Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009)

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

408

Participants

Timeline

Start Date

August 6, 2020

Primary Completion Date

May 31, 2024

Study Completion Date

October 15, 2025

Conditions
Squamous Cell Carcinoma of Head and Neck
Interventions
DRUG

Lenvatinib

20 mg once daily, taken as oral capsules

BIOLOGICAL

Pembrolizumab

200 mg 30-minute IV infusion on day 1 of each 21-day cycle

DRUG

Docetaxel

75 mg/m\^2 administered as an IV infusion on day 1 of each 21-day cycle

DRUG

Capecitabine

1250 mg/m\^2 twice daily on days 1-14 of each 21-day cycle, taken as oral tablets

DRUG

Paclitaxel

80 mg/m\^2 administered as an IV infusion on days 1, 8, and 15 of each 21-day cycle

DRUG

Cetuximab

400 mg/m\^2 loading dose, followed by 250 mg/m\^2 administered as an IV infusion on days 1, 8, and 15 of each 21-day cycle

DRUG

Lenvatinib

24 mg once daily, taken as oral capsules

Trial Locations (120)

333

Chang Gung Memorial Hospital - Linkou Branch ( Site 1203), Taoyuan District

407

Taichung Veterans General Hospital ( Site 1206), Taichung

704

National Cheng Kung University Hospital ( Site 1202), Tainan City

2100

Rigshospitalet University Hospital Copenhagen ( Site 1000), Copenhagen

2148

Blacktown Hospital ( Site 0101), Sydney

2444

Mid North Coast Cancer Institute ( Site 0109), Port Macquarie

3168

Monash Health ( Site 0102), Clayton

4120

Gallipoli Medical Research Ltd-GMRF CTU ( Site 0105), Greenslopes

4814

The Townsville Hospital ( Site 0107), Douglas

5000

Royal Adelaide Hospital ( Site 0110), Adelaide

10016

Laura and Isaac Perlmutter Cancer Center ( Site 1582), New York

10048

National Taiwan University Hospital ( Site 1200), Taipei

11217

Taipei Veterans General Hospital ( Site 1201), Taipei

11501

Perlmutter Cancer Center at Winthrop Oncology Hematology Associates NYU Langone Health ( Site 1597), Mineola

13385

Hopital La Timone ( Site 0503), Marseille

13620

Seoul National University Bundang Hospital ( Site 1801), Seongnam

15009

Centro Oncologico de Galicia ( Site 0706), A Coruña

16499

Ajou University Hospital ( Site 1802), Suwon

17033

Penn State Hershey Medical Center ( Site 1561), Hershey

17325

Gettysburg Cancer Center ( Site 1594), Gettysburg

19111

Fox Chase Cancer Center ( Site 1502), Philadelphia

20007

Georgetown University Medical Center ( Site 1520), Washington D.C.

21201

University of Maryland Greenebaum Cancer Center ( Site 1522), Baltimore

22408

Hematology Oncology Associates of Fredericksburg ( Site 1537), Fredericksburg

27710

Duke Cancer Institute ( Site 1541), Durham

28034

Hospital Ramon y Cajal ( Site 0705), Madrid

28204

Levine Cancer Institute ( Site 1590), Charlotte

29010

Hospital Virgen de la Victoria ( Site 0702), Málaga

29425

Medical University of South Carolina ( Site 1579), Charleston

29607

St Francis Cancer Center-Research Office ( Site 1607), Greenville

30060

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1521), Marietta

30912

Georgia Cancer Center at Augusta University ( Site 1575), Augusta

31404

Memorial Health University Medical Center ( Site 1626), Savannah

32608

UF Health ( Site 1554), Gainesville

32763

Mid Florida Hematology and Oncology Center ( Site 1606), Orange City

33331

Cleveland Clinic Florida ( Site 1596), Weston

34070

Centre de Cancerologie du Grand Montpellier ( Site 0508), Montpellier

39202

Jackson Oncology Associates, PLLC-Clinical Trials ( Site 1625), Jackson

39401

Hattiesburg Clinic ( Site 1515), Hattiesburg

40205

Norton Hospital-Norton Cancer Institute - Downtown ( Site 1601), Louisville

42003

Mercy Health-Paducah Cancer Center ( Site 1623), Paducah

43210

The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C ( Site 1558), Columbus

44106

University Hospital Cleveland ( Site 1578), Cleveland

44195

Cleveland Clinic Main ( Site 1598), Cleveland

45219

University of Cincinnati Medical Center ( Site 1567), Cincinnati

46014

Hospital General de Valencia ( Site 0703), Valencia

47303

IU Health Ball Memorial Hospital, Inc.-IU Health Ball Memorial Cancer Center ( Site 1612), Muncie

