{
    "info": {
        "nct_id": "NCT04220476",
        "official_title": "CIMER: Combined Immunotherapies in Metastatic ER+ Breast Cancer",
        "inclusion_criteria": "* Female ≥ 18 years of age pre and post-menopausal\n* Oligometastatic disease (≤ 5 sites of disease)\n* Premenopausal status is defined as either:\n* Patient had last menstrual period within the last 12 months, OR\n* If on tamoxifen or toremifene within the past 14 days, plasma estradiol and FSH must be in the premenopausal range per local normal range, OR\n* In case of therapy induced amenorrhea, plasma estradiol and/or FSH must be in the premenopausal range per local normal range.\n* Patients who have undergone bilateral oophorectomy are eligible.\n* Post-menopausal status defined as either 1) at least 2 years without menstrual period or 2) patients older than 50 with serological evidence of post-menopausal status or 3) hysterectomized patients of any age with FSH confirmation of post-menopausal status.\n* Eastern Cooperative Oncology Group (ECOG) performance status 0-1\n* Biopsy proven diagnosis of HR+HER2- metastatic breast cancer. ER expression is >10%\n* Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document\n* Hematological WBC ≥ 2000/uL\n* Absolute neutrophil count (ANC) ≥1500/µL\n* Platelets ≥100 000/µL\n* Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/La Renal Creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN\n\nHepatic Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN\n\n* AST (SGOT) and ALT (SGPT) ≤2.5 × ULN\n* Coagulation International normalized ratio (INR) OR prothrombin time (PT)\n* Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy if PT or aPTT is within therapeutic range of intended use of anticoagulants\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 90 Years",
        "exclusion_criteria": "* Active connective tissue disorders, such as lupus or scleroderma requiring flare therapy\n* Current use of systemic chemotherapy, endocrine therapy or HER2-neu targeted therapy\n* Male breast cancer patients\n* Any lesion >5 cm in greatest diameter.\n* Inability to obtain histologic proof of metastatic breast cancer\n* Has received previous endocrine or chemotherapy for metastatic breast cancer.\n* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.\n* Has a known additional malignancy (second primary) that is progressing or has required active treatment within the past 3 years. Note: - - - Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. cervical cancer in situ) that have undergone potentially curative therapy are not excluded.\n* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.\n* Has an active infection requiring systemic therapy. Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required unless mandated by local health authority.\n* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.\n* Patients with uncontrolled brain metastases",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Female ≥ 18 years of age pre and post-menopausal",
            "criterions": [
                {
                    "exact_snippets": "Female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "≥ 18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "pre and post-menopausal",
                    "criterion": "menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": [
                                "pre-menopausal",
                                "post-menopausal"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Oligometastatic disease (≤ 5 sites of disease)",
            "criterions": [
                {
                    "exact_snippets": "Oligometastatic disease (≤ 5 sites of disease)",
                    "criterion": "oligometastatic disease",
                    "requirements": [
                        {
                            "requirement_type": "number of sites",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "sites"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Premenopausal status is defined as either:",
            "criterions": [
                {
                    "exact_snippets": "Premenopausal status",
                    "criterion": "premenopausal status",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "either"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient had last menstrual period within the last 12 months, OR",
            "criterions": [
                {
                    "exact_snippets": "Patient had last menstrual period within the last 12 months",
                    "criterion": "last menstrual period",
                    "requirements": [
                        {
                            "requirement_type": "time since last occurrence",
                            "expected_value": {
                                "operator": "<=",
                                "value": 12,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* If on tamoxifen or toremifene within the past 14 days, plasma estradiol and FSH must be in the premenopausal range per local normal range, OR",
            "criterions": [
                {
                    "exact_snippets": "on tamoxifen or toremifene within the past 14 days",
                    "criterion": "tamoxifen or toremifene usage",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within the past 14 days"
                        }
                    ]
                },
                {
                    "exact_snippets": "plasma estradiol ... must be in the premenopausal range per local normal range",
                    "criterion": "plasma estradiol",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "premenopausal range per local normal range"
                        }
                    ]
                },
                {
                    "exact_snippets": "FSH must be in the premenopausal range per local normal range",
                    "criterion": "FSH",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "premenopausal range per local normal range"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* In case of therapy induced amenorrhea, plasma estradiol and/or FSH must be in the premenopausal range per local normal range.",
