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e-Poster Display Session

254TiP - ENGOT-cx11/KEYNOTE-A18: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab With Chemoradiotherapy in Patients With High-Risk Locally Advanced Cervical Cancer


22 Nov 2020


e-Poster Display Session


Cytotoxic Therapy;  Radiation Oncology

Tumour Site


Domenica Lorusso


D. Lorusso1, Y. Xiang2, N. Colombo3, R. Coleman4, L. Randall5, L. Duska6, K. Hasegawa7, A. Nogueira-Rodrigues8, D. Cibula9, M.R. Mirza10, B. You11, A. Oaknin12, M. Christiaens13, C. Taskiran14, J. Sehouli15, J. Korach16, C. Marth17, S. Keefe18, M. Puglisi18, S. Pignata19

Author affiliations

  • 1 Department Of Medical Research Programming, Università Cattolica del Sacro Cuore–Fondazione Policlinico Universitario, 00168 - Rome/IT
  • 2 Department Of Gynecology And Obstetrics, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing/CN
  • 3 Department Of Gynecology, Instituto Europeo di Oncologia, Milan/IT
  • 4 Department Of Gynecologic Oncology And Reproductive Medicine, University of Texas MD Anderson Cancer Center, Houston/US
  • 5 Department Of Obstetrics And Gynecology, Massey Cancer Center, Virginia Commonwealth, Richmond/US
  • 6 Department Of Obstetrics And Gynecology, University of Virginia, Charlottesville/US
  • 7 Department Of Gynecologic Oncology, Saitama Medical University, Hidaka, Saitama Prefecture/JP
  • 8 Departamento De Clínica Médica, Universidade Federal de Minas Gerais, Belo Horizonte, Minas Gerais/BR
  • 9 Department Of Obstetrics And Gynecology, General Faculty Hospital in Prague, First Faculty of Medicine, Charles University, Prague/CZ
  • 10 Department Of Oncology, Copenhagen University Hospital, Copenhagen/DK
  • 11 Department Of Medical Oncology, CITOHL, IC-HCL, Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Lyon/FR
  • 12 Department Of Medical Oncology, Valle de Hebrón Instituto de Oncología, Barcelona/ES
  • 13 Department Of Radiation Oncology, Universitair Ziekenhuis Leuven, Leuven/BE
  • 14 Department Of Obstetrics And Gynecology, Department Of Gynecologic Oncology, Professor Koc University School of Medicine and VKV American Hospital, Istanbul/TR
  • 15 Deparment Of Gynecology, Charité–Universitätsmedizin Berlin, Berlin/DE
  • 16 Gynecology Oncology Department, Sheba Medical Center, Ramat Gan/IL
  • 17 Department Of Obstetrics And Gynecology, Medizinische Universität Innsbruck, Innsbruck/AT
  • 18 Oncology, Merck & Co., Inc., Kenilworth/US
  • 19 Department Of Uro-gynaecological Oncology, Instituto Nazionale Tumori IRCCS Fondazione G Pascale, Napoli/IT


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Abstract 254TiP


High-risk locally advanced cervical cancer has a poor prognosis, and most patients (pts) experience recurrence in 2 y. External beam radiotherapy (EBRT) with concurrent chemotherapy followed by brachytherapy is the standard of care for locally advanced cervical cancer. The immunostimulatory activity of the PD-1 inhibitor pembrolizumab (pembro) may be enhanced by concurrent chemoradiotherapy (CRT). After the KEYNOTE-158 study, in which pembro had durable antitumor activity, pembro monotherapy was approved for pts with PD-L1–positive recurrent or metastatic cervical cancer who progressed during or after chemotherapy. ENGOT-cx11/KEYNOTE-A18 (NCT04221945) is a phase 3, randomized, placebo (pbo)-controlled study of pembro with concurrent CRT for the treatment of locally advanced cervical cancer.

Trial design

~980 pts with high-risk (FIGO 2014 stage IB2-IIB with node-positive disease or stage III-IVA), locally advanced, histologically confirmed cervical cancer who have not received systemic therapy, immunotherapy, definitive surgery, or radiation will be randomized 1:1 to receive either 5 cycles of pembro 200 mg Q3W + CRT then 15 cycles of pembro 400 mg Q6W or 5 cycles of pbo Q3W + CRT then 15 cycles of pbo Q6W. The CRT regimen includes 5 cycles (with optional 6th dose) of cisplatin 40 mg/m2 Q1W + EBRT then brachytherapy.

Randomization is stratified by planned EBRT type (intensity-modulated radiotherapy [IMRT] or volumetric-modulated arc therapy [VMAT] vs non-IMRT or non-VMAT), cancer stage at screening (stage IB2-IIB vs III-IVA), and planned total radiotherapy dose. Treatment will continue until the pt has received 20 cycles of pembro (5 cycles 200 mg Q3W, 15 cycles 400 mg Q6W) vs pbo (~2 y) or until disease progression, unacceptable toxicity, or withdrawal. Primary endpoints are PFS per RECIST version 1.1 by blinded independent central review and OS. Secondary endpoints are PFS at 2 y; OS at 3 y; CR at 12 wk; ORR; PFS and OS in PD-L1–positive pts; EORTC Quality of Life Questionnaire (QLQ)–Core 30 and Cervical Cancer Module (EORTC QLQ-CX24); and safety. Enrollment is ongoing in 30 countries.

Clinical trial identification

ClinicalTrials.gov identifier, NCT04221945; EudraCT number, 2019-003152-37

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