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NCT02614833

IMP321 (Eftilagimod Alpha) as Adjunctive to a Standard Chemotherapy Paclitaxel Metastatic Breast Carcinoma

AIPAC (Active Immunotherapy PAClitaxel): A Multicentre, Phase IIb, Randomised,Double Blind, Placebo-controlled Study in Hormone Receptor-positive Metastatic Breast Carcinoma Patients Receiving IMP321 (LAG-3Ig Fusion Protein) or Placebo as Adjunctive to a Standard Chemotherapy Treatment Regimen of Paclitaxel

ClinicalTrials.gov
Sponsor
Immutep S.A.S.
Status
Completed
Versions
35
Adjacent patches
34
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

12 shown
Triage: High
2015-11-26
Secondary Outcome Change
v0 to v1 Pre Recruitment Inspect patch
/protocolSection/eligibilityModule/eligibilityCriteria
/protocolSection/outcomesModule/secondaryOutcomes/2/description
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Low
2016-01-26
Administrative Contact Change
v2 to v3 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts
/protocolSection/contactsLocationsModule/locations/0/status
/protocolSection/contactsLocationsModule/locations/1/status
Triage: Low
2016-02-03
Administrative Contact Change
v3 to v4 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts
/protocolSection/contactsLocationsModule/locations/0/status
/protocolSection/contactsLocationsModule/locations/1/status
Triage: Critical
2017-01-13
Primary Outcome Change
v13 to v14 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/0/description
/protocolSection/armsInterventionsModule/armGroups/1/description
/protocolSection/contactsLocationsModule/locations/14
Triage: High
2017-08-04
Eligibility Change
v18 to v19 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/15/status
/protocolSection/contactsLocationsModule/locations/18
/protocolSection/contactsLocationsModule/locations/29/status
Triage: Low
2017-12-04
Administrative Contact Change
v23 to v24 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts/0/email
/protocolSection/contactsLocationsModule/locations/13/status
/protocolSection/contactsLocationsModule/locations/31/status
Triage: High
2018-04-19
Eligibility Change
v27 to v28 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/9/status
/protocolSection/eligibilityModule/eligibilityCriteria
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: High
2018-07-10
Arm Intervention Change
v28 to v29 Early Recruitment Inspect patch
/protocolSection/armsInterventionsModule/armGroups/0/interventionNames/0
/protocolSection/armsInterventionsModule/interventions/0/name
/protocolSection/contactsLocationsModule/locations/11/status
Triage: Medium
2019-07-01
Timeline Significant Shift
v30 to v31 Early Recruitment Inspect patch
/protocolSection/contactsLocationsModule/centralContacts
/protocolSection/contactsLocationsModule/locations/0/status
/protocolSection/contactsLocationsModule/locations/1/status
Triage: Medium
2020-06-25
Timeline Significant Shift
v31 to v32 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/20
/protocolSection/contactsLocationsModule/locations/25
/protocolSection/statusModule/lastUpdatePostDateStruct/date
Triage: Medium
2020-11-10
Timeline Significant Shift
v32 to v33 Late Recruitment Inspect patch
/protocolSection/contactsLocationsModule/locations/26
/protocolSection/contactsLocationsModule/locations/5
/protocolSection/statusModule/completionDateStruct/date
Triage: High
2021-10-04
Enrollment Change
v33 to v34 Late Recruitment Inspect patch
/protocolSection/designModule/enrollmentInfo/count
/protocolSection/designModule/enrollmentInfo/type
/protocolSection/statusModule/completionDateStruct/type