A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010) (KEYNOTE-010)

PHASE3CompletedINTERVENTIONAL
Enrollment

511

Participants

Timeline

Start Date

February 5, 2020

Primary Completion Date

May 30, 2023

Study Completion Date

March 31, 2025

Conditions
Head and Neck Squamous Cell Carcinoma
Interventions
DRUG

Lenvatinib

Lenvatinib, 20 mg (two 10-mg oral capsules) administered QD

BIOLOGICAL

Pembrolizumab

Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W) by intravenous (IV) infusion for up to 35 3-week cycles

DRUG

Placebo

Lenvatinib-matching placebo, oral capsules, administered once daily (QD)

Trial Locations (152)

704

National Cheng Kung University Hospital ( Site 1603), Dawan

833

Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1604), Kaohsiung City

1122

Orszagos Onkologiai Intezet ( Site 2202), Budapest

1145

Uzsoki Utcai Korhaz ( Site 2201), Budapest

2050

Chris OBrien Lifehouse ( Site 1002), Camperdown

2217

St George Hospital ( Site 1001), Kogarah

3526

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

4032

Debreceni Egyetem Klinikai Kozpont ( Site 2206), Debrecen

5000

Royal Adelaide Hospital ( Site 1004), Adelaide

5004

Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 2200), Szolnok

6720

Szegedi Egyetem Szent-Gyorgyi Albert Klinikai Kozpont ( Site 2207), Szeged

10021

Weill Cornell Medicine New York Presbyterian Hospital ( Site 0040), New York

10048

National Taiwan University Hospital ( Site 1600), Taipei

10449

MacKay Memorial Hospital ( Site 1602), Taipei

11217

Taipei Veterans General Hospital ( Site 1601), Taipei

12203

Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 2112), Berlin

13005

Hopital de la Timone ( Site 1903), Marseille

13210

SUNY Upstate Medical University ( Site 0051), Syracuse

13620

Seoul National University Bundang Hospital ( Site 1205), Seongnam-si

15033

Hospital Nacional Guillermo Almenara Irigoyen ( Site 0700), Lima

15072

Hospital Nacional Edgardo Rebagliati Martins ( Site 0702), Lima

15082

Hospital Nacional Arzobispo Loayza ( Site 0703), Lima

15102

Hospital Nacional Cayetano Heredia ( Site 0704), Lima

16499

Ajou University Hospital ( Site 1200), Suwon

17100

ASL Liguria 2 - Ospedale San Paolo ( Site 2401), Savona

20133

Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2400), Milan

20141

IEO Istituto Europeo di Oncologia ( Site 2406), Milan

20142

ASST Santi Paolo e Carlo - Presidio Ospedaliero San Paolo ( Site 2405), Milan

22030

Trakya Universitesi Tip Fakultesi ( Site 2801), Edirne

22031

Inova Schar Cancer Institute ( Site 0009), Fairfax

24060

Blue Ridge Cancer Care ( Site 0015), Blacksburg

25123

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 2402), Brescia

27514

University of North Carolina- Chapel Hill ( Site 0056), Chapel Hill

27710

Duke Cancer Center ( Site 0044), Durham

28041

Hospital Universitario 12 de Octubre ( Site 2702), Madrid

28046

Hospital Universitario La Paz ( Site 2706), Madrid

30060

Northwest Georgia Oncology Centers PC ( Site 0028), Marietta

30459

KRH Klinikum Siloah ( Site 2103), Hanover

30912

Georgia Cancer Center at Augusta University ( Site 0013), Augusta

33021

Memorial Regional Hospital-Memorial Cancer Institute ( Site 0069), Hollywood

34214

Medipol Universite Hastanesi ( Site 2800), Istanbul

35040

Ege Universitesi Tip Fakultesi Hastanesi ( Site 2804), Izmir

35128

Istituto Oncologico Veneto ( Site 2404), Padua

35575

Medical Park Izmir Hospital ( Site 2807), Izmir

40202

University of Louisville, James Graham Brown Cancer Center ( Site 0045), Louisville

