Study of Chemoradiotherapy With or Without Pembrolizumab (MK-3475) For The Treatment of Locally Advanced Cervical Cancer (MK-3475-A18/KEYNOTE-A18/ENGOT-cx11/GOG-3047)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

1,060

Participants

Timeline

Start Date

May 12, 2020

Primary Completion Date

January 7, 2025

Study Completion Date

January 17, 2026

Conditions
Uterine Cervical Neoplasms
Interventions
BIOLOGICAL

Pembrolizumab

IV infusion

DRUG

Placebo for pembrolizumab

IV infusion

DRUG

Cisplatin

IV infusion

RADIATION

External Beam Radiotherapy (EBRT)

Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed

RADIATION

Brachytherapy

Given as a total radiotherapy dose of 80 Gy for volume-directed and 75 Gy for point-directed

Trial Locations (176)

100

National Taiwan University Hospital ( Site 1095), Taipei

104

Mackay Memorial Hospital ( Site 1094), Taipei

333

Linkou Chang Gung Memorial Hospital ( Site 1097), Taoyuan District

1090

Medizinische Universität Wien ( Site 0567), Vienna

1122

Orszagos Onkologiai Intezet ( Site 0846), Budapest

2145

Westmead Hospital ( Site 0973), Westmead

2610

GZA Sint Augustinus ( Site 0356), Wilrijk

2650

UZA University Hospital Antwerp ( Site 0351), Edegem

3000

Peter MacCallum Cancer Centre ( Site 0971), Melbourne

UZ Leuven ( Site 0354), Leuven

3168

Monash Health-Monash Medical Centre ( Site 0970), Clayton

4029

Royal Brisbane and Women s Hospital ( Site 0972), Herston

4032

Debreceni Egyetem Klinikai Kozpont ( Site 0845), Debrecen

5021

Helse Bergen HF Haukeland Universitetssjukehus ( Site 0601), Bergen

6008

St John of God Subiaco Hospital ( Site 0969), Subiaco

6020

Medizinische Universitat Innsbruck ( Site 0566), Innsbruck

7000

C.I.U. Hopital Ambroise Pare ( Site 0353), Mons

8036

Medizinische Universitat Graz ( Site 0569), Graz

9000

AZ St Lucas ( Site 0349), Ghent

9300

OLV Ziekenhuis ( Site 0352), Aalst

10060

Istituto di Candiolo - IRCCS ( Site 0546), Candiolo

10126

A.O.U. Citta della Salute e della Scienza di Torino ( Site 0535), Torino

10400

Ramathibodi Hospital, Mahidol University ( Site 1131), Rajthevee

10408

National Cancer Center ( Site 1065), Goyang-si

11528

Alexandra General Hospital ( Site 0477), Athens

13013

Hospital de Alta Complejidad de La Libertad Virgen de La Puerta ( Site 0287), Trujillo

13353

Charite Universitaetsmedizin Berlin ( Site 0442), Berlin

15036

Instituto de Oncologia y Radioterapia Clinica Ricardo Palma ( Site 0290), Lima

15082

Hospital Nacional Arzobispo Loayza ( Site 0292), Lima

Hospital Nacional Guillermo Almenara Irigoyen ( Site 0291), Lima

15087

Clinica San Gabriel ( Site 0296), San Miguel

15244

Allegheny Health Network West Penn Hospital-Gynecologic Oncology ( Site 0030), Pittsburgh

15706

Hosp Clin Univ de Santiago ( Site 0629), Santiago de Compostela

20132

IRCCS Ospedale San Raffaele ( Site 0539), Milan

20133

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0542), Milan

20141

Istituto Europeo di Oncologia ( Site 0536), Milan

20246

Universitaetsklinikum Hamburg-Eppendorf ( Site 0445), Hamburg

22908

UVA Health System ( Site 0005), Charlottesville

23007

Complejo Hospitalario de Jaen ( Site 0632), Jaén

23219

Virginia Commonwealth University ( Site 0024), Richmond

25000

CHU Jean Minjoz ( Site 0411), Besançon

27514

University of North Carolina at Chapel Hill ( Site 0025), Chapel Hill

28223

HOSPITAL UNIVERSITARIO QUIRONSALUD MADRID-ONCOLOGIA MEDICA ( Site 0638), Pozuelo de Alarcón

