Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

990

Participants

Timeline

Start Date

January 10, 2021

Primary Completion Date

September 15, 2026

Study Completion Date

September 15, 2026

Conditions
Endometrial Neoplasms
Interventions
BIOLOGICAL

Pembrolizumab

IV infusion

DRUG

Carboplatin

IV infusion

DRUG

Paclitaxel

IV infusion

DRUG

Placebo for pembrolizumab

IV infusion

DRUG

Docetaxel

IV infusion docetaxel 75 mg/m\^2 Q3W or 25 mg/m2 QW may be given in place of paclitaxel following sponsor consultation if a participant experiences severe hypersensitivity to paclitaxel or an adverse event requiring discontinuation of paclitaxel.

DRUG

Cisplatin

Cisplatin 75 mg/m\^2 IV infusion Q3W may be given in place of carboplatin following sponsor consultation if a participant experiences severe hypersensitivity to carboplatin or an adverse event requiring discontinuation of carboplatin.

RADIATION

External Beam Radiotherapy (EBRT)

≥4500 cGY given according to local practice, at the discretion of the investigator

DRUG

Cisplatin (as radiosensitizer)

If a participant receives external beam radiotherapy (EBRT), then cisplatin 50 mg/m\^2 IV infusion may be administered as a radiosensitizer at the discretion of the investigator, on days 1 and 29

RADIATION

Brachytherapy

Given according to local practice, at the discretion of the investigator

Trial Locations (231)

333

Linkou Chang Gung Memorial Hospital ( Site 4091), Taoyuan District

1200

Saint-Luc UCL ( Site 2042), Brussels

2100

Rigshospitalet University Hospital ( Site 2515), Copehagen

2730

Herlev Hospital ( Site 2514), Herlev

3000

UZ Leuven ( Site 2040), Leuven

4000

CHC - Groupe Sante ( Site 2041), Liège

CHU Liege Sart-Tilman ( Site 2044), Liège

Roskilde Sygehus ( Site 2513), Roskilde

4615

Soerlandet sykehus HF Kristiansand ( Site 2152), Kristiansand

4800

CHR Verviers ( Site 2035), Verviers

5000

Odense Universitetshospital ( Site 2512), Odense

6020

Medizinische Universitaet Innsbruck ( Site 2001), Innsbruck

7000

C.I.U. Hopital Ambroise Pare ( Site 2039), Mons

8036

Medizinische Universitat Graz ( Site 2004), Graz

8500

AZ Groeninge ( Site 2036), Kortrijk

9000

AZ Maria Middelares Gent ( Site 2032), Ghent

Universitair Ziekenhuis Gent ( Site 2037), Ghent

9019

University Hospital of North Norway ( Site 2153), Tromsø

9100

AZ Nikolaas ( Site 2031), Sint-Niklaas

Aalborg Universitetshospital ( Site 2511), Aalborg

9300

OLV Ziekenhuis ( Site 2038), Aalst

10016

Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 3042), New York

10060

Istituto di Candiolo - IRCCS ( Site 2125), Candiolo

10408

National Cancer Center ( Site 4065), Goyang-si

10449

MacKay Memorial Hospital ( Site 4092), Taipei

10461

Montefiore Medical Center ( Site 3065), The Bronx

11217

Taipei Veterans General Hospital ( Site 4093), Taipei

11501

Perlmutter Cancer Center at NYU Langone Hospital - Long Island ( Site 3076), Mineola

13620

Seoul National University Bundang Hospital ( Site 4063), Seongnam-si

14004

Hospital Universitario Reina Sofia ( Site 2183), Córdoba

14029

Chernihiv Medical Center of Modern Oncology ( Site 2368), Chernihiv

14076

Centre Francois Baclesse ( Site 2062), Caen

14080

Instituto Nacional de Cancerologia ( Site 1124), Mexico City

15224

AHN West Penn Hospital ( Site 3060), Pittsburgh

17007

Hospital Josep Trueta ( Site 2184), Girona

19090

Abington Hospital - Asplundh Cancer Center ( Site 3073), Willow Grove

19107

Sidney Kimmel Cancer Center - Jefferson Health ( Site 3078), Philadelphia

20132

IRCCS Ospedale San Raffaele ( Site 2130), Milan

20133

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2122), Milan

20141

Istituto Europeo di Oncologia IRCCS-Divisione di Ginecologia Oncologica ( Site 2132), Milan

