NCT03414684
Version 18 to 19 · Dana-Farber Cancer Institute
Patch inspector
Manual review pending.
None recorded.
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] 5bb4fb7278525519877fd45f8b780968a97e2fc55518719fe237b174a7c7b76e/protocolSection/outcomesModule/primaryOutcomes/0/measure primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. Progression-free survival
Progression-free Survival
/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit primary_outcome_any_change Any add/remove/replace under primary outcome measures is critical review priority. {
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Objective Response Rate by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1
/protocolSection/outcomesModule/secondaryOutcomes/0/reviewUnit secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
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} /protocolSection/outcomesModule/secondaryOutcomes/1/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Objective response rate by Immune-Related Response Criteria (irRC)
Objective Response Rate by Immune-Related Response Criteria (irRC)
/protocolSection/outcomesModule/secondaryOutcomes/1/reviewUnit secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
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Overall Survival
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Clinical Benefit Rate
/protocolSection/outcomesModule/secondaryOutcomes/3/reviewUnit secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
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Duration of Response
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Time to Objective Response
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} /protocolSection/outcomesModule/secondaryOutcomes/6/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Efficacy among PD-L1-positive patients
Progression-free Survival Among PD-L1-positive Patients
/protocolSection/outcomesModule/secondaryOutcomes/6/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. PFS, ORR according to RECIST 1.1 and irRC, CBR, DOR, TTOR and OS, among patients with PD-L1-positive disease, defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1 (all efficacy endpoints defined as above in outcomes 1-7)
<p>PFS defined as the time from randomization (or registration) 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>
/protocolSection/outcomesModule/secondaryOutcomes/6/reviewUnit secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
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} /protocolSection/outcomesModule/secondaryOutcomes/7/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Efficacy among BRCA-mutant patients
Objective Response Rate by RECIST 1.1 Among PD-L1-positive Patients
/protocolSection/outcomesModule/secondaryOutcomes/7/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. PFS, ORR according to RECIST 1.1 and irRC, CBR, DOR, TTOR and OS, among patients with germline BRCA1 or BRCA2 mutations (all efficacy endpoints defined as above in outcomes 1-7)
<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>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>
/protocolSection/outcomesModule/secondaryOutcomes/7/reviewUnit secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
} /protocolSection/outcomesModule/secondaryOutcomes/8/measure secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. Efficacy of nab-paclitaxel during second-course therapy, among crossover patients
Objective Response Rate by irRC Among PD-L1-positive Patients
/protocolSection/outcomesModule/secondaryOutcomes/8/description secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. PFS, ORR according to RECIST 1.1 and irRC, CBR, DOR, TTOR and OS among patients who crossover to receive nab-paclitaxel + nivolumab + carboplatin after progression on carboplatin alone (all efficacy endpoints defined as above in outcomes 1-7)
<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>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>
/protocolSection/outcomesModule/secondaryOutcomes/8/reviewUnit secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
} /protocolSection/outcomesModule/secondaryOutcomes/9 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Overall Survival Among PD-L1-positive Patients",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "<p>OS defined as the time from randomization (or registration) 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>"
} /protocolSection/outcomesModule/secondaryOutcomes/10 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Clinical Benefit Rate Among PD-L1-positive Patients",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "<p>CBR defined as the proportion 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>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>"
} /protocolSection/outcomesModule/secondaryOutcomes/11 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Duration of Response Among PD-L1-positive Patients",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"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>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>"
} /protocolSection/outcomesModule/secondaryOutcomes/12 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Time to Objective Response Among PD-L1-positive Patients",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "<p>TTOR defined as the time from registration 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>"
} /protocolSection/outcomesModule/secondaryOutcomes/13 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Second-course Progression-free Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "PFS defined as the time from the start of crossover treatment to the earlier of progression (on second-course therapy) or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation."
} /protocolSection/outcomesModule/secondaryOutcomes/14 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Second-course Objective Response Rate by RECIST 1.1 Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"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.,\nduring second-course therapy"
} /protocolSection/outcomesModule/secondaryOutcomes/15 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Second-course Objective Response Rate by irRC Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"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, during second-course therapy"
} /protocolSection/outcomesModule/secondaryOutcomes/16 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Second-course Clinical Benefit Rate Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "CBR defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks, during second course therapy"
} /protocolSection/outcomesModule/secondaryOutcomes/17 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Second-course Duration of Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "DOR defined as the time measurement criteria are met for second-course CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented thereafter.\nPatients without events reported are censored at the last disease evaluation."
} /protocolSection/outcomesModule/secondaryOutcomes/18 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Second-course Time to Objective Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "TTOR defined as the time from start of crossover treatment to the date of the first documented CR or PR by RECIST 1.1 on second-course therapy, whichever is first recorded"
} /protocolSection/outcomesModule/secondaryOutcomes/19 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Second-course Overall Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "Second-course OS defined as the time from the start of crossover treatment to death due from any cause, or censored at date last known alive."
} /protocolSection/outcomesModule/secondaryOutcomes/20 secondary_outcome_any_change Any add/remove/replace under secondary outcome measures is high review priority. {
"measure": "Efficacy Among BRCA-mutant Patients",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "PFS, ORR according to RECIST 1.1 and irRC, CBR, DOR, TTOR and OS, among patients with germline BRCA1 or BRCA2 mutations (all efficacy endpoints defined as above)"
} /protocolSection/statusModule/statusVerifiedDate 2022-10
2022-11
/protocolSection/statusModule/lastUpdateSubmitDate 2022-10-03
2022-11-11
/protocolSection/statusModule/lastUpdatePostDateStruct/date 2022-10-05
2022-12-12
/protocolSection/statusModule/resultsFirstSubmitDate 2022-11-11
/hasResults false
true
/resultsSection {
"moreInfoModule": {
"pointOfContact": {
"email": "Sara_Tolaney@dfci.harvard.edu",
"phone": "617-632-5743",
"title": "Sara Tolaney, MD, MPH",
"organization": "Dana-Farber Cancer Institute"
},
"certainAgreement": {
"piSponsorEmployee": true
}
},
"adverseEventsModule": {
"timeFrame": "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. 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.",
"reviewUnit": {
"resetReasons": [
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]
},
"description": "<p>An SAE is any untoward medical occurrence that:</p><ul><li>results in death</li><li>is life-threatening (i.e., participant was at risk of death at the time of the event)</li><li>requires hospitalization or prolongs existing hospitalization</li><li>results in persistent/significant disability/incapacity</li><li>is a congenital anomaly/birth defect</li><li>is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)</li></ul>",
"eventGroups": [
{
"id": "EG000",
"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>",
"otherNumAtRisk": 37,
"deathsNumAtRisk": 37,
"otherNumAffected": 37,
"seriousNumAtRisk": 37,
"deathsNumAffected": 24,
"seriousNumAffected": 10
},
{
"id": "EG001",
"title": "Arm B: Carboplatin",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"otherNumAtRisk": 38,
"deathsNumAtRisk": 38,
"otherNumAffected": 38,
"seriousNumAtRisk": 38,
"deathsNumAffected": 17,
"seriousNumAffected": 11
},
{
"id": "EG002",
"title": "Arm B: Carboplatin -- Crossover",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"otherNumAtRisk": 18,
"deathsNumAtRisk": 18,
"otherNumAffected": 18,
"seriousNumAtRisk": 18,
"deathsNumAffected": 10,
"seriousNumAffected": 6
}
],
"otherEvents": [
{
"term": "Anemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 25
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 20
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 8
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Blood and lymphatic system disorders - Other, specify",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 4
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 2
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Atrial fibrillation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 2
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 0
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Tinnitus",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 4
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 0
}
],
"organSystem": "Ear and labyrinth disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypothyroidism",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 11
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 3
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 2
}
],
"organSystem": "Endocrine disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Blurred vision",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 0
}
],
"organSystem": "Eye disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Abdominal pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 2
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 3
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Colitis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 0
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Constipation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 18
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 14
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 4
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Diarrhea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 11
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 7
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 9
