{
    "info": {
        "nct_id": "NCT03523572",
        "official_title": "A Phase 1b, Multicenter, Two-Part, Open-Label Study of Trastuzumab Deruxtecan, an Anti-Human Epidermal Growth Factor Receptor-2 (HER2)-Antibody Drug Conjugate (ADC), in Combination With Nivolumab, an Anti-PD-1 Antibody, for Subjects With HER2-expressing Advanced Breast and Urothelial Cancer",
        "inclusion_criteria": "1. Is the age of majority (adulthood) in their country\n2. Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1\n3. Has pathologically documented breast cancer or urothelial cancer that is unresectable or metastatic, and refractory to or intolerant of existing therapy(ies) known to provide clinical benefit, and as specified in each study cohort\n4. Has an adequate archival tumor sample available for the central laboratory to determine eligibility to participate\n5. Has at least 1 measurable lesion per RECIST version 1.1\n6. Has cardiac, bone marrow, kidney, liver, blood and clotting test results required per protocol\n7. Has had an adequate washout period before enrollment since previous surgery and other treatment\n8. If reproduction is possible, agrees to use protocol-defined methods of contraception (or completely abstain from heterosexual intercourse) from screening to at least 7 months for females and males after the last dose of study drug\n9. Agrees to avoid harvesting sperm or ova for any reason from screening to at least 7 months for females and males after the last dose of study drug\n10. Has a life expectancy of at least 3 months\nHealthy volunteers allowed\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Has received prior treatment with nivolumab or trastuzumab deruxtecan\n2. Has medical history of myocardial infarction (MI) within 6 months before enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association classes II-IV). Troponin levels above upper limit of normal (ULN) at screening (as defined by the manufacturer) and without any MI-related symptoms should have a cardiologic consultation before enrollment to rule out MI.\n3. Has a corrected QT interval by Fredericia (QTcF) prolongation to > 470 ms (females) or > 450 ms (males) based on an average of the screening triplicate 12-lead electrocardiogram\n4. Has history of non-infectious interstitial lung disease (ILD/pneumonitis) (that required steroids), has ILD/pneumonitis currently, or it cannot be ruled out by imaging at screening\n5. Has a condition (other than active autoimmune disease) that requires systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of starting study treatment\n6. Is pregnant or breastfeeding, or planning to become pregnant",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "1. Is the age of majority (adulthood) in their country",
            "criterions": [
                {
                    "exact_snippets": "age of majority (adulthood) in their country",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "adulthood",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Has an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 1",
            "criterions": [
                {
                    "exact_snippets": "Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0 to 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": "3. Has pathologically documented breast cancer or urothelial cancer that is unresectable or metastatic, and refractory to or intolerant of existing therapy(ies) known to provide clinical benefit, and as specified in each study cohort",
            "criterions": [
                {
                    "exact_snippets": "pathologically documented breast cancer",
                    "criterion": "breast cancer",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "pathologically documented"
                        }
                    ]
                },
                {
                    "exact_snippets": "pathologically documented ... urothelial cancer",
                    "criterion": "urothelial cancer",
                    "requirements": [
                        {
                            "requirement_type": "documentation",
                            "expected_value": "pathologically documented"
                        }
                    ]
                },
                {
                    "exact_snippets": "unresectable",
                    "criterion": "cancer resectability",
                    "requirements": [
                        {
                            "requirement_type": "resectability",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "metastatic",
                    "criterion": "cancer metastasis",
                    "requirements": [
                        {
                            "requirement_type": "metastasis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "refractory to ... existing therapy(ies)",
                    "criterion": "therapy refractoriness",
                    "requirements": [
                        {
                            "requirement_type": "refractoriness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "intolerant of existing therapy(ies)",
                    "criterion": "therapy intolerance",
                    "requirements": [
                        {
                            "requirement_type": "intolerance",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Has an adequate archival tumor sample available for the central laboratory to determine eligibility to participate",
            "criterions": [
                {
                    "exact_snippets": "adequate archival tumor sample available",
                    "criterion": "archival tumor sample",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Has at least 1 measurable lesion per RECIST version 1.1",
            "criterions": [
                {
                    "exact_snippets": "at least 1 measurable lesion per RECIST version 1.1",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Has cardiac, bone marrow, kidney, liver, blood and clotting test results required per protocol",
