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Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction With First-Line Chemotherapy Plus Pembrolizumab in Triple Negative Breast Cancer (TNBC) (MK-7339-009/KEYLYNK-009)

StatusTerminated
PhasePhase 2
Started2019-12-19
View on ClinicalTrials.gov ↗

Amendment history

The 50 most recent of 85 record versions are listed below. See every version on ClinicalTrials.gov ↗

2026-08-19
Study Status v84
Reclassified as terminated (was completed)
Trial terminated: Business Reasons
2026-02-10
Study Status, References v83
Publications+509 characters
Rugo HS, Cescon DW, Robson ME, Im SA, Dalenc F, Yanez Ruiz E, Reyes-Cosmelli F, Walshe JM, Im YH, Kulyk S, Dudnichenko O, Llinas-Quintero N, Saji S, Miyoshi Y, Bardia A, Harbeck N, Haiderali A, Fan L, Mejia JA, Karantza V, Llombart-Cussac A. KEYLYNK-009: Pembrolizumab plus Olaparib in Locally Recurr [...]
2025-12-01
Active, Not Recruiting→Completed Study Identification, Study Status, IPDSharing v82
Trial statusActive, Not Recruiting→Completed
Completion dateestimated 2025-11-18→confirmed 2025-11-26
2024-11-11
Study Identification, Study Status, References v81
Re-verified, no change to tracked fields
2024-05-20
Study Status, References v80
Completion date2024-09-20→2025-11-18
Show 45 earlier versions
2024-01-17
Study Status, Baseline Characteristics, Outcome Measures (Results), Adverse Events v79
Results first postednot stated→2024-02-14
2023-12-08
Study Status, Study Description, Arms and Interventions, Outcome Measures, Contacts/Locations, Document Section, Participant Flow, Baseline Characteristics, Outcome Measures (Results), Adverse Events, More Information v78
Secondary endpoints15 to 24 entries
OverallProgression-Free Survival (OSPFS) in Participants withWith Programmed Cell Death-Ligand 1 (PD-L1) Positive Tumors with a Combined Positive Score (CPS) ≥10 Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants with Programmed Cell Death-Ligand 1 (PD-L1) Positive Tumors withWith a Combined Positive Score (CPS) ≥10 Overall Survival (OS) in Participants withWith PD-L1 Positive Tumors With a CPS ≥10 PFS in Participants With Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors Progression-Free Survival (PFS) Acc [...] [...]
Primary endpoints2 entries, revised
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1)
Study sites122 entries, revised
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research (Site 222200) Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (Site 1908)
2023-06-22
Study Status, References v77
Re-verified, no change to tracked fields
2023-06-07
Study Status, Study Description, Study Design, Outcome Measures, References v76
Primary completion dateestimated 2026-01-26→confirmed 2022-12-15
Completion date2026-01-26→2024-09-20
Enrollment targetestimated 460→confirmed 462
Secondary endpointsdetails revised at 15 of 15 entries
2022-10-10
Study Status, Eligibility v75
Eligibility criteria+89 characters
[...] expectancy ≥27 weeks from the day of first study treatment Demonstrate adequate organ function within 10 days prior to the start of study treatment A male participant must agree to be abstinent or use contrac [...]
2022-06-03
Study Identification, Study Status, Oversight, Study Description, Study Design, Outcome Measures v74
PhasePhase 2/3→Phase 2
Enrollment target1225→460
Secondary endpoints13 to 15 entries
Overall Survival (OS) in Participants with Programmed Cell Death-Ligand 1 (PD-L1) Positive Tumors with a Combined Positive Score (CPS) ≥10 Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants with Programmed Cell Death-Lig [...] Change From Baseline in Health-Related Quality-of-Life (HRQoLQoL) Using the European Organization for Research and Treatment [...] re Time to Deterioration in Health-Related Quality-of-Life (HRQoLQoL) Using the European Organization for Research and Treatment [...] uropean Quality of Life 5-dimension, 5-level Que [...]
2021-09-29
Recruiting→Active, Not Recruiting Study Status, Contacts/Locations v73
Trial statusRecruiting→Active, Not Recruiting
Study sitesdetails revised at 122 of 122 sites
2021-09-15
Study Status, Contacts/Locations v72
Study sitesdetails revised at 2 of 122 sites
2021-09-02
Study Status, Contacts/Locations v71
Study sitesdetails revised at 2 of 122 sites
2021-08-25
Study Status, Contacts/Locations v70
Study sitescontacts updated at 5 of 122 sites
2021-08-17
Study Status, Contacts/Locations v69
Study sitesdetails revised at 5 of 122 sites
2021-08-04
Study Status, Contacts/Locations v68
Study sitesdetails revised at 2 of 122 sites
2021-07-28
Study Status, Contacts/Locations v67
Study sitesdetails revised at 3 of 122 sites
2021-07-21
Study Status, Contacts/Locations v66
Study sitesdetails revised at 1 of 122 sites
2021-07-14