41014

Hospital de Valme ( Site 2705), Seville

42601

Keimyung University Dongsan Hospital ( Site 1203), Daegu

44280

Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 2803), Malatya

48201

Karmanos Cancer Institute ( Site 0054), Detroit

48202

Henry Ford Health System ( Site 0001), Detroit

50009

Hospital Clinico Universitario Lozano Blesa ( Site 2703), Zaragoza

50937

Universitaetsklinikum Koeln ( Site 2111), Cologne

53792

University of Wisconsin- Madison Carbone Cancer Center ( Site 0006), Madison

58128

Chonnam National University Hwasun Hospital ( Site 1202), Hwasun-gun

59102

St. Vincent Frontier Cancer Center ( Site 0008), Billings

60590

Universitaetsklinikum Frankfurt ( Site 2107), Frankfurt am Main

63110

Washington University School of Medicine ( Site 0060), St Louis

64460

"Hospital Universitario Dr. Jose Eleuterio Gonzalez ( Site 0602)", Monterrey

64570

Christus Muguerza Clinica Vidriera ( Site 0607), Monterrey

66205

University of Kansas Cancer Center ( Site 0033), Westwood

68000

Oaxaca Site Management Organization S.C. ( Site 0603), Oaxaca City

68130

Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0053), Omaha

69008

Centre Leon Berard ( Site 1901), Lyon

72076

Universitaetsklinikum Tuebingen ( Site 2108), Tübingen

76038

Centre Henri Becquerel ( Site 1904), Rouen

77500

Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 0604), Cancún

80045

University of Colorado Cancer Center ( Site 0023), Aurora

89075

Universitaetsklinikum Ulm ( Site 2102), Ulm

92069

California Cancer Associates for Research & Excellence ( Site 0059), San Marcos

92151

Hopital Foch ( Site 1905), Suresnes

93053

Universitaetsklinikum Regensburg ( Site 2100), Regensburg

93720

California Cancer Associates for Research & Excellence ( Site 0025), Fresno

94800

Gustave Roussy ( Site 1906), Villejuif

97213

Providence Portland Medical Center ( Site 0048), Portland

99216

Cancer Care Northwest ( Site 0017), Spokane Valley

100032

Peking Union Medical College Hospital ( Site 3304), Bejiing

100036

Beijing Cancer Hospital ( Site 3314), Beining

115682

FSCC FMBA of Russia ( Site 2603), Moscow

130000

Jilin Cancer Hospital ( Site 3310), Changchun

150054

Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 2605), Yaroslavl

150081

The Third Affiliated Hospital of Harbin Medical University ( Site 3302), Harbin

200032

Fudan University Shanghai Cancer Center ( Site 3324), Shanghai

200120

Shanghai East Hospital ( Site 3300), Shanghai

300060

Tianjin Medical University Cancer Hospital ( Site 3312), Tianjin

310022

Zhejiang Cancer Hospital ( Site 3303), Hangzhou

330029

Jiangxi Cancer Hospital ( Site 3313), Nanchang

350014

Fujian Provincial Cancer Hospital ( Site 3326), Fuzhou

400030

Chongqing Cancer Hospital ( Site 3327), Chongqing

410000

Hunan Cancer Hospital ( Site 3311), Changsha

410008

Xiangya Hospital of Central South University ( Site 3305), Changsha

420029

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2609), Kazan'

430000

Wuhan Union hospital Cancer Center ( Site 3307), Wuhan

430030

Tongji Hospital Tongji Medical,Science & Technology ( Site 3316), Wuhan

450008

Henan Cancer Hospital ( Site 3309), Zhengzhou

530000

Guangxi Medical University Affiliated Tumor Hospital ( Site 3322), Nanning

550003

Guizhou Cancer Hospital ( Site 3330), Guiyang

610047

West China Hospital of Sichuan University ( Site 3308), Chengdu

656045

Altay Regional Oncology Dispensary ( Site 2611), Barnaul

710000

The First Affiliated Hospital of Xi an Jiaotong University ( Site 3328), Xi'an

2360064

Yokohama City University Hospital ( Site 1104), Yokohama

2778577

National Cancer Center Hospital East ( Site 1100), Kashiwa

4648681

Aichi Cancer Center Hospital ( Site 1113), Nagoya

5898511

Kindai University Hospital ( Site 1107), Sayama

7348551

Hiroshima University Hospital ( Site 1109), Hiroshima

06030

University of Connecticut Health Center ( Site 0020), Farmington

02215

Dana Farber Cancer Institute ( Site 0019), Boston

48109-5936

University of Michigan ( Site 0064), Ann Arbor

07601

John Theurer Cancer Center at Hackensack University Medical Center ( Site 0002), Hackensack

