_snippets": "Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded",
                        "criterion": "autoimmune disease exceptions",
                        "requirement": {
                            "requirement_type": "time frame",
                            "expected_value": "within the past 2 years"
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "and_criteria": [
                                {
                                    "and_criteria": [
                                        {
                                            "and_criteria": [
                                                {
                                                    "and_criteria": [
                                                        {
                                                            "exact_snippets": "Active or prior documented autoimmune disease within the past 2 years",
                                                            "criterion": "autoimmune disease",
                                                            "requirement": {
                                                                "requirement_type": "status",
                                                                "expected_value": [
                                                                    "active",
                                                                    "prior"
                                                                ]
                                                            }
                                                        },
                                                        {
                                                            "exact_snippets": "Active or prior documented autoimmune disease within the past 2 years",
                                                            "criterion": "autoimmune disease",
                                                            "requirement": {
                                                                "requirement_type": "documentation",
                                                                "expected_value": true
                                                            }
                                                        }
                                                    ]
                                                },
                                                {
                                                    "exact_snippets": "Active or prior documented autoimmune disease within the past 2 years",
                                                    "criterion": "autoimmune disease",
                                                    "requirement": {
                                                        "requirement_type": "time frame",
                                                        "expected_value": "within the past 2 years"
                                                    }
                                                }
                                            ]
                                        },
                                        {
                                            "not_criteria": {
                                                "and_criteria": [
                                                    {
                                                        "exact_snippets": "Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded",
                                                        "criterion": "autoimmune disease exceptions",
                                                        "requirement": {
                                                            "requirement_type": "condition",
                                                            "expected_value": [
                                                                "vitiligo",
                                                                "Grave's disease",
                                                                "psoriasis"
                                                            ]
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded",
                                                        "criterion": "autoimmune disease exceptions",
                                                        "requirement": {
                                                            "requirement_type": "treatment requirement",
                                                            "expected_value": "not requiring systemic treatment"
                                                        }
                                                    },
                                                    {
                                                        "exact_snippets": "Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded",
                                                        "criterion": "autoimmune disease exceptions",
                                                        "requirement": {
                                                            "requirement_type": "time frame",
                                                            "expected_value": "within the past 2 years"
                                                        }
                                                    }
                                                ]
                                            }
                                        }
                                    ]
                                },
                                {
                                    "not_criteria": {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded",
                                                "criterion": "autoimmune disease exceptions",
                                                "requirement": {
                                                    "requirement_type": "condition",
                                                    "expected_value": [
                                                        "vitiligo",
                                                        "Grave's disease",
                                                        "psoriasis"
                                                    ]
                                                }
                                            },
                                            {
                                                "exact_snippets": "Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded",
                                                "criterion": "autoimmune disease exceptions",
                                                "requirement": {
                                                    "requirement_type": "treatment requirement",
                                                    "expected_value": "not requiring systemic treatment"
                                                }
                                            },
                                            {
                                                "exact_snippets": "Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded",
                                                "criterion": "autoimmune disease exceptions",
