Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001)

PHASE3CompletedINTERVENTIONAL
Enrollment

842

Participants

Timeline

Start Date

April 11, 2019

Primary Completion Date

October 2, 2023

Study Completion Date

February 5, 2025

Conditions
Endometrial Neoplasms
Interventions
DRUG

Lenvatinib

Lenvatinib 4 mg or 10 mg capsules at a total daily dose of 20 mg taken by mouth once per day.

BIOLOGICAL

Pembrolizumab

Pembrolizumab 200 mg IV infusion given on Day 1 of each cycle.

DRUG

Paclitaxel

Paclitaxel 175 mg/m\^2 IV infusion given on Day 1 of each cycle.

DRUG

Carboplatin

Carboplatin 10 mg/mL IV infusion at a total dose of are-under-the-curve (AUC) 6 (per Calvert's formula) given on Day 1 of each cycle.

Trial Locations (195)

333

Linkou Chang Gung Memorial Hospital ( Site 1901), Taoyuan District

404

China Medical University Hospital ( Site 1903), Taichung

1090

Medizinische Universitat Wien ( Site 3300), Vienna

1200

Cliniques Universitaires Saint-Luc ( Site 3203), Brussels

2031

Prince of Wales Hospital [Australia] ( Site 1603), Randwick

2050

Chris OBrien Lifehouse ( Site 1605), Camperdown

2065

Royal North Shore Hospital ( Site 1600), St Leonards

2145

The Crown Princess Mary Cancer Centre - Westmead Hospital ( Site 1602), Westmead

2650

UZA University Hospital Antwerp ( Site 3204), Edegem

3000

UZ Leuven ( Site 3200), Leuven

3002

Epworth Freemasons Hospital ( Site 1609), Melbourne

3168

Monash Health ( Site 1606), Clayton

4101

Mater Misericordiae Ltd ( Site 1608), South Brisbane

5300

Centro Oncologico Riojano Integral ( Site 2605), La Rioja

6009

Sir Charles Gairdner Hospital ( Site 1604), Nedlands

6020

Medizinische Universitat Innsbruck ( Site 3302), Innsbruck

8036

Universitatsklinik fuer Frauenheilkunde und Geburtshilfe ( Site 3301), Graz

8800

AZ Delta ( Site 3206), Roeselare

9000

AZ Maria Middelares Gent ( Site 3202), Ghent

10002

National Taiwan University Hospital ( Site 1904), Taipei

10011

The Blavatnik Family- Chelsea Medical Center at Mount Sinai ( Site 0206), New York

10022

Memorial Sloan Kettering Cancer Center ( Site 0246), New York

10604

Memorial Sloan Kettering Cancer Center - West Harrison ( Site 0274), Harrison

11217

Taipei Veterans General Hospital ( Site 1900), Taipei

11553

Memorial Sloan Kettering Cancer Center - Nassau ( Site 0275), Uniondale

11725

Memorial Sloan-Kettering Cancer Center at Commack ( Site 0267), Commack

13353

Charite Universitaetsmedizin Berlin ( Site 0609), Berlin

13620

Seoul National University Bundang Hospital ( Site 1802), Seongnam-si

14004

Hospital Universitario Reina Sofia ( Site 1207), Córdoba

14642

University of Rochester ( Site 0238), Rochester

15006

Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 1202), A Coruña

16059

Uludag Universitesi Tip Fakultesi ( Site 1307), Bursa

27599

University of North Carolina- Chapel Hill ( Site 0254), Chapel Hill

28040

Hospital Clinico San Carlos ( Site 1209), Madrid

29009

Khmelnitskiy Regional Onkology Dispensary ( Site 1513), Khmelnitskiy

29011

Hospital Materno Infantil [Malaga, Spain] ( Site 1208), Málaga

29090

Hospital San Lucas Cardiologica del Sureste ( Site 3103), Tuxtla Gutiérrez

30174

Ospedale dell Angelo ( Site 0810), Mestre

30912

Georgia Cancer Center at Augusta University ( Site 0222), Augusta

31000

Centro Estatal de Cancerologia de Chihuahua ( Site 3101), Chihuahua City

33136

University of Miami Health System ( Site 0249), Miami

36604

University of South Alabama, Mitchell Cancer Institute ( Site 0245), Mobile

40138

Ospedale Policlinico S. Orsola-Malpighi ( Site 0803), Bologna

40705

Taichung Veterans General Hospital ( Site 1902), Taichung

45147

Universitaetsklinikum Essen ( Site 0616), Essen

46009

Instituto Valenciano de Oncologia - IVO ( Site 1205), Valencia

46014

Hospital General Universitario de Valencia ( Site 1203), Valencia

47014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori ( Site 0800), Meldola

