{
    "info": {
        "nct_id": "NCT02484404",
        "official_title": "Phase I/II Study of the Anti-Programmed Death Ligand-1 Antibody Durvalumab (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Cancers",
        "inclusion_criteria": "Healthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "",
        "miscellaneous_criteria": "* ELIGIBILITY:\n\nINCLUSION CRITERIA GENERAL:\n\n* Patients must be at least 18 years of age.\n* Patients must have adequately controlled blood pressure on a maximum of three antihypertensive medications.\n* Patients who have the following clinical conditions are considered to be at increased risk for cardiac toxicities.\n\nPatients with any cardiac history of the following conditions within 1 year prior to study enrollment are excluded from the study:\n\n* Prior events including myocardial infarction, pericardial effusion, and myocarditis.\n* Prior cardiac arrhythmia including atrial fibrillation and atrial flutter, or requiring concurrent use of drugs or biologics with pro-arrhythmic potential.\n* NYHA Class II or greater heart failure.\n* If cardiac function assessment is clinically indicated or performed, an LVEF less than normal per institutional guidelines, or <55%, if threshold for normal is not otherwise specified by institutional guidelines.\n* QTc prolongation >470 msec or other significant ECG abnormality noted within 14 days of treatment.\n* Hypertensive crisis or hypertensive encephalopathy.\n* Clinically significant peripheral vascular disease or vascular disease, including rapidly growing aortic aneurysm or abdominal aortic aneurysm >5 cm or aortic dissection.\n* Unstable angina.\n\n  * Eligibility for patients with asymptomatic and a previous diagnosis of immune or inflammatory colitis, or patients with chronic diarrhea > 1 month without immune or inflammatory colitis is a PI decision on an individual patient basis.\n  * Patients with a history of cerebrovascular accident or transient ischemic attack within 1 year prior to study enrollment are not eligible.\n  * Patients with a history of previous clinical diagnosis of tuberculosis are not eligible.\n  * Patients with a history of auto-immune disease requiring steroid maintenance, or history of primary immunodeficiency are not eligible.\n  * HIV-positive patients on antiretroviral therapy are ineligible because of potential pharmacokinetic interactions with study drugs, however, patients with long-standing (>5 years) HIV on antiretroviral therapy > 1 month (undetectable HIV viral load and CD4 count > 150 cells/microL) may be eligible if the PI determines no anticipated clinically significant drug-drug interactions.\n  * HBV-or HCV-positive patients are ineligible because of potential reactivation of hepatitis virus following steroids.\n  * Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to MEDI4736, olaparib, cediranib, or to other humanized monoclonal antibodies, or a history of anaphylaxis, angioedema, laryngeal edema, serum sickness, or uncontrolled asthma, are not eligible.\n  * Patients who have had prior immune checkpoint inhibitors, such as MEDI4736 or other PD1 or PD-L1 inhibitors or an anti-CTLA4 therapy are eligible.\n  * Pregnant and breastfeeding women are excluded from this study.\n  * Patients with any other concomitant or prior invasive malignancies are ineligible.\n\nPHASE II MEDI4736 PLUS OLAPARIB OR CEDIRANIB STUDY ELIGIBILITY CRITERIA - OVARIAN CANCER\n\n* Patients must have histologically or cytologically confirmed persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer and have received at least two prior regimens or who are platinum resistant or refractory during or after a first platinum containing regimen.\n* Patients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsy.\n* Patients are allowed to have received prior PARPi, and/or anti-angiogenesis therapy including but not limited to thalidomide, bevacizumab, sunitinib, sorafenib, or other anti-angiogenics. However, patients who were treated with both olaparib and cediranib, either in combination or sequentially are not eligible. For this study, BSI-201 (iniparib) is not considered as PARPi.\n\nPHASE II STUDY MEDI4736 PLUS OLAPARIB ELIGIBILITY CRITERIA TRIPLE NEGATIVE BREAST CANCER\n\n* Patients must have histologically confirmed persistent or recurrent triple-negative breast cancer (TNBC)\n* ER/PR/HER2 status needs to be documented either by an outside source or at NCI.\n* Documentation of germline BRCA1 and BRCA2 mutation (gBRCAm) status will be required for eligibility.\n* Patients must have measurable disease as defined by RECIST v1.1.\n* Patients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsy.\n* Patients who have received prior PARPi are ineligible.\n* Patients must not have evidence of CNS metastasis or leptomeningeal disease within one year prior to enrollment.\n\nPHASE II MEDI4736 PLUS OLAPARIB OR CEDIRANIB STUDY ELIGIBILITY CRITERIA - NON-SMALL CELL LUNG CANCER\n\n* Histologically or cytologically confirmed advanced NSCLC with at least one prior line of platinum-based chemotherapy (or treatment with EGFR, ALK, or BRAF-targeted tyrosine kinase inhibitors if tumors harbor an EGFR-sensitizing mutation, ALK translocation, or BRAF V600E mutation, respectively).\n* Patients must have measurable disease as defined by RECIST v1.1.\n* Patients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsy.\n* Patients who have received anti-angiogenesis therapy are eligible, including but not limited to thalidomide, bevacizumab, sunitinib, sorafenib, or other anti-angiogenics. However, patients who were treated with cediranib, either in combination or monotherapy are not eligible.\n* Current or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736, with the exception 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.\n* Patients who have had prior PARPi are not eligible.\n* Patients with prior history of pneumonitis and/or interstitial lung disease will be excluded.\n\nPHASE II MEDI4736 PLUS OLAPARIB STUDY ELIGIBILITY CRITERIA - METASTATIC CASTRATE-RESISTANT PROSTATE CANCER\n\n* Patients must have metastatic, progressive, castrate resistant prostate cancer (mCRPC).\n* All patients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsy.\n* Patients must have received prior treatment with enzalutamide and/or abiraterone with the exception of patients who were treated with docetaxel and androgen deprivation therapy for metastatic castrate-sensitive prostate cancer and progressed on docetaxel treatment or who progress within one month of the last docetaxel dose.\n* Patients must have undergone bilateral surgical castration or must agree to continue on GnRH agonists/antagonists for the duration of the study.\n* Patients who have had progression of prostate cancer on prior docetaxel treatment for castrate sensitive disease are ineligible.\n* Patients who have had prior treatment with PARPi are not eligible.\n* Patients who have received radionuclide treatment within 6 weeks prior to the first dose of the study treatment are not eligible.\n* Patients with any other concomitant or prior invasive malignancies are ineligible."
