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A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 / ENGOT-ov43 / GOG-3036)

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Trial Profile

A Randomized Phase 3, Double-Blind Study of Chemotherapy With or Without Pembrolizumab Followed by Maintenance With Olaparib or Placebo for the First-Line Treatment of BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (KEYLYNK-001 / ENGOT-ov43 / GOG-3036)

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 18 Mar 2025

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At a glance

  • Drugs Olaparib (Primary) ; Pembrolizumab (Primary) ; Bevacizumab; Carboplatin; Docetaxel; Paclitaxel
  • Indications Carcinoma; Fallopian tube cancer; Ovarian cancer; Peritoneal cancer; Sarcoma
  • Focus Registrational; Therapeutic Use
  • Acronyms KEYLYNK-001; MK-7339-001/KEYLYNK-001/ENGOT-ov43/GOG-3036
  • Sponsors Merck Sharp & Dohme Corp.

Most Recent Events

  • 09 Dec 2024 According to a Merck & Co Media Release, the study did not reach its secondary endpoint of overall survival (OS). The role of KEYTRUDA in the intention-to-treat population remains uncertain at this time. these results will be presented at an upcoming medical meeting and discussed with regulatory authorities.
  • 09 Dec 2024 Primary endpoint has been met. (Progression-Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by the Investigator in Participants with Programmed Death-Ligand 1 (PD-L1)-Positive Tumors (Combined Positive Score [CPS]10) Tumors), according to a Merck & Co Media Release.
  • 09 Dec 2024 Results presented in the Merck & Co Media Release.

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