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An Open-label, Randomized, Phase 2/3 Study of Olaparib Plus Pembrolizumab Versus Chemotherapy Plus Pembrolizumab After Induction of Clinical Benefit With First-line Chemotherapy Plus Pembrolizumab in Participants With Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (TNBC) (KEYLYNK 009)

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-500418-24-00
Acronym
MK-7339-009
Enrollment
111
Registered
2023-02-10
Start date
2020-01-17
Completion date
2025-11-17
Last updated
2025-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Locally Recurrent Inoperable or Metastatic Triple Negative Breast Cancer (TNBC)

Brief summary

Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), Overall Survival (OS)

Detailed description

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 Ligand 1 (PD-L1) Positive Tumors with a Combined Positive Score (CPS) ≥10, Overall Survival (OS) in Participants with Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors, Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants with Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors, Change From Baseline in Health-Related Quality-of-Life (QoL) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 29 and 30 Score, Change From Baseline in Physical Functioning Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 1- 5 Score, Change From Baseline in Emotional Functioning Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 21-24 Score, Change From Baseline in Systemic Therapy Side Effects Using the European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality-of-Life (QoL) Questionnaire (EORTC QLQ-BR23) Items 1-4,6,7, and 8 Score, Time to Deterioration in Health-Related Quality-of-Life (QoL) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 29 and 30 Score, Time to Deterioration in Physical Functioning Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 1-5 Score, Time to Deterioration in Emotional Functioning Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 21-24 Score, Time to Deterioration in Systemic Therapy Side Effects Using the European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality-of-Life (QoL) Questionnaire (EORTC QLQ-BR23) Items 1-4,6,7, and 8 Score, Change From Baseline in Health Outcomes using the European Quality of Life 5-dimension, 5-level Questionnaire (EQ-5D-5L) Visual Analogue Scale (VAS) Score, Number of Participants Who Experienced At Least One Adverse Event (AE), Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)

Interventions

DRUGOlaparib
DRUGCARBOPLATIN
DRUGGEMCITABINE
DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Sponsors

Merck Sharp & Dohme LLC
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1), Overall Survival (OS)

Secondary

MeasureTime frame
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 Ligand 1 (PD-L1) Positive Tumors with a Combined Positive Score (CPS) ≥10, Overall Survival (OS) in Participants with Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors, Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) in Participants with Breast Cancer Susceptibility Gene Mutation (BRCAm) Tumors, Change From Baseline in Health-Related Quality-of-Life (QoL) Using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 29 and 30 Score, Change From Baseline in Physical Functioning Using the European Organization for Research and Treatment of Cancer Quality o

Countries

France, Germany, Hungary, Ireland, Poland, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026