Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ LEAP-011)

PHASE3CompletedINTERVENTIONAL
Enrollment

505

Participants

Timeline

Start Date

May 6, 2019

Primary Completion Date

July 26, 2021

Study Completion Date

May 20, 2024

Conditions
Urothelial Carcinoma
Interventions
BIOLOGICAL

Pembrolizumab

IV infusion

DRUG

Lenvatinib

oral capsule

DRUG

Placebo for lenvatinib

oral capsule

Trial Locations (194)

100

National Taiwan University Hospital ( Site 0211), Taipei

807

Kaohsiung Medical University Chung-Ho Memorial Hospital ( Site 0216), Kaoshiung

1106

Bajcsy Zsilinszki Korhaz es Rendelointezet ( Site 0509), Budapest

1122

Orszagos Onkologiai Intezet ( Site 0503), Budapest

1145

Uzsoki Utcai Korhaz ( Site 0508), Budapest

2100

Rigshospitalet ( Site 0680), Copenhagen

2109

Macquarie University ( Site 0151), North Ryde

2730

Herlev Hospital ( Site 0681), Herlev

3084

Austin Health-Austin Hospital ( Site 0154), Heidelberg

3168

Monash Health ( Site 0160), Clayton

3199

Peninsula Health Frankston Hospital ( Site 0153), Frankston

3526

Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce, Miskolc

4101

Mater Misericordiae Ltd ( Site 0158), South Brisbane

5000

Odense Universitetshospital ( Site 0682), Odense

Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 0507), Szolnok

6000

Bacs-Kiskun Megyei Korhaz ( Site 0510), Kecskemét

7400

Somogy Megyei Kaposi Mor Oktato Korhaz ( Site 0504), Kaposvár

8200

Aarhus Universitets hospital ( Site 0683), Aarhus N

9000

Aalborg Universitets Hospital ( Site 0684), Aalborg

9400

Markusovszky Egyetemi Oktatokorhaz ( Site 0502), Szombathely

10016

Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 0002), New York

10408

National Cancer Center ( Site 0196), Goyang-si

11217

Taipei Veterans General Hospital ( Site 0212), Taipei

12208

St. Peter's Hospital Cancer Care Center ( Site 0042), Albany

13005

Hopital de la Timone ( Site 0246), Marseille

15006

Hospital Teresa Herrera - Chuac ( Site 0357), A Coruña

19049

Helios Kliniken Schwerin GmbH ( Site 0278), Schwerin

19107

Thomas Jefferson University Hospital ( Site 0051), Philadelphia

20132

Ospedale San Raffaele-Oncologia Medica ( Site 0309), Milan

20133

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0301), Milan

20162

ASST Grande Ospedale Metropolitano Niguarda ( Site 0307), Milan

20246

Universitaetsklinikum Hamburg-Eppendorf ( Site 0282), Hamburg

23230

Virginia Cancer Institute ( Site 0099), Richmond

23538

Universitaetsklinikum Schleswig-Holstein-Campus Lubeck ( Site 0277), Lübeck

24116

Staedtisches Krankenhaus Kiel GmbH ( Site 0285), Kiel

28006

Hospital La Princesa ( Site 0862), Madrid

28009

Hospital Universitario Gregorio Maranon ( Site 0352), Madrid

28050

Hospital Universitario HM Sanchinarro ( Site 0356), Madrid

29107

CHIC Quimper ( Site 0245), Quimper

29425

Medical University of South Carolina-Hollings Cancer Center ( Site 0029), Charleston

30060

Northwest Georgia Oncology Centers PC ( Site 0707), Marietta

31076

Clinique Pasteur ( Site 0252), Tolouse

33075

CHU de Bordeaux- Hopital Saint Andre ( Site 0235), Bordeaux

33081

Centro di Riferimento Oncologico CRO ( Site 0304), Aviano

34070

Centre de Cancerologie du Grand Montpellier ( Site 0249), Montpellier

34098

Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 0454), Istanbul

34722

Göztepe Prof. Dr. Süleyman Yalçın Şehir Hastanesi-oncology ( Site 0459), Istanbul

