{
"info": {
"nct_id": "NCT06791460",
"official_title": "Pegylated Liposomal Doxorubicin Plus Adebrelimab with or Without Mirabegron in Relapsed Ovarian Cancer: a Randomized, Controlled, Open-label Trial",
"inclusion_criteria": "* Has provided documented informed consent for the study.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.\n* Has received a front line platinum-based regimen (administered via either intravenous or intraperitoneal route) per local standard of care or treatment guideline following the primary or interval debulking surgery with documented disease recurrence (note: Maintenance treatment following the front line treatment is permitted and counted together as part of the front line treatment).\n* Has a platinum-free interval (PFI) of < 12 months if the last regimen received is a platinum-based, or a treatment-free interval (TFI) of < 12 months if the last regimen received is a non-platinum-based.\n* Has measurable disease at baseline based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.\n* Has a life expectancy of ≥12 weeks.\n* Has provided a tumor tissue sample either collected from prior cytoreductive surgery or fresh newly obtained tumor tissue at screening.\n* Has adequate organ function.\n* Has not recovered from AEs to ≤ Grade 1 or prior treatment level due to a previously administered agent.\nHealthy volunteers allowed\nMust be FEMALE\nMust have minimum age of 18 Years\nMust have maximum age of 75 Years",
"exclusion_criteria": "* Has nonepithelial cancers, borderline tumors, mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma.\n* Has received prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated antigen-4 [CTLA-4], tumor necrosis factor receptors OX-40 or CD137) or has participated in prior adebrelimab studies.\n* Has received prior systemic anticancer therapy including radiation therapy or maintenance therapy within 4 weeks before randomization.\n* Has severe hypersensitivity (≥Grade 3) or uncontrolled hypertension to pegylated liposomal doxorubicin, adebrelimab, mirabegron and any of their excipients.\n* Has undergone major surgery within 3 weeks before randomization or has complications/sequelae that have not yet recovered.\n* Has a known additional malignancy that progressed or required active treatment within the last 5 years.\n* Is pregnant or breastfeeding.\n* Has a history of allogenic tissue/solid organ transplant.\n* Has a history of thrombotic disorders, hemorrhage, hemoptysis, or active gastrointestinal bleeding within 6 months before randomization.\n* Has a history of active autoimmune disease.\n* Has an active infection requiring systemic therapy.\n* Has a history of human immunodeficiency virus (HIV) infection.\n* Has a history of Hepatitis B or C virus infection.\n* Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study.\n* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.",
"miscellaneous_criteria": ""
},
"inclusion_lines": [
{
"line": "* Has provided documented informed consent for the study.",
"criterions": [
{
"exact_snippets": "Has provided documented informed consent",
"criterion": "informed consent",
"requirements": [
{
"requirement_type": "documentation",
"expected_value": true
}
]
}
]
},
{
"line": "* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.",
"criterions": [
{
"exact_snippets": "Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.",
"criterion": "ECOG performance status",
"requirements": [
{
"requirement_type": "value",
"expected_value": [
"0",
"1"
]
}
]
}
]
},
{
"line": "* Has histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma.",
"criterions": [
{
"exact_snippets": "histologically confirmed epithelial ovarian, fallopian tube, or primary peritoneal carcinoma",
"criterion": "carcinoma type",
"requirements": [
{
"requirement_type": "presence",
"expected_value": [
"epithelial ovarian",
"fallopian tube",
"primary peritoneal"
]
}
]
}
]
},
{
"line": "* Has received a front line platinum-based regimen (administered via either intravenous or intraperitoneal route) per local standard of care or treatment guideline following the primary or interval debulking surgery with documented disease recurrence (note: Maintenance treatment following the front line treatment is permitted and counted together as part of the front line treatment).",
"criterions": [
{
"exact_snippets": "Has received a front line platinum-based regimen",
"criterion": "front line platinum-based regimen",
"requirements": [
{
"requirement_type": "receipt",
"expected_value": true
}
]
},
{
