{
    "info": {
        "nct_id": "NCT05092360",
        "official_title": "A Phase 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination With Pembrolizumab Versus Investigator's Choice Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARTISTRY-7)",
        "inclusion_criteria": "* Patient is female and ≥18 years of age.\n* Patient has histologically confirmed diagnosis of EOC (ie, high-grade serous, endometrioid of any grade, clear cell), fallopian tube cancer, or primary peritoneal cancer.\n* Patient has platinum-resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy beyond first-line setting (resistant) or lack of response or disease progression while receiving the most recent platinum-based therapy (refractory). Patient must have progressed radiographically on or after their most recent line of anticancer therapy.\n* Patient must have received at least 1 prior line of systemic anticancer therapy in the platinum sensitive setting, and no more than 5 prior lines of systemic anticancer therapy in the platinum-resistant setting. Patient must have received at least 1 line of therapy containing bevacizumab.\n* Patient has at least one measurable lesion that qualifies as a target lesion based on RECISTv1.1.\n* Patient is willing to undergo a pre-treatment tumor biopsy or provide qualifying archival tumor tissue.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years",
        "exclusion_criteria": "* Patient has primary platinum-refractory disease or primary platinum resistance, defined as disease progression during first-line platinum-based therapy (refractory) or disease progression <3 months after completion of first-line platinum-based therapy (resistant).\n* Patient has histologically confirmed diagnosis of EOC with mucinous or carcinosarcoma subtype.\n* Patient has nonepithelial tumor (eg, germline or stromal cell tumor) or ovarian tumor with low malignant potential (ie, borderline or low-grade serous tumor).\n* Patient requires fluid drainage (eg, paracentesis, thoracentesis, pericardiocentesis) of ≥500 mL within 4 weeks of first dose of study drug.\n* Patient has received prior IL-2-based or IL-15-based cytokine therapy; patient has had exposure, including intralesional, to IL-12 or analogs thereof.\n* Patient has prior exposure to any anti-PD1/PD-L1 therapy.",
        "miscellaneous_criteria": ""
    },
    "inclusion_lines": [
        {
            "line": "* Patient is female and ≥18 years of age.",
            "criterions": [
                {
                    "exact_snippets": "Patient is female",
                    "criterion": "gender",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": "female"
                        }
                    ]
                },
                {
                    "exact_snippets": "≥18 years of age",
                    "criterion": "age",
                    "requirements": [
                        {
                            "requirement_type": "value",
                            "expected_value": {
                                "operator": ">=",
                                "value": 18,
                                "unit": "years"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has histologically confirmed diagnosis of EOC (ie, high-grade serous, endometrioid of any grade, clear cell), fallopian tube cancer, or primary peritoneal cancer.",
            "criterions": [
                {
                    "exact_snippets": "histologically confirmed diagnosis of EOC (ie, high-grade serous, endometrioid of any grade, clear cell)",
                    "criterion": "EOC diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        },
                        {
                            "requirement_type": "subtypes",
                            "expected_value": [
                                "high-grade serous",
                                "endometrioid of any grade",
                                "clear cell"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "fallopian tube cancer",
                    "criterion": "fallopian tube cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "primary peritoneal cancer",
                    "criterion": "primary peritoneal cancer",
                    "requirements": [
                        {
                            "requirement_type": "diagnosis",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has platinum-resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy beyond first-line setting (resistant) or lack of response or disease progression while receiving the most recent platinum-based therapy (refractory). Patient must have progressed radiographically on or after their most recent line of anticancer therapy.",
            "criterions": [
                {
                    "exact_snippets": "platinum-resistant/refractory disease, defined as disease progression within 180 days following the last administered dose of platinum therapy beyond first-line setting (resistant)",
                    "criterion": "platinum-resistant disease",
                    "requirements": [
                        {
                            "requirement_type": "progression time",
                            "expected_value": {
                                "operator": "<=",
                                "value": 180,
                                "unit": "days"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "lack of response or disease progression while receiving the most recent platinum-based therapy (refractory)",
                    "criterion": "platinum-refractory disease",
                    "requirements": [
                        {
                            "requirement_type": "response",
                            "expected_value": "lack of response"
                        },
                        {
                            "requirement_type": "progression",
                            "expected_value": "disease progression"
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient must have progressed radiographically on or after their most recent line of anticancer therapy.",
                    "criterion": "radiographic progression",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": "radiographic progression"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient must have received at least 1 prior line of systemic anticancer therapy in the platinum sensitive setting, and no more than 5 prior lines of systemic anticancer therapy in the platinum-resistant setting. Patient must have received at least 1 line of therapy containing bevacizumab.",
            "criterions": [
                {
                    "exact_snippets": "Patient must have received at least 1 prior line of systemic anticancer therapy in the platinum sensitive setting",
                    "criterion": "prior lines of systemic anticancer therapy in the platinum sensitive setting",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lines"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "no more than 5 prior lines of systemic anticancer therapy in the platinum-resistant setting",
                    "criterion": "prior lines of systemic anticancer therapy in the platinum-resistant setting",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": "<=",
                                "value": 5,
                                "unit": "lines"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "Patient must have received at least 1 line of therapy containing bevacizumab",
                    "criterion": "lines of therapy containing bevacizumab",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "lines"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has at least one measurable lesion that qualifies as a target lesion based on RECISTv1.1.",
            "criterions": [
                {
                    "exact_snippets": "at least one measurable lesion",
                    "criterion": "measurable lesion",
                    "requirements": [
                        {
                            "requirement_type": "quantity",
                            "expected_value": {
                                "operator": ">=",
                                "value": 1,