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Gastroesophageal reflux disease",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 3
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 2
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hemorrhoids",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 0
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Mucositis oral",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 0
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Nausea",
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"term": "Vomiting",
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},
{
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},
{
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],
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},
{
"term": "Back pain",
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},
{
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{
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],
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},
{
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},
{
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],
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},
{
"term": "Enterocolitis",
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{
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],
"organSystem": "Gastrointestinal disorders",
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},
{
"term": "Small intestinal obstruction",
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"groupId": "EG000",
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},
{
"groupId": "EG001",
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],
"organSystem": "Gastrointestinal disorders",
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},
{
"term": "Flu like symptoms",
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"groupId": "EG000",
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},
{
"groupId": "EG001",
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],
"organSystem": "General disorders",
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},
{
"term": "Spinal fracture",
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{
"groupId": "EG000",
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"numAffected": 0
},
{
"groupId": "EG001",
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{
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}
],
"organSystem": "Injury, poisoning and procedural complications",
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},
{
"term": "Pneumonitis",
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{
"groupId": "EG000",
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"numAffected": 0
},
{
"groupId": "EG001",
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{
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],
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}
],
"frequencyThreshold": "5"
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"type": "PRIMARY",
"title": "Progression-free Survival",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "32",
"groupId": "OG000"
},
{
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"groupId": "OG001"
}
]
}
],
"groups": [
{
"id": "OG000",
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},
{
"id": "OG001",
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}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "4.2",
"groupId": "OG000",
"lowerLimit": "2.7",
"upperLimit": "11.5"
},
{
"value": "5.5",
"groupId": "OG001",
"lowerLimit": "4.4",
"upperLimit": "19.2"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.88",
"groupIds": [
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"OG001"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.95",
"ciLowerLimit": "0.49",
"ciUpperLimit": "1.84",
"estimateComment": "Reference level is Arm B, such that hazard ratio corresponds to the effect of treatment on Arm A",
"statisticalMethod": "Log Rank",
"nonInferiorityType": "SUPERIORITY",
"statisticalComment": "stratified log rank test"
}
],
"paramType": "MEDIAN",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame.",
"One or more of these comments also apply to other measures in the record."
]
},
"description": "Defined as the time from randomization (or registration) to the earlier of progression or death due to any cause.\nParticipants alive without disease progression are censored at date of last disease evaluation",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "The primary efficacy analysis was conducted in the intention-to-treat (ITT) population, which denotes the 62 patients who had 0 prior lines of treatment for advanced disease prior to enrollment."
},
{
"type": "SECONDARY",
"title": "Objective Response Rate by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "32",
"groupId": "OG000"
},
{
"value": "30",
"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",
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}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "25.0",
"groupId": "OG000",
"lowerLimit": "11.5",
"upperLimit": "43.4"
},
{
"value": "23.3",
"groupId": "OG001",
"lowerLimit": "9.9",
"upperLimit": "42.3"
}
]
}
]
}
],
"analyses": [
{
"pValue": "1",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Odds Ratio (OR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "1.09",
"ciLowerLimit": "0.29",
"ciUpperLimit": "4.18",
"estimateComment": "Reference level is Arm B, such that the odds ratio corresponds to the effect of treatment on Arm A",
"statisticalMethod": "Fisher Exact",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "NUMBER",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "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",
"unitOfMeasure": "percent of patients achieving response",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "The primary efficacy analysis was conducted in the intention-to-treat (ITT) population, which denotes the 62 patients who had 0 prior lines of treatment for advanced disease prior to enrollment."
},
{
"type": "SECONDARY",
"title": "Objective Response Rate by Immune-Related Response Criteria (irRC)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "32",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "28.1",
"groupId": "OG000",
"lowerLimit": "13.7",
"upperLimit": "46.7"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "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",
"unitOfMeasure": "percent of patients with IR response",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "First-course objective response rate by irRC was only evaluated in the 32 patients that received immunotherapy (on Arm A) in the ITT population.\nBecause of this, statistical testing by arm was not performed."
},
{
"type": "SECONDARY",
"title": "Overall Survival",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "32",
"groupId": "OG000"
},
{
"value": "30",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "16.8",
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG000",
"lowerLimit": "10.4",
"upperLimit": "NA"
},
{
"value": "11.1",
"groupId": "OG001",
"lowerLimit": "8.2",
"upperLimit": "24.4"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.49",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.80",
"ciLowerLimit": "0.43",
"ciUpperLimit": "1.50",
"estimateComment": "Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A",
"statisticalMethod": "Log Rank",
"nonInferiorityType": "SUPERIORITY",
"statisticalComment": "stratified log rank test"
}
],
"paramType": "MEDIAN",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "Defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "The primary efficacy analysis was conducted in the intention-to-treat (ITT) population, which denotes the 62 patients who had 0 prior lines of treatment for advanced disease prior to enrollment."
},
{
"type": "SECONDARY",
"title": "Clinical Benefit Rate",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "32",
"groupId": "OG000"
},
{
"value": "30",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "34.4",
"groupId": "OG000",
"lowerLimit": "18.6",
"upperLimit": "53.2"
},
{
"value": "33.3",
"groupId": "OG001",
"lowerLimit": "17.3",
"upperLimit": "52.8"
}
]
}
]
}
],
"analyses": [
{
"pValue": "1",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Odds Ratio (OR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "1.05",
"ciLowerLimit": "0.32",
"ciUpperLimit": "3.43",
"estimateComment": "Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A",
"statisticalMethod": "Fisher Exact",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "NUMBER",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "Defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks",
"unitOfMeasure": "percent of patients achieving benefit",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "The primary efficacy analysis was conducted in the intention-to-treat (ITT) population, which denotes the 62 patients who had 0 prior lines of treatment for advanced disease prior to enrollment."
},
{
"type": "SECONDARY",
"title": "Duration of Response",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "7",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "19.3",
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG000",
"lowerLimit": "16.8",
"upperLimit": "NA"
},
{
"value": "7.7",
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG001",
"lowerLimit": "2.7",
"upperLimit": "NA"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.36",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.53",
"ciLowerLimit": "0.13",
"ciUpperLimit": "2.12",
"estimateComment": "Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A",
"statisticalMethod": "Log Rank",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "MEDIAN",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "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",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Duration of response was analyzed among the total 15 patients who achieved objective response in the ITT population."
},
{
"type": "SECONDARY",
"title": "Time to Objective Response",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "32",
"groupId": "OG000"
},
{
"value": "30",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "4.6",
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG000",
"lowerLimit": "4.0",
"upperLimit": "NA"
},
{
"value": "11.2",
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG001",
"lowerLimit": "4.7",
"upperLimit": "NA"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.68",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "1.24",
"ciLowerLimit": "0.43",
"ciUpperLimit": "3.43",
"estimateComment": "Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A",
"statisticalMethod": "Log Rank",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "MEDIAN",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "Defined as the time from registration to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "The primary efficacy analysis was conducted in the intention-to-treat (ITT) population, which denotes the 62 patients who had 0 prior lines of treatment for advanced disease prior to enrollment."
},
{
"type": "SECONDARY",
"title": "Progression-free Survival Among PD-L1-positive Patients",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "13",
"groupId": "OG000"
},
{
"value": "11",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "8.3",
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG000",
"lowerLimit": "2.5",
"upperLimit": "NA"
},
{
"value": "4.7",
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG001",
"lowerLimit": "1.6",
"upperLimit": "NA"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.27",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.54",
"ciLowerLimit": "0.18",
"ciUpperLimit": "1.62",
"estimateComment": "Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A",
"statisticalMethod": "Log Rank",
"nonInferiorityType": "SUPERIORITY",
"statisticalComment": "stratified log rank test"
}
],
"paramType": "MEDIAN",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "<p>PFS defined as the time from randomization (or registration) 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>",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "A total of 24 patients were PD-L1-positive in the ITT population."