    },
    "inclusion_lines": [
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [],
    "miscellaneous_lines": [
        {
            "line": "* Patients must be at least 18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "Patients must be at least 18 years of age.",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "N/A",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have adequately controlled blood pressure on a maximum of three antihypertensive medications.",
            "criterions": [
                {
                    "exact_snippets": "adequately controlled blood pressure",
                    "criterion": "blood pressure",
                    "requirements": [
                        {
                            "requirement_type": "control",
                            "expected_value": "adequately controlled"
                        }
                    ]
                },
                {
                    "exact_snippets": "maximum of three antihypertensive medications",
                    "criterion": "antihypertensive medications",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "medications"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have the following clinical conditions are considered to be at increased risk for cardiac toxicities.",
            "criterions": [
                {
                    "exact_snippets": "clinical conditions",
                    "criterion": "clinical conditions",
                    "requirements": [
                        {
                            "requirement_type": "risk for cardiac toxicities",
                            "expected_value": "increased"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Patients with any cardiac history of the following conditions within 1 year prior to study enrollment are excluded from the study:",
            "criterions": [
                {
                    "exact_snippets": "any cardiac history of the following conditions within 1 year prior to study enrollment",
                    "criterion": "cardiac history",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 1 year prior to study enrollment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior events including myocardial infarction, pericardial effusion, and myocarditis.",
            "criterions": [
                {
                    "exact_snippets": "myocardial infarction",
                    "criterion": "myocardial infarction",
                    "requirements": [
                        {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "pericardial effusion",
                    "criterion": "pericardial effusion",
                    "requirements": [
                        {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "myocarditis",
                    "criterion": "myocarditis",
                    "requirements": [
                        {
                            "requirement_type": "prior occurrence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Prior cardiac arrhythmia including atrial fibrillation and atrial flutter, or requiring concurrent use of drugs or biologics with pro-arrhythmic potential.",
            "criterions": [
                {
                    "exact_snippets": "Prior cardiac arrhythmia including atrial fibrillation and atrial flutter",
                    "criterion": "cardiac arrhythmia",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring concurrent use of drugs or biologics with pro-arrhythmic potential",
                    "criterion": "use of drugs or biologics with pro-arrhythmic potential",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* NYHA Class II or greater heart failure.",
            "criterions": [
                {
                    "exact_snippets": "NYHA Class II or greater heart failure",
                    "criterion": "NYHA heart failure class",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "class"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If cardiac function assessment is clinically indicated or performed, an LVEF less than normal per institutional guidelines, or <55%, if threshold for normal is not otherwise specified by institutional guidelines.",
            "criterions": [
                {
                    "exact_snippets": "cardiac function assessment is clinically indicated or performed",
                    "criterion": "cardiac function assessment",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "LVEF less than normal per institutional guidelines",
                    "criterion": "LVEF",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": "less than normal per institutional guidelines"
                        }
                    ]
                },
                {
                    "exact_snippets": "LVEF ... <55%",
                    "criterion": "LVEF",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<",
                                "value": 55,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* QTc prolongation >470 msec or other significant ECG abnormality noted within 14 days of treatment.",
            "criterions": [
                {
                    "exact_snippets": "QTc prolongation >470 msec",