35015

Chungnam National University Hospital ( Site 0195), Daejeon

35032

Universitaetsklinikum Giessen und Marburg GmbH ( Site 0284), Marburg

35100

Ege Universitesi Tulay Aktas Onkoloji Hastanesi ( Site 0462), Izmir

37075

Universitaetsmedizin Goettingen ( Site 0281), Göttingen

37134

Ospedale Borgo Roma-Oncologia ( Site 0308), Verona

40138

Policlinico S. Orsola - Malpighi (Bologna) ( Site 0302), Bologna

40447

China Medical University Hospital ( Site 0213), Taichung

40705

Taichung Veterans General Hospital ( Site 0214), Taichung

42080

Necmettin Erbakan Universitesi Meram Tip Fakultesi Hastanesi ( Site 0456), Konya

44805

Centre Rene Gauducheau ICO ( Site 0250), Saint-Herblain

45147

Universitaetsklinikum Essen ( Site 0274), Essen

48201

Karmanos Cancer Institute ( Site 0712), Detroit

49055

Institut de Cancerologie de l Ouest Site Paul Papin ( Site 0236), Angers

54100

Centre D Oncologie de Gentilly ( Site 0240), Nancy

54290

Sakarya Universitesi Tip Fakultesi Arastirma Hastanesi ( Site 0460), Sakarya

58128

Chonnam National University Hwasun Hospital ( Site 0194), Hwasun Gun

60436

Joliet Oncology Hematology ( Site 0091), Joliet

60637

University of Chicago ( Site 0039), Chicago

62301

Quincy Medical Group ( Site 0022), Quincy

63141

Mercy Hospital Saint Louis - David C. Pratt Cancer Center ( Site 0095), St Louis

64109

Centre Hospitalier de la Cote Basque ( Site 0239), Bayonne

67033

Institut de Cancerologie Strasbourg Europe ( Site 0232), Strasbourg

69373

Centre Leon Berard ( Site 0244), Lyon

70124

Istituto Tumori Giovanni Paolo II ( Site 0306), Bari

70300

Assaf Harofeh Medical Center ( Site 0556), Ẕerifin

70403

National Cheng Kung University Hospital ( Site 0215), Tainan City

72076

Klinikum der Eberhard-Karls-Universitaet Tuebingen ( Site 0271), Tübingen

74146

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 0774), Tulsa

75005

Institut Curie ( Site 0237), Paris

76508

Baylor Scott & White Medical Center - Temple ( Site 0706), Temple

83301

Kaohsiung Chang Gung Memorial Hospital ( Site 0217), Kaohsiung City

85234

Banner MD Anderson Cancer Center ( Site 0016), Gilbert

85925

CHD Vendee-onco-hematologie ( Site 0251), La Roche-sur-Yon

86021

CHU Poitiers ( Site 0253), Poitiers

89169

Comprehensive Cancer Centers of Nevada ( Site 0005), Las Vegas

90404

John Wayne Cancer Institute ( Site 0017), Santa Monica

92868

University of California Irvine Medical Center ( Site 0078), Orange

93611

Community Cancer Institute ( Site 0777), Clovis

94805

Institut Gustave Roussy ( Site 0243), Villejuif

95126

Azienda Ospedaliera per l Emergenza Cannizzaro ( Site 0305), Catania

98109

Seattle Cancer Care Alliance ( Site 0003), Seattle

99218

Cancer Care Northwest ( Site 0009), Spokane

100034

Peking University First Hospital ( Site 0726), Beijing

100071

Fifth Medical Center of CPLA General Hospital ( Site 0732), Beijing

100089

Peking University Third Hospital ( Site 0727), Beijing

117485

Russian Scientific Center of Roentgenoradiology ( Site 0424), Moscow

121359

Central Clinical Hospital with Polyclinic ( Site 0415), Moscow

125367

Medical Rehabilitation Center ( Site 0411), Moscow

150054

Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 0414), Yaroslavl

150081

Harbin Medical University Cancer Hospital ( Site 0750), Harbin

183057

Murmansk Regional Oncology Dispensary ( Site 0420), Murmansk

188663

GBUZ Leningrad Regional Clinical Oncology Dispensary ( Site 0426), Kuzmolovskiy Settlement

