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.
PD-L1 positivity defined as \u22651% of the tumor cell population demonstrating unequivocal staining for PD-L1.
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PD-L1 positivity defined as \u22651% of the tumor cell population demonstrating unequivocal staining for PD-L1.
"},{"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":"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.
PD-L1 positivity defined as \u22651% of the tumor cell population demonstrating unequivocal staining for PD-L1.
"},{"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":"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.
BRCA-mutant patients were those having BRCA1 or BRCA2 mutations.
"},{"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":{"description":"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.
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","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"}},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/22","value":{"description":"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.
BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.
","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"}},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/23","value":{"description":"OS defined as the time from randomization to death due to any cause, or censored at date last known alive.
BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.
","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"}},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/24","value":{"description":"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.
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","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"}},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/25","value":{"description":"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.
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","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"}},{"op":"add","path":"/protocolSection/outcomesModule/secondaryOutcomes/26","value":{"description":"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.
BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.
","measure":"Time to Objective Response Among BRCA-mutant Patients","timeFrame":"Assessed from randomization to the time of first response, up to 3.5 years"}},{"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":"Carboplatin dosage is AUC 6
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.
PD-L1 positivity defined as \u22651% of the tumor cell population demonstrating unequivocal staining for PD-L1.
"},{"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":"OS defined as the time from randomization to death due to any cause, or censored at date last known alive.
PD-L1 positivity defined as \u22651% of the tumor cell population demonstrating unequivocal staining for PD-L1.
"},{"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":"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.
PD-L1 positivity defined as \u22651% of the tumor cell population demonstrating unequivocal staining for PD-L1.
"},{"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; 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BRCA-mutant patients were those having BRCA1 or BRCA2 mutations.
"},{"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":[{"comment":"Upper bound inestimable due to insufficient sample size/number of events","groupId":"OG001","lowerLimit":"4.74","upperLimit":"NA","value":"4.74"}]}]}]},{"op":"add","path":"/resultsSection/outcomeMeasuresModule/outcomeMeasures/22","value":{"classes":[{"categories":[{"measurements":[{"groupId":"OG001","lowerLimit":"1.3","upperLimit":"98.7","value":"50.0"}]}]}],"denoms":[{"counts":[{"groupId":"OG000","value":"0"},{"groupId":"OG001","value":"2"}],"units":"Participants"}],"description":"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.
BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.
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BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.
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BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.
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BRCA-mutant patients were those with BRCA1 or BRCA2 mutations.
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