                                                "requirement": {
                                                    "requirement_type": "time frame",
                                                    "expected_value": "within the past 2 years"
                                                }
                                            }
                                        ]
                                    }
                                }
                            ]
                        },
                        {
                            "not_criteria": {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded",
                                        "criterion": "autoimmune disease exceptions",
                                        "requirement": {
                                            "requirement_type": "condition",
                                            "expected_value": [
                                                "vitiligo",
                                                "Grave's disease",
                                                "psoriasis"
                                            ]
                                        }
                                    },
                                    {
                                        "exact_snippets": "Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded",
                                        "criterion": "autoimmune disease exceptions",
                                        "requirement": {
                                            "requirement_type": "treatment requirement",
                                            "expected_value": "not requiring systemic treatment"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Subjects with vitiligo, Grave's disease, or psoriasis not requiring systemic treatment (within the past 2 years) are not excluded",
                                        "criterion": "autoimmune disease exceptions",
                                        "requirement": {
                                            "requirement_type": "time frame",
                                            "expected_value": "within the past 2 years"
                                        }
                                    }
                                ]
                            }
                        }
                    ]
                },
                "then_criteria": null,
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "12. Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis).",
                "criterions": [
                    {
                        "exact_snippets": "Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)",
                        "criterion": "inflammatory bowel disease",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Active or prior documented inflammatory bowel disease (e.g., Crohn's disease, ulcerative colitis)",
                    "criterion": "inflammatory bowel disease",
                    "requirement": {
                        "requirement_type": "presence",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "13. History of primary immunodeficiency.",
                "criterions": [
                    {
                        "exact_snippets": "History of primary immunodeficiency",
                        "criterion": "primary immunodeficiency",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "History of primary immunodeficiency",
                    "criterion": "primary immunodeficiency",
                    "requirement": {
                        "requirement_type": "history",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "14. History of allogeneic organ transplant.",
                "criterions": [
                    {
                        "exact_snippets": "History of allogeneic organ transplant",
                        "criterion": "allogeneic organ transplant",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "History of allogeneic organ transplant",
                        "criterion": "allogeneic organ transplant",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "15. History of hypersensitivity to Durvalumab, Tremelimumab, or any excipient.",
                "criterions": [
                    {
                        "exact_snippets": "History of hypersensitivity to Durvalumab",
                        "criterion": "hypersensitivity to Durvalumab",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "History of hypersensitivity to ... Tremelimumab",
                        "criterion": "hypersensitivity to Tremelimumab",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "History of hypersensitivity to ... any excipient",
                        "criterion": "hypersensitivity to any excipient",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "History of hypersensitivity to Durvalumab",
                        "criterion": "hypersensitivity to Durvalumab",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "History of hypersensitivity to ... Tremelimumab",
                        "criterion": "hypersensitivity to Tremelimumab",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "History of hypersensitivity to ... any excipient",
                        "criterion": "hypersensitivity to any excipient",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "16. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, active bleeding diatheses including any subject known to have evidence of acute or chronic hepatitis B, hepatitis C or human immunodeficiency virus (HIV), or psychiatric illness/social situations that would limit compliance with study requirements or compromise the ability of the subject to give written informed consent.",
                "criterions": [
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness ... ongoing or active infection",
                        "criterion": "ongoing or active infection",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness ... symptomatic congestive heart failure",
                        "criterion": "symptomatic congestive heart failure",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness ... uncontrolled hypertension",
                        "criterion": "uncontrolled hypertension",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness ... unstable angina pectoris",
                        "criterion": "unstable angina pectoris",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness ... cardiac arrhythmia",
                        "criterion": "cardiac arrhythmia",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness ... active peptic ulcer disease or gastritis",
                        "criterion": "active peptic ulcer disease or gastritis",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness ... active bleeding diatheses",
                        "criterion": "active bleeding diatheses",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness ... evidence of acute or chronic hepatitis B",
                        "criterion": "acute or chronic hepatitis B",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness ... evidence of ... hepatitis C",
