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A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent (KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

Trial Profile

A Phase 3, Randomized, Double-Blind Study of Pembrolizumab Versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent (KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

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

Latest Information Update: 13 Jun 2025

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At a glance

  • Drugs Pembrolizumab (Primary) ; Carboplatin; Cisplatin; Docetaxel; Paclitaxel
  • Indications Adenocarcinoma; Carcinoma; Endometrial cancer; Sarcoma; Squamous cell cancer
  • Focus Registrational; Therapeutic Use
  • Acronyms KEYNOTE-B21
  • Sponsors Merck Sharp & Dohme; Merck Sharp & Dohme Corp.

Most Recent Events

  • 09 Jun 2025 Planned End Date changed from 31 May 2026 to 15 Sep 2026.
  • 09 Jun 2025 Planned primary completion date changed from 31 May 2026 to 15 Sep 2026.
  • 17 Feb 2025 Planned End Date changed from 18 Jun 2025 to 31 May 2026.

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