            "criterions": [
                {
                    "exact_snippets": "therapy induced amenorrhea",
                    "criterion": "therapy induced amenorrhea",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "plasma estradiol ... must be in the premenopausal range",
                    "criterion": "plasma estradiol",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "premenopausal range"
                        }
                    ]
                },
                {
                    "exact_snippets": "FSH must be in the premenopausal range",
                    "criterion": "FSH",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": "premenopausal range"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients who have undergone bilateral oophorectomy are eligible.",
            "criterions": [
                {
                    "exact_snippets": "Patients who have undergone bilateral oophorectomy",
                    "criterion": "bilateral oophorectomy",
                    "requirements": [
                        {
                            "requirement_type": "procedure history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Post-menopausal status defined as either 1) at least 2 years without menstrual period or 2) patients older than 50 with serological evidence of post-menopausal status or 3) hysterectomized patients of any age with FSH confirmation of post-menopausal status.",
            "criterions": [
                {
                    "exact_snippets": "Post-menopausal status defined as either 1) at least 2 years without menstrual period",
                    "criterion": "post-menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "at least 2 years without menstrual period"
                        }
                    ]
                },
                {
                    "exact_snippets": "Post-menopausal status defined as either ... 2) patients older than 50 with serological evidence of post-menopausal status",
                    "criterion": "post-menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "patients older than 50 with serological evidence of post-menopausal status"
                        }
                    ]
                },
                {
                    "exact_snippets": "Post-menopausal status defined as either ... 3) hysterectomized patients of any age with FSH confirmation of post-menopausal status",
                    "criterion": "post-menopausal status",
                    "requirements": [
                        {
                            "requirement_type": "definition",
                            "expected_value": "hysterectomized patients of any age with FSH confirmation of post-menopausal status"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Eastern Cooperative Oncology Group (ECOG) performance status 0-1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status 0-1",
                    "criterion": "ECOG performance status",
                    "requirements": [
                        {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Biopsy proven diagnosis of HR+HER2- metastatic breast cancer. ER expression is >10%",
            "criterions": [
                {
                    "exact_snippets": "Biopsy proven diagnosis of HR+HER2- metastatic breast cancer",
                    "criterion": "HR+HER2- metastatic breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "ER expression is >10%",
                    "criterion": "ER expression",
                    "requirements": [
                        {
                            "requirement_type": "expression level",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "%"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient needs to be able to understand and demonstrate willingness to sign a written informed consent document",
            "criterions": [
                {
                    "exact_snippets": "able to understand",
                    "criterion": "understanding ability",
                    "requirements": [
                        {
                            "requirement_type": "ability",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "demonstrate willingness to sign a written informed consent document",
                    "criterion": "willingness to sign consent",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hematological WBC ≥ 2000/uL",
            "criterions": [
                {
                    "exact_snippets": "Hematological WBC ≥ 2000/uL",
                    "criterion": "WBC",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 2000,
                                "unit": "uL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Absolute neutrophil count (ANC) ≥1500/µL",
            "criterions": [
                {
                    "exact_snippets": "Absolute neutrophil count (ANC) ≥1500/µL",
                    "criterion": "absolute neutrophil count (ANC)",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1500,
                                "unit": "µL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Platelets ≥100 000/µL",
            "criterions": [
                {
                    "exact_snippets": "Platelets ≥100 000/µL",
                    "criterion": "platelet count",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 100000,
                                "unit": "/µL"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/La Renal Creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN OR ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN",
            "criterions": [
                {
                    "exact_snippets": "Hemoglobin ≥9.0 g/dL or ≥5.6 mmol/L",
                    "criterion": "hemoglobin level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 9.0,
                                        "unit": "g/dL"
                                    },
                                    {
                                        "operator": ">=",
                                        "value": 5.6,
                                        "unit": "mmol/L"