"exact_snippets": "administered via either intravenous or intraperitoneal route",
"criterion": "route of administration",
"requirements": [
{
"requirement_type": "route",
"expected_value": [
"intravenous",
"intraperitoneal"
]
}
]
},
{
"exact_snippets": "per local standard of care or treatment guideline",
"criterion": "adherence to local standard of care or treatment guideline",
"requirements": [
{
"requirement_type": "adherence",
"expected_value": true
}
]
},
{
"exact_snippets": "following the primary or interval debulking surgery",
"criterion": "timing relative to surgery",
"requirements": [
{
"requirement_type": "timing",
"expected_value": "following primary or interval debulking surgery"
}
]
},
{
"exact_snippets": "with documented disease recurrence",
"criterion": "disease recurrence",
"requirements": [
{
"requirement_type": "documentation",
"expected_value": true
}
]
}
]
},
{
"line": "* Has a platinum-free interval (PFI) of < 12 months if the last regimen received is a platinum-based, or a treatment-free interval (TFI) of < 12 months if the last regimen received is a non-platinum-based.",
"criterions": [
{
"exact_snippets": "platinum-free interval (PFI) of < 12 months if the last regimen received is a platinum-based",
"criterion": "platinum-free interval",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": "<",
"value": 12,
"unit": "months"
}
},
{
"requirement_type": "last regimen type",
"expected_value": "platinum-based"
}
]
},
{
"exact_snippets": "treatment-free interval (TFI) of < 12 months if the last regimen received is a non-platinum-based",
"criterion": "treatment-free interval",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": "<",
"value": 12,
"unit": "months"
}
},
{
"requirement_type": "last regimen type",
"expected_value": "non-platinum-based"
}
]
}
]
},
{
"line": "* Has measurable disease at baseline based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.",
"criterions": [
{
"exact_snippets": "Has measurable disease at baseline based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1.",
"criterion": "measurable disease",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
},
{
"requirement_type": "evaluation criteria",
"expected_value": "Response Evaluation Criteria in Solid Tumors (RECIST) 1.1"
}
]
}
]
},
{
"line": "* Has a life expectancy of ≥12 weeks.",
"criterions": [
{
"exact_snippets": "life expectancy of ≥12 weeks",
"criterion": "life expectancy",
"requirements": [
{
"requirement_type": "duration",
"expected_value": {
"operator": ">=",
"value": 12,
"unit": "weeks"
}
}
]
}
]
},
{
"line": "* Has provided a tumor tissue sample either collected from prior cytoreductive surgery or fresh newly obtained tumor tissue at screening.",
"criterions": [
{
"exact_snippets": "provided a tumor tissue sample",
"criterion": "tumor tissue sample",
"requirements": [
{
"requirement_type": "availability",
"expected_value": true
}
]
},
{
"exact_snippets": "collected from prior cytoreductive surgery",
"criterion": "tumor tissue sample source",
"requirements": [
{
"requirement_type": "source",
"expected_value": "prior cytoreductive surgery"
}
]
},
{
"exact_snippets": "fresh newly obtained tumor tissue at screening",
"criterion": "tumor tissue sample source",
"requirements": [
{
"requirement_type": "source",
"expected_value": "fresh newly obtained at screening"
}
]
}
]
},
{
"line": "* Has adequate organ function.",
"criterions": [
{
"exact_snippets": "adequate organ function",
"criterion": "organ function",
"requirements": [
{
"requirement_type": "adequacy",
"expected_value": true
}
]
}
]
},
{
"line": "* Has not recovered from AEs to ≤ Grade 1 or prior treatment level due to a previously administered agent.",
"criterions": [
{
"exact_snippets": "Has not recovered from AEs to ≤ Grade 1",
"criterion": "adverse events (AEs) recovery",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": "<=",
"value": 1,
"unit": "Grade"
}
}
]
}
]
},
{
"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"
}
}
]
}
]
},
{
"line": "Must have maximum age of 75 Years",
"criterions": [
{
"exact_snippets": "maximum age of 75 Years",
"criterion": "age",
"requirements": [
{
"requirement_type": "maximum",
"expected_value": {
"operator": "<=",
"value": 75,
"unit": "Years"
}
}
]
}
]
}
],
"exclusion_lines": [
{
"line": "* Has nonepithelial cancers, borderline tumors, mucinous, seromucinous that is predominantly mucinous, malignant Brenner's tumor and undifferentiated carcinoma.",
"criterions": [
{
"exact_snippets": "nonepithelial cancers",
"criterion": "nonepithelial cancers",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "borderline tumors",