20760

Turku University Hospital ( Site 2542), Turku

22190

Hôpital Privé Des Côtes d'Armor ( Site 2063), Plérin

23040

Investigacion Onco Farmaceutica S de RL de CV ( Site 1127), La Paz

23298

VCU Massey Cancer Center ( Site 3068), Richmond

23538

Universitätsklinikum Schleswig-Holstein ( Site 2101), Lübeck

25000

CHU Besancon - Hopital Jean Minjoz ( Site 2068), Besançon

25123

Azienda Ospedaliera Spedali Civili di Brescia ( Site 2135), Brescia

27710

Duke Cancer Center ( Site 3072), Durham

28027

Clinica Universitaria de Navarra ( Site 2181), Madrid

28040

Hospital Clinico San Carlos ( Site 2187), Madrid

28046

Hospital Universitario La Paz ( Site 2186), Madrid

29009

"MNE Khmelnytskyi regional antitumor center ( Site 2365)", Khmelnitskyi

29090

Hospital San Lucas Cardiologica del Sureste ( Site 1122), Tuxtla Gutiérrez

30342

Northside Hospital ( Site 3036), Atlanta

30625

Medizinische Hochschule Hannover-Department of Obstetrics and Gynecology ( Site 2109), Hanover

31059

Institut Universitaire du Cancer Toulouse - Oncopole ( Site 2065), Toulouse

33076

Institut Bergonie ( Site 2067), Bordeaux

33140

Mount Sinai Cancer Center ( Site 3081), Miami Beach

33520

Tampere University Hospital ( Site 2541), Tampere

34214

Medipol Universite Hastanesi ( Site 2352), Istanbul

34298

Institut Regional du Cancer de Montpellier - ICM ( Site 2069), Montpellier

35100

Ege University Medical Faculty ( Site 2351), Izmir

35128

Istituto Oncologico Veneto IRCCS-Oncologia 2 ( Site 2134), Padua

35249

University of Alabama - Birmingham ( Site 3061), Birmingham

35575

I.E.U. Medical Point Hastanesi ( Site 2356), Izmir

36604

University of South Alabama, Mitchell Cancer Institute ( Site 3058), Mobile

40207

Norton Cancer Institute - St. Matthews ( Site 3056), Louisville

40705

Taichung Veterans General Hospital ( Site 4094), Taichung

43018

The Municipal Enterprise Volyn Regional Medical Oncology Centre ( Site 2362), Lutsk

43210

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

44101

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2482), Gliwice

44277

Hopital prive du Confluent ( Site 2061), Nantes

45136

Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung ( Site 2105), Essen

46202

Indiana University Melvin and Bren Simon Cancer Center ( Site 3071), Indianapolis

46845

Parkview Cancer Institute ( Site 3067), Fort Wayne

50006

Changhua Christian Hospital ( Site 4095), Changhua

52242

University of Iowa Hospital and Clinics ( Site 3046), Iowa City

53127

Universitätsklinikum Bonn-Gynaecological oncology ( Site 2103), Bonn

54519

Institut De Cancerologie De Lorraine ( Site 2072), Vandœuvre-lès-Nancy

57104

Sanford Gynecology Oncology ( Site 3045), Sioux Falls

58000

"Municipal Enterprise Bukovinian сlinical oncology сenter ( Site 2366)", Chernivtsi

58122

Sanford Fargo Medical Center-Roger Maris Cancer Center ( Site 3080), Fargo

60611

Northwestern Memorial Hospital ( Site 3044), Chicago

61024

SO Grigoriev Institute for Medical Radiology and Oncology of NAMS of Ukraine ( Site 2363), Kharkiv

62500

Fakultní nemocnice Brno Bohunice-Gynekologicko-porodnicka klinika ( Site 2394), Brno