                                    }
                                ]
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Creatinine OR Measured or calculated creatinine clearance (GFR can also be used in place of creatinine or CrCl) ≤1.5 × ULN",
                    "criterion": "creatinine level",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "creatinine clearance (GFR can also be used in place of creatinine or CrCl) ... ≥30 mL/min for participant with creatinine levels >1.5 × institutional ULN",
                    "criterion": "creatinine clearance",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": ">=",
                                "value": 30,
                                "unit": "mL/min"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Hepatic Total bilirubin ≤1.5 ×ULN OR direct bilirubin ≤ULN for participants with total bilirubin levels >1.5 × ULN",
            "criterions": [
                {
                    "exact_snippets": "Hepatic Total bilirubin ≤1.5 ×ULN",
                    "criterion": "total bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "direct bilirubin ≤ULN",
                    "criterion": "direct bilirubin",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* AST (SGOT) and ALT (SGPT) ≤2.5 × ULN",
            "criterions": [
                {
                    "exact_snippets": "AST (SGOT) ... ≤2.5 × ULN",
                    "criterion": "AST (SGOT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "ALT (SGPT) ... ≤2.5 × ULN",
                    "criterion": "ALT (SGPT)",
                    "requirements": [
                        {
                            "requirement_type": "level",
                            "expected_value": {
                                "operator": "<=",
                                "value": 2.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Coagulation International normalized ratio (INR) OR prothrombin time (PT)",
            "criterions": [
                {
                    "exact_snippets": "Coagulation International normalized ratio (INR)",
                    "criterion": "International normalized ratio (INR)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "prothrombin time (PT)",
                    "criterion": "prothrombin time (PT)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Activated partial thromboplastin time (aPTT) ≤1.5 × ULN unless participant is receiving anticoagulant therapy if PT or aPTT is within therapeutic range of intended use of anticoagulants",
            "criterions": [
                {
                    "exact_snippets": "Activated partial thromboplastin time (aPTT) ≤1.5 × ULN",
                    "criterion": "activated partial thromboplastin time (aPTT)",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": "<=",
                                "value": 1.5,
                                "unit": "× ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "unless participant is receiving anticoagulant therapy",
                    "criterion": "anticoagulant therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "if PT or aPTT is within therapeutic range of intended use of anticoagulants",
                    "criterion": "PT or aPTT within therapeutic range",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must be FEMALE",
            "criterions": [
                {
                    "exact_snippets": "Must be FEMALE",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have maximum age of 90 Years",
            "criterions": [
                {
                    "exact_snippets": "maximum age of 90 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "maximum",
                            "expected_value": {
                                "operator": "<=",
                                "value": 90,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Active connective tissue disorders, such as lupus or scleroderma requiring flare therapy",
            "criterions": [
                {
                    "exact_snippets": "Active connective tissue disorders, such as lupus or scleroderma",
                    "criterion": "connective tissue disorders",
                    "requirements": [
                        {
                            "requirement_type": "activity",
                            "expected_value": "active"
                        }
                    ]
                },
                {
                    "exact_snippets": "requiring flare therapy",
                    "criterion": "flare therapy",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Current use of systemic chemotherapy, endocrine therapy or HER2-neu targeted therapy",
            "criterions": [
                {
                    "exact_snippets": "Current use of systemic chemotherapy",
                    "criterion": "systemic chemotherapy",
                    "requirements": [
                        {
                            "requirement_type": "current use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Current use of ... endocrine therapy",
                    "criterion": "endocrine therapy",
                    "requirements": [
                        {
                            "requirement_type": "current use",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Current use of ... HER2-neu targeted therapy",
                    "criterion": "HER2-neu targeted therapy",
                    "requirements": [
                        {
                            "requirement_type": "current use",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Male breast cancer patients",
            "criterions": [
                {
                    "exact_snippets": "Male breast cancer patients",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "male"
                        }
                    ]
                },
                {
                    "exact_snippets": "Male breast cancer patients",
                    "criterion": "disease",
                    "requirements": [
                        {
                            "requirement_type": "expected_value",