29425

Hollings Cancer Center ( Site 0007), Charleston

31059

Institut Claudius Regaud ( Site 0417), Toulouse

32804

AdventHealth Orlando-AdventHealth Medical Group Gynecological Oncology ( Site 0009), Orlando

34093

I.U. Cerrahpasa Medical Faculty ( Site 0755), Istanbul

40002

Srinagarind Hospital. Khon Kaen University ( Site 1132), Mueang

40138

A.O. Universitaria Policlinico S. Orsola-Malpighi ( Site 0541), Bologna

40536

University of Kentucky Markey Cancer Center ( Site 0015), Lexington

42601

Keimyung University Dongsan Medical Center ( Site 1066), Daegu

43210

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C, Columbus

46845

Parkview Research Center at Parkview Regional Medical Center ( Site 0026), Fort Wayne

48201

Karmanos Cancer Institute ( Site 0018), Detroit

50009

Hospital Clinico Universitario Lozano Blesa ( Site 0630), Zaragoza

50200

Maharaj Nakorn Chiang Mai Hospital ( Site 1133), Chiang Mai

55404

Minnesota Oncology Hematology, PA ( Site 8007), Minneapolis

57104

Sanford Gynecology Oncology ( Site 0003), Sioux Falls

58501

Sanford Bismarck Medical Center ( Site 0046), Bismarck

61024

Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 0876), Kharkiv

68167

Universitätsmedizin Mannheim-Department of Obstetrics and Gynecology ( Site 0443), Mannheim

69310

Centre Hospitalier Lyon Sud ( Site 0413), Pierre-Bénite

70433

Women's Cancer Care ( Site 0039), Covington

70817

Our Lady of the Lake Regional Medical Center. ( Site 0031), Baton Rouge

73100

Ospedale Vito Fazzi ( Site 0547), Lecce

76104

Texas Oncology-Fort Worth Cancer Center ( Site 8001), Fort Worth

77380

Texas Oncology-The Woodlands ( Site 8003), The Woodlands

78240

Texas Oncology-San Antonio Medical Center ( Site 8002), San Antonio

78731

Texas Oncology-Austin Central ( Site 8006), Austin

79031

Lviv State Oncology Regional Treatment and Diagnostic Center ( Site 0882), Lviv

79106

Universitaetsklinikum Freiburg ( Site 0454), Freiburg im Breisgau

80131

Fondazione Giovanni Pascale Di Napoli ( Site 0544), Napoli

80262

University of Colorado Health Sciences Center and Hospital ( Site 0028), Denver

80336

Klinikum der Universitaet in Muenchen ( Site 0446), Munich

81675

Klinikum Rechts der Isar. Technischen Universitaet Muenchen ( Site 0453), Munich

85016

HonorHealth Research Institute - Biltmore ( Site 8009), Phoenix

87106

University of New Mexico Comprehensive Cancer Center-Clinical Research Office ( Site 0019), Albuquerque

90095

UCLA Hematology/Oncology - Westwood (Building 200 Suite 120) ( Site 0027), Los Angeles

90110

Songklanagarind Hospital ( Site 1130), Hat Yai

92663

Hoag Memorial Hospital Presbyterian ( Site 0038), Newport Beach

95817

UC Davis Comprehensive Cancer Center ( Site 0017), Sacramento

97210

Legacy Good Samaritan Medical Center ( Site 0013), Portland

97401

Willamette Valley Cancer Institute and Research Center ( Site 8000), Eugene

100730

Peking Union Medical College Hospital ( Site 1001), Beijing

110321

Instituto Nacional de Cancerologia E.S.E ( Site 0228), Bogotá

125284

MSROI named after P.A. Hertsen branch of FSBI NMRC Radiology ( Site 0722), Moscow

