{
    "info": {
        "nct_id": "NCT05870748",
        "official_title": "REFRaME-O1: A Phase 2/3 Open-label Study Evaluating the Efficacy and Safety of Luveltamab Tazevibulin (STRO-002) Versus Investigator's Choice (IC) Chemotherapy in Women With Relapsed Platinum-resistant Epithelial Ovarian Cancer (Including Fallopian Tube or Primary Peritoneal Cancers) Expressing Folate Receptor Alpha (FOLR1)",
        "inclusion_criteria": "1. High grade serous epithelial ovarian cancer, fallopian tube or primary peritoneal cancer\n2. Age ≥ 18 years\n3. ECOG performance status 0 to 1\n4. Positive FOLR1 expression per central laboratory testing\n5. Relapsed platinum-resistant epithelial ovarian cancer and received a total of 1 to 3 prior regimens\n6. Prior bevacizumab treatment is required, if labeled and available as standard of care per institutional guidelines, unless subject has documented contraindication\n7. At least 1 measurable target lesion per RECIST v1.1\n8. Adequate organ function\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "1. Low grade (Grade 1) ovarian carcinoma, clear cell, mucinous, endometrioid, sarcomatous, and mixed histology ovarian carcinomas\n2. Prior treatment with a FOLR1- targeting ADCs or with ADCs that contain a tubulin inhibitor\n3. Primary platinum-refractory disease\n4. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion protein treatment\n5. Pre-existing clinically significant ocular disorders, severe chronic obstructive pulmonary disease or asthma, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition\n6. Previous solid organ transplantation\n7. History or clinical signs of meningeal or active central nervous system involvement\n8. Concurrent participation in another therapeutic treatment trial",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "identified_line": {
                "line": "1. High grade serous epithelial ovarian cancer, fallopian tube or primary peritoneal cancer",
                "criterions": [
                    {
                        "exact_snippets": "High grade serous epithelial ovarian cancer",
                        "criterion": "ovarian cancer",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "high grade serous epithelial"
                        }
                    },
                    {
                        "exact_snippets": "fallopian tube ... cancer",
                        "criterion": "fallopian tube cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "primary peritoneal cancer",
                        "criterion": "primary peritoneal cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "High grade serous epithelial ovarian cancer",
                                "criterion": "ovarian cancer",
                                "requirement": {
                                    "requirement_type": "type",
                                    "expected_value": "high grade serous epithelial"
                                }
                            },
                            {
                                "exact_snippets": "fallopian tube ... cancer",
                                "criterion": "fallopian tube cancer",
                                "requirement": {
                                    "requirement_type": "presence",
                                    "expected_value": true
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "primary peritoneal cancer",
                        "criterion": "primary peritoneal cancer",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "2. Age ≥ 18 years",
                "criterions": [
                    {
                        "exact_snippets": "Age ≥ 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Age ≥ 18 years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. ECOG performance status 0 to 1",
                "criterions": [
                    {
                        "exact_snippets": "ECOG performance status 0 to 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "ECOG performance status 0 to 1",
                        "criterion": "ECOG performance status",
                        "requirement": {
                            "requirement_type": "range",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 0,
                                        "unit": "N/A"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 1,
                                        "unit": "N/A"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "4. Positive FOLR1 expression per central laboratory testing",
                "criterions": [
                    {
                        "exact_snippets": "Positive FOLR1 expression",
                        "criterion": "FOLR1 expression",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Positive FOLR1 expression",
                        "criterion": "FOLR1 expression",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": "positive"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Relapsed platinum-resistant epithelial ovarian cancer and received a total of 1 to 3 prior regimens",
                "criterions": [
                    {
                        "exact_snippets": "Relapsed platinum-resistant epithelial ovarian cancer",
                        "criterion": "epithelial ovarian cancer",
                        "requirement": {
                            "requirement_type": "relapse status",
                            "expected_value": "platinum-resistant"
                        }
                    },
                    {
                        "exact_snippets": "received a total of 1 to 3 prior regimens",
                        "criterion": "prior treatment regimens",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "regimens"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "regimens"
                                    }
                                ]
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Relapsed platinum-resistant epithelial ovarian cancer",
                        "criterion": "epithelial ovarian cancer",
                        "requirement": {
                            "requirement_type": "relapse status",
                            "expected_value": "platinum-resistant"
                        }
                    },
                    {
                        "exact_snippets": "received a total of 1 to 3 prior regimens",
                        "criterion": "prior treatment regimens",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "comparisons": [
                                    {
                                        "operator": ">=",
                                        "value": 1,