48105

VA Ann Arbor Healthcare System ( Site 1584), Ann Arbor

48201

Barbara Ann Karmanos Cancer Institute ( Site 1566), Detroit

48202

Henry Ford Health System ( Site 1544), Detroit

50034

Instituto de Cancerología ( Site 0408), Medellín

52242

University of Iowa ( Site 1572), Iowa City

53226

Medical College of Wisconsin Clinical Cancer Center ( Site 1574), Milwaukee

59102

St. Vincent Frontier Cancer Center ( Site 1507), Billings

60201

NorthShore University HealthSystem - Evanston Hospital ( Site 1614), Evanston

60607

Rush University Medical Center ( Site 1560), Chicago

63003

Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 0510), Clermont-Ferrand

63110

Washington University School of Medicine ( Site 1500), St Louis

66205

University of Kansas Cancer Center ( Site 1538), Westwood

68105

University Of Nebraska Medical Center ( Site 1570), Omaha

68130

Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 1627), Omaha

70808

Our Lady of the Lake RMC-Clinical Research ( Site 1624), Baton Rouge

70809

Mary Bird Perkins Cancer Center Baton Rouge ( Site 1622), Baton Rouge

74146

Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1508), Tulsa

75005

Institut Curie ( Site 0500), Paris

76038

Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen ( Site 0509), Rouen

76104

The Center For Cancer And Blood Disorders ( Site 1569), Fort Worth

83301

Chang Gung Medical Foundation - Kaohsiung ( Site 1204), Kaohsiung City

83854

Beacon Cancer Care ( Site 1599), Post Falls

84106

Utah Cancer Specialists ( Site 1621), Salt Lake City

84112

Huntsman Cancer Institute ( Site 1532), Salt Lake City

90095

UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568), Los Angeles

91010

City of Hope ( Site 1519), Duarte

94800

Institut Gustave Roussy ( Site 0505), Villejuif

98405

MultiCare Health System-MultiCare Oncology - Puget Sound ( Site 1609), Tacoma

110221

Administradora Country S.A.S - Clínica del Country ( Site 0407), Bogotá

200001

Sociedad De Oncologia Y Hematologia Del Cesar ( Site 0404), Valledupar

200542

S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1704), Craiova

230002

IMAT S.A.S ( Site 0409), Montería

300239

Cabinet Medical Oncomed ( Site 1707), Timișoara

400015

Cardiomed SRL Cluj-Napoca ( Site 1701), Cluj-Napoca

Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1702), Cluj-Napoca

404332

China Medical University Hospital ( Site 1205), Taichung

407280

S.C. Radiotherapy Center Cluj S.R.L ( Site 1706), Floreşti

3109601

Rambam Health Care Campus-Oncology Division ( Site 0602), Haifa

5265601

Chaim Sheba Medical Center ( Site 0600), Ramat Gan

8400000

Soroka Medical Center-Oncology ( Site 0604), Beersheba

9112001

Hadassah Medical Center. Ein Kerem ( Site 0601), Jerusalem

06510

Yale-New Haven Hospital-Yale Cancer Center ( Site 1505), New Haven

02118

Boston Medical Center ( Site 1605), Boston

01655

University of Massachusetts Chan Medical School ( Site 1616), Worcester

07601

John Theurer Cancer Center at Hackensack University Medical Center ( Site 1555), Hackensack

08901

Rutgers Cancer Institute of New Jersey ( Site 1523), New Brunswick

22031-4867

Inova Schar Cancer Institute ( Site 1550), Fairfax

91350-200

Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0806), Porto Alegre

01509-010

A. C. Camargo Cancer Center ( Site 0809), São Paulo

T2N 5G2

Arthur J.E. Child Comprehensive Cancer Centre ( Site 0304), Calgary

V5Z 4E6

BC Cancer-Vancouver Center ( Site 0306), Vancouver

L8V 5C2

Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0307), Hamilton

M4N 3M5

Sunnybrook Research Institute ( Site 0308), Toronto

0379

Oslo universitetssykehus, Radiumhospitalet ( Site 1102), Oslo

4434-502

Unidade Local de Saude Gaia/Espinho - Hospital Eduardo Santos Silva ( Site 1401), Vila Nova de Gaia

4200-072

Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1400), Porto

013823

MEMORIAL HEALTHCARE INTERNATIONAL S.R.L. ( Site 1703), Bucharest

030171

Spitalul Clinic Colțea ( Site 1708), Bucharest

03722

Severance Hospital Yonsei University Health System ( Site 1800), Seoul

06351

Samsung Medical Center ( Site 1803), Seoul

08908

Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 0700), L'Hospitalet de Llobregat

08036

HOSPITAL CLÍNIC DE BARCELONA ( Site 0707), Barcelona

08035

Hospital Universitari Vall d Hebron ( Site 0701), Barcelona

AB25 2ZN

Aberdeen Royal Infirmary ( Site 0911), Aberdeen

HU16 5JQ

Castle Hill Hospital ( Site 0910), Cottingham

G12 0YN

The Beatson West of Scotland Cancer Centre ( Site 0909), Glasgow

SE1 9RT

Guy s and St Thomas Hospital NHS Foundation Trust ( Site 0903), London

SO16 6YD

University Hospital Southampton NHS Foundation Trust ( Site 0905), Southampton

SW3 6JJ

Royal Marsden Hospital ( Site 0902), London

W6 8RF

Charing Cross Hospital ( Site 0908), London

TA1 5DA

Musgrove Park Hospital ( Site 0904), Taunton

SM2 5PT

Royal Marsden Hospital. ( Site 0901), Sutton

m20 4bx

The Christie NHS Foundation Trust ( Site 0907), Manchester

All Listed Sponsors
collaborator

Eisai Inc.

INDUSTRY

lead

Merck Sharp & Dohme LLC

INDUSTRY

NCT04428151 - Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) vs. Standard Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma That Progressed After Platinum Therapy and Immunotherapy (MK-7902-009/E7080-G000-228/LEAP-009) | Biotech Hunter | Biotech Hunter