                    "criterion": "QTc prolongation",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 470,
                                "unit": "msec"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "other significant ECG abnormality",
                    "criterion": "ECG abnormality",
                    "requirements": [
                        {
                            "requirement_type": "significance",
                            "expected_value": "significant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hypertensive crisis or hypertensive encephalopathy.",
            "criterions": [
                {
                    "exact_snippets": "Hypertensive crisis",
                    "criterion": "hypertensive crisis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "hypertensive encephalopathy",
                    "criterion": "hypertensive encephalopathy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Clinically significant peripheral vascular disease or vascular disease, including rapidly growing aortic aneurysm or abdominal aortic aneurysm >5 cm or aortic dissection.",
            "criterions": [
                {
                    "exact_snippets": "Clinically significant peripheral vascular disease",
                    "criterion": "peripheral vascular disease",
                    "requirements": [
                        {
                            "requirement_type": "severity",
                            "expected_value": "clinically significant"
                        }
                    ]
                },
                {
                    "exact_snippets": "vascular disease",
                    "criterion": "vascular disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "rapidly growing aortic aneurysm",
                    "criterion": "aortic aneurysm",
                    "requirements": [
                        {
                            "requirement_type": "growth rate",
                            "expected_value": "rapidly growing"
                        }
                    ]
                },
                {
                    "exact_snippets": "abdominal aortic aneurysm >5 cm",
                    "criterion": "abdominal aortic aneurysm",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "cm"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "aortic dissection",
                    "criterion": "aortic dissection",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Unstable angina.",
            "criterions": [
                {
                    "exact_snippets": "Unstable angina",
                    "criterion": "unstable angina",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eligibility for patients with asymptomatic and a previous diagnosis of immune or inflammatory colitis, or patients with chronic diarrhea > 1 month without immune or inflammatory colitis is a PI decision on an individual patient basis.",
            "criterions": [
                {
                    "exact_snippets": "asymptomatic and a previous diagnosis of immune or inflammatory colitis",
                    "criterion": "immune or inflammatory colitis",
                    "requirements": [
                        {
                            "requirement_type": "symptoms",
                            "expected_value": "asymptomatic"
                        },
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": "previous"
                        }
                    ]
                },
                {
                    "exact_snippets": "chronic diarrhea > 1 month without immune or inflammatory colitis",
                    "criterion": "chronic diarrhea",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "month"
                            }
                        },
                        {
                            "requirement_type": "association",
                            "expected_value": "without immune or inflammatory colitis"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a history of cerebrovascular accident or transient ischemic attack within 1 year prior to study enrollment are not eligible.",
            "criterions": [
                {
                    "exact_snippets": "history of cerebrovascular accident",
                    "criterion": "cerebrovascular accident",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... transient ischemic attack",
                    "criterion": "transient ischemic attack",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time since event",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a history of previous clinical diagnosis of tuberculosis are not eligible.",
            "criterions": [
                {
                    "exact_snippets": "history of previous clinical diagnosis of tuberculosis",
                    "criterion": "tuberculosis diagnosis history",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a history of auto-immune disease requiring steroid maintenance, or history of primary immunodeficiency are not eligible.",
            "criterions": [
                {
                    "exact_snippets": "history of auto-immune disease requiring steroid maintenance",
                    "criterion": "auto-immune disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "steroid maintenance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of primary immunodeficiency",
                    "criterion": "primary immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HIV-positive patients on antiretroviral therapy are ineligible because of potential pharmacokinetic interactions with study drugs, however, patients with long-standing (>5 years) HIV on antiretroviral therapy > 1 month (undetectable HIV viral load and CD4 count > 150 cells/microL) may be eligible if the PI determines no anticipated clinically significant drug-drug interactions.",
            "criterions": [
                {
                    "exact_snippets": "HIV-positive patients",
                    "criterion": "HIV status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "on antiretroviral therapy",
                    "criterion": "antiretroviral therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "long-standing (>5 years) HIV",