                                        "unit": "regimens"
                                    },
                                    {
                                        "operator": "<=",
                                        "value": 3,
                                        "unit": "regimens"
                                    }
                                ]
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Prior bevacizumab treatment is required, if labeled and available as standard of care per institutional guidelines, unless subject has documented contraindication",
                "criterions": [
                    {
                        "exact_snippets": "Prior bevacizumab treatment is required",
                        "criterion": "bevacizumab treatment",
                        "requirement": {
                            "requirement_type": "prior treatment",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "if labeled and available as standard of care per institutional guidelines",
                        "criterion": "bevacizumab treatment",
                        "requirement": {
                            "requirement_type": "availability",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "unless subject has documented contraindication",
                        "criterion": "contraindication to bevacizumab",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "condition": {
                    "and_criteria": [
                        {
                            "and_criteria": [
                                {
                                    "exact_snippets": "if labeled and available as standard of care per institutional guidelines",
                                    "criterion": "bevacizumab treatment",
                                    "requirement": {
                                        "requirement_type": "availability",
                                        "expected_value": true
                                    }
                                },
                                {
                                    "not_criteria": {
                                        "exact_snippets": "unless subject has documented contraindication",
                                        "criterion": "contraindication to bevacizumab",
                                        "requirement": {
                                            "requirement_type": "presence",
                                            "expected_value": false
                                        }
                                    }
                                }
                            ]
                        }
                    ]
                },
                "then_criteria": {
                    "exact_snippets": "Prior bevacizumab treatment is required",
                    "criterion": "bevacizumab treatment",
                    "requirement": {
                        "requirement_type": "prior treatment",
                        "expected_value": true
                    }
                },
                "else_criteria": null
            }
        },
        {
            "identified_line": {
                "line": "7. At least 1 measurable target lesion per RECIST v1.1",
                "criterions": [
                    {
                        "exact_snippets": "At least 1 measurable target lesion per RECIST v1.1",
                        "criterion": "measurable target lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "At least 1 measurable target lesion per RECIST v1.1",
                        "criterion": "measurable target lesion",
                        "requirement": {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lesion"
                            }
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Adequate organ function",
                "criterions": [
                    {
                        "exact_snippets": "Adequate organ function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Adequate organ function",
                        "criterion": "organ function",
                        "requirement": {
                            "requirement_type": "adequacy",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Healthy volunteers allowed",
                "criterions": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Healthy volunteers allowed",
                        "criterion": "volunteer health status",
                        "requirement": {
                            "requirement_type": "status",
                            "expected_value": "healthy"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must be FEMALE",
                "criterions": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Must be FEMALE",
                        "criterion": "gender",
                        "requirement": {
                            "requirement_type": "expected_value",
                            "expected_value": "female"
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "Must have minimum age of 18 Years",
                "criterions": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "minimum age of 18 Years",
                        "criterion": "age",
                        "requirement": {
                            "requirement_type": "minimum",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "Years"
                            }
                        }
                    }
                ]
            }
        }
    ],
    "exclusion_lines": [
        {
            "identified_line": {
                "line": "1. Low grade (Grade 1) ovarian carcinoma, clear cell, mucinous, endometrioid, sarcomatous, and mixed histology ovarian carcinomas",
                "criterions": [
                    {
                        "exact_snippets": "Low grade (Grade 1) ovarian carcinoma",
                        "criterion": "ovarian carcinoma grade",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": "Grade 1"
                        }
                    },
                    {
                        "exact_snippets": "clear cell, mucinous, endometrioid, sarcomatous, and mixed histology ovarian carcinomas",
                        "criterion": "ovarian carcinoma histology",
                        "requirement": {
                            "requirement_type": "histology",
                            "expected_value": [
                                "clear cell",
                                "mucinous",
                                "endometrioid",
                                "sarcomatous",
