Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advance Melanoma (MK-7902-003/E7080-G000-312/LEAP-003)

PHASE3CompletedINTERVENTIONAL
Enrollment

674

Participants

Timeline

Start Date

March 12, 2019

Primary Completion Date

January 18, 2023

Study Completion Date

November 1, 2024

Conditions
Malignant Melanoma
Interventions
BIOLOGICAL

Pembrolizumab

IV infusion

DRUG

Lenvatinib

Oral capsule

DRUG

Placebo for lenvatinib

Oral capsule

Trial Locations (119)

1090

Medizinische Universitat Wien ( Site 0778), Vienna

2060

Melanoma Institute Australia ( Site 0452), North Sydney

2145

Westmead Hospital ( Site 0451), Westmead

2196

Sandton Oncology Medical Group PTY LTD ( Site 0802), Johannesburg

2480

Lismore Base Hospital ( Site 0453), Lismore

3128

Eastern Health ( Site 0457), Box Hill

4031

Universitaetsspital Basel ( Site 0094), Basel

4102

Princess Alexandra Hospital ( Site 0454), Wooloongabba

6045

Cancer Care Langenhoven Drive Oncology Centre ( Site 0805), Port Elizabeth

6150

Fiona Stanley Hospital ( Site 0456), Murdoch

7000

Kantonsspital Graubuenden ( Site 0091), Chur

7570

Cape Town Oncology Trials Pty Ltd ( Site 0803), Kraaifontein

8036

LKH Universitatsklinikum Graz ( Site 0776), Graz

8058

Universitaetsspital Zuerich ( Site 0092), Zuerich-Flughafen

8401

Kantonsspital Winterthur ( Site 0095), Winterthur

13385

Hopital La Timone ( Site 0002), Marseille

15006

Complejo Hospitalario Universitario A Coruna. CHUAC ( Site 0182), A Coruña

20133

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0064), Milan

20141

Istituto Europeo di Oncologia ( Site 0067), Milan

21079

CHU Dijon Bourgogne ( Site 0010), Dijon

21614

Hautkrebszentrum Buxtehude ( Site 0037), Buxtehude

24105

Universitaetsklinikum Schleswig-Holstein Campus Kiel ( Site 0033), Kiel

24127

ASST Papa Giovanni XXIII ( Site 0062), Bergamo

27514

University of North Carolina - Cancer Hospital ( Site 0751), Chapel Hill

28009

Hospital General Universitario Gregorio Maranon ( Site 0191), Madrid

28034

Hospital Universitario Ramon y Cajal ( Site 0183), Madrid

28046

Hospital Universitario La Paz ( Site 0184), Madrid

29010

Hospital Universitario Carlos Haya ( Site 0186), Málaga

30322

UCSF Helen Diller Family Comprehensive Cancer Center ( Site 0704), San Francisco

30625

Klinik fur Dermatologie Allergologie und Venerologie ( Site 0035), Hannover

31059

Institut Claudius Regaud IUCT Oncopole ( Site 0003), Toulouse

32207

Baptist MD Anderson Cancer Center ( Site 0767), Jacksonville

32763

Mid-Florida Cancer Centers ( Site 0764), Orange City

35001

Hospital Universitario Insular de Gran Canaria ( Site 0189), Las Palmas de Gran Canaria

