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Clinical trial · no report yet · Phase 3

NCT04634877

Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

  • NCT04634877 ↗
  • Active not recruiting
  • Merck Sharp & Dohme LLC
  • 30 commentary sources found
  • Standard

We haven't built a report for this trial yet. This page shows the registry record and the public commentary we found that names the trial. A report reads that commentary and sets out what clinicians said about the trial, each point linked to its source. How reports are made.

Commentary we found

Podcasts, YouTube videos and X posts in our index that name this trial. A report screens them, searches for more and cites what clinicians said when it is built.

ChannelFound
YouTube16
Podcasts13
X threads1

The trial

ClinicalTrials.gov
Official title
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)
Phase
Phase 3
Status
Active not recruiting
Conditions
Endometrial Neoplasms
Interventions
Pembrolizumab; Carboplatin; Paclitaxel; Placebo for pembrolizumab; Docetaxel; Cisplatin; External Beam Radiotherapy (EBRT); Cisplatin (as radiosensitizer); Brachytherapy
Arms
  • Pembrolizumab + Chemotherapy · Experimental
  • Placebo + Chemotherapy · Placebo comparator
Enrollment
990 (estimated)
Primary outcomes
  • Disease-Free Survival (DFS) as Assessed Radiographically by Investigator or by Histopathologic Confirmation of Suspected Disease Recurrence
  • Overall Survival (OS)
Sponsor
Merck Sharp & Dohme LLC with European Network of Gynaecological Oncological Trial Groups (ENGOT), Gynecologic Oncology Group
Start
Jan 10, 2021
Primary completion
Nov 20, 2026 (estimated)
Results posted
No
Registry record
NCT04634877 · updated Sep 18, 2026

Publications

linked from the registry
  • Van Gorp T, Cibula D, Lv W, Backes F, Ortac F, Hasegawa K, Lindemann K, Savarese A, Laenen A, Kim YM, Bodnar L, Barretina-Ginesta MP, Gilbert L, Pothuri B, Chen X, Flores MB, Levy T, Colombo N, Papadimitriou C, Buchanan T, Hanker LC, Eminowicz G, Rob L, Black D, Lichfield J, Lin G, Orlowski R, Keefe S, Lortholary A, Slomovitz B; ENGOT-en11/GOG-3053/KEYNOTE-B21 investigators. ENGOT-en11/GOG-3053/KEYNOTE-B21: a randomised, double-blind, phase III study of pembrolizumab or placebo plus adjuvant chemotherapy with or without radiotherapy in patients with newly diagnosed, high-risk endometrial cancer. Ann Oncol. 2024 Nov;35(11):968-980. doi: 10.1016/j.annonc.2024.08.2242. Epub 2024 Sep 14. PubMed 39284383
  • Slomovitz BM, Cibula D, Lv W, Ortac F, Hietanen S, Backes F, Kikuchi A, Lorusso D, Danska-Bidzinska A, Samouelian V, Barretina-Ginesta MP, Vulsteke C, Lai CH, Pothuri B, Zhang Y, Magallanes-Maciel M, Amit A, Guarneri V, Zagouri F, Bell M, Welz J, Eminowicz G, Hruda M, Willmott LJ, Lichfield J, Wang W, Orlowski R, Aktan G, Gladieff L, Van Gorp T. Pembrolizumab or Placebo Plus Adjuvant Chemotherapy With or Without Radiotherapy for Newly Diagnosed, High-Risk Endometrial Cancer: Results in Mismatch Repair-Deficient Tumors. J Clin Oncol. 2025 Jan 20;43(3):251-259. doi: 10.1200/JCO-24-01887. Epub 2024 Oct 16. PubMed 39411812