                                "mixed"
                            ]
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Low grade (Grade 1) ovarian carcinoma",
                        "criterion": "ovarian carcinoma grade",
                        "requirement": {
                            "requirement_type": "grade",
                            "expected_value": "Grade 1"
                        }
                    },
                    {
                        "exact_snippets": "clear cell, mucinous, endometrioid, sarcomatous, and mixed histology ovarian carcinomas",
                        "criterion": "ovarian carcinoma histology",
                        "requirement": {
                            "requirement_type": "histology",
                            "expected_value": [
                                "clear cell",
                                "mucinous",
                                "endometrioid",
                                "sarcomatous",
                                "mixed"
                            ]
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "3. Primary platinum-refractory disease",
                "criterions": [
                    {
                        "exact_snippets": "Primary platinum-refractory disease",
                        "criterion": "platinum-refractory disease",
                        "requirement": {
                            "requirement_type": "type",
                            "expected_value": "primary"
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Primary platinum-refractory disease",
                    "criterion": "platinum-refractory disease",
                    "requirement": {
                        "requirement_type": "type",
                        "expected_value": "primary"
                    }
                }
            }
        },
        {
            "identified_line": {
                "line": "4. History of severe allergic or anaphylactic reactions to monoclonal antibody therapy or to antibody-related fusion protein treatment",
                "criterions": [
                    {
                        "exact_snippets": "History of severe allergic or anaphylactic reactions to monoclonal antibody therapy",
                        "criterion": "severe allergic or anaphylactic reactions to monoclonal antibody therapy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of severe allergic or anaphylactic reactions ... to antibody-related fusion protein treatment",
                        "criterion": "severe allergic or anaphylactic reactions to antibody-related fusion protein treatment",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "History of severe allergic or anaphylactic reactions to monoclonal antibody therapy",
                        "criterion": "severe allergic or anaphylactic reactions to monoclonal antibody therapy",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History of severe allergic or anaphylactic reactions ... to antibody-related fusion protein treatment",
                        "criterion": "severe allergic or anaphylactic reactions to antibody-related fusion protein treatment",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "5. Pre-existing clinically significant ocular disorders, severe chronic obstructive pulmonary disease or asthma, clinically significant cardiac or cerebrovascular disease, or other significant concurrent, uncontrolled medical condition",
                "criterions": [
                    {
                        "exact_snippets": "Pre-existing clinically significant ocular disorders",
                        "criterion": "ocular disorders",
                        "requirement": {
                            "requirement_type": "significance",
                            "expected_value": "clinically significant"
                        }
                    },
                    {
                        "exact_snippets": "Pre-existing clinically significant ocular disorders",
                        "criterion": "ocular disorders",
                        "requirement": {
                            "requirement_type": "pre-existence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "severe chronic obstructive pulmonary disease",
                        "criterion": "chronic obstructive pulmonary disease",
                        "requirement": {
                            "requirement_type": "severity",
                            "expected_value": "severe"
                        }
                    },
                    {
                        "exact_snippets": "clinically significant cardiac or cerebrovascular disease",
                        "criterion": "cardiac or cerebrovascular disease",
                        "requirement": {
                            "requirement_type": "significance",
                            "expected_value": "clinically significant"
                        }
                    },
                    {
                        "exact_snippets": "other significant concurrent, uncontrolled medical condition",
                        "criterion": "other medical condition",
                        "requirement": {
                            "requirement_type": "significance",
                            "expected_value": "significant"
                        }
                    },
                    {
                        "exact_snippets": "other significant concurrent, uncontrolled medical condition",
                        "criterion": "other medical condition",
                        "requirement": {
                            "requirement_type": "control",
                            "expected_value": "uncontrolled"
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "and_criteria": [
                            {
                                "and_criteria": [
                                    {
                                        "exact_snippets": "Pre-existing clinically significant ocular disorders",
                                        "criterion": "ocular disorders",
                                        "requirement": {
                                            "requirement_type": "significance",
                                            "expected_value": "clinically significant"
                                        }
                                    },
                                    {
                                        "exact_snippets": "Pre-existing clinically significant ocular disorders",
                                        "criterion": "ocular disorders",