                    "criterion": "duration of HIV",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "antiretroviral therapy > 1 month",
                    "criterion": "duration of antiretroviral therapy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "month"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "undetectable HIV viral load",
                    "criterion": "HIV viral load",
                    "requirements": [
                        {
                            "requirement_type": "detectability",
                            "expected_value": "undetectable"
                        }
                    ]
                },
                {
                    "exact_snippets": "CD4 count > 150 cells/microL",
                    "criterion": "CD4 count",
                    "requirements": [
                        {
                            "requirement_type": "count",
                            "expected_value": {
                                "operator": ">",
                                "value": 150,
                                "unit": "cells/microL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "PI determines no anticipated clinically significant drug-drug interactions",
                    "criterion": "clinically significant drug-drug interactions",
                    "requirements": [
                        {
                            "requirement_type": "determination by PI",
                            "expected_value": "no anticipated"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* HBV-or HCV-positive patients are ineligible because of potential reactivation of hepatitis virus following steroids.",
            "criterions": [
                {
                    "exact_snippets": "HBV-or HCV-positive",
                    "criterion": "HBV or HCV status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to MEDI4736, olaparib, cediranib, or to other humanized monoclonal antibodies, or a history of anaphylaxis, angioedema, laryngeal edema, serum sickness, or uncontrolled asthma, are not eligible.",
            "criterions": [
                {
                    "exact_snippets": "history of allergic reactions attributed to compounds of similar chemical or biologic composition to MEDI4736, olaparib, cediranib, or to other humanized monoclonal antibodies",
                    "criterion": "allergic reactions to similar compounds",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of anaphylaxis",
                    "criterion": "anaphylaxis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... angioedema",
                    "criterion": "angioedema",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... laryngeal edema",
                    "criterion": "laryngeal edema",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... serum sickness",
                    "criterion": "serum sickness",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "history of ... uncontrolled asthma",
                    "criterion": "uncontrolled asthma",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have had prior immune checkpoint inhibitors, such as MEDI4736 or other PD1 or PD-L1 inhibitors or an anti-CTLA4 therapy are eligible.",
            "criterions": [
                {
                    "exact_snippets": "prior immune checkpoint inhibitors, such as MEDI4736 or other PD1 or PD-L1 inhibitors or an anti-CTLA4 therapy",
                    "criterion": "prior immune checkpoint inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Pregnant and breastfeeding women are excluded from this study.",
            "criterions": [
                {
                    "exact_snippets": "Pregnant ... are excluded",
                    "criterion": "pregnancy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding ... are excluded",
                    "criterion": "breastfeeding",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with any other concomitant or prior invasive malignancies are ineligible.",
            "criterions": [
                {
                    "exact_snippets": "any other concomitant or prior invasive malignancies",
                    "criterion": "invasive malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "PHASE II MEDI4736 PLUS OLAPARIB OR CEDIRANIB STUDY ELIGIBILITY CRITERIA - OVARIAN CANCER",
            "criterions": [
                {
                    "exact_snippets": "OVARIAN CANCER",
                    "criterion": "ovarian cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have histologically or cytologically confirmed persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer and have received at least two prior regimens or who are platinum resistant or refractory during or after a first platinum containing regimen.",
            "criterions": [
                {
                    "exact_snippets": "histologically or cytologically confirmed",
                    "criterion": "cancer confirmation method",
                    "requirements": [
                        {
                            "requirement_type": "method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "persistent or recurrent ovarian, fallopian tube, or primary peritoneal cancer",
                    "criterion": "cancer type",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "ovarian",
                                "fallopian tube",
                                "primary peritoneal"
                            ]
                        },
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "persistent",
                                "recurrent"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "received at least two prior regimens",
                    "criterion": "prior treatment regimens",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2,
                                "unit": "regimens"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "platinum resistant or refractory during or after a first platinum containing regimen",
                    "criterion": "platinum resistance",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "resistant",
