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NCT03025035

Pembrolizumab in Combination With Olaparib in Advanced BRCA-mutated or HDR-defect Breast Cancer

Open Label, Phase II Pilot Study of Immune Checkpoint Inhibition With Pembrolizumab in Combination With PARP Inhibition With Olaparib in Advanced BRCA-mutated or HDR-defect Breast Cancers

ClinicalTrials.gov
Sponsor
Yuan Yuan
Status
Completed
Versions
26
Adjacent patches
25
Severity is deterministic, reproducible, uncalibrated triage metadata, not validated review priority or proven wrongdoing. New Evidence Record packages are generated for deterministic event-class membership, not by triage rank alone.

Material event timeline

22 shown
Triage: Low
2017-01-18
Timeline Minor Adjustment
v0 to v1 Pre Recruitment Inspect patch
/protocolSection/descriptionModule/detailedDescription
/protocolSection/oversightModule/isFdaRegulatedDevice
/protocolSection/oversightModule/isFdaRegulatedDrug
Triage: Medium
2017-06-07
Timeline Major Slip
v1 to v2 Pre Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/0/status
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Medium
2017-12-12
Timeline Significant Shift
v2 to v3 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/0/contacts/2
/protocolSection/contactsLocationsModule/locations/0/contacts/3
/protocolSection/contactsLocationsModule/locations/0/contacts/4
Triage: Medium
2018-02-14
Timeline Major Slip
v3 to v4 Early Recruitment Inspect patch
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
/protocolSection/statusModule/primaryCompletionDateStruct/date
Triage: Low
2018-09-07
Administrative Contact Change
v4 to v5 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts/0/email
/protocolSection/contactsLocationsModule/centralContacts/0/name
/protocolSection/contactsLocationsModule/centralContacts/0/phone
Triage: High
2019-09-04
Status Termination
v6 to v7 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts
/protocolSection/contactsLocationsModule/locations/0/contacts
/protocolSection/contactsLocationsModule/locations/0/status
Triage: High
2020-04-02
Arm Intervention Change
v7 to v8 Post Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/0/description
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/1
/protocolSection/armsInterventionsModule/armGroups/0/label
Triage: Critical
2020-10-01
Primary Outcome Change
v8 to v9 Post Recruitment Inspect patch
/protocolSection/outcomesModule/primaryOutcomes/0/description
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: Critical
2020-11-02
Status Termination
v9 to v10 Post Recruitment Inspect patch Evidence Record
/protocolSection/contactsLocationsModule/centralContacts
/protocolSection/contactsLocationsModule/locations/0/contacts
/protocolSection/contactsLocationsModule/locations/0/status
Triage: High
2021-05-03
Eligibility Change
v10 to v11 Early Recruitment Inspect patch
/protocolSection/eligibilityModule/eligibilityCriteria
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: High
2021-08-27
Arm Intervention Change
v11 to v12 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/0/description
/protocolSection/armsInterventionsModule/interventions/1/description
/protocolSection/armsInterventionsModule/interventions/1/otherNames
Triage: High
2021-11-10
Eligibility Change
v12 to v13 Early Recruitment Inspect patch
/protocolSection/eligibilityModule/eligibilityCriteria
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: High
2022-05-20
Eligibility Change
v13 to v14 Early Recruitment Inspect patch
/protocolSection/eligibilityModule/eligibilityCriteria
/protocolSection/outcomesModule/otherOutcomes
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: High
2023-02-01
Enrollment Change
v14 to v15 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts
/protocolSection/contactsLocationsModule/locations/0/contacts
/protocolSection/contactsLocationsModule/locations/0/status
Triage: High
2023-06-03
Enrollment Change
v15 to v16 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts
/protocolSection/contactsLocationsModule/locations/0/contacts
/protocolSection/contactsLocationsModule/locations/0/status
Triage: Medium
2023-12-15
Timeline Major Slip
v16 to v17 Early Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/lastUpdatePostDateStruct/date
/protocolSection/statusModule/lastUpdateSubmitDate
Triage: Low
2024-12-06
Timeline Actualized Earlier
v18 to v19 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts
/protocolSection/contactsLocationsModule/locations/0/contacts
/protocolSection/contactsLocationsModule/locations/0/status
Triage: High
2025-05-08
Adverse Event Group Change
v20 to v21 Late Recruitment Inspect patch Evidence Record
/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date
/protocolSection/outcomesModule/primaryOutcomes/0/description
/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit
Triage: Low
2025-05-23
Results Reconciliation
v21 to v22 Late Recruitment Inspect patch Evidence Record
/annotationSection/annotationModule/unpostedAnnotation/unpostedEvents/0/date
/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Low
2025-05-28
Results Reconciliation
v22 to v23 Late Recruitment Inspect patch Evidence Record
/annotationSection
/protocolSection/outcomesModule/primaryOutcomes/0/reviewUnit
/protocolSection/outcomesModule/primaryOutcomes/0/timeFrame
Triage: Low
2026-01-19
Timeline Actualized Earlier
v24 to v25 Late Recruitment Inspect patch
/protocolSection/statusModule/completionDateStruct/date
/protocolSection/statusModule/completionDateStruct/type
/protocolSection/statusModule/lastUpdatePostDateStruct/date