Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775])

PHASE3CompletedINTERVENTIONAL
Enrollment

827

Participants

Timeline

Start Date

June 11, 2018

Primary Completion Date

October 26, 2020

Study Completion Date

February 26, 2025

Conditions
Endometrial Neoplasms
Interventions
DRUG

Pembrolizumab

200 mg administered by IV infusion on Day 1 of each 21-day cycle.

DRUG

Lenvatinib

20 mg administered orally (PO) QD during each 21-day cycle.

DRUG

Paclitaxel

80 mg/m\^2 administered by IV on a 28-day cycle: 3 weeks receiving paclitaxel once a week and 1 week not receiving paclitaxel.

DRUG

Doxorubicin

60 mg/m\^2 administered by IV on Day 1 of each 21-day cycle.

Trial Locations (169)

168

Policlinico Universitario Agostino Gemelli, Roma

813

Kaohsiung Veterans General Hospital, Kaohsiung City

833

Kaohsiung Chang Gung Memorial Hospital of the C.G.M.F., Kaohsiung City

1023

Auckland City Hospital, Auckland

2065

Royal North Shore Hospital, Sydney

3000

Peter MacCallum Cancer Centre, Melbourne

3080

Seoul National University Hospital, Seoul

3310

Grupo Medico Camino SC, Mexico City

4029

Royal Brisbane and Women s Hospital, Herston

5505

Asan Medical Center, Seoul

6008

St John of God, Subiaco

6351

Samsung Medical Center, Seoul

8035

Hospital General Universitari Vall d Hebron, Barcelona

8908

Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals, L'Hospitalet de Llobregat

