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185 ENGOT-en11/GOG-3053/KEYNOTE-B21: phase 3 study of pembrolizumab or placebo + adjuvant chemotherapy ± radiotherapy for high-risk endometrial cancer
  1. T Van Gorp1,
  2. MR Mirza2,
  3. A Lortholary3,
  4. IB Vergote4,
  5. D Cibula5,
  6. A Walther6,
  7. A Savarese7,
  8. MP Barretina-Ginesta8,
  9. FU Ortac9,
  10. C Papadimitriou10,
  11. L Bodnar11,
  12. CH Lai12,
  13. K Hasegawa13,
  14. X Xie14,
  15. EL Barber15,
  16. R Coleman16,
  17. J Lichfield17,
  18. A Grandhi18 and
  19. B Slomovitz19
  1. 1UZ Leuven, 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. 7Istituto Nazionale Tumori Regina Elena, Rome, Italy
  8. 8Catalan Institute of Oncology and Girona Biomedical Research Institute, Medical School University of Girona, Girona, Spain
  9. 9Ankara 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. 15Northwestern University Feinberg School of Medicine, Chicago, IL, USA
  16. 16US Oncology Research, The Woodlands, TX, USA
  17. 17MSD, UK
  18. 18Merck and Co., Inc., Kenilworth, NJ, USA
  19. 19Broward Health, Fort Lauderdale, FL, USA


Introduction/Background*Pembrolizumab, an anti-PD-1 antibody, has demonstrated activity in patients with previously treated mismatch repair (MMR) deficient (dMMR; 57.1% objective response rate [ORR] as monotherapy and 63.6% ORR as combination therapy with lenvatinib) and MMR proficient (pMMR; 36.2% ORR as combination therapy with lenvatinib) endometrial cancer. 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 endometrial cancer.

Methodology Eligible patients are ≥18 years old with newly diagnosed, high-risk (stage I/II non-endometrioid or with p53 abnormality and any histology, stage III/IVA), previously untreated endometrial cancer following surgery with curative intent with no evidence of disease post-operatively. Approximately 990 patients are randomized to receive pembrolizumab 200 mg or placebo every 3 weeks (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 International Federation of Gynecology and Obstetrics surgical stage (I/II vs III/IVA). Dual primary endpoints are disease-free survival (DFS; per investigator assessment) and overall survival (OS). Secondary endpoints include DFS (per blinded independent central review), DFS (per investigator assessment) and OS by biomarker status (PD-L1 and tumor mutational burden), safety (per National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0), and quality of life (per European Organization for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30 [EORTC QLQ-C30] and Endometrial Cancer Module [EORTC QLQ-EN24]). Enrolment began December 2020 and is ongoing at 221 sites in 28 countries.



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