64570

Christus Muguerza Clinica Vidriera ( Site 1125), Monterrey

64710

I Can Oncology Center SA de CV ( Site 1126), Monterrey

69310

Centre Hospitalier Lyon Sud ( Site 2064), Pierre-Bénite

70029

Kuopio University Hospital ( Site 2543), Kuopio

71103

WK Physicians Network/Gynecologic Oncology Associates ( Site 3047), Shreveport

71640

Klinikum Ludwigsburg ( Site 2111), Ludwigsburg

72076

Universitaetsklinikum Tuebingen ( Site 2113), Tübingen

74078

SLK-Kliniken Heilbronn GmbH ( Site 2116), Heilbronn

75014

Hopital Cochin ( Site 2070), Paris

75390

UT Southwestern Medical Center ( Site 3063), Dallas

79031

Lviv State Regional Oncological Center ( Site 2361), Lviv

80045

University Of Colorado ( Site 3051), Aurora

80131

Azienda Ospedaliera Universitaria Federico II ( Site 2123), Napoli

Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 2127), Napoli

85016

HonorHealth Research Institute - Biltmore ( Site 3043), Phoenix

85711

Arizona Oncology Associates PC- HOPE ( Site 3049), Tucson

94800

Gustave Roussy ( Site 2071), Villejuif

97210

Legacy Good Samaritan Medical Center ( Site 3033), Portland

100036

Beijing Cancer Hospital ( Site 4048), Beijing

100730

Peking Union Medical College Hospital ( Site 4036), Beijing

111511

Instituto Nacional de Cancerología E.S.E ( Site 1094), Bogotá

115478

FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 2634), Moscow

125284

Moscow Research Oncology Institute named after P.A. Hertsen ( Site 2631), Moscow

130021

The First Bethune Hospital of Jilin University ( Site 4057), Changchun

150054

Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 2641), Yaroslavl

150081

Harbin Medical University Cancer Hospital ( Site 4033), Harbin

163045

Arkhangelsk Clinical Oncological Dispensary ( Site 2637), Arkhangelsk

197758

Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 2636), Saint Petersburg

200090

Obstetrics and Gynecology Hosp. Fudan University ( Site 4041), Shanghai

200127

Shanghai Renji Hospital Affiliated to Jiao Tong University ( Site 4053), Shanghai

201204

Shanghai First Maternity and Infant Hospital-Gynecology department ( Site 4001), Shanghai

210008

Nanjing Drum Tower Hospital ( Site 4037), Nanjing

230001

Anhui Provincial Hospital-Obstetrics and Gynecology ( Site 4034), Hefei

300060

Tianjin Medical University Cancer Institute & Hospital ( Site 4054), Tianjin

310003

The First Affiliated Hospital, Zhejiang University-Gynecology ( Site 4002), Hangzhou

310006

Women s Hospital School of Medicine Zhejiang University ( Site 4032), Hangzhou

325000

The First Affiliated Hospital of Wenzhou Medical University ( Site 4056), Wenzhou

361003

The First Affiliated Hospital of Xiamen University ( Site 4060), Xiamen

400030

Chongqing Cancer Hospital ( Site 4040), Chongqing

410008

Xiangya Hospital Central-South University ( Site 4035), Changsha

410013

Hunan Cancer Hospital ( Site 4050), Changsha

420029

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2646), Kazan'

430032

National Research Ogarev Mordovia State University ( Site 2648), Saransk

430079

Hubei Cancer Hospital ( Site 4059), Wuhan

443031

Samara Regional Clinical Oncology Center-Chemotherapy Dapartment ( Site 2649), Samara

450054

Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 2645), Ufa

454087

Chelyabinsk Regional Clinical Center Oncology and Nuclear Medicine ( Site 2644), Chelyabinsk

510080

The First Affiliated Hospital ( Site 4043), Guangzhou

520002

Instituto Cancerologico de Narino Ltda ( Site 1092), Pasto

530021

Guangxi Medical University Affiliated Tumor Hospital ( Site 4049), Nanning

Jiangxi Maternal and Child Health Hospital ( Site 4051), Nanchang

603126

Nizhegorodsky Regional Oncology Dispensary-chemotherapy department (Branch№1) ( Site 2639), Nizhny Novgorod

