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A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Plus ADT Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (KEYNOTE-991)

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Trial Profile

A Phase 3, Randomized, Double-blind Trial of Pembrolizumab (MK-3475) Plus Enzalutamide Plus ADT Versus Placebo Plus Enzalutamide Plus ADT in Participants With Metastatic Hormone-Sensitive Prostate Cancer (mHSPC) (KEYNOTE-991)

Status: Discontinued
Phase of Trial: Phase III

Latest Information Update: 30 May 2025

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At a glance

  • Drugs Enzalutamide (Primary) ; Pembrolizumab (Primary) ; Antiandrogens
  • Indications Adenocarcinoma; Prostate cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms KEYNOTE-991
  • Sponsors Merck Sharp & Dohme Corp.

Most Recent Events

  • 25 May 2025 Planned End Date changed from 3 Dec 2025 to 2 Feb 2026.
  • 14 Feb 2025 Planned End Date changed from 15 Jun 2026 to 3 Dec 2025.
  • 20 May 2024 Planned End Date changed from 2 Feb 2026 to 15 Jun 2026.

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