                        "criterion": "hepatitis C",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness ... evidence of ... human immunodeficiency virus (HIV)",
                        "criterion": "human immunodeficiency virus (HIV)",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness ... psychiatric illness/social situations that would limit compliance with study requirements",
                        "criterion": "psychiatric illness/social situations",
                        "requirement": {
                            "requirement_type": "impact on compliance",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Uncontrolled intercurrent illness ... psychiatric illness/social situations that would ... compromise the ability of the subject to give written informed consent",
                        "criterion": "psychiatric illness/social situations",
                        "requirement": {
                            "requirement_type": "impact on informed consent",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness ... ongoing or active infection",
                                "criterion": "ongoing or active infection",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness ... symptomatic congestive heart failure",
                                "criterion": "symptomatic congestive heart failure",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness ... uncontrolled hypertension",
                                "criterion": "uncontrolled hypertension",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness ... unstable angina pectoris",
                                "criterion": "unstable angina pectoris",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness ... cardiac arrhythmia",
                                "criterion": "cardiac arrhythmia",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness ... active peptic ulcer disease or gastritis",
                                "criterion": "active peptic ulcer disease or gastritis",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness ... active bleeding diatheses",
                                "criterion": "active bleeding diatheses",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness ... evidence of acute or chronic hepatitis B",
                                "criterion": "acute or chronic hepatitis B",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness ... evidence of ... hepatitis C",
                                "criterion": "hepatitis C",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness ... evidence of ... human immunodeficiency virus (HIV)",
                                "criterion": "human immunodeficiency virus (HIV)",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness ... psychiatric illness/social situations that would limit compliance with study requirements",
                                "criterion": "psychiatric illness/social situations",
                                "requirement": {
                                    "requirement_type": "impact on compliance",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Uncontrolled intercurrent illness ... psychiatric illness/social situations that would ... compromise the ability of the subject to give written informed consent",
                                "criterion": "psychiatric illness/social situations",
                                "requirement": {
                                    "requirement_type": "impact on informed consent",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "17. Known history of previous clinical diagnosis of tuberculosis.",
                "criterions": [
                    {
                        "exact_snippets": "Known history of previous clinical diagnosis of tuberculosis",
                        "criterion": "tuberculosis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Known history of previous clinical diagnosis of tuberculosis",
                    "criterion": "tuberculosis",
                    "requirement": {
                        "requirement_type": "history",
                        "expected_value": true
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "18. History of leptomeningeal carcinomatosis or brain metastasis.",
                "criterions": [
                    {
                        "exact_snippets": "History of leptomeningeal carcinomatosis",
                        "criterion": "leptomeningeal carcinomatosis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of ... brain metastasis",
                        "criterion": "brain metastasis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "History of leptomeningeal carcinomatosis",
                        "criterion": "leptomeningeal carcinomatosis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of ... brain metastasis",
                        "criterion": "brain metastasis",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "19. Unresolved partial or complete small or large bowel obstruction.",
                "criterions": [
                    {
                        "exact_snippets": "Unresolved partial or complete small or large bowel obstruction",
                        "criterion": "bowel obstruction",
                        "requirement": {
                            "requirement_type": "resolution",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Unresolved partial or complete small or large bowel obstruction",
                        "criterion": "bowel obstruction",
                        "requirement": {
                            "requirement_type": "completeness",
                            "expected_value": [
                                "partial",
                                "complete"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "Unresolved partial or complete small or large bowel obstruction",
                        "criterion": "bowel obstruction",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": [
                                "small bowel",
                                "large bowel"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Unresolved partial or complete small or large bowel obstruction",
                                "criterion": "bowel obstruction",
                                "requirement": {
                                    "requirement_type": "resolution",
                                    "expected_value": false
                                }
                            },
                            {
                                "exact_snippets": "Unresolved partial or complete small or large bowel obstruction",
                                "criterion": "bowel obstruction",
                                "requirement": {
                                    "requirement_type": "completeness",
                                    "expected_value": [
                                        "partial",
                                        "complete"
                                    ]
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Unresolved partial or complete small or large bowel obstruction",
                        "criterion": "bowel obstruction",
                        "requirement": {
                            "requirement_type": "location",