194044

Clinical Hospital Saint Luka ( Site 0421), Saint Petersburg

200032

Fudan University Shanghai Cancer Center ( Site 0721), Shanghai

Zhongshan Hospital Fudan University ( Site 0725), Shanghai

210008

Nanjing Drum Tower Hospital ( Site 0737), Nanjing

310009

Second Affiliated Hospital, Zhejiang University ( Site 0734), Hangzhou

310014

Zhejiang Provincial People's Hospital ( Site 0735), Hangzhou

361003

The First Affiliated Hospital of Xiamen University ( Site 0743), Xiamen

400030

Chongqing Cancer Hospital ( Site 0741), Chongging

410013

Hunan Cancer Hospital ( Site 0745), Changsha

430079

Hubei Cancer Hospital ( Site 0744), Wuhan

510060

Sun Yat-Sen University Cancer Center ( Site 0752), Guangdong

510230

The First Affiliated Hospital of Guangzhou Medical University ( Site 0749), Guangzhou

510289

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University ( Site 0746), Guangzhou

603074

Volga District Medical Center Federal Medical and Biological Agency ( Site 0413), Nizhny Novgorod

644013

Omsk Clinical Oncology Dispensary ( Site 0418), Omsk

710061

The First Affiliated Hospital of Xi an Jiaotong University ( Site 0738), Xian

830011

Cancer Hospital Affiliated to Xinjiang Medical University ( Site 0751), Ürümqi

1834111

Ha Emek Medical Center ( Site 0560), Afula

3109601

Rambam Medical Center ( Site 0552), Haifa

4428164

Meir Medical Center ( Site 0554), Kfar Saba

4941492

Rabin Medical Center ( Site 0553), Petah Tikva

5265601

Sheba Medical Center ( Site 0551), Ramat Gan

6423906

Sourasky Medical Center ( Site 0561), Tel Aviv

7747629

Assuta Ashdod Public ( Site 0562), Ashdod

9103102

Shaare Zedek Medical Center ( Site 0559), Jerusalem

9112001

Hadassah Ein Kerem Medical Center ( Site 0558), Jerusalem

04074

New England Cancer Specialists ( Site 0047), Scarborough

B1884BBF

Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0577), Berazategui

C1120AAT

Centro de Urología CDU ( Site 0590), Buenos Aires

C1426ANZ

Instituto Medico Alexander Fleming ( Site 0578), Buenos Aires

Centro Medico Dra De Salvo ( Site 0593), Buenos Aires

R8500ACE

Centro de Investigaciones Clinicas - Clinica Viedma ( Site 0585), Viedma

S2000KZE

Centro Oncológico de Rosario ( Site 0584), Rosario

C1012AAR

Instituto de Investigaciones Metabolicas ( Site 0589), Buenos Aires

X5008HHW

CEMAIC ( Site 0581), Córdoba

M5500AYB

Centro Oncologico de Integracion Regional. COIR ( Site 0576), Mendoza

L8V 5C2

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0101), Hamilton

L1G 2B9

Lakeridge Health ( Site 0103), Oshawa

M4N 3M5

Sunnybrook Research Institute ( Site 0106), Toronto

G1R 2J6

CHUQ-Univ Laval-Hotel Dieu de Quebec ( Site 0104), Québec

J1H5N4

CIUSSS de l Estrie Centre Hospitalier Universitaire de Sherbrooke ( Site 0102), Sherbrooke

