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  • EPV036/#142 European network for gynaecological oncological trial (ENGOT)-CX11/gynecologic oncology group (GOG) 3047/keynote-A18: phase 3 trial of pembrolizumab plus chemoradiotherapy in high-risk locally advanced cervical cancer

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EPV036/#142 European network for gynaecological oncological trial (ENGOT)-CX11/gynecologic oncology group (GOG) 3047/keynote-A18: phase 3 trial of pembrolizumab plus chemoradiotherapy in high-risk locally advanced cervical cancer
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  1. D Lorusso1,
  2. Y Xiang2,
  3. N Colombo3,
  4. RL Coleman4,
  5. LM Randall5,
  6. L Duska6,
  7. K Hasegawa7,
  8. A Nogueira-Rodrigues8,
  9. D Cibula9,
  10. M Mirza10,
  11. B You11,
  12. A Oaknin12,
  13. M Christiaens13,
  14. C Taskiran14,
  15. J Sehouli15,
  16. J Korach16,
  17. C Marth17,
  18. K Yamada18,
  19. M Puglisi18 and
  20. S Pignata19
  1. 1Associate Professor of Obstetrics and Gynecology, Catholic University of Sacred Heart, Clinical Research Development Unit Fondazione Policlinico Gemelli Irccs, Rome, Italy
  2. 2Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Department of Gynecology and Obstetrics, Beijing, China
  3. 3Instituto Europeo di Oncologia, Department of Gynecology, Milan, Italy
  4. 4University of Texas MD anderson Cancer Center, Department of Gynecologic Oncology and Reproductive Medicine, Houston, USA
  5. 5Massey Cancer Center, Virginia Commonwealth University, Department of Obstetrics and Gynecology, Richmond, USA
  6. 6University of Virginia, Department of Obstetrics and Gynecology, Charlottesville, USA
  7. 7Saitama Medical University, Hidaka, Department of Gynecologic Oncology, Saitama Prefecture, Japan
  8. 8Universidade Federal de Minas Gerais, Belo Horizonte, Departamento De Clínica Médica, Minas Gerais, Brazil
  9. 9General Faculty Hospital in Prague, First Faculty of Medicine, Charles University, Department of Obstetrics and Gynecology, Prague, Czech Republic
  10. 10Copenhagen University Hospital, Department of Oncology, Copenhagen, Denmark
  11. 11CITOHL, IC-HCL, Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Department of Medical Oncology, Lyon, France
  12. 12Vall d’Hebron Institute of Oncology (VHIO), Hospital Universitari Vall d’Hebron, Vall d’Hebron Barcelona Hospital Campus, Department of Medical Oncology, Barcelona, Spain
  13. 13Universitair Ziekenhuis Leuven, Department of Radiation Oncology, Leuven, Belgium
  14. 14Professor Koc University School of Medicine and VKV American Hospital, Department of Obstetrics and Gynecology, Division of Gynecologic Oncology and Turkish Society of Gynecologic Oncology, Istanbul, Turkey
  15. 15Charité–Universitätsmedizin Berlin, Deparment of Gynecology, Berlin, Germany
  16. 16Sheba Medical Center, Gynecology Oncology Department, Ramat Gan, Israel
  17. 17Medizinische Universität Innsbruck, Department of Obstetrics and Gynecology, Innsbruck, Austria
  18. 18Merck and Co., Inc., Clinical Development, Kenilworth, USA
  19. 19Instituto Nazionale Tumori IRCCS Fondazione G Pascale, Department of Uro-gynaecological Oncology, Napoli, Italy

Abstract

Objectives High-risk locally advanced cervical cancer has a poor prognosis. External beam radiotherapy (EBRT) with concurrent chemotherapy followed by brachytherapy is the standard of care. The immunostimulatory activity of pembrolizumab may be enhanced by concurrent chemoradiotherapy (CCRT). Pembrolizumab monotherapy is approved for patients with PD-L1–positive recurrent or metastatic cervical cancer that progressed during or after chemotherapy. The phase 3 ENGOT-cx11/GOG 3047/KEYNOTE-A18 (NCT04221945) study is evaluating pembrolizumab with CCRT in patients with locally advanced cervical cancer.

Methods ~980 patients with high-risk (FIGO 2014 stage IB2-IIB with node-positive disease or stage III-IVA), locally advanced, previously untreated cervical cancer will be randomized 1:1 to receive either 5 cycles of pembrolizumab 200 mg Q3W plus CCRT followed by 15 cycles of pembrolizumab 400 mg Q6W or 5 cycles of placebo Q3W plus CCRT followed by 15 cycles of placebo Q6W. CCRT includes 5 cycles (optional 6th dose) of cisplatin 40 mg/m2 Q1W plus EBRT followed by brachytherapy. Randomization is stratified by planned EBRT type (intensity-modulated radiotherapy [IMRT] or volumetric-modulated arc therapy [VMAT] vs non-IMRT or non-VMAT), screening cancer stage (IB2-IIB vs III-IVA), and planned total radiotherapy dose. Treatment will continue for 20 cycles or disease progression, unacceptable toxicity, or withdrawal. Primary endpoints are PFS per RECIST v1.1 by investigator and OS. Secondary endpoints include PFS by BICR, PFS at 2 years, OS at 3 years, CR at 12 weeks, ORR, OS and PFS by PD-L1 status, QoL, and safety. Enrollment began May 2020 and is planned for 193 sites in 30 countries.

Results Not applicable

Conclusions Not applicable

https://doi.org/10.1136/ijgc-2021-IGCS.104

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