60135-237

Oncocentro Ceara ( Site 0412), Fortaleza

35162-189

Fundacao Sao Francisco Xavier ( Site 0409), Ipatinga

87015-200

ELO Pesquisa Clinica ( Site 0405), Maringá

99010-260

Hospital de Passo Fundo ( Site 0401), Passo Fundo

96020-080

Clinica LACKS ( Site 0402), Pelotas

91350-200

Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0414), Porto Alegre

01509-900

A.C. Camargo Cancer Center ( Site 0407), São Paulo

M5G 1Z5

Princess Margaret Cancer Centre ( Site 0200), Toronto

H4A 3J1

McGill University Health Centre ( Site 0206), Montreal

G1J 1Z4

Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0, Québec

04103

Universitätsklinikum Leipzig-Department for ENT ( Site 2106), Leipzig

466-8560

Nagoya University Hospital ( Site 1106), Nagoya

260-8717

Chiba cancer center ( Site 1110), Chiba

673-8558

Hyogo Cancer Center ( Site 1112), Akashi

761-0793

Kagawa University Hospital ( Site 1108), Kita-gun

411-8777

Shizuoka Cancer Center Hospital and Research Institute ( Site 1105), Sunto-gun

810-8563

National Hospital Organization Kyushu Medical Center ( Site 1111), Fukuoka

104-0045

National Cancer Center Hospital ( Site 1102), Tokyo

135-8550

The Cancer Institute Hospital of JFCR ( Site 1103), Tokyo

Unknown

Tokyo Medical and Dental University Hospital ( Site 1101), Tokyo

06100

Cryptex Investigación Clínica S.A. de C.V. ( Site 0608), Cuauhtémoc, Mexico City

Lima 34

Instituto Nacional de Enfermedades Neoplasicas ( Site 0701), Lima

62-500

Przychodnia Lekarska Komed ( Site 2500), Konin

60-780

Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 2509), Poznan

85-796

Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 2508), Bydgoszcz

31-826

Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 2502), Krakow

53-413

Dolnoslaskie Centrum Onkologii. ( Site 2507), Wroclaw

02-781

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Glowy i Szyi ( Site, Warsaw

81-519

Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 2504), Gdynia

44-101

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2506), Gliwice

05505

Asan Medical Center ( Site 1201), Songpa-gu

03312

The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 1204), Seoul

08908

Hospital Duran i Reynals ( Site 2701), L'Hospitalet de Llobregat

08035

H.U. Vall de Hebron ( Site 2700), Barcelona

06230

Hacettepe Universitesi Tip Fakultesi ( Site 2805), Ankara

06800

Ankara Sehir Hastanesi ( Site 2802), Ankara

AB25 2ZN

Aberdeen Royal Infirmary ( Site 2905), Aberdeen

SE1 9RT

Guy's Hospital in London ( Site 2908), London

SW3 6JJ

Royal Marsden NHS Foundation Trust ( Site 2910), London

HA6 2RN

Mount Vernon Cancer Centre ( Site 2902), Northwood

SM2 5PT

Royal Marsden Hospital ( Site 2904), Sutton

NG5 1PB

Nottingham City Hospital ( Site 2907), Nottingham

TA1 5DA

Taunton and Somerset Hospital ( Site 2900), Taunton

M20 4BX

Christie NHS Foundation Trust ( Site 2903), Manchester

All Listed Sponsors
collaborator

Eisai Inc.

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT04199104 - A Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) as First Line (1L) Intervention in a Programmed Cell Death-ligand 1 (PD-L1) Selected Population With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (MK-7902-010) (KEYNOTE-010) | Biotech Hunter | Biotech Hunter