610041

Sichuan Cancer Hospital ( Site 4039), Chengdu

634028

Tomsk Scientific Research Institute of Oncology-Chemotherapy ( Site 2638), Tomsk

650118

Yunnan Province Cancer Hospital-Gynecology Department ( Site 4055), Kunming

660133

Krasnoyarsk Regional Clinical oncology dispensary ( Site 2643), Krasnoyarsk

710061

The First Affiliated Hospital of Xi an Jiaotong University ( Site 4045), Xi'an

760032

Fundacion Valle del Lili ( Site 1093), Santiago de Cali

3109601

Rambam Medical Center ( Site 2307), Haifa

4800827

Centro Investigación del Cáncer James Lind ( Site 1061), Temuco

4941492

Rabin Medical Center ( Site 2305), Petah Tikva

5262000

Chaim Sheba Medical Center ( Site 2301), Ramat Gan

5822012

Edith Wolfson Medical Center ( Site 2306), Holon

7500921

Fundacion Arturo Lopez Perez FALP ( Site 1062), Santiago

7910295

Ehime University Hospital ( Site 4187), Tōon

8330032

Centro de Cancer Nuestra Senora de la Esperanza ( Site 1063), Santiago

8420383

Bradfordhill-Clinical Area ( Site 1070), Santiago

9112001

Hadassah Medical Center. Ein Kerem ( Site 2303), Jerusalem

92093-0698

UCSD Moores Cancer Center ( Site 3053), La Jolla

06511

Smilow Cancer Hospital at Yale New Haven ( Site 3070), New Haven

01655

University of Massachusetts Medical School ( Site 3037), Worcester

B1884BBF

Centro de Oncología e Investigación de Buenos Aires ( Site 1005), Berazategui

C1012AAR

IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 1006), Caba

IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 1010), Buenos Aires

B7600FZO

Instituto de Investigaciones Clinicas Mar del Plata ( Site 1003), Mar del Plata

C1280AEB

Hospital Britanico de Buenos Aires ( Site 1002), Buenos Aires

S2000KZE

Instituto de Oncologia de Rosario ( Site 1004), Rosario

C1118AAT

Hospital Aleman ( Site 1001), Buenos Aires

C1431FWO

CEMIC ( Site 1009), Buenos Aires

F5300COE

Centro Oncologico Riojano Integral ( Site 1007), La Rioja

T2N 4N2

Tom Baker Cancer Centre ( Site 3007), Calgary

K7L 2V7

Kingston Health Sciences Centre ( Site 3003), Kingston

H2X 0C1

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 3006), Montreal

H4A 3J1

McGill University Health Centre ( Site 3005), Montreal

G1J 1Z4

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 3, Québec

Unknown

Oncocentro ( Site 1065), Viña del Mar

Leicester Royal Infirmary. Univ. Hosp. of Leicester NHS Trust ( Site 2249), Leicester

050030

Clínica Vida Fundación - Sede Poblado ( Site 1096), Medellín

100 34

Fakultni nemocnice Kralovske Vinohrady ( Site 2393), Prague

120 00

Vseobecna fakultni nemocnice v Praze ( Site 2391), Prague

775 20

Fakultni nemocnice Olomouc ( Site 2392), Olomouc

06189

Centre Antoine Lacassagne ( Site 2073), Nice

01307

Universitaetsklinikum Carl Gustav Carus Dresden-Klinik und Poliklinik für Frauenheilkunde und Gebur, Dresden