                            "expected_value": [
                                "small bowel",
                                "large bowel"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "20. Receipt of live attenuated vaccination within 30 days prior to study entry or within 30 days of receiving Durvalumab OR Tremelimumab.",
                "criterions": [
                    {
                        "exact_snippets": "Receipt of live attenuated vaccination within 30 days prior to study entry",
                        "criterion": "live attenuated vaccination",
                        "requirement": {
                            "requirement_type": "time since receipt",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Receipt of live attenuated vaccination ... within 30 days of receiving Durvalumab OR Tremelimumab",
                        "criterion": "live attenuated vaccination",
                        "requirement": {
                            "requirement_type": "time since receipt",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Receipt of live attenuated vaccination within 30 days prior to study entry",
                                "criterion": "live attenuated vaccination",
                                "requirement": {
                                    "requirement_type": "time since receipt",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 30,
                                        "unit": "days"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Receipt of live attenuated vaccination ... within 30 days of receiving Durvalumab OR Tremelimumab",
                                "criterion": "live attenuated vaccination",
                                "requirement": {
                                    "requirement_type": "time since receipt",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 30,
                                        "unit": "days"
                                    }
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "22. Any medical, social, or psychological condition that would interfere with evaluation of study treatment or interpretation of patient safety or study results.",
                "criterions": [
                    {
                        "exact_snippets": "Any medical, social, or psychological condition that would interfere with evaluation of study treatment or interpretation of patient safety or study results.",
                        "criterion": "medical condition",
                        "requirement": {
                            "requirement_type": "interference with evaluation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Any medical, social, or psychological condition that would interfere with evaluation of study treatment or interpretation of patient safety or study results.",
                        "criterion": "social condition",
                        "requirement": {
                            "requirement_type": "interference with evaluation",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Any medical, social, or psychological condition that would interfere with evaluation of study treatment or interpretation of patient safety or study results.",
                        "criterion": "psychological condition",
                        "requirement": {
                            "requirement_type": "interference with evaluation",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any medical, social, or psychological condition that would interfere with evaluation of study treatment or interpretation of patient safety or study results.",
                                "criterion": "medical condition",
                                "requirement": {
                                    "requirement_type": "interference with evaluation",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any medical, social, or psychological condition that would interfere with evaluation of study treatment or interpretation of patient safety or study results.",
                                "criterion": "social condition",
                                "requirement": {
                                    "requirement_type": "interference with evaluation",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Any medical, social, or psychological condition that would interfere with evaluation of study treatment or interpretation of patient safety or study results.",
                                "criterion": "psychological condition",
                                "requirement": {
                                    "requirement_type": "interference with evaluation",
                                    "expected_value": true
                                }
                            }
                        ]
                    }
                ]
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [
        {
            "identified_line": {
                "line": "3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.",
                "criterions": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": [
                                "0",
                                "1"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "0"
                        }
                    },
                    {
                        "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": "1"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Adequate normal organ and marrow function as defined by: Hemoglobin >/= 9.0 g/dL (transfusion is allowed to correct anemia); Absolute neutrophil count (ANC) >/= 1.5 x 10^9/L (> 1500 per mm^3); Platelet count >/= 100 x 10^9/L (>100,000 per mm^3); Serum bilirubin </= 1.5 x institutional upper limit of normal (ULN) unless diagnosed with Gilbert's syndrome; AST and ALT </= 2.5 x ULN unless liver metastases are present, in which case it must be </= 5x ULN; Serum creatinine CL >40 mL/min by the Cockcroft-Gault formula ( Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance: Creatinine CL (mL/min) = [Weight (kg) x (140 - Age) x 0.85]/[72 x serum creatinine (mg/dL)].",
                "criterions": [
                    {
                        "exact_snippets": "Hemoglobin >/= 9.0 g/dL",
                        "criterion": "hemoglobin level",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 9.0,
                                "unit": "g/dL"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Absolute neutrophil count (ANC) >/= 1.5 x 10^9/L (> 1500 per mm^3)",
                        "criterion": "absolute neutrophil count (ANC)",
                        "requirement": {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1.5,
                                "unit": "x 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Platelet count >/= 100 x 10^9/L (>100,000 per mm^3)",
                        "criterion": "platelet count",
                        "requirement": {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100,
                                "unit": "x 10^9/L"
                            }
                        }
                    },
                    {
                        "exact_snippets": "Serum bilirubin </= 1.5 x institutional upper limit of normal (ULN) unless diagnosed with Gilbert's syndrome",