                            "expected_value": "breast cancer"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Any lesion >5 cm in greatest diameter.",
            "criterions": [
                {
                    "exact_snippets": "Any lesion >5 cm in greatest diameter.",
                    "criterion": "lesion size",
                    "requirements": [
                        {
                            "requirement_type": "size",
                            "expected_value": {
                                "operator": ">",
                                "value": 5,
                                "unit": "cm"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Inability to obtain histologic proof of metastatic breast cancer",
            "criterions": [
                {
                    "exact_snippets": "Inability to obtain histologic proof of metastatic breast cancer",
                    "criterion": "histologic proof of metastatic breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "obtainability",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has received previous endocrine or chemotherapy for metastatic breast cancer.",
            "criterions": [
                {
                    "exact_snippets": "Has received previous endocrine or chemotherapy for metastatic breast cancer.",
                    "criterion": "previous treatment for metastatic breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "treatment type",
                            "expected_value": [
                                "endocrine",
                                "chemotherapy"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "Has a diagnosis of immunodeficiency",
                    "criterion": "immunodeficiency",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "is receiving chronic systemic steroid therapy",
                    "criterion": "chronic systemic steroid therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "dosing exceeding 10 mg daily of prednisone equivalent",
                    "criterion": "steroid therapy dosage",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg daily of prednisone equivalent"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug",
                    "criterion": "immunosuppressive therapy",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 7 days prior to the first dose of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has a known additional malignancy (second primary) that is progressing or has required active treatment within the past 3 years. Note: - - - Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. cervical cancer in situ) that have undergone potentially curative therapy are not excluded.",
            "criterions": [
                {
                    "exact_snippets": "Has a known additional malignancy (second primary) that is progressing",
                    "criterion": "additional malignancy",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has a known additional malignancy (second primary) ... has required active treatment within the past 3 years",
                    "criterion": "additional malignancy",
                    "requirements": [
                        {
                            "requirement_type": "active treatment",
                            "expected_value": {
                                "operator": "<=",
                                "value": 3,
                                "unit": "years"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. cervical cancer in situ) that have undergone potentially curative therapy are not excluded",
                    "criterion": "basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ",
                    "requirements": [
                        {
                            "requirement_type": "curative therapy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment.",
            "criterions": [
                {
                    "exact_snippets": "Has active autoimmune disease",
                    "criterion": "active autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "has required systemic treatment in the past 2 years",
                    "criterion": "systemic treatment for autoimmune disease",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "past 2 years"
                        }
                    ]
                },
                {
                    "exact_snippets": "Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment",
                    "criterion": "replacement therapy",
                    "requirements": [
                        {
                            "requirement_type": "consideration as systemic treatment",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has an active infection requiring systemic therapy. Has a known history of Human Immunodeficiency Virus (HIV). Note: No HIV testing is required unless mandated by local health authority.",
            "criterions": [
                {
                    "exact_snippets": "active infection requiring systemic therapy",
                    "criterion": "active infection",
                    "requirements": [
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "known history of Human Immunodeficiency Virus (HIV)",
                    "criterion": "Human Immunodeficiency Virus (HIV)",
                    "requirements": [
                        {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.",
            "criterions": [
                {
                    "exact_snippets": "known psychiatric or substance abuse disorders",
                    "criterion": "psychiatric or substance abuse disorders",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patients with uncontrolled brain metastases",
            "criterions": [
                {
                    "exact_snippets": "uncontrolled brain metastases",
                    "criterion": "brain metastases",
                    "requirements": [
                        {
                            "requirement_type": "control status",
                            "expected_value": "uncontrolled"
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}