Raw JSON Patch
[
{
"op": "replace",
"path": "/protocolSection/statusModule/statusVerifiedDate",
"value": "2023-01"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdateSubmitDate",
"value": "2023-01-03"
},
{
"op": "replace",
"path": "/protocolSection/statusModule/lastUpdatePostDateStruct/date",
"value": "2023-01-26"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstSubmitQcDate",
"value": "2023-01-03"
},
{
"op": "add",
"path": "/protocolSection/statusModule/resultsFirstPostDateStruct",
"value": {
"date": "2023-01-26",
"type": "ACTUAL"
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/description",
"value": "Defined as the time from randomization to the earlier of progression or death due to any cause.\nParticipants alive without disease progression are censored at date of last disease evaluation"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame",
"value": "Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/description",
"value": "Defined as the percentage of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits [i.e., "non-CR/non-PD" in non-target lesions]; and no new lesions) based on RECIST 1.1"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/timeFrame",
"value": "Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/0/reviewUnit"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/timeFrame",
"value": "Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/description",
"value": "Defined as the time from randomization to death due to any cause, or censored at date last known alive"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/timeFrame",
"value": "Assessed from date of randomization until the date of death from any cause, up to 3.5 years"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/2/reviewUnit"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/timeFrame",
"value": "Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/description",
"value": "Defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.\nPatients without events reported are censored at the last disease evaluation."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/timeFrame",
"value": "Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) to the time of first progression, up to 2.75 years"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/4/reviewUnit"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/description",
"value": "Defined as the time from randomization to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/timeFrame",
"value": "Assessed from randomization to the time of first response, up to 3.5 years"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/5/reviewUnit"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/description",
"value": "<p>PFS defined as the time from randomization to the earlier of progression or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation.</p><p>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/timeFrame",
"value": "Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/6/reviewUnit"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/7/timeFrame",
"value": "Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/7/reviewUnit"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/8/timeFrame",
"value": "Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/8/reviewUnit"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/9/description",
"value": "<p>OS defined as the time from randomization to death due to any cause, or censored at date last known alive.</p><p>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/9/timeFrame",
"value": "Assessed from date of randomization until the date of death from any cause, up to 3.5 years"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/9/reviewUnit"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/10/timeFrame",
"value": "Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/10/reviewUnit"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/11/timeFrame",
"value": "Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) to the time of first progression, up to 2.75 years"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/11/reviewUnit"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/12/description",
"value": "<p>TTOR defined as the time from randomization to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded.</p><p>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/12/timeFrame",
"value": "Assessed from randomization to the time of first response, up to 3.5 years"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/12/reviewUnit"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/13/description",
"value": "PFS defined as the time from the start of crossover treatment to the earlier of progression (on crossover therapy) or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation."
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/13/timeFrame",
"value": "Assessed from the start of crossover therapy to the date of first documented progression on crossover therapy or the date of death from any cause, whichever came first, up to 2.8 years"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/13/reviewUnit"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/14/description",
"value": "ORR defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits [i.e., "non-CR/non-PD" in non-target lesions]; and no new lesions) based on RECIST 1.1.,\nduring crossover therapy"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/14/timeFrame",
"value": "Assessed from the start of crossover treatment until disease progression, intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 2.8 years"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/14/reviewUnit"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/15/timeFrame",
"value": "Assessed from the start of crossover treatment until disease progression, intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 2.8 years"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/15/reviewUnit"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/16/timeFrame",
"value": "Assessed from the start of crossover treatment until disease progression, intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 2.8 years"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/16/reviewUnit"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/17/timeFrame",
"value": "Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) on crossover therapy to the time of first progression on crossover therapy, up to 2.5 years"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/17/reviewUnit"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/18/timeFrame",
"value": "Assessed from the start of crossover therapy to the time of first response on crossover therapy, up to 2.8 years"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/18/reviewUnit"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/19/timeFrame",
"value": "Assessed from the start of crossover therapy until the date of death from any cause, up to 2.8 years"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/19/reviewUnit"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/20/measure",
"value": "Progression-free Survival Among BRCA-mutant Patients"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/20/description",
"value": "<p>PFS defined as the time from randomization to the earlier of progression or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation.</p><p>BRCA-mutant patients were those having BRCA1 or BRCA2 mutations.</p>"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/20/timeFrame",