},
{
"type": "SECONDARY",
"title": "Objective Response Rate by RECIST 1.1 Among PD-L1-positive Patients",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "13",
"groupId": "OG000"
},
{
"value": "11",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "23.1",
"groupId": "OG000",
"lowerLimit": "5.0",
"upperLimit": "53.8"
},
{
"value": "27.3",
"groupId": "OG001",
"lowerLimit": "6.0",
"upperLimit": "61.0"
}
]
}
]
}
],
"analyses": [
{
"pValue": "1",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Odds Ratio (OR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.81",
"ciLowerLimit": "0.08",
"ciUpperLimit": "7.78",
"estimateComment": "Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A",
"statisticalMethod": "Fisher Exact",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "NUMBER",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"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>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>",
"unitOfMeasure": "percent of patients achieving response",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "A total of 24 patients were PD-L1-positive in the ITT population."
},
{
"type": "SECONDARY",
"title": "Objective Response Rate by irRC Among PD-L1-positive Patients",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "13",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "30.8",
"groupId": "OG000",
"lowerLimit": "9.1",
"upperLimit": "61.4"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"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>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>",
"unitOfMeasure": "percent of patients with IR response",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "A total of 13 patients were treated with immunotherapy (on Arm A) and were PD-L1-positive in the ITT population.\nBecause first-course irORR was only assessed for patients on Arm A, no statistical testing by arm was performed."
},
{
"type": "SECONDARY",
"title": "Overall Survival Among PD-L1-positive Patients",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "13",
"groupId": "OG000"
},
{
"value": "11",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "17.6",
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG000",
"lowerLimit": "4.9",
"upperLimit": "NA"
},
{
"value": "10.7",
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG001",
"lowerLimit": "6.7",
"upperLimit": "NA"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.61",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.75",
"ciLowerLimit": "0.26",
"ciUpperLimit": "2.16",
"estimateComment": "Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A",
"statisticalMethod": "Log Rank",
"nonInferiorityType": "SUPERIORITY",
"statisticalComment": "stratified log rank test"
}
],
"paramType": "MEDIAN",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "<p>OS defined as the time from randomization (or registration) 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>",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "A total of 24 patients were PD-L1-positive in the ITT population."
},
{
"type": "SECONDARY",
"title": "Clinical Benefit Rate Among PD-L1-positive Patients",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "13",
"groupId": "OG000"
},
{
"value": "11",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "30.8",
"groupId": "OG000",
"lowerLimit": "9.1",
"upperLimit": "61.4"
},
{
"value": "36.4",
"groupId": "OG001",
"lowerLimit": "10.9",
"upperLimit": "69.2"
}
]
}
]
}
],
"analyses": [
{
"pValue": "1",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Odds Ratio (OR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.79",
"ciLowerLimit": "0.10",
"ciUpperLimit": "5.93",
"estimateComment": "Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A",
"statisticalMethod": "Fisher Exact",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "NUMBER",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "<p>CBR defined as the proportion 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>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>",
"unitOfMeasure": "percent of patients achieving benefit",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "A total of 24 patients were PD-L1-positive in the ITT population."
},
{
"type": "SECONDARY",
"title": "Duration of Response Among PD-L1-positive Patients",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "3",
"groupId": "OG000"
},
{
"value": "3",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "16.8",
"comment": "Bounds inestimable due to insufficient sample size/number of events",
"groupId": "OG000",
"lowerLimit": "NA",
"upperLimit": "NA"
},
{
"value": "4.9",
"comment": "Upper bound inestimable due to insufficient sample size/number of events",
"groupId": "OG001",
"lowerLimit": "2.0",
"upperLimit": "NA"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"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>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Duration of response was assessed only among the 6 PD-L1-positive patients in the ITT population who achieved objective response.\nDue to insufficient sample size, statistical testing by arm was not performed."
},
{
"type": "SECONDARY",
"title": "Time to Objective Response Among PD-L1-positive Patients",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "13",
"groupId": "OG000"
},
{
"value": "11",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "NA",
"comment": "Median and upper bound inestimable due to insufficient number of responses",
"groupId": "OG000",
"lowerLimit": "3.4",
"upperLimit": "NA"
},
{
"value": "NA",
"comment": "Median and upper bound inestimable due to insufficient number of responses",
"groupId": "OG001",
"lowerLimit": "3.0",
"upperLimit": "NA"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.73",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.75",
"ciLowerLimit": "0.14",
"ciUpperLimit": "3.89",
"estimateComment": "Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A",
"statisticalMethod": "Log Rank",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "MEDIAN",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "<p>TTOR defined as the time from registration 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>",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "A total of 24 patients were PD-L1-positive in the ITT population."
},
{
"type": "SECONDARY",
"title": "Second-course Progression-free Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "10",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "4.1",
"comment": "Upper bound inestimable due to insufficient sample size / number of events",
"groupId": "OG001",
"lowerLimit": "1.9",
"upperLimit": "NA"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "PFS defined as the time from the start of crossover treatment to the earlier of progression (on second-course therapy) or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation.",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "10 patients in the ITT population who were initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab"
},
{
"type": "SECONDARY",
"title": "Second-course Objective Response Rate by RECIST 1.1 Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "10",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "20.0",
"groupId": "OG001",
"lowerLimit": "2.5",
"upperLimit": "55.6"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"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.,\nduring second-course therapy",
"unitOfMeasure": "percent of patients achieving response",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab"
},
{
"type": "SECONDARY",
"title": "Second-course Objective Response Rate by irRC Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "10",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "20.0",
"groupId": "OG001",
"lowerLimit": "2.5",
"upperLimit": "55.6"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"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, during second-course therapy",
"unitOfMeasure": "percent of patients with IR response",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab"
},
{
"type": "SECONDARY",
"title": "Second-course Clinical Benefit Rate Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "10",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "30.0",
"groupId": "OG001",
"lowerLimit": "6.7",
"upperLimit": "65.2"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "CBR defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks, during second course therapy",
"unitOfMeasure": "percent of patients achieving benefit",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab"
},
{
"type": "SECONDARY",
"title": "Second-course Duration of Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "1.81",
"comment": "Upper bound inestimable due to insufficient sample size",
"groupId": "OG001",
"lowerLimit": "1.81",
"upperLimit": "NA"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "DOR defined as the time measurement criteria are met for second-course CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented thereafter.\nPatients without events reported are censored at the last disease evaluation.",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab, and only 2 of these patients achieved objective response"
},
{
"type": "SECONDARY",
"title": "Second-course Time to Objective Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "10",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "NA",
"comment": "Median and upper bound inestimable due to insufficient number of responses",
"groupId": "OG001",
"lowerLimit": "3.5",
"upperLimit": "NA"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "TTOR defined as the time from start of crossover treatment to the date of the first documented CR or PR by RECIST 1.1 on second-course therapy, whichever is first recorded",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab"
},
{
"type": "SECONDARY",
"title": "Second-course Overall Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "10",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "12.9",
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG001",
"lowerLimit": "6.4",
"upperLimit": "NA"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "Second-course OS defined as the time from the start of crossover treatment to death due from any cause, or censored at date last known alive.",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "10 patients in the ITT population who were initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab"
},
{
"type": "SECONDARY",
"title": "Efficacy 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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "PFS, ORR according to RECIST 1.1 and irRC, CBR, DOR, TTOR and OS, among patients with germline BRCA1 or BRCA2 mutations (all efficacy endpoints defined as above)",
"reportingStatus": "POSTED",
"populationDescription": "Efficacy among BRCA-mutant patients was not analyzed, as there was an insufficient number of patients with BRCA mutations in the ITT population to facilitate meaningful analyses.",
"measureCategoriesReviewUnit": {
"resetReasons": [
"Required information appears to be missing."