05100

Azienda Ospedaliera Santa Maria ( Site 0303), Terni

036-8563

Hirosaki University Hospital ( Site 0123), Hirosaki

277-8577

National Cancer Center Hospital East ( Site 0128), Kashiwa

791-0295

Ehime University Hospital ( Site 0137), Tōon

060-8543

Sapporo Medical University Hospital ( Site 0122), Sapporo

305-8576

University of Tsukuba Hospital ( Site 0126), Tsukuba

252-0375

Kitasato University Hospital ( Site 0129), Sagamihara

634-8522

Nara Medical University Hospital ( Site 0133), Kashihara

350-1298

Saitama Medical University International Medical Center ( Site 0125), Hidaka

755-8505

Yamaguchi University Hospital ( Site 0135), Ube

010-8543

Akita University Hospital ( Site 0124), Akita

260-8717

Chiba Cancer Center ( Site 0127), Chiba

852-8501

Nagasaki University Hospital ( Site 0136), Nagasaki

545-8586

Osaka City University Hospital ( Site 0132), Osaka

770-8503

Tokushima University Hospital ( Site 0134), Tokushima

113-8519

Medical Hospital, Tokyo Medical And Dental University ( Site 0130), Tokyo

6815 AD

Ziekenhuis Rijnstate ( Site 0342), Arnhem

6229 HX

Maastricht Universitair Medisch Centrum - MUMC ( Site 0334), Maastricht

5912 BL

VieCuri Medisch Centrum ( Site 0340), Venlo

4819 EV

Amphia Ziekenhuis Breda ( Site 0331), Breda

7416 SE

Deventer Ziekenhuis ( Site 0341), Deventer

3015 GD

Erasmus MC ( Site 0332), Rotterdam

2545 AA

Haga Ziekenhuis ( Site 0333), The Hague

3543 AZ

St. Antonius Ziekenhuis ( Site 0335), Utrecht

33-100

Szpital Wojewodzki ( Site 1062), Tarnów

50-556

Uniwersytecki Szpital Kliniczny im. Jana Mikulicza-Radeckiego ( Site 0535), Wroclaw

05-400

Europejskie Centrum Zdrowia Otwock ( Site 0532), Otwock

08-110

Urologica Praktyka Lekarska Adam Marcheluk ( Site 0543), Siedlce

01-748

Luxmed Onkologia sp. z o. o. ( Site 0541), Warsaw

43-300

Szpital Miejski im. Jana Pawła II w Bielsku-Białej ( Site 0542), Bielsko-Biala

02841

Korea University Anam Hospital ( Site 0197), Seoul

03080

Seoul National University Hospital ( Site 0191), Seoul

03722

Severance Hospital ( Site 0192), Seoul

05368

Veterans Health Service Medical Center ( Site 0198), Seoul

06351

Samsung Medical Center ( Site 0193), Seoul

08916

Institut Catala d Oncologia Hospital Germans Trias i Pujol ( Site 0351), Badalona

08908

ICO L Hospitalet ( Site 0361), L'Hospitalet de Llobregat

08243

Xarxa Assistencial Universitaria Manresa ( Site 0354), Manresa

06080

Hospital Infanta Cristina ( Site 0355), Badajoz

08035

Hospital General Universitari Vall d Hebron ( Site 0358), Barcelona

01330

Cukurova Universitesi Tıp Fakultesi Balcalı Hastanesi ( Site 0457), Adana

06800

Ankara Sehir Hastanesi ( Site 0455), Ankara

07020

Antalya Memorial Hospital Department of Medical Oncology ( Site 0461), Antalya

S10 2SJ

Weston Park Hospital ( Site 0387), Sheffield

RM7 0AG

Queens Hospital-Purple Zone ( Site 0377), Romford

SG1 4AB

Lister Hospital ( Site 0376), Stevenage

CT1 3NG

Kent and Canterbury Hospital ( Site 0390), Canterbury

PR2 9HT

Royal Preston Hospital ( Site 0379), Preston

EC1A 7BE

Saint Bartholomew s Hospital - London ( Site 0386), London

NW1 2PG

University College London Hospital NHS Foundation Trust ( Site 0380), London

W6 8RF

Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 0378), London

NG5 1PB

Nottingham University Hospital NHS Trust ( Site 0383), Nottingham

PL6 8DH

Derriford Hospital ( Site 0388), Plymouth

ST4 6QG

Royal Stoke University Hospital Univ. Hosps of North Midlands NHST ( Site 0392), Stoke-on-Trent

All Listed Sponsors
collaborator

Eisai Inc.

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03898180 - Study of First-line Pembrolizumab (MK-3475) With Lenvatinib (MK-7902/E7080) in Urothelial Carcinoma Cisplatin-ineligible Participants Whose Tumors Express Programmed Cell Death-Ligand 1 and in Participants Ineligible for Platinum-containing Chemotherapy (MK-7902-011/E7080-G000-317/ LEAP-011) | Biotech Hunter | Biotech Hunter