                        "criterion": "serum bilirubin",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "x ULN"
                            }
                        }
                    },
                    {
                        "exact_snippets": "AST and ALT </= 2.5 x ULN unless liver metastases are present, in which case it must be </= 5x ULN",
                        "criterion": "AST and ALT levels",
                        "requirement": {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "x ULN"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 5,
                                        "unit": "x ULN"
                                    }
                                ]
                            }
                        }
                    },
                    {
                        "exact_snippets": "Serum creatinine CL >40 mL/min by the Cockcroft-Gault formula",
                        "criterion": "serum creatinine clearance",
                        "requirement": {
                            "requirement_type": "clearance",
                            "expected_value": {
                                "operator": ">",
                                "value": 40,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Hemoglobin >/= 9.0 g/dL",
                                "criterion": "hemoglobin level",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 9.0,
                                        "unit": "g/dL"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Absolute neutrophil count (ANC) >/= 1.5 x 10^9/L (> 1500 per mm^3)",
                                "criterion": "absolute neutrophil count (ANC)",
                                "requirement": {
                                    "requirement_type": "count",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 1.5,
                                        "unit": "x 10^9/L"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Platelet count >/= 100 x 10^9/L (>100,000 per mm^3)",
                                "criterion": "platelet count",
                                "requirement": {
                                    "requirement_type": "count",
                                    "expected_value": {
                                        "operator": ">=",
                                        "value": 100,
                                        "unit": "x 10^9/L"
                                    }
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "Serum bilirubin </= 1.5 x institutional upper limit of normal (ULN) unless diagnosed with Gilbert's syndrome",
                                "criterion": "serum bilirubin",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 1.5,
                                        "unit": "x ULN"
                                    }
                                }
                            },
                            {
                                "exact_snippets": "Serum bilirubin </= 1.5 x institutional upper limit of normal (ULN) unless diagnosed with Gilbert's syndrome",
                                "criterion": "diagnosis of Gilbert's syndrome",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "exact_snippets": "AST and ALT </= 2.5 x ULN unless liver metastases are present, in which case it must be </= 5x ULN",
                                "criterion": "AST and ALT levels",
                                "requirement": {
                                    "requirement_type": "level",
                                    "expected_value": {
                                        "operator": "<=",
                                        "value": 2.5,
                                        "unit": "x ULN"
                                    }
                                }
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "AST and ALT </= 2.5 x ULN unless liver metastases are present, in which case it must be </= 5x ULN",
                                        "criterion": "AST and ALT levels",
                                        "requirement": {
                                            "requirement_type": "level",
                                            "expected_value": {
                                                "operator": "<=",
                                                "value": 5,
                                                "unit": "x ULN"
                                            }
                                        }
                                    },
                                    {
                                        "exact_snippets": "AST and ALT </= 2.5 x ULN unless liver metastases are present, in which case it must be </= 5x ULN",
                                        "criterion": "liver metastases",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "exact_snippets": "Serum creatinine CL >40 mL/min by the Cockcroft-Gault formula",
                        "criterion": "serum creatinine clearance",
                        "requirement": {
                            "requirement_type": "clearance",
                            "expected_value": {
                                "operator": ">",
                                "value": 40,
                                "unit": "mL/min"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. Histology (reviewed at MDACC) showing recurrent high grade epithelial ovarian, peritoneal, or fallopian tube cancer of clear cell histology or mixed carcinoma with a clear cell component. In addition, subjects for the molecularly defined expansion cohort will also include patients with recurrent uterine serous carcinoma (who have received at least one prior line of platinum-based chemotherapy), and must have somatic mutations testing (performed by MD Anderson or a CLIA certified test offered by a commercial vendor such as Foundation One or Caris) that demonstrates a nonsynonymous PPP2R1A mutation (other protein phosphatase 2A or related pathway mutations/alterations may be eligible if approved by the PI). Synonymous mutations and variants of uncertain significance do not qualify.",
                "criterions": [
                    {
                        "exact_snippets": "Histology (reviewed at MDACC) showing recurrent high grade epithelial ovarian, peritoneal, or fallopian tube cancer of clear cell histology or mixed carcinoma with a clear cell component.",
                        "criterion": "cancer type",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": [
                                "recurrent high grade epithelial ovarian",
                                "peritoneal",
                                "fallopian tube cancer of clear cell histology",
                                "mixed carcinoma with a clear cell component"
                            ]
                        }
                    },
                    {
                        "exact_snippets": "subjects for the molecularly defined expansion cohort will also include patients with recurrent uterine serous carcinoma (who have received at least one prior line of platinum-based chemotherapy)",
                        "criterion": "uterine serous carcinoma",