]
}
}
]
},
"participantFlowModule": {
"groups": [
{
"id": "FG000",
"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": "FG001",
"title": "Arm B: Carboplatin",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"periods": [
{
"title": "First-course Treatment",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"comment": "39 patients were randomized to Arm A, but only 37 started protocol therapy",
"groupId": "FG000",
"numSubjects": "37"
},
{
"comment": "39 patients were randomized to Arm B, but only 38 started treatment",
"groupId": "FG001",
"numSubjects": "38"
}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"comment": "<p>There was no completion of treatment, per protocol.\nPatients were to remain on treatment until:</p><ul><li>Disease progression</li><li>Complete response (and treated for at least 24 weeks, with at least two treatments occurring beyond the date when the initial CR was declared)</li><li>Intercurrent illness</li><li>Unacceptable adverse event(s)</li><li>Withdrawal of consent</li><li>General/specific changes in the patient's condition that render the patient unacceptable for further treatment</li></ul>",
"groupId": "FG000",
"numSubjects": "0"
},
{
"comment": "<p>There was no completion of treatment, per protocol.\nPatients were to remain on treatment until:</p><ul><li>Disease progression</li><li>Complete response (and treated for at least 24 weeks, with at least two treatments occurring beyond the date when the initial CR was declared)</li><li>Intercurrent illness</li><li>Unacceptable adverse event(s)</li><li>Withdrawal of consent</li><li>General/specific changes in the patient's condition that render the patient unacceptable for further treatment</li></ul>",
"groupId": "FG001",
"numSubjects": "0"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "37"
},
{
"groupId": "FG001",
"numSubjects": "38"
}
]
}
],
"reviewUnit": {
"resetReasons": [
"A free-text field appears to include results data or conclusions drawn from the data. All results data must be reported in a tabular format."
]
},
"dropWithdraws": [
{
"type": "Complete response",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "1"
}
]
},
{
"type": "Intercurrent illness",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
},
{
"groupId": "FG001",
"numSubjects": "0"
}
]
},
{
"type": "Progressive Disease",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "31"
},
{
"groupId": "FG001",
"numSubjects": "32"
}
]
},
{
"type": "Adverse Event",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
},
{
"groupId": "FG001",
"numSubjects": "2"
}
]
},
{
"type": "Physician Decision",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "1"
}
]
},
{
"type": "Withdrawal by Subject",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "1"
}
]
},
{
"type": ""Patient proceeded with chest wall excision"",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
},
{
"groupId": "FG001",
"numSubjects": "0"
}
]
},
{
"type": ""Participant needed palliative radiation, which is not permitted on study"",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "1"
}
]
},
{
"type": "Still on treatment",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "3"
},
{
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{
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},
{
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},
{
"comment": "<p>There was no completion of treatment, per protocol.\nPatients were to remain on treatment until:</p><ul><li>Disease progression</li><li>Complete response (and treated for at least 24 weeks, with at least two treatments occurring beyond the date when the initial CR was declared)</li><li>Intercurrent illness</li><li>Unacceptable adverse event(s)</li><li>Withdrawal of consent</li><li>General/specific changes in the patient's condition that render the patient unacceptable for further treatment</li></ul>",
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}
],
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},
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{
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},
{
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},
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},
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},
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},
{
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},
{
"value": "64",
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}
]
},
{
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{
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],
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},
{
"title": "Germline BRCA Status",
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"categories": [
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"title": "gBRCA1 mutation",
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]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
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},
{
"title": "Programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) Status -- Local",
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},
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},
{
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},
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]
}
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},
{
"title": "Stromal tumor-infiltrating lymphocytes (sTILs)",
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},
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]
},
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},
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]
}
],
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},
{
"title": "Eastern Cooperative Oncology Group (ECOG) Performance Status",
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]
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],
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]
},
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},
{
"title": "Inflammatory breast cancer",
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{
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"title": "Yes",
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"value": "1",
"groupId": "BG000"
},
{
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},
{
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]
},
{
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}
],
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},
{
"title": "Prior anthracycline in neoadjuvant/adjuvant setting",
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"title": "Yes",
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},
{
"title": "Prior taxane in neoadjuvant/adjuvant setting",
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],
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},
{
"title": "Prior platinum in neoadjuvant/adjuvant setting",
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"title": "Yes",
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"value": "33",
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},
{
"title": "Number of lines of prior chemotherapy for advanced disease",
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]
},
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"title": "1",
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],
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},
{
"title": "Baseline lactate dehydrogenase (LDH)",
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"categories": [
{
"title": "<= Upper Limit of Normal",
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{
"value": "23",
"groupId": "BG000"
},
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}
],
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}
],
"populationDescription": "78 patients were enrolled and randomized, but only 75 patients started protocol therapy.\nThe primary analysis population is the treated population, thus baseline characteristics are shown for the 75 patients that started protocol therapy."
}
} /annotationSection {
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"date": "2022-12-09",
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} /protocolSection/sponsorCollaboratorsModule/responsibleParty/investigatorFullName Sara Tolaney
Sara Tolaney, MD
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"path": "/protocolSection/outcomesModule/secondaryOutcomes/7/measure",
"value": "Objective Response Rate by RECIST 1.1 Among PD-L1-positive Patients"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/7/description",
"value": "<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>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/7/reviewUnit",
"value": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
}
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/8/measure",
"value": "Objective Response Rate by irRC Among PD-L1-positive Patients"
},
{
"op": "replace",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/8/description",
"value": "<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>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>"
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/8/reviewUnit",
"value": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/9",
"value": {
"measure": "Overall Survival Among PD-L1-positive Patients",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "<p>OS defined as the time from randomization (or registration) 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": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/10",
"value": {
"measure": "Clinical Benefit Rate Among PD-L1-positive Patients",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "<p>CBR defined as the proportion 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>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/11",
"value": {
"measure": "Duration of Response Among PD-L1-positive Patients",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"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>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/12",
"value": {
"measure": "Time to Objective Response Among PD-L1-positive Patients",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "<p>TTOR defined as the time from registration 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": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/13",
"value": {
"measure": "Second-course Progression-free Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "PFS defined as the time from the start of crossover treatment to the earlier of progression (on second-course therapy) or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation."
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/14",
"value": {
"measure": "Second-course Objective Response Rate by RECIST 1.1 Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"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.,\nduring second-course therapy"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/15",
"value": {
"measure": "Second-course Objective Response Rate by irRC Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"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, during second-course therapy"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/16",
"value": {
"measure": "Second-course Clinical Benefit Rate Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "CBR defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks, during second course therapy"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/17",
"value": {
"measure": "Second-course Duration of Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "DOR defined as the time measurement criteria are met for second-course CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented thereafter.\nPatients without events reported are censored at the last disease evaluation."
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/18",
"value": {
"measure": "Second-course Time to Objective Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "TTOR defined as the time from start of crossover treatment to the date of the first documented CR or PR by RECIST 1.1 on second-course therapy, whichever is first recorded"
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/19",
"value": {
"measure": "Second-course Overall Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "Second-course OS defined as the time from the start of crossover treatment to death due from any cause, or censored at date last known alive."