48149

Universitaetsklinikum Muenster ( Site 0615), Münster

49055

Clinical oncology dispensary of Dnipro ( Site 1512), Dnipro

49102

City Clinical Hosp.4 of DCC ( Site 1501), Dnipro

52100

Medical Oncology Ospedale San Donato ( Site 0812), Arezzo

55404

Minnesota Oncology Hematology, PA ( Site 8003), Minneapolis

57104

Sanford Cancer Center Oncology Clinic ( Site 0205), Sioux Falls

58102

Roger Maris Cancer Center ( Site 0277), Fargo

61024

Grigoriev Institute for medical Radiology NAMS of Ukraine ( Site 1511), Kharkiv

61070

Communal non profit enterprise Regional Clinical Oncology Center ( Site 1509), Kharkiv

64710

I CAN Oncology SA de SV ( Site 3102), Monterrey

65055

MI Odessa Regional Oncological Centre ( Site 1504), Odesa

65199

HELIOS Dr. Horst Schmidt Kliniken Wiesbaden ( Site 0623), Wiesbaden

68167

Universitaetsmedizin Mannheim. Klinik fuer Kinder und Jugendmedizin ( Site 0622), Mannheim

70124

IRCCS Giovanni Paolo II. Ospedale Oncologico ( Site 0801), Bari

70433

Women's Cancer Care ( Site 0208), Covington

72100

Ospedale Antonio Perrino ( Site 0806), Brindisi

75235

Parkland Health & Hospital System ( Site 0272), Dallas

76018

MI Precarpathian Clinical Oncology Center ( Site 1503), Ivano-Frankivsk

77380

Texas Oncology-The Woodlands ( Site 8000), The Woodlands

80045

University of Colorado Cancer Center ( Site 0204), Aurora

80131

Istituto Nazionale Tumori Fondazione Pascale ( Site 0808), Napoli

85711

Arizona Oncology Associates PC- HOPE ( Site 8005), Tucson

90095

UCLA Hematology and Oncology Clinic (Westwood) ( Site 0233), Los Angeles

93053

Caritas-Krankenhaus St. Josef Regensburg ( Site 0613), Regensburg

95126

Azienda Ospedaliera per l Emergenza Cannizzaro ( Site 0807), Catania

97401

Willamette Valley Cancer Institute and Research Center ( Site 8004), Eugene

98686

Legacy Salmon Creek Medical Center ( Site 0253), Vancouver

100032

Beijing Obstetrics and Gynecology Hospital Capital Medical University ( Site 2505), Beijing

Peking Union Medical College Hospital ( Site 2501), Beijing

100142

Beijing Cancer Hospital ( Site 2504), Beijing

115478

Russian Oncological Research Center n.a. N.N.Blokhin of MoH ( Site 1100), Moscow

115682

FSBI-FRCC of Special Types Med. Care and Technologies FMBA of Russia ( Site 1102), Moscow

125367

Medical Rehabilitation Center ( Site 1101), Moscow

194017

St.Petersburg Clinical Hospital RAS ( Site 1124), Saint Petersburg

195271

Railway Hospital of OJSC ( Site 1122), Saint Petersburg

197758

National Medical Research Center of Oncology N.A. N.N. Petrov ( Site 1103), Saint Petersburg

198255

SPb SBHI City Clinical Oncological Dispensary ( Site 1104), Saint Petersburg

200032

Fudan University Shanghai Cancer Center ( Site 2500), Shanghai

200090

Obstetrics and Gynecology Hosp. Fudan University ( Site 2503), Shanghai

210011

Nanjing Maternity and Child Health Care Hospital ( Site 2508), Nanjing

230001

Anhui Provincial Cancer Hospital ( Site 2509), Hefei

310006

Women s Hospital School of Medicine Zhejiang University ( Site 2511), Hangzhou

310022

Zhejiang Cancer Hospital ( Site 2506), Hangzhou

400030

Chongqing Cancer Hospital ( Site 2513), Chongqing

410008

Xiangya Hospital Central-South University ( Site 2512), Changsha

420029

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1108), Kazan'