10002

National Taiwan University Hospital, Taipei

10022

Memorial Sloan Kettering Cancer Center, New York

10408

National Cancer Center, Goyang-si

11217

Taipei Veterans General Hospital, Taipei

14076

Centre de Lutte Contre le Cancer Francois Baclesse, Caen

14642

University of Rochester, Rochester

16110

Acibadem Bursa Hastanesi, Bursa

20132

Ospedale San Raffaele, Milan

20133

Fondazione IRCCS Istituto Nazionale dei Tumori, Milan

20141

Istituto Europeo di Oncologia, Milan

20902

Maryland Oncology Hematology, P.A., Wheaton

21204

Greater Baltimore Medical Center, Baltimore

22190

Centre Armoricain de Radiotherapie Imagerie medicale et Oncologie, Plérin

23040

Investigacion Onco Farmaceutica S de RL de CV, La Paz

27710

Duke University Medical Center, Durham

28007

Hospital Universitario Gregorio Maranon, Madrid

28027

Clinica Universitaria Navarra - Madrid, Madrid

28034

Hospital Ramon y Cajal, Madrid

28040

Hospital Clinico San Carlos, Madrid

30912

Georgia Cancer Center at Augusta University, Augusta

32804

Florida Hospital Cancer Institute, Orlando

33076

Institut Bergonie, Bordeaux

33136

University of Miami Health System, Miami

33305

Chang Gung Medical Foundation. Linkou Branch, Taoyuan District

34298

Institut Regional du Cancer de Montpellier - ICM, Montpellier

34303

Acibadem Universitesi Atakent Hastanesi, Istanbul

34349

Florence Nightingale Gayrettepe Hastanesi, Istanbul

35040

Ege Universitesi Tip Fakultesi, Izmir

35042

Centre Eugene Marquis, Rennes

38138

UT West Cancer Center, Germantown

40705

Taichung Veterans General Hospital, Taichung

44277

Hopital prive du Confluent, Nantes

46026

Hospital Universitario y Politecnico La Fe de Valencia, Valencia

47014

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola

50015

Rodrigo Botero SAS, Medellín

50032

Fundacion Colombiana de Cancerologia Clinica Vida, Medellín

50080

Centro Hemato Oncologico Privado, Toluca

57104

Sanford Gynecology Oncology, Sioux Falls

59020

Centre Oscar Lambret, Lille

60201

North Shore University Health System, Evanston

64060

Alivia Clinica de Alta Especialidad S.A. de C.V., Monterrey

69008

Centre Leon Berard, Lyon

69310

Centre Hospitalier Lyon Sud, Pierre-Bénite

70112

University Medical Center New Orleans, New Orleans

73104

Stephenson Cancer Center, Oklahoma City

75014

Groupe Hospitalier Broca Cochin Hotel Dieu, Paris

75020

Hopital Diaconesses Croix Saint Simon, Paris

77030

The University of Texas MD Anderson Cancer Center, Houston

78240

Texas Oncology-San Antonio Medical Center, San Antonio

78745

Texas Oncology-South Austin, Austin

80131

Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli

84101

Soroka Medical Center, Beersheba

84106

Utah Cancer Specialists, Salt Lake City

85016

Arizona Oncology Associates, PC- HAL, Phoenix

90095

University of California Los Angeles, Santa Monica

91900

Faicic S de RL de CV, Veracruz

94158

University of California San Francisco, San Francisco

94800

Institut Gustave Roussy, Villejuif

95126

Azienda Ospedaliera per l Emergenza Cannizzaro, Catania

97401

Willamette Valley Cancer Institute and Research Center, Eugene

110221

Clinica del Country, Bogota

111321

Clinica Colsanitas S.A. - Sede Clinica Universitaria Colombia, Bogotá

115478

FSBI National Medical Oncology Research Center n.a. N.N. Blokhina, Moscow

115682

FSBI-FRCC of Special Types Med. Care & Technologies FMBA of Russia, Moscow

191014

Leningrad Regional Oncology Center, Saint Petersburg

198255

SPb SBHI City Clinical Oncological Dispensary, Saint Petersburg

230002

Oncomedica S.A., Montería

420029

Republican Clinical Oncology Dispensary of Tatarstan MoH, Kazan'