}
},
{
"op": "add",
"path": "/protocolSection/outcomesModule/secondaryOutcomes/20",
"value": {
"measure": "Efficacy Among BRCA-mutant Patients",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "PFS, ORR according to RECIST 1.1 and irRC, CBR, DOR, TTOR and OS, among patients with germline BRCA1 or BRCA2 mutations (all efficacy endpoints defined as above)"
}
},
{
"op": "replace",
"path": "/hasResults",
"value": true
},
{
"op": "add",
"path": "/resultsSection",
"value": {
"moreInfoModule": {
"pointOfContact": {
"email": "Sara_Tolaney@dfci.harvard.edu",
"phone": "617-632-5743",
"title": "Sara Tolaney, MD, MPH",
"organization": "Dana-Farber Cancer Institute"
},
"certainAgreement": {
"piSponsorEmployee": true
}
},
"adverseEventsModule": {
"timeFrame": "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. 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.",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "<p>An SAE is any untoward medical occurrence that:</p><ul><li>results in death</li><li>is life-threatening (i.e., participant was at risk of death at the time of the event)</li><li>requires hospitalization or prolongs existing hospitalization</li><li>results in persistent/significant disability/incapacity</li><li>is a congenital anomaly/birth defect</li><li>is an important medical event (that may not be immediately life-threatening or result in hospitalization but may jeopardize the subject / require intervention)</li></ul>",
"eventGroups": [
{
"id": "EG000",
"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>",
"otherNumAtRisk": 37,
"deathsNumAtRisk": 37,
"otherNumAffected": 37,
"seriousNumAtRisk": 37,
"deathsNumAffected": 24,
"seriousNumAffected": 10
},
{
"id": "EG001",
"title": "Arm B: Carboplatin",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"otherNumAtRisk": 38,
"deathsNumAtRisk": 38,
"otherNumAffected": 38,
"seriousNumAtRisk": 38,
"deathsNumAffected": 17,
"seriousNumAffected": 11
},
{
"id": "EG002",
"title": "Arm B: Carboplatin -- Crossover",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>",
"otherNumAtRisk": 18,
"deathsNumAtRisk": 18,
"otherNumAffected": 18,
"seriousNumAtRisk": 18,
"deathsNumAffected": 10,
"seriousNumAffected": 6
}
],
"otherEvents": [
{
"term": "Anemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 25
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 20
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 8
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Blood and lymphatic system disorders - Other, specify",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 4
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 2
}
],
"organSystem": "Blood and lymphatic system disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Atrial fibrillation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 2
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 0
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Tinnitus",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 4
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 0
}
],
"organSystem": "Ear and labyrinth disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypothyroidism",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 11
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 3
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 2
}
],
"organSystem": "Endocrine disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Blurred vision",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 0
}
],
"organSystem": "Eye disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Abdominal pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 2
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 3
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Colitis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 0
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Constipation",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 18
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 14
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 4
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Diarrhea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 11
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 7
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 9
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Gastroesophageal reflux disease",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 3
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 2
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hemorrhoids",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 0
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Mucositis oral",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 0
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Nausea",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 21
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 26
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 7
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Vomiting",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 8
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 3
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Chills",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 0
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Edema limbs",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 5
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 0
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Fatigue",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 28
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 28
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 11
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Fever",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 5
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 5
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 5
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Infusion related reaction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 8
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 0
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Localized edema",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 3
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 3
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Non-cardiac chest pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 0
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 10
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 13
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 4
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Infections and infestations - Other, specify",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 2
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Lung infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 4
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Sinusitis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Skin infection",
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"numAtRisk": 37,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 2
},
{
"groupId": "EG002",
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"numAffected": 0
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypoxia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 2
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 2
},
{
"groupId": "EG002",
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"numAffected": 1
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hypotension",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 1
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 0
}
],
"organSystem": "Vascular disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Pericardial effusion",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 0
}
],
"organSystem": "Cardiac disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Vomiting",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 0
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Fatigue",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 0
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 2
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Upper respiratory infection",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 0
}
],
"organSystem": "Infections and infestations",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Hyperglycemia",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 0
}
],
"organSystem": "Metabolism and nutrition disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Back pain",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 0
}
],
"organSystem": "Musculoskeletal and connective tissue disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Cough",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 0
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Pleural effusion",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 1
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 1
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Enterocolitis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Small intestinal obstruction",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 1
}
],
"organSystem": "Gastrointestinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Flu like symptoms",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 1
}
],
"organSystem": "General disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Spinal fracture",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 1
}
],
"organSystem": "Injury, poisoning and procedural complications",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
},
{
"term": "Pneumonitis",
"stats": [
{
"groupId": "EG000",
"numAtRisk": 37,
"numAffected": 0
},
{
"groupId": "EG001",
"numAtRisk": 38,
"numAffected": 0
},
{
"groupId": "EG002",
"numAtRisk": 18,
"numAffected": 1
}
],
"organSystem": "Respiratory, thoracic and mediastinal disorders",
"assessmentType": "SYSTEMATIC_ASSESSMENT",
"sourceVocabulary": "CTCAE (4.0)"
}
],
"frequencyThreshold": "5"
},
"outcomeMeasuresModule": {
"outcomeMeasures": [
{
"type": "PRIMARY",
"title": "Progression-free Survival",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "32",
"groupId": "OG000"
},
{
"value": "30",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "4.2",
"groupId": "OG000",
"lowerLimit": "2.7",
"upperLimit": "11.5"
},
{
"value": "5.5",
"groupId": "OG001",
"lowerLimit": "4.4",
"upperLimit": "19.2"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.88",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.95",
"ciLowerLimit": "0.49",
"ciUpperLimit": "1.84",
"estimateComment": "Reference level is Arm B, such that hazard ratio corresponds to the effect of treatment on Arm A",
"statisticalMethod": "Log Rank",
"nonInferiorityType": "SUPERIORITY",
"statisticalComment": "stratified log rank test"
}
],
"paramType": "MEDIAN",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame.",
"One or more of these comments also apply to other measures in the record."
]
},
"description": "Defined as the time from randomization (or registration) to the earlier of progression or death due to any cause.\nParticipants alive without disease progression are censored at date of last disease evaluation",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "The primary efficacy analysis was conducted in the intention-to-treat (ITT) population, which denotes the 62 patients who had 0 prior lines of treatment for advanced disease prior to enrollment."
},
{
"type": "SECONDARY",
"title": "Objective Response Rate by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "32",
"groupId": "OG000"
},
{
"value": "30",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "25.0",
"groupId": "OG000",
"lowerLimit": "11.5",
"upperLimit": "43.4"
},
{
"value": "23.3",
"groupId": "OG001",
"lowerLimit": "9.9",
"upperLimit": "42.3"
}
]
}
]
}
],
"analyses": [
{
"pValue": "1",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Odds Ratio (OR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "1.09",
"ciLowerLimit": "0.29",
"ciUpperLimit": "4.18",
"estimateComment": "Reference level is Arm B, such that the odds ratio corresponds to the effect of treatment on Arm A",
"statisticalMethod": "Fisher Exact",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "NUMBER",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "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",
"unitOfMeasure": "percent of patients achieving response",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "The primary efficacy analysis was conducted in the intention-to-treat (ITT) population, which denotes the 62 patients who had 0 prior lines of treatment for advanced disease prior to enrollment."
},
{
"type": "SECONDARY",
"title": "Objective Response Rate by Immune-Related Response Criteria (irRC)",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "32",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "28.1",
"groupId": "OG000",
"lowerLimit": "13.7",
"upperLimit": "46.7"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "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",
"unitOfMeasure": "percent of patients with IR response",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "First-course objective response rate by irRC was only evaluated in the 32 patients that received immunotherapy (on Arm A) in the ITT population.\nBecause of this, statistical testing by arm was not performed."
},
{
"type": "SECONDARY",
"title": "Overall Survival",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "32",
"groupId": "OG000"
},
{
"value": "30",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "16.8",
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG000",
"lowerLimit": "10.4",
"upperLimit": "NA"
},
{
"value": "11.1",
"groupId": "OG001",
"lowerLimit": "8.2",
"upperLimit": "24.4"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.49",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.80",
"ciLowerLimit": "0.43",
"ciUpperLimit": "1.50",
"estimateComment": "Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A",
"statisticalMethod": "Log Rank",
"nonInferiorityType": "SUPERIORITY",
"statisticalComment": "stratified log rank test"
}
],
"paramType": "MEDIAN",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "Defined as the time from randomization (or registration) to death due to any cause, or censored at date last known alive",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "The primary efficacy analysis was conducted in the intention-to-treat (ITT) population, which denotes the 62 patients who had 0 prior lines of treatment for advanced disease prior to enrollment."
