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A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone Versus Placebo Plus Docetaxel Plus Prednisone in Participants With Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE-921)

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Trial Profile

A Phase 3, Randomized, Double-blind Study of Pembrolizumab (MK-3475) Plus Docetaxel Plus Prednisone Versus Placebo Plus Docetaxel Plus Prednisone in Participants With Chemotherapy-naïve Metastatic Castration-Resistant Prostate Cancer (mCRPC) Who Have Progressed on a Next Generation Hormonal Agent (NHA) (KEYNOTE-921)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 24 Jul 2024

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At a glance

  • Drugs Pembrolizumab (Primary) ; Dexamethasone; Docetaxel; Prednisone
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms KEYNOTE-921; MK-3475-921/KEYNOTE-921
  • Sponsors Merck Sharp & Dohme Corp.

Most Recent Events

  • 10 Aug 2023 Status changed from active, no longer recruiting to completed.
  • 18 Feb 2023 With Amendment 6 all participants will be unblinded and placebo treatment will be stopping. Participants who are deemed to be deriving clinical benefit from treatment may continue at the discretion of the investigator.
  • 18 Feb 2023 Results presented at the 2023 Genitourinary Cancers Symposium

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