                                        "requirement": {
                                            "requirement_type": "pre-existence",
                                            "expected_value": true
                                        }
                                    }
                                ]
                            },
                            {
                                "exact_snippets": "severe chronic obstructive pulmonary disease",
                                "criterion": "chronic obstructive pulmonary disease",
                                "requirement": {
                                    "requirement_type": "severity",
                                    "expected_value": "severe"
                                }
                            }
                        ]
                    },
                    {
                        "exact_snippets": "clinically significant cardiac or cerebrovascular disease",
                        "criterion": "cardiac or cerebrovascular disease",
                        "requirement": {
                            "requirement_type": "significance",
                            "expected_value": "clinically significant"
                        }
                    },
                    {
                        "and_criteria": [
                            {
                                "exact_snippets": "other significant concurrent, uncontrolled medical condition",
                                "criterion": "other medical condition",
                                "requirement": {
                                    "requirement_type": "significance",
                                    "expected_value": "significant"
                                }
                            },
                            {
                                "exact_snippets": "other significant concurrent, uncontrolled medical condition",
                                "criterion": "other medical condition",
                                "requirement": {
                                    "requirement_type": "control",
                                    "expected_value": "uncontrolled"
                                }
                            }
                        ]
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "6. Previous solid organ transplantation",
                "criterions": [
                    {
                        "exact_snippets": "Previous solid organ transplantation",
                        "criterion": "solid organ transplantation",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "and_criteria": [
                    {
                        "exact_snippets": "Previous solid organ transplantation",
                        "criterion": "solid organ transplantation",
                        "requirement": {
                            "requirement_type": "history",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "7. History or clinical signs of meningeal or active central nervous system involvement",
                "criterions": [
                    {
                        "exact_snippets": "History or clinical signs of meningeal ... involvement",
                        "criterion": "meningeal involvement",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History or clinical signs of ... active central nervous system involvement",
                        "criterion": "active central nervous system involvement",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "History or clinical signs of meningeal ... involvement",
                        "criterion": "meningeal involvement",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "History or clinical signs of ... active central nervous system involvement",
                        "criterion": "active central nervous system involvement",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        },
        {
            "identified_line": {
                "line": "8. Concurrent participation in another therapeutic treatment trial",
                "criterions": [
                    {
                        "exact_snippets": "Concurrent participation in another therapeutic treatment trial",
                        "criterion": "participation in another therapeutic treatment trial",
                        "requirement": {
                            "requirement_type": "concurrency",
                            "expected_value": true
                        }
                    }
                ]
            },
            "logical_structure": {
                "not_criteria": {
                    "exact_snippets": "Concurrent participation in another therapeutic treatment trial",
                    "criterion": "participation in another therapeutic treatment trial",
                    "requirement": {
                        "requirement_type": "concurrency",
                        "expected_value": true
                    }
                }
            }
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [
        {
            "identified_line": {
                "line": "2. Prior treatment with a FOLR1- targeting ADCs or with ADCs that contain a tubulin inhibitor",
                "criterions": [
                    {
                        "exact_snippets": "Prior treatment with a FOLR1- targeting ADCs",
                        "criterion": "prior treatment with FOLR1-targeting ADCs",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    },
                    {
                        "exact_snippets": "Prior treatment ... with ADCs that contain a tubulin inhibitor",
                        "criterion": "prior treatment with ADCs containing a tubulin inhibitor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    }
                ]
            },
            "logical_structure": {
                "or_criteria": [
                    {
                        "exact_snippets": "Prior treatment with a FOLR1- targeting ADCs",
                        "criterion": "prior treatment with FOLR1-targeting ADCs",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    },
                    {
                        "exact_snippets": "Prior treatment ... with ADCs that contain a tubulin inhibitor",
                        "criterion": "prior treatment with ADCs containing a tubulin inhibitor",
                        "requirement": {
                            "requirement_type": "presence",
                            "expected_value": true
                        }
                    }
                ]
            }
        }
    ],
    "failed_miscellaneous": []
}