},
{
"type": "SECONDARY",
"title": "Clinical Benefit Rate",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "32",
"groupId": "OG000"
},
{
"value": "30",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "34.4",
"groupId": "OG000",
"lowerLimit": "18.6",
"upperLimit": "53.2"
},
{
"value": "33.3",
"groupId": "OG001",
"lowerLimit": "17.3",
"upperLimit": "52.8"
}
]
}
]
}
],
"analyses": [
{
"pValue": "1",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Odds Ratio (OR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "1.05",
"ciLowerLimit": "0.32",
"ciUpperLimit": "3.43",
"estimateComment": "Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A",
"statisticalMethod": "Fisher Exact",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "NUMBER",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "Defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks",
"unitOfMeasure": "percent of patients achieving benefit",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "The primary efficacy analysis was conducted in the intention-to-treat (ITT) population, which denotes the 62 patients who had 0 prior lines of treatment for advanced disease prior to enrollment."
},
{
"type": "SECONDARY",
"title": "Duration of Response",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "8",
"groupId": "OG000"
},
{
"value": "7",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "19.3",
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG000",
"lowerLimit": "16.8",
"upperLimit": "NA"
},
{
"value": "7.7",
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG001",
"lowerLimit": "2.7",
"upperLimit": "NA"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.36",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.53",
"ciLowerLimit": "0.13",
"ciUpperLimit": "2.12",
"estimateComment": "Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A",
"statisticalMethod": "Log Rank",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "MEDIAN",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "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",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Duration of response was analyzed among the total 15 patients who achieved objective response in the ITT population."
},
{
"type": "SECONDARY",
"title": "Time to Objective Response",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "32",
"groupId": "OG000"
},
{
"value": "30",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "4.6",
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG000",
"lowerLimit": "4.0",
"upperLimit": "NA"
},
{
"value": "11.2",
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG001",
"lowerLimit": "4.7",
"upperLimit": "NA"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.68",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "1.24",
"ciLowerLimit": "0.43",
"ciUpperLimit": "3.43",
"estimateComment": "Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A",
"statisticalMethod": "Log Rank",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "MEDIAN",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "Defined as the time from registration to the date of the first documented CR or PR by RECIST 1.1, whichever is first recorded",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "The primary efficacy analysis was conducted in the intention-to-treat (ITT) population, which denotes the 62 patients who had 0 prior lines of treatment for advanced disease prior to enrollment."
},
{
"type": "SECONDARY",
"title": "Progression-free Survival Among PD-L1-positive Patients",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "13",
"groupId": "OG000"
},
{
"value": "11",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "8.3",
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG000",
"lowerLimit": "2.5",
"upperLimit": "NA"
},
{
"value": "4.7",
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG001",
"lowerLimit": "1.6",
"upperLimit": "NA"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.27",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.54",
"ciLowerLimit": "0.18",
"ciUpperLimit": "1.62",
"estimateComment": "Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A",
"statisticalMethod": "Log Rank",
"nonInferiorityType": "SUPERIORITY",
"statisticalComment": "stratified log rank test"
}
],
"paramType": "MEDIAN",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "<p>PFS defined as the time from randomization (or registration) 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>",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "A total of 24 patients were PD-L1-positive in the ITT population."
},
{
"type": "SECONDARY",
"title": "Objective Response Rate by RECIST 1.1 Among PD-L1-positive Patients",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "13",
"groupId": "OG000"
},
{
"value": "11",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "23.1",
"groupId": "OG000",
"lowerLimit": "5.0",
"upperLimit": "53.8"
},
{
"value": "27.3",
"groupId": "OG001",
"lowerLimit": "6.0",
"upperLimit": "61.0"
}
]
}
]
}
],
"analyses": [
{
"pValue": "1",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Odds Ratio (OR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.81",
"ciLowerLimit": "0.08",
"ciUpperLimit": "7.78",
"estimateComment": "Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A",
"statisticalMethod": "Fisher Exact",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "NUMBER",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"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>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>",
"unitOfMeasure": "percent of patients achieving response",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "A total of 24 patients were PD-L1-positive in the ITT population."
},
{
"type": "SECONDARY",
"title": "Objective Response Rate by irRC Among PD-L1-positive Patients",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "13",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "30.8",
"groupId": "OG000",
"lowerLimit": "9.1",
"upperLimit": "61.4"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"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>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>",
"unitOfMeasure": "percent of patients with IR response",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "A total of 13 patients were treated with immunotherapy (on Arm A) and were PD-L1-positive in the ITT population.\nBecause first-course irORR was only assessed for patients on Arm A, no statistical testing by arm was performed."
},
{
"type": "SECONDARY",
"title": "Overall Survival Among PD-L1-positive Patients",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "13",
"groupId": "OG000"
},
{
"value": "11",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "17.6",
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG000",
"lowerLimit": "4.9",
"upperLimit": "NA"
},
{
"value": "10.7",
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG001",
"lowerLimit": "6.7",
"upperLimit": "NA"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.61",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.75",
"ciLowerLimit": "0.26",
"ciUpperLimit": "2.16",
"estimateComment": "Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A",
"statisticalMethod": "Log Rank",
"nonInferiorityType": "SUPERIORITY",
"statisticalComment": "stratified log rank test"
}
],
"paramType": "MEDIAN",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "<p>OS defined as the time from randomization (or registration) 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>",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "A total of 24 patients were PD-L1-positive in the ITT population."
},
{
"type": "SECONDARY",
"title": "Clinical Benefit Rate Among PD-L1-positive Patients",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "13",
"groupId": "OG000"
},
{
"value": "11",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "30.8",
"groupId": "OG000",
"lowerLimit": "9.1",
"upperLimit": "61.4"
},
{
"value": "36.4",
"groupId": "OG001",
"lowerLimit": "10.9",
"upperLimit": "69.2"
}
]
}
]
}
],
"analyses": [
{
"pValue": "1",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Odds Ratio (OR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.79",
"ciLowerLimit": "0.10",
"ciUpperLimit": "5.93",
"estimateComment": "Reference level is Arm B, such that the odds ratio corresponds to treatment on Arm A",
"statisticalMethod": "Fisher Exact",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "NUMBER",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "<p>CBR defined as the proportion 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>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>",
"unitOfMeasure": "percent of patients achieving benefit",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "A total of 24 patients were PD-L1-positive in the ITT population."
},
{
"type": "SECONDARY",
"title": "Duration of Response Among PD-L1-positive Patients",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "3",
"groupId": "OG000"
},
{
"value": "3",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "16.8",
"comment": "Bounds inestimable due to insufficient sample size/number of events",
"groupId": "OG000",
"lowerLimit": "NA",
"upperLimit": "NA"
},
{
"value": "4.9",
"comment": "Upper bound inestimable due to insufficient sample size/number of events",
"groupId": "OG001",
"lowerLimit": "2.0",
"upperLimit": "NA"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"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>PD-L1 positivity defined as ≥1% of the tumor cell population demonstrating unequivocal staining for PD-L1.</p>",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "Duration of response was assessed only among the 6 PD-L1-positive patients in the ITT population who achieved objective response.\nDue to insufficient sample size, statistical testing by arm was not performed."
