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A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Paclitaxel With or Without Bevacizumab for the Treatment of Platinum-resistant Recurrent Ovarian Cancer (KEYNOTE-B96/ENGOT-ov65)

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Trial Profile

A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Paclitaxel With or Without Bevacizumab for the Treatment of Platinum-resistant Recurrent Ovarian Cancer (KEYNOTE-B96/ENGOT-ov65)

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

Latest Information Update: 28 Nov 2025

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At a glance

  • Drugs Bevacizumab (Primary) ; Docetaxel (Primary) ; Paclitaxel (Primary) ; Pembrolizumab (Primary)
  • Indications Carcinoma; Fallopian tube cancer; Ovarian cancer; Peritoneal cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms KEYNOTE-B96
  • Sponsors Merck Sharp & Dohme

Most Recent Events

  • 18 Oct 2025 According to the Merck and Co Media Release, final analysis data will be presented at an upcoming medical meeting.
  • 18 Oct 2025 According to the Merck and Co Media Release, based on this data the U.S. FDA has accepted for priority review a new supplemental Biologics License Application (sBLA) for KEYTRUDA plus chemotherapy with or without bevacizumab for certain patients with platinum-resistant recurrent ovarian cancer. The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action, date of Feb. 20, 2026.
  • 18 Oct 2025 Results presented in the Merck & Co Media Release.

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