                                "refractory"
                            ]
                        },
                        {
                            "requirement_type": "timing",
                            "expected_value": "during or after a first platinum containing regimen"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsy.",
            "criterions": [
                {
                    "exact_snippets": "at least one lesion deemed safe to biopsy",
                    "criterion": "lesion",
                    "requirements": [
                        {
                            "requirement_type": "safety for biopsy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to undergo a mandatory baseline biopsy",
                    "criterion": "willingness to undergo biopsy",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients are allowed to have received prior PARPi, and/or anti-angiogenesis therapy including but not limited to thalidomide, bevacizumab, sunitinib, sorafenib, or other anti-angiogenics. However, patients who were treated with both olaparib and cediranib, either in combination or sequentially are not eligible. For this study, BSI-201 (iniparib) is not considered as PARPi.",
            "criterions": [
                {
                    "exact_snippets": "Patients are allowed to have received prior PARPi",
                    "criterion": "prior PARPi",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Patients are allowed to have received ... anti-angiogenesis therapy",
                    "criterion": "prior anti-angiogenesis therapy",
                    "requirements": [
                        {
                            "requirement_type": "receipt",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who were treated with both olaparib and cediranib ... are not eligible",
                    "criterion": "treatment with both olaparib and cediranib",
                    "requirements": [
                        {
                            "requirement_type": "eligibility",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "PHASE II STUDY MEDI4736 PLUS OLAPARIB ELIGIBILITY CRITERIA TRIPLE NEGATIVE BREAST CANCER",
            "criterions": [
                {
                    "exact_snippets": "TRIPLE NEGATIVE BREAST CANCER",
                    "criterion": "breast cancer subtype",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": "triple negative"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have histologically confirmed persistent or recurrent triple-negative breast cancer (TNBC)",
            "criterions": [
                {
                    "exact_snippets": "histologically confirmed",
                    "criterion": "histological confirmation",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "persistent or recurrent",
                    "criterion": "cancer persistence or recurrence",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": [
                                "persistent",
                                "recurrent"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "triple-negative breast cancer (TNBC)",
                    "criterion": "triple-negative breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* ER/PR/HER2 status needs to be documented either by an outside source or at NCI.",
            "criterions": [
                {
                    "exact_snippets": "ER/PR/HER2 status needs to be documented",
                    "criterion": "ER/PR/HER2 status",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Documentation of germline BRCA1 and BRCA2 mutation (gBRCAm) status will be required for eligibility.",
            "criterions": [
                {
                    "exact_snippets": "germline BRCA1 and BRCA2 mutation (gBRCAm) status",
                    "criterion": "germline BRCA1 and BRCA2 mutation status",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have measurable disease as defined by RECIST v1.1.",
            "criterions": [
                {
                    "exact_snippets": "measurable disease as defined by RECIST v1.1",
                    "criterion": "measurable disease",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsy.",
            "criterions": [
                {
                    "exact_snippets": "at least one lesion deemed safe to biopsy",
                    "criterion": "lesion",
                    "requirements": [
                        {
                            "requirement_type": "safety for biopsy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to undergo a mandatory baseline biopsy",
                    "criterion": "willingness to undergo biopsy",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have received prior PARPi are ineligible.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received prior PARPi",
                    "criterion": "prior PARPi treatment",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must not have evidence of CNS metastasis or leptomeningeal disease within one year prior to enrollment.",
            "criterions": [
                {
                    "exact_snippets": "evidence of CNS metastasis",
                    "criterion": "CNS metastasis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "evidence of ... leptomeningeal disease",
                    "criterion": "leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "within one year prior to enrollment",
                    "criterion": "time since last evidence of CNS metastasis or leptomeningeal disease",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "year"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "PHASE II MEDI4736 PLUS OLAPARIB OR CEDIRANIB STUDY ELIGIBILITY CRITERIA - NON-SMALL CELL LUNG CANCER",
            "criterions": [
                {
                    "exact_snippets": "NON-SMALL CELL LUNG CANCER",
                    "criterion": "non-small cell lung cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Histologically or cytologically confirmed advanced NSCLC with at least one prior line of platinum-based chemotherapy (or treatment with EGFR, ALK, or BRAF-targeted tyrosine kinase inhibitors if tumors harbor an EGFR-sensitizing mutation, ALK translocation, or BRAF V600E mutation, respectively).",
