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)
Summary
The purpose of this study is to compare pembrolizumab + adjuvant chemotherapy with placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to disease-free survival (DFS) as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to overall survival (OS). The primary hypotheses are that pembrolizumab + adjuvant chemotherapy is superior to placebo + adjuvant chemotherapy, with or without radiotherapy, with respect to DFS as assessed radiographically by the investigator or by histopathologic confirmation of suspected disease recurrence, and with respect to OS.
Timeline
- Start
- 2021-01-10
- Primary completion
- 2026-09-15
- Completion
- 2026-09-15
Outcome
Missed primary endpoint
paper CONCLUSIONS: Adjuvant pembrolizumab plus chemotherapy did not improve DFS in patients with newly diagnosed, high-risk, all-comer endometrial cancer. PMID 39284383 ↗
paper hazard ratio 1.02, 95% confidence interval (CI) 0.79-1.32; P = 0.570 PMID 39284383 ↗
Publications
- Results 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.
- Results 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pembrolizumab | Monoclonal antibody | 400 mg | Intravenous |
| Background | Carboplatin | Small molecule | 5 unknown | Intravenous |
| Background | Carboplatin | Small molecule | 6 unknown | Intravenous |
| Background | Cisplatin | Other / unclassified | 50 mg/m2 | Intravenous |
| Background | Cisplatin | Other / unclassified | 75 mg/m2 | Intravenous |
| Background | Docetaxel | Small molecule | 25 mg/m2 | Intravenous |
| Background | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Background | Paclitaxel | Small molecule | 175 mg/m2 | Intravenous |