},
{
"type": "SECONDARY",
"title": "Time to Objective Response Among PD-L1-positive Patients",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "13",
"groupId": "OG000"
},
{
"value": "11",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "NA",
"comment": "Median and upper bound inestimable due to insufficient number of responses",
"groupId": "OG000",
"lowerLimit": "3.4",
"upperLimit": "NA"
},
{
"value": "NA",
"comment": "Median and upper bound inestimable due to insufficient number of responses",
"groupId": "OG001",
"lowerLimit": "3.0",
"upperLimit": "NA"
}
]
}
]
}
],
"analyses": [
{
"pValue": "0.73",
"groupIds": [
"OG000",
"OG001"
],
"paramType": "Hazard Ratio (HR)",
"ciNumSides": "TWO_SIDED",
"ciPctValue": "95",
"paramValue": "0.75",
"ciLowerLimit": "0.14",
"ciUpperLimit": "3.89",
"estimateComment": "Reference level is Arm B, such that the hazard ratio corresponds to treatment on Arm A",
"statisticalMethod": "Log Rank",
"nonInferiorityType": "SUPERIORITY"
}
],
"paramType": "MEDIAN",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "<p>TTOR defined as the time from registration 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>",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "A total of 24 patients were PD-L1-positive in the ITT population."
},
{
"type": "SECONDARY",
"title": "Second-course Progression-free Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "10",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "4.1",
"comment": "Upper bound inestimable due to insufficient sample size / number of events",
"groupId": "OG001",
"lowerLimit": "1.9",
"upperLimit": "NA"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "PFS defined as the time from the start of crossover treatment to the earlier of progression (on second-course therapy) or death due to any cause; participants alive without disease progression are censored at date of last disease evaluation.",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "10 patients in the ITT population who were initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab"
},
{
"type": "SECONDARY",
"title": "Second-course Objective Response Rate by RECIST 1.1 Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "10",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "20.0",
"groupId": "OG001",
"lowerLimit": "2.5",
"upperLimit": "55.6"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"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.,\nduring second-course therapy",
"unitOfMeasure": "percent of patients achieving response",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab"
},
{
"type": "SECONDARY",
"title": "Second-course Objective Response Rate by irRC Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "10",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "20.0",
"groupId": "OG001",
"lowerLimit": "2.5",
"upperLimit": "55.6"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"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, during second-course therapy",
"unitOfMeasure": "percent of patients with IR response",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab"
},
{
"type": "SECONDARY",
"title": "Second-course Clinical Benefit Rate Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "10",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "30.0",
"groupId": "OG001",
"lowerLimit": "6.7",
"upperLimit": "65.2"
}
]
}
]
}
],
"paramType": "NUMBER",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "CBR defined as the proportion of patients achieving a complete response or partial response by RECIST 1.1, or stable disease lasting greater than or equal to 24 weeks, during second course therapy",
"unitOfMeasure": "percent of patients achieving benefit",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab"
},
{
"type": "SECONDARY",
"title": "Second-course Duration of Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "1.81",
"comment": "Upper bound inestimable due to insufficient sample size",
"groupId": "OG001",
"lowerLimit": "1.81",
"upperLimit": "NA"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "DOR defined as the time measurement criteria are met for second-course CR or PR by RECIST 1.1 (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented thereafter.\nPatients without events reported are censored at the last disease evaluation.",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab, and only 2 of these patients achieved objective response"
},
{
"type": "SECONDARY",
"title": "Second-course Time to Objective Response Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "10",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "NA",
"comment": "Median and upper bound inestimable due to insufficient number of responses",
"groupId": "OG001",
"lowerLimit": "3.5",
"upperLimit": "NA"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "TTOR defined as the time from start of crossover treatment to the date of the first documented CR or PR by RECIST 1.1 on second-course therapy, whichever is first recorded",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "10 patients in the ITT population initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab"
},
{
"type": "SECONDARY",
"title": "Second-course Overall Survival Among Patients Who Crossed Over to Nab-paclitaxel Plus Nivolumab",
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "0",
"groupId": "OG000"
},
{
"value": "10",
"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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "12.9",
"comment": "Upper bound inestimable due to insufficient number of events",
"groupId": "OG001",
"lowerLimit": "6.4",
"upperLimit": "NA"
}
]
}
]
}
],
"paramType": "MEDIAN",
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "Second-course OS defined as the time from the start of crossover treatment to death due from any cause, or censored at date last known alive.",
"unitOfMeasure": "months",
"dispersionType": "95% Confidence Interval",
"reportingStatus": "POSTED",
"populationDescription": "10 patients in the ITT population who were initially randomized to Arm B (carboplatin monotherapy) crossed over to receive nab-paclitaxel plus nivolumab"
},
{
"type": "SECONDARY",
"title": "Efficacy 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",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"timeFrame": "3.5 years",
"reviewUnit": {
"resetReasons": [
"There does not appear to be sufficient information to understand the Time Frame."
]
},
"description": "PFS, ORR according to RECIST 1.1 and irRC, CBR, DOR, TTOR and OS, among patients with germline BRCA1 or BRCA2 mutations (all efficacy endpoints defined as above)",
"reportingStatus": "POSTED",
"populationDescription": "Efficacy among BRCA-mutant patients was not analyzed, as there was an insufficient number of patients with BRCA mutations in the ITT population to facilitate meaningful analyses.",
"measureCategoriesReviewUnit": {
"resetReasons": [
"Required information appears to be missing."
]
}
}
]
},
"participantFlowModule": {
"groups": [
{
"id": "FG000",
"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": "FG001",
"title": "Arm B: Carboplatin",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
}
],
"periods": [
{
"title": "First-course Treatment",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"comment": "39 patients were randomized to Arm A, but only 37 started protocol therapy",
"groupId": "FG000",
"numSubjects": "37"
},
{
"comment": "39 patients were randomized to Arm B, but only 38 started treatment",
"groupId": "FG001",
"numSubjects": "38"
}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"comment": "<p>There was no completion of treatment, per protocol.\nPatients were to remain on treatment until:</p><ul><li>Disease progression</li><li>Complete response (and treated for at least 24 weeks, with at least two treatments occurring beyond the date when the initial CR was declared)</li><li>Intercurrent illness</li><li>Unacceptable adverse event(s)</li><li>Withdrawal of consent</li><li>General/specific changes in the patient's condition that render the patient unacceptable for further treatment</li></ul>",
"groupId": "FG000",
"numSubjects": "0"
},
{
"comment": "<p>There was no completion of treatment, per protocol.\nPatients were to remain on treatment until:</p><ul><li>Disease progression</li><li>Complete response (and treated for at least 24 weeks, with at least two treatments occurring beyond the date when the initial CR was declared)</li><li>Intercurrent illness</li><li>Unacceptable adverse event(s)</li><li>Withdrawal of consent</li><li>General/specific changes in the patient's condition that render the patient unacceptable for further treatment</li></ul>",
"groupId": "FG001",
"numSubjects": "0"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "37"
},
{
"groupId": "FG001",
"numSubjects": "38"
}
]
}
],
"reviewUnit": {
"resetReasons": [
"A free-text field appears to include results data or conclusions drawn from the data. All results data must be reported in a tabular format."