150054

Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0734), Yaroslavl

150081

Harbin Medical University Cancer Hospital ( Site 1013), Harbin

197758

GBUZ SPb CRPCstmc(o) ( Site 0746), Saint Petersburg

National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 0725), Saint Petersburg

200032

Shanghai Cancer Hospital ( Site 1000), Shanghai

201204

Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 1039), Shanghai

230001

Anhui Provincial Hospital ( Site 1029), Hefei

230031

Anhui Provincial Cancer Hospital ( Site 1007), Hefei

233004

Hunan Cancer Hospital ( Site 1015), Changsha

310014

Zhejiang Provincial People's Hospital ( Site 1021), Hangzhou

310022

Zhejiang Cancer Hospital ( Site 1004), Hangzhou

361003

The First Affiliated Hospital of Xiamen University ( Site 1025), Xiamen

400030

Chongqing Cancer Hospital ( Site 1030), Chongqing

410008

Xiangya Hospital Central-South University ( Site 1009), Changsha

454087

Chelyabinsk Regional Clinical Center Oncology and Nuclear Medicine ( Site 0741), Chelyabinsk

510080

The First Affiliated Hospital.Sun Yat-sen University ( Site 1005), Guangzhou

530021

Affiliated Cancer Hospital of Guangxi Medical University ( Site 1036), Nanning

610041

Sichuan Cancer Hospital ( Site 1018), Chengdu

660133

Krasnoyarsk Regional Clinical Oncological Dispensary ( Site 0729), Krasnoyarsk

760032

Fundacion Valle del Lili ( Site 0230), Santiago de Cali

760042

Centro Medico Imbanaco de Cali S.A ( Site 0227), Santiago de Cali

830054

The First Affiliated Hospital of Xinjiang Medical University ( Site 1012), Ürümqi

2778577

National Cancer Center Hospital East ( Site 1159), Kashiwa

3109601

Rambam Medical Center ( Site 0815), Haifa

4800827

Centro Investigación del Cáncer James Lind ( Site 0194), Temuco

5262000

Chaim Sheba Medical Center ( Site 0814), Ramat Gan

6423906

Sourasky Medical Center ( Site 0819), Tel Aviv

7510032

Sociedad Oncovida S.A. ( Site 0196), Santiago

7630370

Iram Cancer Research ( Site 0198), Santiago

9112001

Hadassah Medical Center. Ein Kerem ( Site 0816), Jerusalem

14048900

Hospital de Clínicas de Ribeirão Preto ( Site 0171), Ribeirão Preto

06510

Smilow Cancer Center at Yale-New Haven ( Site 0023), New Haven

30130-100

Hospital das Clinicas da UFMG ( Site 0172), Belo Horizonte

59075-740

Liga Norte Riograndense Contra o Cancer ( Site 0170), Natal

04014-002

Núcleo de Pesquisa Clínica da Rede São Camilo ( Site 0166), São Paulo

20220-410

Instituto Nacional Do Cancer II ( Site 0173), Rio de Janeiro

M5G 2M9

Princess Margaret Cancer Centre ( Site 0102), Toronto

H2X 0A9

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0101), Montreal

H4A 3J1

McGill University Health Centre ( Site 0105), Montreal

G1J 1Z4

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0, Québec

Unknown

Oncocentro ( Site 0195), Viña del Mar

Royal Devon and Exeter Foundation Trust Hospital ( Site 0699), Exeter

050021

Fundacion Centro de Investigacion Clinica CIC ( Site 0231), Medellín

602 00

Fakultni Nemocnice Brno Bohunice ( Site 0912), Brno

708 52

Fakultni nemocnice Ostrava ( Site 0909), Ostrava

100 34

Fakultni nemocnice Kralovske Vinohrady ( Site 0913), Prague

01307

Universitaetsklinikum Carl Gustav Carus der Technischen Univ ( Site 0452), Dresden