                                "unit": "N/A"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "qualifies as a target lesion based on RECISTv1.1",
                    "criterion": "target lesion qualification",
                    "requirements": [
                        {
                            "requirement_type": "qualification standard",
                            "expected_value": "RECISTv1.1"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient is willing to undergo a pre-treatment tumor biopsy or provide qualifying archival tumor tissue.",
            "criterions": [
                {
                    "exact_snippets": "Patient is willing to undergo a pre-treatment tumor biopsy",
                    "criterion": "willingness to undergo pre-treatment tumor biopsy",
                    "requirements": [
                        {
                            "requirement_type": "willingness",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "provide qualifying archival tumor tissue",
                    "criterion": "qualifying archival tumor tissue",
                    "requirements": [
                        {
                            "requirement_type": "availability",
                            "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": "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"
                            }
                        }
                    ]
                }
            ]
        }
    ],
    "exclusion_lines": [
        {
            "line": "* Patient has primary platinum-refractory disease or primary platinum resistance, defined as disease progression during first-line platinum-based therapy (refractory) or disease progression <3 months after completion of first-line platinum-based therapy (resistant).",
            "criterions": [
                {
                    "exact_snippets": "primary platinum-refractory disease ... disease progression during first-line platinum-based therapy (refractory)",
                    "criterion": "primary platinum-refractory disease",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": "during first-line platinum-based therapy"
                        }
                    ]
                },
                {
                    "exact_snippets": "primary platinum resistance ... disease progression <3 months after completion of first-line platinum-based therapy (resistant)",
                    "criterion": "primary platinum resistance",
                    "requirements": [
                        {
                            "requirement_type": "progression",
                            "expected_value": {
                                "operator": "<",
                                "value": 3,
                                "unit": "months"
                            }
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has histologically confirmed diagnosis of EOC with mucinous or carcinosarcoma subtype.",
            "criterions": [
                {
                    "exact_snippets": "histologically confirmed diagnosis of EOC",
                    "criterion": "EOC diagnosis",
                    "requirements": [
                        {
                            "requirement_type": "confirmation method",
                            "expected_value": "histologically confirmed"
                        }
                    ]
                },
                {
                    "exact_snippets": "mucinous or carcinosarcoma subtype",
                    "criterion": "EOC subtype",
                    "requirements": [
                        {
                            "requirement_type": "subtype",
                            "expected_value": [
                                "mucinous",
                                "carcinosarcoma"
                            ]
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has nonepithelial tumor (eg, germline or stromal cell tumor) or ovarian tumor with low malignant potential (ie, borderline or low-grade serous tumor).",
            "criterions": [
                {
                    "exact_snippets": "nonepithelial tumor (eg, germline or stromal cell tumor)",
                    "criterion": "nonepithelial tumor",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                },
                {
                    "exact_snippets": "ovarian tumor with low malignant potential (ie, borderline or low-grade serous tumor)",
                    "criterion": "ovarian tumor with low malignant potential",
                    "requirements": [
                        {
                            "requirement_type": "presence",
                            "expected_value": false
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient requires fluid drainage (eg, paracentesis, thoracentesis, pericardiocentesis) of ≥500 mL within 4 weeks of first dose of study drug.",
            "criterions": [
                {
                    "exact_snippets": "Patient requires fluid drainage (eg, paracentesis, thoracentesis, pericardiocentesis)",
                    "criterion": "fluid drainage",
                    "requirements": [
                        {
                            "requirement_type": "necessity",
                            "expected_value": true
                        }
                    ]
                },
                {
                    "exact_snippets": "≥500 mL",
                    "criterion": "fluid drainage amount",
                    "requirements": [
                        {
                            "requirement_type": "amount",
                            "expected_value": {
                                "operator": ">=",
                                "value": 500,
                                "unit": "mL"
                            }
                        }
                    ]
                },
                {
                    "exact_snippets": "within 4 weeks of first dose of study drug",
                    "criterion": "timing of fluid drainage",
                    "requirements": [
                        {
                            "requirement_type": "time frame",
                            "expected_value": "within 4 weeks of first dose of study drug"
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has received prior IL-2-based or IL-15-based cytokine therapy; patient has had exposure, including intralesional, to IL-12 or analogs thereof.",
            "criterions": [
                {
                    "exact_snippets": "Patient has received prior IL-2-based or IL-15-based cytokine therapy",
                    "criterion": "prior cytokine therapy",
                    "requirements": [
                        {
                            "requirement_type": "type",
                            "expected_value": [
                                "IL-2-based",
                                "IL-15-based"
                            ]
                        }
                    ]
                },
                {
                    "exact_snippets": "patient has had exposure, including intralesional, to IL-12 or analogs thereof",
                    "criterion": "exposure to IL-12 or analogs",
                    "requirements": [
                        {
                            "requirement_type": "exposure",
                            "expected_value": true
                        }
                    ]
                }
            ]
        },
        {
            "line": "* Patient has prior exposure to any anti-PD1/PD-L1 therapy.",
            "criterions": [
                {
                    "exact_snippets": "prior exposure to any anti-PD1/PD-L1 therapy",
                    "criterion": "anti-PD1/PD-L1 therapy exposure",
                    "requirements": [
                        {
                            "requirement_type": "prior exposure",
                            "expected_value": true
                        }
                    ]
                }
            ]
        }
    ],
    "miscellaneous_lines": [],
    "failed_inclusion": [],
    "failed_exclusion": [],
    "failed_miscellaneous": []
}