{"entity":{"id":"nct04191135","kind":"trial","name":"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)","aka":[],"tldr":"Replacing chemotherapy with olaparib alongside pembrolizumab did not improve the primary progression-free survival outcome in metastatic TNBC.","summary":"The registry lists NCT04191135 as terminated, last updated 2026-09-14. Enrolment is 462 actual participants. Interventions: Pembrolizumab, Olaparib, Carboplatin, Gemcitabine. Primary measures include Progression-Free Survival (PFS); Overall Survival (OS). The registry reason for stopping is: Business Reasons Results are posted in the registry. The primary paper reports 460 participants receiving induction and 271 randomised; these analysis populations differ from the registry total of 462. Median PFS was 5.5 versus 5.6 months (HR 0.98, 95% CI 0.72-1.33, p=0.4556), and OS 25.1 versus 23.4 months (HR 0.95, 95% CI 0.64-1.40). Exploratory tumour-BRCA subgroup estimates were imprecise and do not establish a positive subgroup trial.","status":"withdrawn","asOf":"2026-10-06","links":[{"label":"ClinicalTrials.gov NCT04191135","url":"https://clinicaltrials.gov/study/NCT04191135"},{"label":"Primary KEYLYNK-009 publication","url":"https://doi.org/10.1158/1078-0432.CCR-25-1818"}],"tags":[],"related":[],"cancers":["breast-cancer","tnbc"],"sections":[],"technologies":[],"targets":["parp"],"drugs":["olaparib"],"companies":[],"institutions":[],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04191135","phase":"2","setting":"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)","sponsor":"Merck Sharp & Dohme LLC","started":"2019-12-19","startedType":"actual","enrolled":462,"enrolledBasis":"registry","outcomes":[{"endpoint":"Progression-free survival, randomised maintenance population","primary":true,"unit":"months","arms":[{"name":"Pembrolizumab plus olaparib","value":5.5},{"name":"Pembrolizumab plus chemotherapy","value":5.6}],"hr":0.98,"ci":[0.72,1.33],"p":"0.4556","source":"https://doi.org/10.1158/1078-0432.CCR-25-1818"},{"endpoint":"Overall survival, randomised maintenance population","unit":"months","arms":[{"name":"Pembrolizumab plus olaparib","value":25.1},{"name":"Pembrolizumab plus chemotherapy","value":23.4}],"hr":0.95,"ci":[0.64,1.4],"source":"https://doi.org/10.1158/1078-0432.CCR-25-1818"}]},"route":"/trials/nct04191135/","neighbours":{"cancer":[{"id":"breast-cancer","kind":"cancer","name":"Breast cancer (all types)","route":"/cancers/breast-cancer/"},{"id":"tnbc","kind":"cancer","name":"Triple-negative breast cancer (TNBC)","route":"/cancers/tnbc/"}],"target":[{"id":"parp","kind":"target","name":"PARP","route":"/targets/parp/"}],"drug":[{"id":"olaparib","kind":"drug","name":"Olaparib","route":"/drugs/olaparib/"}]}}