35128

Istituto Oncologico Veneto ( Site 0063), Padua

39008

Hospital Universitario Marques de Valdecilla ( Site 0181), Santander

41404

Kyungpook National University Chilgok Hospital ( Site 0553), Daegu

53100

Azienda Ospedaliera Universitaria Senese ( Site 0065), Siena

55432

Minnesota Oncology Specialist, PA ( Site 0766), Fridley

59037

CHRU Lille - Hopital Claude Huriez ( Site 0004), Lille

59102

St. Vincent Frontier Cancer Center ( Site 0724), Billings

60068

AMG Oncology ( Site 0714), Park Ridge

61615

Illinois Cancer Care, PC ( Site 0765), Peoria

70300

Shamir Medical Center-Assaf Harofeh ( Site 0308), Ẕerifin

76000

CHU de Rouen ( Site 0013), Rouen

80045

University of Colorado Cancer Center ( Site 0708), Aurora

80131

Istituto Nazionale Tumori Fondazione Pascale ( Site 0061), Napoli

86021

CHU de la Miletrie Poitiers ( Site 0011), Poitiers

90025

The Angeles Clinic and Research Institute ( Site 0707), Los Angeles

90404

John Wayne Cancer Institute ( Site 0706), Santa Monica

91054

Universitaetsklinikum Erlangen ( Site 0044), Erlangen

92100

Hopital Ambroise Pare Boulogne ( Site 0007), Boulogne-Billancourt

94115

California Pacific Medical Center Research Institute ( Site 0705), San Francisco

94805

Institut Gustave Roussy ( Site 0001), Villejuif

95100

Centre Hospitalier Victor Dupouy ( Site 0012), Argenteuil

97080

Universitaetsklinikum Wuerzburg-Department of Dermatology ( Site 0036), Würzburg

97239

OHSU Center for Health & Healing ( Site 0731), Portland

100036

Beijing Cancer Hospital ( Site 0601), Beijing

130021

The First Hospital Of Jilin University ( Site 0603), Changchun

200032

Fudan University Shanghai Cancer Center ( Site 0607), Shanghai

210008

Nanjing Drum Tower Hospital ( Site 0609), Nanjing

300060

Tianjin Medical University Cancer Institute & Hospital ( Site 0606), Tianjin

310018

Sir Run Run Shaw Hospital ( Site 0605), Hangzhou

310022

Zhejiang Cancer Hospital ( Site 0608), Hangzhou

350014

Fujian Provincial Cancer Hospital ( Site 0612), Fuzhou

430030

Yunnan Cancer Hospital ( Site 0604), Kunming

450003

Henan Cancer Hospital ( Site 0610), Zhengzhou

510000

Sun Yat-Sen University Cancer Center ( Site 0602), Guangzhou

1834111

HaEmek Medical Center ( Site 0306), Afula

2520598

Oncocentro ( Site 0424), Viña del Mar

3109601

Rambam Medical Center ( Site 0301), Haifa

4780000

Centro Investigación del Cáncer James Lind ( Site 0425), Temuco

4941492

Rabin Medical Center ( Site 0302), Petah Tikva

5262000

Chaim Sheba Medical Center ( Site 0304), Ramat Gan

6423906

Sourasky Medical Center ( Site 0307), Tel Aviv

7500921

Fundacion Arturo Lopez Perez FALP ( Site 0421), Santiago

8330024

Pontificia Universidad Catolica de Chile ( Site 0422), Santiago

8420383

Sociedad Medica Aren y Bachero Limitada ( Site 0426), Santiago

8457108

Soroka Medical Center ( Site 0303), Beersheba

9112001

Hadassah Ein Karem Hebrew University Medical Center ( Site 0305), Jerusalem

06510

Yale Cancer Center ( Site 0709), New Haven

07960

Atlantic Health System ( Site 0768), Morristown

07652

Valley Hospital ( Site 0749), Paramus

22031-4867

Inova Schar Cancer Institute ( Site 0739), Fairfax

30130-090

PERSONAL - Oncologia de Precisao e Personalizada ( Site 0399), Belo Horizonte

98700-000

Hospital de Caridade de Ijui ( Site 0391), Ijuí

99010-080

Hospital Sao Vicente de Paulo ( Site 0396), Passo Fundo

90610-000

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da Pucrs ( Site 0397), Porto Alegre

20220-410

Instituto Nacional de Cancer Hospital do Cancer II ( Site 0394), Rio de Janeiro

V1Y 5L3

BC Cancer-Kelowna - Sindi Ahluwalia Hawkins Centre ( Site 0661), Kelowna

V7L 2L7

Lions Gate Hospital ( Site 0662), North Vancouver

M4N 3M5

Sunnybrook Research Institute ( Site 0654), Toronto

H2W 3E4

Centre Hospitalier de l Universite de Montreal - CHUM ( Site 0652), Montreal

H4A 3J1

McGill University Health Centre ( Site 0651), Montreal

06200

Hopital ARCHET 2 ( Site 0009), Nice

01307

Universitaetsklinikum Carl Gustav Carus ( Site 0041), Dresden

04103

Universitaetsklinikum Leipzig ( Site 0040), Leipzig

07548

SRH Wald-Klinikum Gera GmbH ( Site 0042), Gera

60-780

Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 0272), Poznan

85-796

Centrum Onkologii im.prof. F. Lukaszczyka w Bydgoszczy ( Site 0273), Bydgoszcz

30-510

Pratia MCM Krakow ( Site 0280), Krakow

80-214

Uniwersyteckie Centrum Kliniczne ( Site 0281), Gdansk

44-102

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0278), Gliwice

03080

Seoul National University Hospital ( Site 0554), Seoul

03722

Severance Hospital Yonsei University Health System ( Site 0552), Seoul

06351

Samsung Medical Center ( Site 0551), Seoul

08908

Hospital Duran i Reinals ICO de Hospitalet ( Site 0187), Hospitalet Del Llobregat

08036

Hospital Clinic i Provincial Barcelona ( Site 0190), Barcelona

551 85

Laenssjukhuset Ryhov ( Site 0215), Jönköping

351 85

Centrallasarettet Vaxjo ( Site 0214), Vaxjo

221 85

Skanes Universitetssjukhus ( Site 0213), Lund

171 64

Karolinska Universitetssjukhuset ( Site 0211), Solna

751 85

Akademiska Sjukhuset ( Site 0218), Uppsala

901 85

Norrlands Universitetssjukhus ( Site 0216), Umeå

413 45

Sahlgrenska Universitetssjukhuset ( Site 0212), Gothenburg

EH4 2XU

Western General Hospital ( Site 0121), Edinburgh

SE1 9RT

Guys and St Thomas NHS Foundation Trust ( Site 0126), London

PL6 8DH

Derriford Hospital ( Site 0129), Plymouth

SA2 8QA

Singleton Hospital ( Site 0131), Swansea

All Listed Sponsors
collaborator

Eisai Inc.

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT03820986 - Safety and Efficacy Study of Pembrolizumab (MK-3475) Combined With Lenvatinib (MK-7902/E7080) as First-line Intervention in Adults With Advance Melanoma (MK-7902-003/E7080-G000-312/LEAP-003) | Biotech Hunter | Biotech Hunter