263 32

General Hospital of Patras. St Andrews ( Site 2421), Pátrai

115 28

Geniko Panepistimako Nosokomeio ARETEIO ( Site 2423), Athens

Perifereiako Geniko Nosokomeio ALEXANDRA ( Site 2425), Athens

124 62

Athens University Hospital ATTIKON ( Site 2424), Chaïdári

151 23

Hospital Hygeia ( Site 2426), Marousi

546 45

Euromedica General Clinic of Thessaloniki ( Site 2422), Thessaloniki

00144

Istittuto Nazionale dei Tumori Regina Elena IRCCS - IFO ( Site 2121), Roma

00168

Fondazione Policlinico Universitario Agostino Gemelli ( Site 2124), Rome

464-8681

Aichi Cancer Center Hospital ( Site 4190), Nagoya

277-8577

National Cancer Center Hospital East ( Site 4197), Kashiwa

791-0280

National Hospital Organization Shikoku Cancer Center ( Site 4181), Matsuyama

830-0011

Kurume University Hospital ( Site 4186), Kurume

373-8550

Gunma Prefectural Cancer Center ( Site 4183), Ōta

060-8648

Hokkaido University Hospital ( Site 4194), Sapporo

673-8558

Hyogo Cancer Center ( Site 4195), Akashi

028-3695

Iwate Medical University Hospital ( Site 4189), Shiwa-gun

903-0215

University of the Ryukyus Hospital ( Site 4184), Nakagami-gun

350-1298

Saitama Medical University International Medical Center ( Site 4182), Hidaka

411-8777

Shizuoka Cancer Center Hospital and Research Institute ( Site 4192), Sunto-gun

811-1395

National Hospital Organization Kyushu Cancer Center ( Site 4193), Fukuoka

951-8566

Niigata Cancer Center Hospital ( Site 4185), Niigata

541-8567

Osaka International Cancer Institute ( Site 4188), Osaka

135-8550

The Cancer Institute Hospital of JFCR ( Site 4196), Tokyo

160-8582

Keio University Hospital ( Site 4191), Tokyo

04700

Centro Oncologico Internacional. SEDNA ( Site 1121), Mexico City

06700

Hospital Angeles Roma ( Site 1123), Mexico City

0379

Oslo Universitetssykehus Radiumhospitalet ( Site 2151), Oslo

61-866

Wielkopolskie Centrum Onkologii im.M.Sklodowskiej-Curie ( Site 2484), Poznan

08-110

Mazowiecki Szpital Wojewódzki w Siedlcach-Siedleckie Centrum Onkologii ( Site 2487), Siedlce

00-315

Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 2481), Warsaw

15-027

Bialostockie Centrum Onkologii ( Site 2483), Bialystok

10-228

SPZOZ MSWIA z Warminsko-Mazurskim Centrum Onkologii w Olsztynie ( Site 2486), Olsztyn

25-734

Swietokrzyskie Centrum Onkologii SPZOZ ( Site 2485), Kielce

03722

Severance Hospital Yonsei University Health System ( Site 4062), Seoul

05505

Asan Medical Center ( Site 4061), Seoul

06351

Samsung Medical Center ( Site 4064), Seoul

08035

Hospital Vall D Hebron ( Site 2182), Barcelona

08036

Hospital Clinic i Provincial ( Site 2185), Barcelona

171 76

Karolinska Universitetssjukhuset Solna ( Site 2220), Solna

751 85

Blod-och Tumorsjukdomar ( Site 2221), Uppsala

581 85

Universitetssjukhuset i Linkoping. ( Site 2222), Linköping

01250

Baskent Adana Dr Turgut Noyan Uygulama ve Arastirma Merkezi ( Site 2355), Adana

01330

Cukurova Uni. Tip Fakultesi ( Site 2353), Adana

06490

Baskent Universitesi Ankara Hastanesi ( Site 2354), Ankara

06590

Ankara Universitesi Tıp Fakultesi Hastanesi ( Site 2350), Ankara

08720

LISOD - Israeli Oncological Hospital MedX-ray International Group, LLC ( Site 2364), Kiev

BS2 8ED

Bristol Haematology and Oncology Centre ( Site 2244), Bristol

HU165JQ

Castle Hill Hospital-Academic Oncology ( Site 2252), Cottingham

G12 0YN

Beatson West of Scotland Cancer Centre ( Site 2247), Glasgow

NW1 2PG

UCLH NHS Foundation Trust ( Site 2242), London

SW3 6JJ

Royal Marsden NHS Foundation Trust ( Site 2248), London

SM25PT

Royal Marsden Hospital Sutton-Surrey ( Site 2241), Sutton

M20 4BX

The Christie Hospital NHS Foundation Trust ( Site 2243), Manchester

All Listed Sponsors
collaborator

European Network for Gynaecological Oncological Trial Groups

UNKNOWN

collaborator

Gynecologic Oncology Group

NETWORK

lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT04634877 - Study of Pembrolizumab (MK-3475) in Combination With Adjuvant Chemotherapy With or Without Radiotherapy in Participants With Newly Diagnosed Endometrial Cancer After Surgery With Curative Intent (MK-3475-B21 / KEYNOTE-B21 / ENGOT-en11 / GOG-3053) | Biotech Hunter | Biotech Hunter