"value": "Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years"
},
{
"op": "remove",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/20/reviewUnit"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/21",
"value": {
"measure": "Objective Response Rate by RECIST 1.1 Among BRCA-mutant Patients",
"timeFrame": "Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years",
"description": "<p>ORR defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits [i.e., "non-CR/non-PD" in non-target lesions]; and no new lesions) based on RECIST 1.1.</p><p>BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.</p>"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/22",
"value": {
"measure": "Objective Response Rate by irRC Among BRCA-mutant Patients",
"timeFrame": "Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years",
"description": "<p>ORR by irRC defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters [irSPD] of 50% or greater) based on irRC.</p><p>BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.</p>"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/23",
"value": {
"measure": "Overall Survival Among BRCA-mutant Patients",
"timeFrame": "From date of randomization until the date of death from any cause, assessed up to 3.5 years",
"description": "<p>OS defined as the time from randomization to death due to any cause, or censored at date last known alive.</p><p>BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.</p>"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/24",
"value": {
"measure": "Clinical Benefit Rate Among BRCA-mutant Patients",
"timeFrame": "Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years",
"description": "<p>CBR defined as the percentage of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks.</p><p>BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.</p>"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/25",
"value": {
"measure": "Duration of Response Among BRCA-mutant Patients",
"timeFrame": "Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) to the time of first progression, up to 3.5 years",
"description": "<p>DOR defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.\nPatients without events reported are censored at the last disease evaluation.</p><p>BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.</p>"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/26",
"value": {
"measure": "Time to Objective Response Among BRCA-mutant Patients",
"timeFrame": "Assessed from randomization to the time of first response, up to 3.5 years",
"description": "<p>TTOR defined as the time from randomization to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded.</p><p>BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.</p>"
}
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/groups/1/title",
"value": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/groups/1/description",
"value": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) before the protocol amendment continued to receive nivolumab monotherapy after the amendment, rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/milestones/0/achievements/0/comment",
"value": "39 patients were randomized to Arm A"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/milestones/0/achievements/0/numSubjects",
"value": "39"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/milestones/0/achievements/1/comment",
"value": "39 patients were randomized to Arm B"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/milestones/0/achievements/1/numSubjects",
"value": "39"
},
{
"op": "add",
"path": "/resultsSection/participantFlowModule/periods/0/milestones/1",
"value": {
"type": "Started Treatment",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "37"
},
{
"groupId": "FG001",
"numSubjects": "38"
}
]
}
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/milestones/3/achievements/0/numSubjects",
"value": "39"
},
{
"op": "replace",
"path": "/resultsSection/participantFlowModule/periods/0/milestones/3/achievements/1/numSubjects",
"value": "39"
},
{
"op": "add",
"path": "/resultsSection/participantFlowModule/periods/0/dropWithdraws/9",
"value": {
"type": "Never started protocol therapy",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "2"
},
{
"groupId": "FG001",
"numSubjects": "1"
}
]
}
},
{
"op": "remove",
"path": "/resultsSection/participantFlowModule/periods/0/reviewUnit"
},
{
"op": "replace",
"path": "/resultsSection/baselineCharacteristicsModule/groups/1/title",
"value": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion"
},
{
"op": "replace",
"path": "/resultsSection/baselineCharacteristicsModule/measures/9/classes/0/categories/0/title",
"value": "0-Fully active, able to carry on pre-disease performance without restriction"
},
{
"op": "replace",
"path": "/resultsSection/baselineCharacteristicsModule/measures/9/classes/0/categories/1/title",
"value": "1-Restricted in strenuous physical activity but able to perform work of a light or sedentary nature"
},
{
"op": "remove",
"path": "/resultsSection/baselineCharacteristicsModule/measures/9/reviewUnit"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/description",
"value": "Defined as the time from randomization to the earlier of progression or death due to any cause.\nParticipants alive without disease progression are censored at date of last disease evaluation"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/timeFrame",
"value": "Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/groups/1/title",
"value": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/0/reviewUnit"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/description",
"value": "Defined as the percentage of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits [i.e., "non-CR/non-PD" in non-target lesions]; and no new lesions) based on RECIST 1.1"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/unitOfMeasure",
"value": "percent of patients"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/timeFrame",
"value": "Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/groups/1/title",
"value": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/1/reviewUnit"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/unitOfMeasure",
"value": "percent of patients"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/timeFrame",
"value": "Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/groups/1/title",
"value": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/2/reviewUnit"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/description",
"value": "Defined as the time from randomization to death due to any cause, or censored at date last known alive"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/timeFrame",
"value": "Assessed from date of randomization until the date of death from any cause, up to 3.5 years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/groups/1/title",
"value": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/3/reviewUnit"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/unitOfMeasure",
"value": "percent of patients"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/timeFrame",
"value": "Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/groups/1/title",
"value": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/4/reviewUnit"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/description",
