2026-08-17
notable
Study Status, Participant Flow, Outcome Measures (Results) v24
Trial completed
Completion dateestimated 2026-07-30→confirmed 2026-08-05
2023-01-03
minor
Study Status, Outcome Measures, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events v20
Results first postednot stated→2023-01-26
Secondary endpoints21 to 27 entries
EfficacyProgression-free Survival Among BRCA-mutant Patients
Objective Response Rate by RECIST 1.1 Among BRCA-mutant Patients
Objective Response Rate by irRC Among BRCA-mutant Patients
Overall Survival Among BRCA-mutant Patients
Clinical Benefit Rate Among BRCA-mutant Patients
Duration of Response Among BRCA-mutant Patients
Time to Objective Response Among B [...]
Show 19 earlier versions
2022-11-11
minor
Study Status, Sponsor/Collaborators, Outcome Measures, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v19
Secondary endpoints9 to 21 entries
Objective responseResponse rateRate by Response Evaluation Criteria in Solid Tumours (RECIST) 1.1
Objective responseResponse rateRate by Immune-Related Response Criteria (irRC)
Overall survivalSurvival
Clinical benefitBenefit rateRate
Duration of responseResponse
Time to objectiveObjective responseResponse
EfficacyProgression-free amongSurvival Among PD-L1-positive patientsPatients
Objective Response Rate by RECIST 1.1 Among PD-L1-positive Patients
Objective Response Rate by irRC Among PD-L1-positive Patients
Overall Survival Among PD-L1-positive Patients
Clinical Benefit Rate Among PD-L1-posi [...] [...]
Primary endpoints1 entry, revised
Progression-free survivalSurvival
2022-10-03
minor
Study Status, Outcome Measures v18
Secondary endpoints8 to 9 entries
OverallObjective response rate by Response RateEvaluation Criteria in Solid Tumours (RECIST) 1.1
Objective response rate by Immune-Related Response Criteria (irRC)
Overall Survivalsurvival
Clinical Benefitbenefit Raterate
Duration of Responseresponse
Time to Objectiveobjective Responseresponse
Efficacy among PD-L1-positive patients
Efficacy among BRCA-mutant carrierspatients
Incidence RateEfficacy of eachnab-paclitaxel Toxicityduring (safetysecond-course andtherapy, tolerability)
Incidence Rate of each Toxicity (safety and tolerability) foramong crossover patients
Primary endpoints1 entry, revised
Progression-free survival (PFS)
2022-09-19
minor
Study Status, Arms and Interventions v17
Re-verified, no change to tracked fields
2022-08-24
minor
Study Status v16
Primary completion dateestimated 2022-06-30→confirmed 2021-09-28
2022-03-21
minor
Study Status v15
Re-verified, no change to tracked fields
2022-02-15
minor
Study Status v14
Primary completion date2021-12-30→2022-06-30
2021-10-19
minor
Study Status, Contacts/Locations v13
2021-08-04
minor
Study Status v12
Primary completion date2021-06-30→2021-12-30
2021-06-23
minor
Study Status v11
Re-verified, no change to tracked fields
2020-12-14
notable
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v10
Trial statusRecruiting→Active, Not Recruiting
Enrollment targetestimated 132→confirmed 78
Study sitesdetails revised at 11 of 11 sites
2020-11-09
minor
Study Status, Contacts/Locations v9
2020-08-12
minor
Study Status, Contacts/Locations v8
2020-06-24
minor
Study Status v7
Re-verified, no change to tracked fields
2019-11-06
minor
Study Identification, Study Status, Outcome Measures, Eligibility v6
Eligibility criteria-13 characters
[...] t, the most recent sample will be considered for inclusion.
Participants must have PD-L1 status available at the time of registration.
Standard local testing with any PD-L1 antibody that has been validated in a CLIA-certified environment will be acceptable for including patients on trial..
Primary or metastatic samples may be tested for PD-L1 status.
Participants must have measurable or evaluable disease by RE [...] d to carboplatin alone who decide to crossover to nivolumab monotherapyand nab-paclitaxel at time of progression, a mandatory biopsy will be required if tumor is safely accessible prior t [...] [...]
Secondary endpoints7 to 8 entries
Incidence Rate of each Toxicity (safety and tolerability) for crossover patients
2018-10-01
minor
Study Status, Contacts/Locations v5
Study sitesdetails revised at 2 of 9 sites
2018-08-27
minor
Study Status, Contacts/Locations v4
2018-05-22
minor
Study Status, Eligibility, Contacts/Locations v3
Eligibility criteria+22 characters
[...] esearch biopsy, if tumor is safely accessible, at baseline.
ParticipantsPreviously collected archival tissue will also be obtained on all participants.
For participants for whom newly-obtained samples cannot be provided (e.g.
inaccessible or participant safety concern) maythe submitarchival antissue archivedalone specimenwill be acceptable.
Tissue needs to be located and availableavailability confirmed at time of registration (See Section 9 for more details).
Participants willmust beagree offeredto ana optionalmandatory repeat biopsy 3-6 weeks after starting treatment, if tumor is safely acces [...] [...]
2018-04-09
minor
Study Status, Contacts/Locations v2
2018-01-30
notable
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2018-02-10→confirmed 2018-01-30
Study sites2 entries, revised
Dana-Farber Cancer Institute