430032

Mordovia Republican Oncological Dispensary, Saransk

450054

Republican Clinical Oncology Dispensary of Republic of Bashkortostan, Ufa

624028

Tomsk National Research Medical Center of Russian Academy of Sciences, Tomsk

656049

Altay Regional Oncology Dispensary, Barnaul

760032

Fundacion Valle del Lili, Santiago de Cali

3525408

Rambam Medical Center, Haifa

4941492

Rabin Medical Center, Petah Tikva

5262000

Chaim Sheba Medical Center, Ramat Gan

5822012

Edith Wolfson Medical Center, Holon

9112001

Hadassah Medical Center. Ein Kerem, Jerusalem

06510

Smilow Cancer Hospital at Yale New Haven, New Haven

07601

John Theurer Cancer Center at Hackensack University Med Ctr, Hackensack

07666

Holy Name Medical Center, Teaneck

75390-9032

University of Texas Southwestern Medical Center at Dallas, Dallas

B1884BBF

Centro de Oncologia e Investigacion Buenos Aires COIBA, Berazategui

B7602CBM

Hospital Privado de la Comunidad, Mar del Plata

C1012AAR

Instituto de Investigaciones Metabolicas, Buenos Aires

C1118AAT

Hospital Aleman, Buenos Aires

C1417DTB

Instituto de Oncologia Angel H. Roffo, Buenos Aires

C1426ANZ

Instituto Medico Especializado Alexander Fleming, Buenos Aires

F5300COE

Centro Oncologico Riojano Integral, La Rioja

74175-120

Hospital Araujo Jorge, Goiânia

20220-410

Instituto Nacional do Cancer II, Rio de Janeiro

90035-903

Hospital de Clinicas de Porto Alegre, Porto Alegre

90610-000

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs, Porto Alegre

17210-080

Fundacao Dr Amaral Carvalho, Jaú

01246-000

Instituto do Cancer de Sao Paulo - ICESP, São Paulo

01317-000

Clinica de Pesquisas e Ctro de Estudos Onc. Ginecol. e Mamaria Ltda, São Paulo

30130-100

Faculdade de Medicina da Universidade Federal de Minas Gerais, Belo Horizonte

T2N 4N2

Tom Baker Cancer Centre, Calgary

R3E 0V9

Cancer Care Manitoba, Winnipeg

N6A 5W9

London Health Sciences Centre, London

K1H 8L6

Ottawa General Hospital, Ottawa

M4N 3M5

Sunnybrook Health Science Centre, Toronto

M5G 2M9

Princess Margaret Cancer Centre, Toronto

H1T 2M4

CIUSSS de l Est de L Ile de Montreal - Hopital Maisonneuve-Rosemont, Montreal

H2X 3E4

Centre Hospitalier de l Universite de Montreal - CHUM, Montreal

H3T 1E2

Jewish General Hospital, Montreal

J1H 5N4

CIUSSS de l'Estrie-CHUS, Sherbrooke

G1R 2J6

CHU de Quebec-Universite Laval-Hotel Dieu de Quebec, Québec

08002

Biomelab S A S, Barranquilla

Unknown

EISAI Trial Site 4, Berlin

EISAI Trial Site 2, Dresden

EISAI Trial Site 1, Erlangen

EISAI Trial Site 6, Hamburg

EISAI Trial Site 3, Rostock

EISAI Trial Site 5, Tübingen

EISAI Trial Site 9, Nagoya

EISAI Trial Site 18, Kashiwa

EISAI Trial Site 7, Matsuyama

EISAI Trial Site 15, Tōon

EISAI Trial Site 5, Kurume

EISAI Trial Site 11, Sapporo

EISAI Trial Site 8, Akashi

EISAI Trial Site 17, Tsukuba

EISAI Trial Site 4, Morioka

EISAI Trial Site 19, Isehara

EISAI Trial Site 14, Sendai

EISAI Trial Site 1, Hidaka

EISAI Trial Site 2, Sunto-gun

EISAI Trial Site 16, Kagoshima

EISAI Trial Site 3, Niigata

EISAI Trial Site 10, Tokyo

EISAI Trial Site 12, Tokyo

EISAI Trial Site 13, Tokyo

EISAI Trial Site 6, Tokyo

D07 R2WY

Mater Misericordiae University Hospital, Dublin

31-115

Centrum Onkologii Instytut im. Marii Sklodowskiej Curie, Krakow

02-781

Centrum Onkologii. Instytut im. Marii Sklodowskiej-Curie, Warsaw

43-300

Beskidzkie Centrum Onkologii im. Jana Pawla II, Bielsko-Biala

81-159

Szpital Morski im. PCK Szpitale Wojewodzkie w Gdyni Sp. z o.o., Gdynia

44-101

Centrum Onkologii Instytut im. Marii Sklodowskiej Curie, Gliwice

93-338

Instytut Centrum Zdrowia Matki Polki, Lodz

70-111

Pomorski Uniwersytet Medyczny w Szczecinie, Szczecin

00-315

Szpital Kliniczny im Ks Anny Mazowieckiej, Warsaw

01250

Basken Adana Dr.Turgut Noyan Uygulama ve Arastirma Merkezi, Adana

06000

Hacettepe University Medical Faculty, Ankara

06490

Baskent Universitesi Ankara Hastanesi, Ankara

BN2 5BE

Royal Sussex County Hospital, Brighton

CB2 0QQ

Addenbrookes Hospital, Cambridge

EC1A 7BE

Barts Health NHS Trust - St Bartholomew s Hospital, London

SE1 9RT

Guy s & St Thomas NHS Foundation Trust, London

SM2 5PT

The Royal Marsden Foundation Trust, London

SW3 6JJ

The Royal Marsden NHS Foundation Trust, London

W12 0HS

Imperial College Healthcare NHS Trust, London

WC1E 6AG

University College Hospital, London

SO16 6YD

University Hospital Southampton NHS Foundation Trust, Southampton

All Listed Sponsors
collaborator

Merck Sharp & Dohme LLC

INDUSTRY

lead

Eisai Inc.

INDUSTRY

NCT03517449 - Lenvatinib in Combination With Pembrolizumab Versus Treatment of Physician's Choice in Participants With Advanced Endometrial Cancer (MK-3475-775/E7080-G000-309 Per Merck Standard Convention [KEYNOTE-775]) | Biotech Hunter | Biotech Hunter