"value": "Defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.\nPatients without events reported are censored at the last disease evaluation."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/timeFrame",
"value": "Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) to the time of first progression, up to 2.75 years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/groups/1/title",
"value": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/5/reviewUnit"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/description",
"value": "Defined as the time from randomization to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/timeFrame",
"value": "Assessed from randomization to the time of first response, up to 3.5 years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/groups/1/title",
"value": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/6/reviewUnit"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/description",
"value": "<p>PFS defined as the time from randomization to the earlier of progression or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation.</p><p>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/timeFrame",
"value": "Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/groups/1/title",
"value": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/7/reviewUnit"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/unitOfMeasure",
"value": "percent of patients"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/timeFrame",
"value": "Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/groups/1/title",
"value": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/8/reviewUnit"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/unitOfMeasure",
"value": "percent of patients"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/timeFrame",
"value": "Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/groups/1/title",
"value": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/9/reviewUnit"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/10/description",
"value": "<p>OS defined as the time from randomization to death due to any cause, or censored at date last known alive.</p><p>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/10/timeFrame",
"value": "Assessed from date of randomization until the date of death from any cause, up to 3.5 years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/10/groups/1/title",
"value": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/10/reviewUnit"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/11/unitOfMeasure",
"value": "percent of patients"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/11/timeFrame",
"value": "Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/11/groups/1/title",
"value": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/11/reviewUnit"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/12/timeFrame",
"value": "Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) to the time of first progression, up to 2.75 years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/12/groups/1/title",
"value": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/12/reviewUnit"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/13/description",
"value": "<p>TTOR defined as the time from randomization to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded.</p><p>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/13/timeFrame",
"value": "Assessed from randomization to the time of first response, up to 3.5 years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/13/groups/1/title",
"value": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/13/reviewUnit"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/14/description",
"value": "PFS defined as the time from the start of crossover treatment to the earlier of progression (on crossover therapy) or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/14/timeFrame",
"value": "Assessed from the start of crossover therapy to the date of first documented progression on crossover therapy or the date of death from any cause, whichever came first, up to 2.8 years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/14/groups/1/title",
"value": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/14/reviewUnit"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/15/description",
"value": "ORR defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits [i.e., "non-CR/non-PD" in non-target lesions]; and no new lesions) based on RECIST 1.1.,\nduring crossover therapy"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/15/unitOfMeasure",
"value": "percent of patients"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/15/timeFrame",
"value": "Assessed from the start of crossover treatment until disease progression, intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 2.8 years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/15/groups/1/title",
"value": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/15/reviewUnit"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/16/unitOfMeasure",
"value": "percent of patients"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/16/timeFrame",
"value": "Assessed from the start of crossover treatment until disease progression, intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 2.8 years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/16/groups/1/title",
"value": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/16/reviewUnit"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/17/unitOfMeasure",
"value": "percent of patients"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/17/timeFrame",
"value": "Assessed from the start of crossover treatment until disease progression, intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 2.8 years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/17/groups/1/title",
"value": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/17/reviewUnit"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/18/timeFrame",
"value": "Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) on crossover therapy to the time of first progression on crossover therapy, up to 2.5 years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/18/groups/1/title",
"value": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/18/reviewUnit"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/19/timeFrame",
"value": "Assessed from the start of crossover therapy to the time of first response on crossover therapy, up to 2.8 years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/19/groups/1/title",
"value": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/19/reviewUnit"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/20/timeFrame",
"value": "Assessed from the start of crossover therapy until the date of death from any cause, up to 2.8 years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/20/groups/1/title",
"value": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/20/reviewUnit"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/21/title",
"value": "Progression-free Survival Among BRCA-mutant Patients"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/21/description",
"value": "<p>PFS defined as the time from randomization to the earlier of progression or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation.</p><p>BRCA-mutant patients were those having BRCA1 or BRCA2 mutations.</p>"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/21/populationDescription",
"value": "A total of 2 patients in the ITT population had BRCA1 or BRCA2 mutations."