            "criterions": [
                {
                    "exact_snippets": "Histologically or cytologically confirmed advanced NSCLC",
                    "criterion": "advanced NSCLC",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": [
                                "histologically",
                                "cytologically"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "at least one prior line of platinum-based chemotherapy",
                    "criterion": "prior platinum-based chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "line"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "treatment with EGFR, ALK, or BRAF-targeted tyrosine kinase inhibitors",
                    "criterion": "treatment with targeted tyrosine kinase inhibitors",
                    "requirements": [
                        {
                            "requirement_type": "targets",
                            "expected_value": [
                                "EGFR",
                                "ALK",
                                "BRAF"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "tumors harbor an EGFR-sensitizing mutation",
                    "criterion": "EGFR-sensitizing mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ALK translocation",
                    "criterion": "ALK translocation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "BRAF V600E mutation",
                    "criterion": "BRAF V600E mutation",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have measurable disease as defined by RECIST v1.1.",
            "criterions": [
                {
                    "exact_snippets": "measurable disease as defined by RECIST v1.1",
                    "criterion": "disease measurability",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "RECIST v1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsy.",
            "criterions": [
                {
                    "exact_snippets": "at least one lesion deemed safe to biopsy",
                    "criterion": "lesion",
                    "requirements": [
                        {
                            "requirement_type": "safety for biopsy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to undergo a mandatory baseline biopsy",
                    "criterion": "willingness to undergo biopsy",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have received anti-angiogenesis therapy are eligible, including but not limited to thalidomide, bevacizumab, sunitinib, sorafenib, or other anti-angiogenics. However, patients who were treated with cediranib, either in combination or monotherapy are not eligible.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have received anti-angiogenesis therapy are eligible, including but not limited to thalidomide, bevacizumab, sunitinib, sorafenib, or other anti-angiogenics.",
                    "criterion": "anti-angiogenesis therapy",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who were treated with cediranib, either in combination or monotherapy are not eligible.",
                    "criterion": "cediranib treatment",
                    "requirements": [
                        {
                            "requirement_type": "treatment history",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736, with the exception 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.",
            "criterions": [
                {
                    "exact_snippets": "Current or prior use of immunosuppressive medication within 28 days before the first dose of MEDI4736",
                    "criterion": "use of immunosuppressive medication",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 28 days before the first dose of MEDI4736"
                        }
                    ]
                },
                {
                    "exact_snippets": "intranasal and inhaled corticosteroids or systemic corticosteroids at physiological doses, which are not to exceed 10 mg/day of prednisone or an equivalent corticosteroid",
                    "criterion": "use of corticosteroids",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "intranasal",
                                "inhaled",
                                "systemic at physiological doses"
                            ]
                        },
                        {
                            "requirement_type": "dose",
                            "expected_value": {
                                "operator": "<=",
                                "value": 10,
                                "unit": "mg/day of prednisone or an equivalent corticosteroid"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have had prior PARPi are not eligible.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have had prior PARPi",
                    "criterion": "prior PARPi treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with prior history of pneumonitis and/or interstitial lung disease will be excluded.",
            "criterions": [
                {
                    "exact_snippets": "prior history of pneumonitis",
                    "criterion": "pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior history of ... interstitial lung disease",
                    "criterion": "interstitial lung disease",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "PHASE II MEDI4736 PLUS OLAPARIB STUDY ELIGIBILITY CRITERIA - METASTATIC CASTRATE-RESISTANT PROSTATE CANCER",
            "criterions": [
                {
                    "exact_snippets": "METASTATIC CASTRATE-RESISTANT PROSTATE CANCER",
                    "criterion": "prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": "metastatic castrate-resistant"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have metastatic, progressive, castrate resistant prostate cancer (mCRPC).",
            "criterions": [
                {
                    "exact_snippets": "metastatic",
                    "criterion": "metastatic cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "progressive",