04103

Universitaetsklinik Leipzig ( Site 0456), Leipzig

262 00

General Hospital of Patras. St Andrews ( Site 0473), Pátrai

151 23

Hospital Hygeia ( Site 0478), Athens

546 45

Euromedica General Clinic of Thessaloniki ( Site 0474), Thessaloniki

01010

Centro de Investigaciones Clinicas de Latinoamerica S.A. - CELAN ( Site 0321), Guatemala City

Oncologika S.A. ( Site 0323), Guatemala City

Oncomedica ( Site 0320), Guatemala City

01015

Grupo Angeles SA ( Site 0319), Guatemala City

01016

Medi-K Cayala ( Site 0318), Guatemala City

09002

Centro Medico Integral De Cancerología (CEMIC) ( Site 0322), Quetzaltenango

T12 DC4A

Cork University Hospital ( Site 0504), Cork

D8

St James Hospital ( Site 0505), Dublin

00144

Istituto Nazionale Tumori Regina Elena ( Site 0540), Rome

00168

Policlinico Universitario Gemelli ( Site 0538), Roma

464-8681

Aichi Cancer Center Hospital ( Site 1155), Nagoya

791-0280

National Hospital Organization Shikoku Cancer Center ( Site 1162), Matsuyama

790-0295

Ehime University Hospital ( Site 1157), Tōon

830-0011

Kurume University Hospital ( Site 1164), Kurume

060-8648

Hokkaido University Hospital ( Site 1163), Sapporo

028-3695

Iwate Medical University Hospital ( Site 1165), Shiwa-gun

903-0215

University of the Ryukyus Hospital ( Site 1156), Nakagami-gun

350-1298

Saitama Medical University International Medical Center ( Site 1168), Hidaka

362-0806

Saitama Cancer Center ( Site 1169), Kitaadachi-gun

181-8611

Kyorin University Hospital ( Site 1158), Mitaka

811-1395

National Hospital Organization Kyushu Cancer Center ( Site 1167), Fukuoka

890-8760

Kagoshima City Hospital ( Site 1166), Kagoshima

541-8567

Osaka International Cancer Institute ( Site 1161), Osaka

104-0045

National Cancer Center Hospital ( Site 1172), Tokyo

135-8550

Japanese Foundation for Cancer Research-Gynecologic Oncology ( Site 1171), Tokyo

160-8582

Keio University Hospital ( Site 1170), Tokyo

0379

Oslo Universitetssykehus Radiumhospitalet ( Site 0600), Oslo

04001

Centro Medico Monte Carmelo ( Site 0289), Arequipa

07021

Hospital Nacional Daniel Alcides Carrion ( Site 0293), Callao

05505

Asan Medical Center ( Site 1062), Seoul

03722

Severance Hospital ( Site 1063), Seoul

06351

Samsung Medical Center ( Site 1064), Seoul

08916

Hospital Germans Trias i Pujol-Instituto Catalán de Oncología de Badalona ( Site 0637), Badalona

08035

Hospital Universitari Vall d Hebron ( Site 0634), Barcelona

171 76

Karolinska Universitetssjukhuset ( Site 0784), Stockholm

01130

Acibadem Adana Hastanesi ( Site 0756), Adana

06490

Baskent Universitesi Ankara Hastanesi ( Site 0754), Ankara

SW3 6JJ

ROYAL MARSDEN HOSPITAL (CHELSEA) ( Site 0701), London

SM3 5PT

Royal Marsden Hospital (Sutton)-Gynaecology Unit ( Site 0696), London

All Listed Sponsors
collaborator

GOG Foundation

NETWORK

collaborator

European Network of Gynaecological Oncological Trial Groups (ENGOT)

OTHER

lead

Merck Sharp & Dohme LLC

INDUSTRY