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EPV107/#258 ENGOT-EN11/GOG-3053/KEYNOTE-B21: phase 3 study of pembrolizumab or placebo in combination with adjuvant chemotherapy with/without radiotherapy in patients with newly diagnosed high-risk endometrial cancer
  1. T Van Gorp1,
  2. M Mirza2,
  3. A Lortholary3,
  4. I Vergote4,
  5. D Cibula5,
  6. A Walther6,
  7. A Savarese7,
  8. M-P Barretina-Ginesta8,
  9. F Ortaç9,
  10. C Papadimitriou10,
  11. L Bodnar11,
  12. C-H Lai12,
  13. K Hasegawa13,
  14. X Xie14,
  15. EL Barber15,
  16. RL Coleman16,
  17. S Keefe17,
  18. R Orlowski17 and
  19. B Slomovitz18
  1. 1UZ Leuven, Gynaecological Oncology, Leuven, Belgium
  2. 2NSGO-CTU and Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark
  3. 3Centre Catherine de Sienne, Hôpital Privé Du Confluent, Nantes, France
  4. 4BGOG and University Hospitals Leuven, Leuven Cancer Institute, Leuven, Belgium
  5. 5Department of Obstetrics and Gynecology, General Faculty Hospital In Prague, First Faculty of Medicine, Charles University, Prague, Czech Republic
  6. 6Bristol Cancer Institute, University Hospitals Bristol, Bristol, UK
  7. 7Department of Medical Oncology, Istituto Nazionale Tumori Regina Elena, Rome, Italy
  8. 8Catalan Institute of Oncology and Girona Biomedical Research Institute, Medical School University of Girona, Girona, Spain
  9. 9Department of Obstetrics and Gynecology, Ankara University School of Medicine, Ankara, Turkey
  10. 10Aretaieio University Hospital, National and Kapodistrian University of Athens, Athens, Greece
  11. 11Department of Oncology and Immunooncology, Warmian-masurian Cancer Center of The Ministry of The Interior and Administration’s Hospital, Olsztyn, Poland
  12. 12TGOG and Department of Gynecology and Obstetrics, Chang Gung Memorial Hospital, Linkou Branch, Taoyuan, Taiwan
  13. 13Department of Gynecologic Oncology, Saitama Medical University, Hidaka, Saitama Prefecture, Japan
  14. 14Women’s Hospital, School of Medicine, Zhejiang University, Hangzhou, China
  15. 15Department of Gynecologic Oncology, Northwestern University Feinberg School of Medicine, Chicago, USA
  16. 16Department of Gynecologic Oncology, Us Oncology Research, The Woodlands, USA
  17. 17Oncology, Merck and Co., Inc., Kenilworth, USA
  18. 18Department of Gynecologic Oncology, Broward Health, Fort Lauderdale, USA


Objectives Pembrolizumab, an anti–PD-1 antibody, has demonstrated activity as monotherapy and in combination with lenvatinib in patients with previously treated mismatch repair (MMR) deficient and MMR proficient endometrial cancer (EC). ENGOT-en11/GOG-3053/KEYNOTE-B21 (NCT04634877) is a phase 3, randomized, double-blind study of pembrolizumab or placebo in combination with adjuvant chemotherapy with/without radiotherapy in patients with EC.

Methods Eligible patients are ≥18 years with newly diagnosed high-risk (stage I/II non-endometrioid or with p53 abnormality and any histology, stage III/IVa), previously untreated EC following surgery with curative intent with no evidence of disease post-operatively. ∼990 patients will be randomized to receive pembrolizumab 200 mg or placebo Q3W for 6 cycles plus chemotherapy (carboplatin area under the curve [AUC] 5/6 plus paclitaxel 175 mg/m2 Q3W or carboplatin AUC 2/2.7 plus paclitaxel 60 mg/m2 QW) in stage 1. Patients receive pembrolizumab 400 mg or placebo Q6W for 6 cycles in stage 2. Radiotherapy (external beam radiotherapy [EBRT] and/or brachytherapy) ± radiosensitizing cisplatin 50 mg/m2 (days 1 and 29) may be administered after completion of chemotherapy. Randomization is stratified by MMR status (pMMR vs dMMR) and, within pMMR, by planned radiation therapy (cisplatin-EBRT vs EBRT vs no EBRT), histology (endometrioid vs non-endometrioid), and FIGO surgical stage (I/II vs III/IVA). Dual primary endpoints are disease-free survival (DFS; per investigator assessment) and OS. Secondary endpoints include DFS (per BICR), DFS (per investigator assessment) and OS by biomarker status (PD-L1 and tumor mutational burden), safety, and QoL. Enrollment began December 2020 and is ongoing in 28 countries.

Results Not applicable

Conclusions Not applicable

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