                        "requirement": {
                            "requirement_type": "recurrence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "subjects for the molecularly defined expansion cohort will also include patients with recurrent uterine serous carcinoma (who have received at least one prior line of platinum-based chemotherapy)",
                        "criterion": "uterine serous carcinoma",
                        "requirement": {
                            "requirement_type": "prior treatment",
                            "expected_value": "at least one prior line of platinum-based chemotherapy"
                        }
                    },
                    {
                        "exact_snippets": "somatic mutations testing (performed by MD Anderson or a CLIA certified test offered by a commercial vendor such as Foundation One or Caris) that demonstrates a nonsynonymous PPP2R1A mutation",
                        "criterion": "somatic mutations",
                        "requirement": {
                            "requirement_type": "testing",
                            "expected_value": "performed by MD Anderson or a CLIA certified test offered by a commercial vendor such as Foundation One or Caris"
                        }
                    },
                    {
                        "exact_snippets": "somatic mutations testing (performed by MD Anderson or a CLIA certified test offered by a commercial vendor such as Foundation One or Caris) that demonstrates a nonsynonymous PPP2R1A mutation",
                        "criterion": "somatic mutations",
                        "requirement": {
                            "requirement_type": "mutation type",
                            "expected_value": "nonsynonymous PPP2R1A mutation"
                        }
                    },
                    {
                        "exact_snippets": "other protein phosphatase 2A or related pathway mutations/alterations may be eligible if approved by the PI",
                        "criterion": "protein phosphatase 2A or related pathway mutations/alterations",
                        "requirement": {
                            "requirement_type": "eligibility",
                            "expected_value": "if approved by the PI"
                        }
                    },
                    {
                        "exact_snippets": "Synonymous mutations and variants of uncertain significance do not qualify.",
                        "criterion": "mutation qualification",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": [
                                "synonymous mutations",
                                "variants of uncertain significance"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Histology (reviewed at MDACC) showing recurrent high grade epithelial ovarian, peritoneal, or fallopian tube cancer of clear cell histology or mixed carcinoma with a clear cell component.",
                                        "criterion": "cancer type",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": [
                                                "recurrent high grade epithelial ovarian",
                                                "peritoneal",
                                                "fallopian tube cancer of clear cell histology",
                                                "mixed carcinoma with a clear cell component"
                                            ]
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "subjects for the molecularly defined expansion cohort will also include patients with recurrent uterine serous carcinoma (who have received at least one prior line of platinum-based chemotherapy)",
                                        "criterion": "uterine serous carcinoma",
                                        "requirement": {
                                            "requirement_type": "recurrence",
                                            "expected_value": true
                                        }
                                    },
                                    {
                                        "exact_snippets": "subjects for the molecularly defined expansion cohort will also include patients with recurrent uterine serous carcinoma (who have received at least one prior line of platinum-based chemotherapy)",
                                        "criterion": "uterine serous carcinoma",
                                        "requirement": {
                                            "requirement_type": "prior treatment",
                                            "expected_value": "at least one prior line of platinum-based chemotherapy"
                                        }
                                    },
                                    {
                                        "and_criteria": [
                                            {
                                                "exact_snippets": "somatic mutations testing (performed by MD Anderson or a CLIA certified test offered by a commercial vendor such as Foundation One or Caris) that demonstrates a nonsynonymous PPP2R1A mutation",
                                                "criterion": "somatic mutations",
                                                "requirement": {
                                                    "requirement_type": "testing",
                                                    "expected_value": "performed by MD Anderson or a CLIA certified test offered by a commercial vendor such as Foundation One or Caris"
                                                }
                                            },
                                            {
                                                "exact_snippets": "somatic mutations testing (performed by MD Anderson or a CLIA certified test offered by a commercial vendor such as Foundation One or Caris) that demonstrates a nonsynonymous PPP2R1A mutation",
                                                "criterion": "somatic mutations",
                                                "requirement": {
                                                    "requirement_type": "mutation type",
                                                    "expected_value": "nonsynonymous PPP2R1A mutation"
                                                }
                                            }
                                        ]
                                    }
                                ]
                            }
                        ]
                    },
                    {
                        "or_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "somatic mutations testing (performed by MD Anderson or a CLIA certified test offered by a commercial vendor such as Foundation One or Caris) that demonstrates a nonsynonymous PPP2R1A mutation",
                                        "criterion": "somatic mutations",
                                        "requirement": {
                                            "requirement_type": "mutation type",
                                            "expected_value": "nonsynonymous PPP2R1A mutation"