            "criterions": [
                {
                    "exact_snippets": "Has cardiac ... test results required per protocol",
                    "criterion": "cardiac test results",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has ... bone marrow ... test results required per protocol",
                    "criterion": "bone marrow test results",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has ... kidney ... test results required per protocol",
                    "criterion": "kidney test results",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has ... liver ... test results required per protocol",
                    "criterion": "liver test results",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has ... blood ... test results required per protocol",
                    "criterion": "blood test results",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has ... clotting test results required per protocol",
                    "criterion": "clotting test results",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "7. Has had an adequate washout period before enrollment since previous surgery and other treatment",
            "criterions": [
                {
                    "exact_snippets": "adequate washout period before enrollment since previous surgery",
                    "criterion": "washout period since previous surgery",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "adequate washout period before enrollment since ... other treatment",
                    "criterion": "washout period since other treatment",
                    "requirements": [
                        {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "8. If reproduction is possible, agrees to use protocol-defined methods of contraception (or completely abstain from heterosexual intercourse) from screening to at least 7 months for females and males after the last dose of study drug",
            "criterions": [
                {
                    "exact_snippets": "If reproduction is possible",
                    "criterion": "reproduction capability",
                    "requirements": [
                        {
                            "requirement_type": "possibility",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "agrees to use protocol-defined methods of contraception (or completely abstain from heterosexual intercourse)",
                    "criterion": "contraception or abstinence",
                    "requirements": [
                        {
                            "requirement_type": "agreement",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "from screening to at least 7 months for females and males after the last dose of study drug",
                    "criterion": "duration of contraception or abstinence",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "from screening to at least 7 months after the last dose of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "9. Agrees to avoid harvesting sperm or ova for any reason from screening to at least 7 months for females and males after the last dose of study drug",
            "criterions": [
                {
                    "exact_snippets": "Agrees to avoid harvesting sperm or ova",
                    "criterion": "harvesting sperm or ova",
                    "requirements": [
                        {
                            "requirement_type": "avoidance",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "from screening to at least 7 months for females and males after the last dose of study drug",
                    "criterion": "time period for avoidance",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": "from screening to at least 7 months after the last dose of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "10. Has a life expectancy of at least 3 months",
            "criterions": [
                {
                    "exact_snippets": "life expectancy of at least 3 months",
                    "criterion": "life expectancy",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">=",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "Healthy volunteers allowed",
            "criterions": [
                {
                    "exact_snippets": "Healthy volunteers allowed",
                    "criterion": "volunteer health status",
                    "requirements": [
                        {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    ]
                }
            ]
        },
        {
            "line": "Must have minimum age of 18 Years",
            "criterions": [
                {
                    "exact_snippets": "minimum age of 18 Years",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "1. Has received prior treatment with nivolumab or trastuzumab deruxtecan",
            "criterions": [
                {
                    "exact_snippets": "Has received prior treatment with nivolumab",
                    "criterion": "prior treatment with nivolumab",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "Has received prior treatment with ... trastuzumab deruxtecan",
                    "criterion": "prior treatment with trastuzumab deruxtecan",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "2. Has medical history of myocardial infarction (MI) within 6 months before enrollment, symptomatic congestive heart failure (CHF) (New York Heart Association classes II-IV). Troponin levels above upper limit of normal (ULN) at screening (as defined by the manufacturer) and without any MI-related symptoms should have a cardiologic consultation before enrollment to rule out MI.",
            "criterions": [
                {
                    "exact_snippets": "medical history of myocardial infarction (MI) within 6 months before enrollment",
                    "criterion": "myocardial infarction (MI)",
                    "requirements": [
                        {
                            "requirement_type": "medical history",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": {