430079

Hubei Cancer Hospital ( Site 2510), Wuhan

443031

Samara Regional Clinical Oncology Center ( Site 1117), Samara

510080

The First Affiliated Hospital.Sun Yat-sen University ( Site 2507), Guangzhou

530021

Guang Xi Tumour Hospital, Department of Chemotherapy ( Site 2517), Nanning

634028

Siberian State Medical University ( Site 1121), Tomsk

660133

Krasnoyarsk Regional Clinical oncology dispensary ( Site 1118), Krasnoyarsk

710061

The first affiliated Hospital of Xi an Jiaotong University ( Site 2502), Xi'an

830054

The First Affiliated Hospital of Xinjiang Medical University ( Site 2515), Ürümqi

3525408

Rambam Medical Center ( Site 0700), Haifa

4428132

Meir Medical Center ( Site 0702), Kfar Saba

5262000

Chaim Sheba Medical Center ( Site 0707), Ramat Gan

5822012

Edith Wolfson Medical Center ( Site 0703), Holon

06511

Smilow Cancer Hospital at Yale New Haven ( Site 0202), New Haven

04074

Maine Medical Partners ( Site 0217), Scarborough

07920

Memorial Sloan-Kettering Cancer Center At Basking Ridge ( Site 0268), Basking Ridge

07601

John Theurer Cancer Center at Hackensack University Med Ctr ( Site 0226), Hackensack

07748

Memorial Sloan Kettering Cancer Center- Monmouth ( Site 0273), Middletown

07645

MSKCC-Bergen ( Site 0276), Montvale

07666

Holy Name Medical Center ( Site 0235), Teaneck

75390-9015

University of Texas Southwestern Medical Center ( Site 0264), Dallas

C1012AAR

IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 2607), Caba

B1900AXI

Hospital Italiano de La Plata ( Site 2601), La Plata

B7600FZO

Instituto de Investigaciones Clinicas Mar del Plata ( Site 2606), Mar del Plata

C1118AAT

Hospital Aleman ( Site 2600), Buenos Aires

C1199ABB

Hospital Italiano de Buenos Aires ( Site 2603), Buenos Aires

60430-230

Instituto do Cancer do Ceara ( Site 2703), Fortaleza

74605-070

Hospital Araujo Jorge Associacao de Combate ao Cancer de Goias ( Site 2702), Goiânia

30130-100

Faculdade de Medicina da Universidade Federal de Minas Gerais ( Site 2708), Belo Horizonte