"criterion": "borderline tumors",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "mucinous",
"criterion": "mucinous tumors",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "seromucinous that is predominantly mucinous",
"criterion": "seromucinous tumors",
"requirements": [
{
"requirement_type": "predominance",
"expected_value": "mucinous"
}
]
},
{
"exact_snippets": "malignant Brenner's tumor",
"criterion": "malignant Brenner's tumor",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "undifferentiated carcinoma",
"criterion": "undifferentiated carcinoma",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Has received prior therapy with an anti-programmed cell death (PD)-1, anti-PD-L1, anti-PD-L2 agent or with an agent directed to another co-inhibitory T-cell receptor (e.g. cytotoxic T-lymphocyte-associated antigen-4 [CTLA-4], tumor necrosis factor receptors OX-40 or CD137) or has participated in prior adebrelimab studies.",
"criterions": [
{
"exact_snippets": "Has received prior therapy with an anti-programmed cell death (PD)-1",
"criterion": "prior therapy with anti-PD-1",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Has received prior therapy with ... anti-PD-L1",
"criterion": "prior therapy with anti-PD-L1",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Has received prior therapy with ... anti-PD-L2",
"criterion": "prior therapy with anti-PD-L2",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Has received prior therapy with ... agent directed to another co-inhibitory T-cell receptor",
"criterion": "prior therapy with agent directed to co-inhibitory T-cell receptor",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Has received prior therapy with ... cytotoxic T-lymphocyte-associated antigen-4 [CTLA-4]",
"criterion": "prior therapy with CTLA-4",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Has received prior therapy with ... tumor necrosis factor receptors OX-40",
"criterion": "prior therapy with OX-40",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Has received prior therapy with ... tumor necrosis factor receptors ... CD137",
"criterion": "prior therapy with CD137",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "has participated in prior adebrelimab studies",
"criterion": "participation in prior adebrelimab studies",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Has received prior systemic anticancer therapy including radiation therapy or maintenance therapy within 4 weeks before randomization.",
"criterions": [
{
"exact_snippets": "Has received prior systemic anticancer therapy",
"criterion": "prior systemic anticancer therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "including radiation therapy",
"criterion": "prior radiation therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "maintenance therapy",
"criterion": "prior maintenance therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "within 4 weeks before randomization",
"criterion": "time since last therapy",
"requirements": [
{
"requirement_type": "time since last therapy",
"expected_value": {
"operator": "<=",
"value": 4,
"unit": "weeks"
}
}
]
}
]
},
{
"line": "* Has severe hypersensitivity (≥Grade 3) or uncontrolled hypertension to pegylated liposomal doxorubicin, adebrelimab, mirabegron and any of their excipients.",
"criterions": [
{
"exact_snippets": "severe hypersensitivity (≥Grade 3) ... to pegylated liposomal doxorubicin, adebrelimab, mirabegron and any of their excipients",
"criterion": "hypersensitivity to pegylated liposomal doxorubicin, adebrelimab, mirabegron and any of their excipients",
"requirements": [
{
"requirement_type": "severity",
"expected_value": {
"operator": ">=",
"value": 3,
"unit": "Grade"
}
}
]
},
{
"exact_snippets": "uncontrolled hypertension to pegylated liposomal doxorubicin, adebrelimab, mirabegron and any of their excipients",
"criterion": "hypertension to pegylated liposomal doxorubicin, adebrelimab, mirabegron and any of their excipients",
"requirements": [
{
"requirement_type": "control",
"expected_value": "uncontrolled"
}
]
}
]
},
{
"line": "* Has undergone major surgery within 3 weeks before randomization or has complications/sequelae that have not yet recovered.",
"criterions": [
{
"exact_snippets": "Has undergone major surgery within 3 weeks before randomization",
"criterion": "major surgery",
"requirements": [
{
"requirement_type": "time since surgery",
"expected_value": {
"operator": "<=",
"value": 3,
"unit": "weeks"
}
}
]
},
{
"exact_snippets": "has complications/sequelae that have not yet recovered",