                                "operator": "<=",
                                "value": 6,
                                "unit": "months"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "symptomatic congestive heart failure (CHF) (New York Heart Association classes II-IV)",
                    "criterion": "congestive heart failure (CHF)",
                    "requirements": [
                        {
                            "requirement_type": "symptomatic",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "severity",
                            "expected_value": [
                                "New York Heart Association class II",
                                "New York Heart Association class III",
                                "New York Heart Association class IV"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "Troponin levels above upper limit of normal (ULN) at screening",
                    "criterion": "Troponin levels",
                    "requirements": [
                        {
                            "requirement_type": "comparison",
                            "expected_value": {
                                "operator": ">",
                                "value": 1,
                                "unit": "ULN"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "without any MI-related symptoms should have a cardiologic consultation before enrollment to rule out MI",
                    "criterion": "MI-related symptoms",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "3. Has a corrected QT interval by Fredericia (QTcF) prolongation to > 470 ms (females) or > 450 ms (males) based on an average of the screening triplicate 12-lead electrocardiogram",
            "criterions": [
                {
                    "exact_snippets": "corrected QT interval by Fredericia (QTcF) prolongation to > 470 ms (females)",
                    "criterion": "QTcF prolongation (females)",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 470,
                                "unit": "ms"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "corrected QT interval by Fredericia (QTcF) prolongation to ... > 450 ms (males)",
                    "criterion": "QTcF prolongation (males)",
                    "requirements": [
                        {
                            "requirement_type": "duration",
                            "expected_value": {
                                "operator": ">",
                                "value": 450,
                                "unit": "ms"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "4. Has history of non-infectious interstitial lung disease (ILD/pneumonitis) (that required steroids), has ILD/pneumonitis currently, or it cannot be ruled out by imaging at screening",
            "criterions": [
                {
                    "exact_snippets": "Has history of non-infectious interstitial lung disease (ILD/pneumonitis) (that required steroids)",
                    "criterion": "history of non-infectious interstitial lung disease (ILD/pneumonitis)",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "required steroids"
                        }
                    ]
                },
                {
                    "exact_snippets": "has ILD/pneumonitis currently",
                    "criterion": "current ILD/pneumonitis",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "it cannot be ruled out by imaging at screening",
                    "criterion": "ILD/pneumonitis ruled out by imaging",
                    "requirements": [
                        {
                            "requirement_type": "confirmation",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "5. Has a condition (other than active autoimmune disease) that requires systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of starting study treatment",
            "criterions": [
                {
                    "exact_snippets": "Has a condition (other than active autoimmune disease) that requires systemic treatment with either corticosteroids (>10 mg daily prednisone equivalent) or other immunosuppressive medications within 14 days of starting study treatment",
                    "criterion": "condition requiring systemic treatment",
                    "requirements": [
                        {
                            "requirement_type": "exclusion",
                            "expected_value": "active autoimmune disease"
                        },
                        {
                            "requirement_type": "treatment",
                            "expected_value": "systemic treatment with corticosteroids or other immunosuppressive medications"
                        },
                        {
                            "requirement_type": "corticosteroid dosage",
                            "expected_value": {
                                "operator": ">",
                                "value": 10,
                                "unit": "mg daily prednisone equivalent"
                            }
                        },
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 14 days of starting study treatment"
                        }
                    ]
                }
            ]
        },
        {
            "line": "6. Is pregnant or breastfeeding, or planning to become pregnant",
            "criterions": [
                {
                    "exact_snippets": "Is pregnant",
                    "criterion": "pregnancy status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "breastfeeding",
                    "criterion": "breastfeeding status",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "planning to become pregnant",
                    "criterion": "pregnancy intention",
                    "requirements": [
                        {
                            "requirement_type": "intention",
                            "expected_value": false
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}