98700-000

Hospital de Caridade de Ijui ( Site 2712), Ijuí

90610-000

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 2701), Porto Alegre

15090-000

Hospital de Base de Sao Jose de Rio Preto ( Site 2704), São José do Rio Preto

20220-410

Instituto Nacional do Cancer II ( Site 2707), Rio de Janeiro

01317-001

Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda ( Site 2706), São Paulo

01321-001

Real e Benemerita Associacao Portuguesa de Beneficencia ( Site 2713), São Paulo

01509-900

A.C. Camargo Cancer Center ( Site 2705), São Paulo

T6G 1Z2

Cross Cancer Institute ( Site 0408), Edmonton

V1Y 5L3

BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0402), Kelowna

V5Z 4E6

BC Cancer-Vancouver Center ( Site 0412), Vancouver

L8V 1C3

Juravinski Cancer Centre ( Site 0406), Hamilton

K7L 2V7

Kingston Health Sciences Centre ( Site 0401), Kingston

L5M 2N1

The Credit Valley Hospital ( Site 0403), Mississauga

M4N 3M5

Sunnybrook Research Institute ( Site 0410), Toronto

M5G 2M9

Princess Margaret Cancer Centre ( Site 0409), Toronto

H1T 2M4

CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont ( Site 0414), Montreal

H2X 3E4

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0411), Montreal

H4A 3J1

McGill University Health Centre ( Site 0404), Montreal

J1H 5N4

CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0417), Sherbrooke

07747

Universitaetsklinikum Jena ( Site 0612), Jena

T12 YE02

Cork University Hospital ( Site 1400), Cork

Dublin 8

St James Hospital ( Site 1401), Dublin

00168

Policlinico Universitario Agostino Gemelli ( Site 0805), Rome

791-0295

Ehime University Hospital ( Site 2413), Tōon

830-0011

Kurume University Hospital ( Site 2403), Kurume

373-8550

Gunma Prefectural Cancer Center ( Site 2404), Ōta

003-0804

National Hospital Organization Hokkaido Cancer Center ( Site 2408), Sapporo

673-8558

Hyogo Cancer Center ( Site 2414), Akashi

211-8533

Nippon Medical School Musashi Kosugi Hospital ( Site 2417), Kawasaki

216-8511

St. Marianna University School of Medicine Hospital ( Site 2416), Kawasaki

903-0215

University of the Ryukyus Hospital ( Site 2412), Nakagami-gun

350-1298

Saitama Medical University International Medical Center ( Site 2410), Hidaka

362-0806

Saitama Cancer Center ( Site 2406), Kitaadachi-gun

359-8513

National Defense Medical College Hospital ( Site 2418), Tokorozawa

181-8611

Kyorin University Hospital ( Site 2402), Mitaka

811-1395

National Hospital Organization Kyushu Cancer Center ( Site 2405), Fukuoka

951-8566

Niigata Cancer Center Hospital ( Site 2415), Niigata

541-8567

Osaka International Cancer Institute ( Site 2409), Osaka

135-8550

The Cancer Institute Hospital of JFCR ( Site 2401), Tokyo

142-8666

Showa University Hospital ( Site 2419), Tokyo

160-8582

Keio University Hospital ( Site 2411), Tokyo

03720

Centro de Investigacion Clinica Gramel ( Site 3107), Mexico City

04700

Centro Oncologico Internacional. SEDNA ( Site 3106), Mexico City

06760

Consultorio Dentro de la Torre Medica Dalinde Oncologia Medica ( Site 3108), Mexico City

61-866

Wielkopolskie Centrum Onkologii im.M.Sklodowskiej-Curie ( Site 1004), Poznan

31-826

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 1019), Krakow

20-081

Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie ( Site 1008), Lublin

00-315

Szpital Kliniczny im Ks Anny Mazowieckiej ( Site 1011), Warsaw

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1009), Warsaw

15-027

Bialostockie Centrum Onkologii ( Site 1005), Bialystok

44-102

Centrum Onkologii Instytut im. MSC Oddział w Gliwicach ( Site 1017), Gliwice

93-338

Instytut Centrum Zdrowia Matki Polki ( Site 1020), Lodz

03080

Seoul National University Hospital ( Site 1801), Seoul

03722

Severance Hospital Yonsei University Health System ( Site 1804), Seoul

05505

Asan Medical Center ( Site 1800), Seoul

06351

Samsung Medical Center ( Site 1803), Seoul

08916

Institut Catala d Oncologia Badalona ( Site 1201), Badalona

08003

Parc de Salut Mar ( Site 1200), Barcelona

01120

Baskent Universitesi Adana Uygulama ve Arastirma Hastanesi ( Site 1303), Adana

01330

Cukurova Uni. Tip Fakultesi ( Site 1302), Adana

05600

Gazi Universitesi Tip Fakultesi ( Site 1308), Ankara

06490

Baskent Universitesi Ankara Hastanesi ( Site 1300), Ankara

07070

Akdeniz Universitesi Tıp Fakultesi ( Site 1301), Antalya

08173

Medical Center Asklepion LLC ( Site 1514), Khodosovka

03022

National Cancer Institute of the MoH of Ukraine ( Site 1510), Kyiv

03126

Medical and Diagnostic Centre LLC Dobryi Prognoz ( Site 1507), Kyiv

03115

Kyiv City Clinical Oncology Centre ( Site 1505), Kyiv

EH4 2XU

Western General Hospital ( Site 1411), Edinburgh

NW1 2PG

UCLH NHS Foundation Trust ( Site 1405), London

HA6 2RN

Mount Vernon Cancer Centre ( Site 1409), Northwood

OX3 7LE

Churchill Hospital ( Site 1406), Oxford

TS4 3BW

The James Cook University Hospital ( Site 1403), Middlesbrough

NE7 7DN

Northern Centre for Cancer Care ( Site 1408), Newcastle upon Tyne

All Listed Sponsors
collaborator

Eisai Inc.

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03884101 - Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Versus Chemotherapy for Endometrial Carcinoma (ENGOT-en9 / MK-7902-001) | Biotech Hunter | Biotech Hunter