"criterion": "complications/sequelae",
"requirements": [
{
"requirement_type": "recovery status",
"expected_value": false
}
]
}
]
},
{
"line": "* Has a known additional malignancy that progressed or required active treatment within the last 5 years.",
"criterions": [
{
"exact_snippets": "known additional malignancy",
"criterion": "additional malignancy",
"requirements": [
{
"requirement_type": "progression",
"expected_value": true
},
{
"requirement_type": "treatment",
"expected_value": {
"operator": "<=",
"value": 5,
"unit": "years"
}
}
]
}
]
},
{
"line": "* Is pregnant or breastfeeding.",
"criterions": [
{
"exact_snippets": "Is pregnant",
"criterion": "pregnancy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
},
{
"exact_snippets": "breastfeeding",
"criterion": "breastfeeding",
"requirements": [
{
"requirement_type": "presence",
"expected_value": false
}
]
}
]
},
{
"line": "* Has a history of allogenic tissue/solid organ transplant.",
"criterions": [
{
"exact_snippets": "Has a history of allogenic tissue/solid organ transplant.",
"criterion": "allogenic tissue/solid organ transplant",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* Has a history of thrombotic disorders, hemorrhage, hemoptysis, or active gastrointestinal bleeding within 6 months before randomization.",
"criterions": [
{
"exact_snippets": "history of thrombotic disorders",
"criterion": "thrombotic disorders",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "history of ... hemorrhage",
"criterion": "hemorrhage",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "history of ... hemoptysis",
"criterion": "hemoptysis",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "active gastrointestinal bleeding within 6 months before randomization",
"criterion": "gastrointestinal bleeding",
"requirements": [
{
"requirement_type": "activity",
"expected_value": true
},
{
"requirement_type": "time frame",
"expected_value": "within 6 months before randomization"
}
]
}
]
},
{
"line": "* Has a history of active autoimmune disease.",
"criterions": [
{
"exact_snippets": "Has a history of active autoimmune disease.",
"criterion": "autoimmune disease",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
},
{
"requirement_type": "activity",
"expected_value": "active"
}
]
}
]
},
{
"line": "* Has an active infection requiring systemic therapy.",
"criterions": [
{
"exact_snippets": "active infection requiring systemic therapy",
"criterion": "infection",
"requirements": [
{
"requirement_type": "activity",
"expected_value": "active"
},
{
"requirement_type": "treatment",
"expected_value": "systemic therapy"
}
]
}
]
},
{
"line": "* Has a history of human immunodeficiency virus (HIV) infection.",
"criterions": [
{
"exact_snippets": "Has a history of human immunodeficiency virus (HIV) infection.",
"criterion": "HIV infection",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* Has a history of Hepatitis B or C virus infection.",
"criterions": [
{
"exact_snippets": "Has a history of Hepatitis B",
"criterion": "Hepatitis B virus infection",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
},
{
"exact_snippets": "Has a history of ... C virus infection",
"criterion": "Hepatitis C virus infection",
"requirements": [
{
"requirement_type": "history",
"expected_value": true
}
]
}
]
},
{
"line": "* Has a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance that might confound the results of the study.",
"criterions": [
{
"exact_snippets": "Has a history or current evidence of any condition",
"criterion": "condition",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Has a history or current evidence of any ... therapy",
"criterion": "therapy",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Has a history or current evidence of any ... laboratory abnormality",
"criterion": "laboratory abnormality",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "Has a history or current evidence of any ... other circumstance",
"criterion": "other circumstance",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
},
{
"line": "* Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.",
"criterions": [
{
"exact_snippets": "known psychiatric ... disorder",
"criterion": "psychiatric disorder",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
},
{
"exact_snippets": "known ... substance abuse disorder",
"criterion": "substance abuse disorder",
"requirements": [
{
"requirement_type": "presence",
"expected_value": true
}
]
}
]
}
],
"miscellaneous_lines": [],
"failed_inclusion": [],
"failed_exclusion": [],
"failed_miscellaneous": []
}