]
},
"dropWithdraws": [
{
"type": "Complete response",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "1"
}
]
},
{
"type": "Intercurrent illness",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
},
{
"groupId": "FG001",
"numSubjects": "0"
}
]
},
{
"type": "Progressive Disease",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "31"
},
{
"groupId": "FG001",
"numSubjects": "32"
}
]
},
{
"type": "Adverse Event",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
},
{
"groupId": "FG001",
"numSubjects": "2"
}
]
},
{
"type": "Physician Decision",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "1"
}
]
},
{
"type": "Withdrawal by Subject",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "1"
}
]
},
{
"type": ""Patient proceeded with chest wall excision"",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "1"
},
{
"groupId": "FG001",
"numSubjects": "0"
}
]
},
{
"type": ""Participant needed palliative radiation, which is not permitted on study"",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "1"
}
]
},
{
"type": "Still on treatment",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "3"
},
{
"groupId": "FG001",
"numSubjects": "0"
}
]
}
]
},
{
"title": "Crossover Treatment",
"milestones": [
{
"type": "STARTED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "18"
}
]
},
{
"type": "COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"comment": "<p>There was no completion of treatment, per protocol.\nPatients were to remain on treatment until:</p><ul><li>Disease progression</li><li>Complete response (and treated for at least 24 weeks, with at least two treatments occurring beyond the date when the initial CR was declared)</li><li>Intercurrent illness</li><li>Unacceptable adverse event(s)</li><li>Withdrawal of consent</li><li>General/specific changes in the patient's condition that render the patient unacceptable for further treatment</li></ul>",
"groupId": "FG001",
"numSubjects": "0"
}
]
},
{
"type": "NOT COMPLETED",
"achievements": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "18"
}
]
}
],
"dropWithdraws": [
{
"type": "Progressive disease",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "12"
}
]
},
{
"type": "Adverse Event",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "3"
}
]
},
{
"type": "Physician Decision",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "1"
}
]
},
{
"type": "Still on treatment",
"reasons": [
{
"groupId": "FG000",
"numSubjects": "0"
},
{
"groupId": "FG001",
"numSubjects": "2"
}
]
}
]
}
],
"recruitmentDetails": "The first patient was enrolled on February 12, 2018, and the last patient was enrolled on September 23, 2020.",
"preAssignmentDetails": "96 patients were assessed for eligibility, and 18 were found to be ineligible.\nA total of 78 patients were enrolled and randomized."
},
"baselineCharacteristicsModule": {
"denoms": [
{
"units": "Participants",
"counts": [
{
"value": "37",
"groupId": "BG000"
},
{
"value": "38",
"groupId": "BG001"
},
{
"value": "75",
"groupId": "BG002"
}
]
}
],
"groups": [
{
"id": "BG000",
"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": "BG001",
"title": "Arm B: Carboplatin",
"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) continued to receive nivolumab monotherapy rather than nivolumab plus nab-paclitaxel</li></ul></li></ul>"
},
{
"id": "BG002",
"title": "Total",
"description": "Total of all reporting groups"
}
],
"measures": [
{
"title": "Age, Continuous",
"classes": [
{
"categories": [
{
"measurements": [
{
"value": "59.1",
"groupId": "BG000",
"lowerLimit": "27.9",
"upperLimit": "75.8"
},
{
"value": "59.1",
"groupId": "BG001",
"lowerLimit": "25.4",
"upperLimit": "75.5"
},
{
"value": "59.1",
"groupId": "BG002",
"lowerLimit": "25.4",
"upperLimit": "75.8"
}
]
}
]
}
],
"paramType": "MEDIAN",
"unitOfMeasure": "years",
"dispersionType": "FULL_RANGE"
},
{
"title": "Age, Customized",
"classes": [
{
"title": "Age, years",
"categories": [
{
"title": "<40",
"measurements": [
{
"value": "1",
"groupId": "BG000"
},
{
"value": "4",
"groupId": "BG001"
},
{
"value": "5",
"groupId": "BG002"
}
]
},
{
"title": "40-59",
"measurements": [
{
"value": "19",
"groupId": "BG000"
},
{
"value": "16",
"groupId": "BG001"
},
{
"value": "35",
"groupId": "BG002"
}
]
},
{
"title": ">=60",
"measurements": [
{
"value": "17",
"groupId": "BG000"
},
{
"value": "18",
"groupId": "BG001"
},
{
"value": "35",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Sex: Female, Male",
"classes": [
{
"categories": [
{
"title": "Female",
"measurements": [
{
"value": "37",
"groupId": "BG000"
},
{
"value": "38",
"groupId": "BG001"
},
{
"value": "75",
"groupId": "BG002"
}
]
},
{
"title": "Male",
"measurements": [
{
"value": "0",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "0",
"groupId": "BG002"
}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Ethnicity (NIH/OMB)",
"classes": [
{
"categories": [
{
"title": "Hispanic or Latino",
"measurements": [
{
"value": "2",
"groupId": "BG000"
},
{
"value": "0",
"groupId": "BG001"
},
{
"value": "2",
"groupId": "BG002"
}
]
},
{
"title": "Not Hispanic or Latino",
"measurements": [
{
"value": "33",
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},
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"title": "Germline BRCA Status",
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},
{
"title": "Programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) Status -- Local",
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"title": "Positive",
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"value": "6",
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],
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},
{
"title": "Programmed death-ligand 1 (PD-L1) immunohistochemistry (IHC) Status -- Central, SP142",
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"title": "Positive (>=1% IC)",
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},
{
"title": "Stromal tumor-infiltrating lymphocytes (sTILs)",
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},
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"title": "10-49%",
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},
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"title": ">=50%",
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},
{
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}
]
}
],
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},
{
"title": "Eastern Cooperative Oncology Group (ECOG) Performance Status",
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"title": "0",
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}
],
"paramType": "COUNT_OF_PARTICIPANTS",
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},
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},
{
"title": "Inflammatory breast cancer",
"classes": [
{
"categories": [
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"title": "Yes",
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{
"title": "No",
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]
}
]
}
],
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},
{
"title": "Prior anthracycline in neoadjuvant/adjuvant setting",
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"categories": [
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"title": "Yes",
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"value": "1",
"groupId": "BG000"
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]
},
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"title": "No",
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"value": "36",
"groupId": "BG000"
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{
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]
}
]
}
],
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},
{
"title": "Prior taxane in neoadjuvant/adjuvant setting",
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"title": "Yes",
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"value": "9",
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}
]
},
{
"title": "No",
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"value": "28",
"groupId": "BG000"
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{
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]
}
]
}
],
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},
{
"title": "Prior platinum in neoadjuvant/adjuvant setting",
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"categories": [
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"title": "Yes",
"measurements": [
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"value": "4",
"groupId": "BG000"
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{
"value": "3",
"groupId": "BG001"
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{
"value": "7",
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}
]
},
{
"title": "No",
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"value": "33",
"groupId": "BG000"
},
{
"value": "35",
"groupId": "BG001"
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{
"value": "68",
"groupId": "BG002"
}
]
}
]
}
],
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},
{
"title": "Number of lines of prior chemotherapy for advanced disease",
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{
"categories": [
{
"title": "0",
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"value": "32",
"groupId": "BG000"
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{
"value": "30",
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}
]
},
{
"title": "1",
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}
]
}
]
}
],
"paramType": "COUNT_OF_PARTICIPANTS",
"unitOfMeasure": "Participants"
},
{
"title": "Baseline lactate dehydrogenase (LDH)",
"classes": [
{
"categories": [
{
"title": "<= Upper Limit of Normal",
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"value": "23",
"groupId": "BG000"
},
{
"value": "24",
"groupId": "BG001"
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{
"value": "47",
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}
]
},
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"title": "> Upper Limit of Normal",
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},
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},
{
"title": "Unknown",
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"value": "4",
"groupId": "BG000"
},
{
"value": "0",
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}
]
}
]
}
],
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}
],
"populationDescription": "78 patients were enrolled and randomized, but only 75 patients started protocol therapy.\nThe primary analysis population is the treated population, thus baseline characteristics are shown for the 75 patients that started protocol therapy."
}
}
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{
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"path": "/annotationSection",
"value": {
"annotationModule": {
"unpostedAnnotation": {
"unpostedEvents": [
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"date": "2022-12-09",
"type": "RESET"
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],
"unpostedResponsibleParty": "Sara Tolaney, MD, Principal Investigator, Dana-Farber Cancer Institute"
}
}
}
},
{
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"date": "2021-02-02",
"size": 1531659,
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"hasSap": true,
"filename": "Prot_SAP_000.pdf",
"typeAbbrev": "Prot_SAP",
"uploadDate": "2022-11-11T13:13",
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