Study Status, Contacts/Locations v65
Study sitesdetails revised at 2 of 122 sites
2021-07-07
Study Status, Contacts/Locations v64
Study sitesdetails revised at 1 of 122 sites
2021-06-30
Study Status, Contacts/Locations v63
Study sitesdetails revised at 2 of 122 sites
2021-06-20
Study Status, Study Design, Outcome Measures, Eligibility, Contacts/Locations v62
Enrollment target932→1225
Study sites120→122
Eligibility criteria+191 characters
[...] ating sperm during the intervention period and for at least 180the time needed to eliminate each study intervention (95 days afterfor theolaparib lastand dosechemotherapy; ofno studyrequirement treatmentfor pembrolizumab) A female participant must not be pregnant or breastfeeding [...] a, oocytes) during the intervention period and for at least the time needed to eliminate each study intervention (180 days afterfor theolaparib lastand dosechemotherapy; of120 studydays treatmentfor pembrolizumab) Post-induction Period: Has received up to 6 cycles but not [...] ive of MDS/AML Has a history of (non-infectiou [...]
Secondary endpointsdetails revised at 4 of 13 entries
2021-06-03
Study Status, Contacts/Locations v61
Study sitesdetails revised at 1 of 120 sites
2021-05-12
Study Status, Contacts/Locations v60
Study sitesdetails revised at 1 of 120 sites
2021-05-05
Study Status, Contacts/Locations v59
Study sites120 entries, revised
SociedadCentro deInvestigación Investigacionesdel MedicasCáncer LimitadasJames Lind ( Site 0510)
2021-04-28
Study Status, Contacts/Locations v58
Study sitesdetails revised at 1 of 120 sites
2021-04-09
Study Status, Contacts/Locations v57
Study sites119→120
2021-04-01
Study Status, Contacts/Locations v56
Study sites119 entries, revised
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie ( Site 1908)
2021-03-17
Study Status, Contacts/Locations v55
Study sites119 entries, revised
Narodowy Instytut Onkologii im.- MariiOddzial Sklodowskiej-Curiew Gliwicach ( Site 1912)
2021-03-11
Study Status, Contacts/Locations v54
Study sitesdetails revised at 1 of 119 sites
2021-03-04
Study Status, Contacts/Locations v53
Study sites119 entries, revised
National Hospital Organization - Osaka National Hospital - Institute For Clinical Research ( Site 2200)22
2021-02-25
Study Status, Contacts/Locations v52
Study sites115→119
2021-02-12
Study Status, Contacts/Locations v51
Study sitesdetails revised at 1 of 115 sites
2021-02-04
Study Status, Contacts/Locations v50
Study sitesdetails revised at 1 of 115 sites
2021-01-28
Study Status, Contacts/Locations v49
Study sitesdetails revised at 3 of 115 sites
2021-01-20
Study Status, Contacts/Locations v48
Study sitesdetails revised at 2 of 115 sites
2021-01-15
Study Status, Contacts/Locations v47
Study sitesdetails revised at 1 of 115 sites
2020-12-09
Study Status, Contacts/Locations v46
Study sites114→115
2020-11-25
Study Status, Contacts/Locations v45
Study sites112→114
2020-11-19
Study Status, Contacts/Locations v44
Study sites109→112
2020-11-10
Study Status, Contacts/Locations v43
Study sites108→109
2020-11-06
Study Status, Contacts/Locations v42
Study sitesdetails revised at 1 of 108 sites
2020-10-28
Study Status, Contacts/Locations v41
Study sites107→108
2020-10-21
Study Status, Contacts/Locations v40
Study sites105→107
2020-10-15
Study Status, Contacts/Locations v39
Study sitesdetails revised at 2 of 105 sites
2020-10-07
Study Status, Contacts/Locations v38
Study sitesdetails revised at 2 of 105 sites
2020-10-01
Study Status, Contacts/Locations v37
Study sites104→105
2020-09-25
Study Status, Contacts/Locations v36
Study sitesdetails revised at 1 of 104 sites
2020-09-16
Study Status, Contacts/Locations v35
Study sites102→104
The purpose of this study is to compare the efficacy of olaparib (MK-7339) plus pembrolizumab (MK-3475) with chemotherapy plus pembrolizumab after induction with first-line chemotherapy plus pembrolizumab in triple negative breast cancer (TNBC). The primary hypotheses are: 1. Olaparib plus pembrolizumab is superior to chemotherapy plus pembrolizumab with respect to progression-free survival (PFS). 2. Olaparib plus pembrolizumab is superior to chemotherapy plus pembrolizumab with respect to overall survival (OS). As of Amendment 3, study enrollment was discontinued. Participants who were receiving benefit from the study intervention could continue treatment until criteria for discontinuation are met. Participants who are on study treatment or in follow-up phase will no longer have tumor response assessments by BICR.
Trial Details
NCT Number NCT04191135
Lead Sponsor Merck Sharp & Dohme LLC
Conditions Triple Negative Breast Neoplasms
Enrollment 462 participants
Start Date 2019-12-19
Primary Completion 2022-12-15 (estimated)
Study Completion 2025-11-26 (estimated)
Updated on ClinicalTrials.gov 2026-09-14