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/21/timeFrame",
"value": "Assessed from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, up to 3.5 years"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/21/groups/1/title",
"value": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion"
},
{
"op": "replace",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/21/denoms/0/counts/1/value",
"value": "2"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/21/reviewUnit"
},
{
"op": "remove",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/21/measureCategoriesReviewUnit"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/21/paramType",
"value": "MEDIAN"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/21/dispersionType",
"value": "95% Confidence Interval"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/21/unitOfMeasure",
"value": "months"
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/21/classes",
"value": [
{
"categories": [
{
"measurements": [
{
"value": "4.74",
"comment": "Upper bound inestimable due to insufficient sample size/number of events",
"groupId": "OG001",
"lowerLimit": "4.74",
"upperLimit": "NA"
}
]
}
]
}
]
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/22",
"value": {
"type": "SECONDARY",
"title": "Objective Response Rate by RECIST 1.1 Among BRCA-mutant Patients",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "2",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab",
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>"
},
{
"id": "OG001",
"title": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion",
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) before the protocol amendment continued to receive nivolumab monotherapy after the amendment, rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "50.0",
"groupId": "OG001",
"lowerLimit": "1.3",
"upperLimit": "98.7"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years",
"description": "<p>ORR defined as the proportion of patients achieving a complete response (complete disappearance of all target and non-target lesions; no new lesions) or partial response (at least 30% decrease in the sum of the diameters of target lesions; persistence of one or more non-target lesion(s) and/or maintenance of tumor marker level above the normal limits [i.e., "non-CR/non-PD" in non-target lesions]; and no new lesions) based on RECIST 1.1.</p><p>BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.</p>",
"unitOfMeasure": "percent of patients",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "A total of 2 patients in the ITT population had BRCA1 or BRCA2 mutations."
}
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/23",
"value": {
"type": "SECONDARY",
"title": "Objective Response Rate by irRC Among BRCA-mutant Patients",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "0",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab",
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>"
},
{
"id": "OG001",
"title": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion",
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) before the protocol amendment continued to receive nivolumab monotherapy after the amendment, rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"timeFrame": "Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years",
"description": "<p>ORR by irRC defined as the proportion of patients achieving an immune-related complete response (complete disappearance of all target and non-target lesions; no new measurable/unmeasurable lesions) or immune-related partial response (a decrease of the immune-related sum of product diameters [irSPD] of 50% or greater) based on irRC.</p><p>BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.</p>",
"reportingStatus": "POSTED",
"populationDescription": "There were 0 patients treated with immunotherapy (on Arm A) and had BRCA1 or BRCA2 mutations in the ITT population."
}
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/24",
"value": {
"type": "SECONDARY",
"title": "Overall Survival Among BRCA-mutant Patients",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "2",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab",
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>"
},
{
"id": "OG001",
"title": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion",
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) before the protocol amendment continued to receive nivolumab monotherapy after the amendment, rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "24.4",
"comment": "Bounds inestimable due to insufficient sample size/number of events",
"groupId": "OG001",
"lowerLimit": "NA",
"upperLimit": "NA"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "From date of randomization until the date of death from any cause, assessed up to 3.5 years",
"description": "<p>OS defined as the time from randomization to death due to any cause, or censored at date last known alive.</p><p>BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.</p>",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "A total of 2 patients in the ITT population had BRCA1 or BRCA2 mutations."