                                        }
                                    }
                                ]
                            },
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "other protein phosphatase 2A or related pathway mutations/alterations may be eligible if approved by the PI",
                                        "criterion": "protein phosphatase 2A or related pathway mutations/alterations",
                                        "requirement": {
                                            "requirement_type": "eligibility",
                                            "expected_value": "if approved by the PI"
                                        }
                                    }
                                ]
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Have measurable disease based on modified RECIST 1.1. For the purposes of this study measurable disease is defined at least one \"target\" lesion that can be accurately measured in at least one dimension (longest dimension to be recorded). Each target lesion must be >20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI, or >10 mm when measured by spiral CT. The target lesion must be distinct from other tumor areas selected for pre-treatment biopsies. Pre-treatment imaging must be performed within 4 weeks of starting therapy.",
                "criterions": [
                    {
                        "exact_snippets": "measurable disease based on modified RECIST 1.1",
                        "criterion": "measurable disease",
                        "requirement": {
                            "requirement_type": "standard",
                            "expected_value": "modified RECIST 1.1"
                        }
                    },
                    {
                        "exact_snippets": "at least one \"target\" lesion that can be accurately measured in at least one dimension",
                        "criterion": "target lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    },
                    {
                        "exact_snippets": "at least one \"target\" lesion that can be accurately measured in at least one dimension",
                        "criterion": "target lesion",
                        "requirement": {
                            "requirement_type": "measurability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Each target lesion must be >20 mm when measured by conventional techniques, including palpation, plain x-ray, CT, and MRI",
                        "criterion": "target lesion size (conventional techniques)",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 20,
                                "unit": "mm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "or >10 mm when measured by spiral CT",
                        "criterion": "target lesion size (spiral CT)",
                        "requirement": {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mm"
                            }
                        }
                    },
                    {
                        "exact_snippets": "The target lesion must be distinct from other tumor areas selected for pre-treatment biopsies",
                        "criterion": "target lesion distinctness",
                        "requirement": {
                            "requirement_type": "distinctness",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Pre-treatment imaging must be performed within 4 weeks of starting therapy",
                        "criterion": "pre-treatment imaging timing",
                        "requirement": {
                            "requirement_type": "timing",
                            "expected_value": {
                                "operator": "<=",
                                "value": 4,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Must be FEMALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "1. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site).",
                "criterions": [
                    {
                        "exact_snippets": "Involvement in the planning and/or conduct of the study",
                        "criterion": "involvement in study planning or conduct",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "2. Previous enrollment or randomization in the present study.",
                "criterions": [
                    {
                        "exact_snippets": "Previous enrollment or randomization in the present study.",
                        "criterion": "previous enrollment or randomization",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Previous enrollment or randomization in the present study.",
                        "criterion": "previous enrollment or randomization",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Participation in another clinical study with an investigational product administered during the last 28 days.",
                "criterions": [
                    {
                        "exact_snippets": "Participation in another clinical study",
                        "criterion": "participation in another clinical study",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "investigational product administered during the last 28 days",
                        "criterion": "investigational product administration",
                        "requirement": {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Participation in another clinical study",
                        "criterion": "participation in another clinical study",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "investigational product administered during the last 28 days",
                        "criterion": "investigational product administration",
                        "requirement": {
                            "requirement_type": "time since last administration",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "9. Any unresolved toxicity (> CTCAE grade 1) from previous anti-cancer therapy, excluding alopecia. Subjects with irreversible toxicity greater than grade 1 that is not reasonably expected to be exacerbated by the investigational product may be included (e.g., hearing loss, peripherally neuropathy).",
                "criterions": [
                    {
                        "exact_snippets": "unresolved toxicity (> CTCAE grade 1) from previous anti-cancer therapy",
                        "criterion": "unresolved toxicity from previous anti-cancer therapy",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "CTCAE grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "excluding alopecia",
                        "criterion": "alopecia",
                        "requirement": {
                            "requirement_type": "exclusion",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "irreversible toxicity greater than grade 1 that is not reasonably expected to be exacerbated by the investigational product",
                        "criterion": "irreversible toxicity",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "grade"
                            }
                        }
                    },
                    {
