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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)

Trial Profile

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: Active, no longer recruiting
Phase of Trial: Phase II/III

Latest Information Update: 19 Jun 2024

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At a glance

  • Drugs Olaparib (Primary) ; Pembrolizumab (Primary) ; Carboplatin; Gemcitabine
  • Indications Advanced breast cancer; Male breast cancer; Triple negative breast cancer
  • Focus Therapeutic Use
  • Acronyms KEYLYNK-009
  • Sponsors Merck Sharp & Dohme; Merck Sharp & Dohme Corp.

Most Recent Events

  • 20 May 2024 Planned End Date changed from 20 Sep 2024 to 18 Nov 2025.
  • 09 Dec 2023 Primary endpoint has not been met. (Overall Survival (OS))
  • 09 Dec 2023 Primary endpoint has not been met. (Progression-Free Survival (PFS) According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1))

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