}
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/25",
"value": {
"type": "SECONDARY",
"title": "Clinical Benefit Rate Among BRCA-mutant Patients",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "2",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab",
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>"
},
{
"id": "OG001",
"title": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion",
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) before the protocol amendment continued to receive nivolumab monotherapy after the amendment, rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "50.0",
"groupId": "OG001",
"lowerLimit": "1.3",
"upperLimit": "98.7"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "Assessed from the start of treatment until disease progression, complete response (after at least 24 weeks of treatment), intercurrent illness, unacceptable toxicity, noncompliance/withdrawal, or general/specific worsening of condition, up to 3.5 years",
"description": "<p>CBR defined as the percentage of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks.</p><p>BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.</p>",
"unitOfMeasure": "percent of patients",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "A total of 2 patients in the ITT population had BRCA1 or BRCA2 mutations."
}
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/26",
"value": {
"type": "SECONDARY",
"title": "Duration of Response Among BRCA-mutant Patients",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "1",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab",
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>"
},
{
"id": "OG001",
"title": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion",
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) before the protocol amendment continued to receive nivolumab monotherapy after the amendment, rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "2.04",
"comment": "Bounds inestimable due to insufficient sample size/number of events",
"groupId": "OG001",
"lowerLimit": "NA",
"upperLimit": "NA"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "Assessed from the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) to the time of first progression, up to 3.5 years",
"description": "<p>DOR defined as the time measurement criteria are met for CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.\nPatients without events reported are censored at the last disease evaluation.</p><p>BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.</p>",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Only 1 patient in the ITT cohort that had a BRCA1 or BRCA2 mutation also achieved objective response."
}
},
{
"op": "add",
"path": "/resultsSection/outcomeMeasuresModule/outcomeMeasures/27",
"value": {
"type": "SECONDARY",
"title": "Time to Objective Response Among BRCA-mutant Patients",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "2",
"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
"title": "Arm A: Carboplatin + Nivolumab",
"description": "<ul><li>Nivolumab is administered every three weeks intravenously</li><li>Nivolumab dosage is 360mg</li><li>Carboplatin is administered every three weeks intravenously</li><li>Carboplatin dosage is AUC 6</li></ul>"
},
{
"id": "OG001",
"title": "Arm B: Carboplatin, Then Nivolumab +/- Nab-paclitaxel After Progression, Per Physician Discretion",
"description": "<ul><li>Carboplatin is administered every three weeks intravenously</li><li><p>Carboplatin dosage is AUC 6</p><ul><li>Upon disease progression, patients on Arm B had the opportunity to cross over to receive single-agent nivolumab (pre-amendment), or combination nivolumab plus nab-paclitaxel (post-amendment); patients that were active on the original crossover treatment (nivolumab monotherapy) before the protocol amendment continued to receive nivolumab monotherapy after the amendment, rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "3.2",
"comment": "Upper bound inestimable due to insufficient sample size/number of events",
"groupId": "OG001",
"lowerLimit": "3.2",
"upperLimit": "NA"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "Assessed from randomization to the time of first response, up to 3.5 years",
"description": "<p>TTOR defined as the time from randomization to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded.</p><p>BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.</p>",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "A total of 2 patients in the ITT population had BRCA1 or BRCA2 mutations."
}
},
{
"op": "replace",
"path": "/resultsSection/adverseEventsModule/timeFrame",
"value": "Adverse event data were collected on the first day of each cycle of treatment, as well as at the end of treatment, for both arms, up to 3.5 years. Additionally, patients on Arm A and crossover patients (only) had an adverse events assessment 100 days (-15/+30 days) after the last dose of nivolumab, up to 3.5 years."
},
{
"op": "remove",
"path": "/resultsSection/adverseEventsModule/reviewUnit"
},
{
"op": "remove",
"path": "/annotationSection"
}
]