                        "exact_snippets": "irreversible toxicity greater than grade 1 that is not reasonably expected to be exacerbated by the investigational product",
                        "criterion": "irreversible toxicity",
                        "requirement": {
                            "requirement_type": "exacerbation by investigational product",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "21. Subjects who are pregnant, breast-feeding or of reproductive potential who are not employing an effective method of birth control or are not willing to employ effective birth control from screening to 180 days after the last dose of Durvalumab + Tremelimumab combination therapy or 90 days after the last dose of Durvalumab monotherapy, whichever is the longer time period.",
                "criterions": [
                    {
                        "exact_snippets": "Subjects who are pregnant",
                        "criterion": "pregnancy",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "breast-feeding",
                        "criterion": "breast-feeding",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "of reproductive potential who are not employing an effective method of birth control",
                        "criterion": "reproductive potential and birth control",
                        "requirement": {
                            "requirement_type": "reproductive potential",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "of reproductive potential who are not employing an effective method of birth control",
                        "criterion": "reproductive potential and birth control",
                        "requirement": {
                            "requirement_type": "birth control",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "not willing to employ effective birth control from screening to 180 days after the last dose of Durvalumab + Tremelimumab combination therapy or 90 days after the last dose of Durvalumab monotherapy, whichever is the longer time period",
                        "criterion": "willingness to employ birth control",
                        "requirement": {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "Subjects who are pregnant",
                                "criterion": "pregnancy",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "breast-feeding",
                                "criterion": "breast-feeding",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "of reproductive potential who are not employing an effective method of birth control",
                                "criterion": "reproductive potential and birth control",
                                "requirement": {
                                    "requirement_type": "reproductive potential",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "of reproductive potential who are not employing an effective method of birth control",
                                "criterion": "reproductive potential and birth control",
                                "requirement": {
                                    "requirement_type": "birth control",
                                    "expected_value": false
                                }
                            }
                        ]
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "of reproductive potential who are not employing an effective method of birth control",
                                "criterion": "reproductive potential and birth control",
                                "requirement": {
                                    "requirement_type": "reproductive potential",
                                    "expected_value": true
                                }
                            },
                            {
                                "exact_snippets": "not willing to employ effective birth control from screening to 180 days after the last dose of Durvalumab + Tremelimumab combination therapy or 90 days after the last dose of Durvalumab monotherapy, whichever is the longer time period",
                                "criterion": "willingness to employ birth control",
                                "requirement": {
                                    "requirement_type": "willingness",
                                    "expected_value": false
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "23. Subjects with uncontrolled seizures.",
                "criterions": [
                    {
                        "exact_snippets": "uncontrolled seizures",
                        "criterion": "seizures",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "24. Non-English speakers will be excluded from participating in the patient-reported outcomes component of the study.",
                "criterions": [
                    {
                        "exact_snippets": "Non-English speakers will be excluded",
                        "criterion": "language proficiency",
                        "requirement": {
                            "requirement_type": "language",
                            "expected_value": "English"
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        },
        {
            "identified_line": {
                "line": "6. Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) </= 28 days prior to the first dose of study drug (</= 21 days prior to the first dose of study drug for subjects who have received prior TKIs [e.g., erlotinib, gefitinib and crizotinib] and </= 6 weeks for nitrosourea, mitomycin C, or bevacizumab). (If sufficient wash-out time has not occurred due to the schedule or PK properties of an agent, a longer wash-out period may be required.)",
                "criterions": [
                    {
                        "exact_snippets": "Receipt of the last dose of anti-cancer therapy (chemotherapy, immunotherapy, endocrine therapy, targeted therapy, biologic therapy, tumor embolization, monoclonal antibodies, other investigational agent) </= 28 days prior to the first dose of study drug",
                        "criterion": "anti-cancer therapy",
                        "requirement": {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 28,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "subjects who have received prior TKIs [e.g., erlotinib, gefitinib and crizotinib] and </= 21 days prior to the first dose of study drug",
                        "criterion": "prior TKIs",
                        "requirement": {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 21,
                                "unit": "days"
                            }
                        }
                    },
                    {
                        "exact_snippets": "nitrosourea, mitomycin C, or bevacizumab ... </= 6 weeks",
                        "criterion": "nitrosourea, mitomycin C, or bevacizumab",
                        "requirement": {
                            "requirement_type": "time since last dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "exact_snippets": "failed",
                "criterion": "failed",
                "requirement": {
                    "requirement_type": "failed",
                    "expected_value": "failed"
                }
            }
        }
    ],
    "failed_miscellaneous": []
}