                    "criterion": "progressive cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "castrate resistant prostate cancer (mCRPC)",
                    "criterion": "castrate resistant prostate cancer",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* All patients must have at least one lesion deemed safe to biopsy and be willing to undergo a mandatory baseline biopsy.",
            "criterions": [
                {
                    "exact_snippets": "at least one lesion deemed safe to biopsy",
                    "criterion": "lesion",
                    "requirements": [
                        {
                            "requirement_type": "safety for biopsy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "willing to undergo a mandatory baseline biopsy",
                    "criterion": "willingness to undergo biopsy",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have received prior treatment with enzalutamide and/or abiraterone with the exception of patients who were treated with docetaxel and androgen deprivation therapy for metastatic castrate-sensitive prostate cancer and progressed on docetaxel treatment or who progress within one month of the last docetaxel dose.",
            "criterions": [
                {
                    "exact_snippets": "Patients must have received prior treatment with enzalutamide and/or abiraterone",
                    "criterion": "prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "medications",
                            "expected_value": [
                                "enzalutamide",
                                "abiraterone"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "patients who were treated with docetaxel and androgen deprivation therapy for metastatic castrate-sensitive prostate cancer",
                    "criterion": "prior treatment",
                    "requirements": [
                        {
                            "requirement_type": "medications",
                            "expected_value": [
                                "docetaxel",
                                "androgen deprivation therapy"
                            ]
                        },
                        {
                            "requirement_type": "condition",
                            "expected_value": "metastatic castrate-sensitive prostate cancer"
                        }
                    ]
                },
                {
                    "exact_snippets": "progressed on docetaxel treatment",
                    "criterion": "progression",
                    "requirements": [
                        {
                            "requirement_type": "medication",
                            "expected_value": "docetaxel"
                        }
                    ]
                },
                {
                    "exact_snippets": "progress within one month of the last docetaxel dose",
                    "criterion": "progression",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "month"
                            }
                        },
                        {
                            "requirement_type": "medication",
                            "expected_value": "docetaxel"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients must have undergone bilateral surgical castration or must agree to continue on GnRH agonists/antagonists for the duration of the study.",
            "criterions": [
                {
                    "exact_snippets": "undergone bilateral surgical castration",
                    "criterion": "bilateral surgical castration",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "agree to continue on GnRH agonists/antagonists for the duration of the study",
                    "criterion": "GnRH agonists/antagonists",
                    "requirements": [
                        {
                            "requirement_type": "continuation",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have had progression of prostate cancer on prior docetaxel treatment for castrate sensitive disease are ineligible.",
            "criterions": [
                {
                    "exact_snippets": "progression of prostate cancer",
                    "criterion": "prostate cancer progression",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prior docetaxel treatment",
                    "criterion": "prior docetaxel treatment",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "castrate sensitive disease",
                    "criterion": "castrate sensitive disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have had prior treatment with PARPi are not eligible.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have had prior treatment with PARPi",
                    "criterion": "prior treatment with PARPi",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have received radionuclide treatment within 6 weeks prior to the first dose of the study treatment are not eligible.",
            "criterions": [
                {
                    "exact_snippets": "received radionuclide treatment within 6 weeks prior to the first dose of the study treatment",
                    "criterion": "radionuclide treatment",
                    "requirements": [
                        {
                            "requirement_type": "time since last treatment",
                            "expected_value": {
                                "operator": "<",
                                "value": 6,
                                "unit": "weeks"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with any other concomitant or prior invasive malignancies are ineligible.",
            "criterions": [
                {
                    "exact_snippets": "any other concomitant or prior invasive malignancies",
                    "criterion": "invasive malignancies",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": [
        {
            "line": "* ELIGIBILITY:",
            "criterions": []
        },
        {
            "line": "INCLUSION CRITERIA GENERAL:",
            "criterions": []
        }
    ]
}