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)

April 12, 2024 updated by: Merck Sharp & Dohme LLC

A Phase 2, Randomized, Open-label Three-arm Clinical Study to Evaluate the Safety and Efficacy of Lenvatinib (E7080/MK-7902) in Combination With Pembrolizumab (MK-3475) Versus Standard of Care Chemotherapy and Lenvatinib Monotherapy in Participants With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) That Have Progressed After Platinum Therapy and Immunotherapy (PD-1/PD-L1 Inhibitors) (LEAP-009)

This study is designed to assess the safety and efficacy of lenvatinib in combination with pembrolizumab versus standard of care (SOC) chemotherapy, and to also assess the safety and efficacy of lenvatinib monotherapy in participants with recurrent/metastatic head and neck squamous cell carcinoma (R/M HNSCC) that have progressed after platinum therapy and a programmed cell death protein 1 (PD-1) or anti-programmed death ligand 1 (PD-L1) inhibitor. The primary hypothesis is that lenvatinib + pembrolizumab is superior to SOC chemotherapy with respect to ORR per modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

400

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Blacktown, New South Wales, Australia, 2148
        • Recruiting
        • Blacktown Hospital ( Site 0101)
        • Contact:
          • Study Coordinator
          • Phone Number: +61402348016
      • Port Macquarie, New South Wales, Australia, 2444
        • Completed
        • Mid North Coast Cancer Institute ( Site 0109)
    • Queensland
      • Douglas, Queensland, Australia, 4814
        • Recruiting
        • The Townsville Hospital ( Site 0107)
        • Contact:
          • Study Coordinator
          • Phone Number: +61744331111
      • Greenslopes, Queensland, Australia, 4120
        • Recruiting
        • Gallipoli Medical Research Ltd-GMRF CTU ( Site 0105)
        • Contact:
          • Study Coordinator
          • Phone Number: +61733947284
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital ( Site 0110)
        • Contact:
          • Study Coordinator
          • Phone Number: (08) 70742342
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Recruiting
        • Monash Health ( Site 0102)
        • Contact:
          • Study Coordinator
          • Phone Number: +61385722392
  • Brazil
      • Sao Paulo, Brazil, 01509-010
        • Recruiting
        • A. C. Camargo Cancer Center ( Site 0809)
        • Contact:
          • Study Coordinator
          • Phone Number: +5511985659911
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 91350-200
        • Recruiting
        • Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0806)
        • Contact:
          • Study Coordinator
          • Phone Number: +5551993590437
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4N2
        • Recruiting
        • Tom Baker Cancer Centre ( Site 0304)
        • Contact:
          • Study Coordinator
          • Phone Number: 4035213093
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Completed
        • BC Cancer-Vancouver Center ( Site 0306)
    • Ontario
      • Hamilton, Ontario, Canada, L8V 5C2
        • Recruiting
        • Hamilton Health Sciences-Juravinski Cancer Centre ( Site 0307)
        • Contact:
          • Study Coordinator
          • Phone Number: 9053879495
      • Toronto, Ontario, Canada, M4N 3M5
        • Recruiting
        • Sunnybrook Research Institute ( Site 0308)
        • Contact:
          • Study Coordinator
          • Phone Number: 416-480-4617
  • Colombia
    • Antioquia
      • Medellin, Antioquia, Colombia, 050025
        • Recruiting
        • Instituto de Cancerología ( Site 0408)
        • Contact:
          • Study Coordinator
          • Phone Number: 3409393 EXT 5414
    • Cesar
      • Valledupar, Cesar, Colombia, 200001
        • Recruiting
        • Sociedad De Oncologia Y Hematologia Del Cesar ( Site 0404)
        • Contact:
          • Study Coordinator
          • Phone Number: 57 3157411877
    • Cordoba
      • Montería, Cordoba, Colombia, 230002
        • Recruiting
        • Oncomédica S.A.S ( Site 0409)
        • Contact:
          • Study Coordinator
          • Phone Number: 3105394868
    • Cundinamarca
      • Bogotá, Cundinamarca, Colombia, 110221
        • Recruiting
        • Administradora Country S.A.S - Clínica del Country ( Site 0407)
        • Contact:
          • Study Coordinator
          • Phone Number: 3005725172
  • Denmark
    • Hovedstaden
      • Copenhagen, Hovedstaden, Denmark, 2100
        • Recruiting
        • Rigshospitalet University Hospital Copenhagen ( Site 1000)
        • Contact:
          • Study Coordinator
          • Phone Number: +4535453545
  • France
      • Paris, France, 75005
        • Recruiting
        • Institut Curie ( Site 0500)
        • Contact:
          • Study Coordinator
          • Phone Number: 33144324086
    • Bouches-du-Rhone
      • Marseille, Bouches-du-Rhone, France, 13385
        • Recruiting
        • Hopital La Timone ( Site 0503)
        • Contact:
          • Study Coordinator
          • Phone Number: +33491385708
    • Herault
      • Montpellier, Herault, France, 34070
        • Recruiting
        • Centre de Cancerologie du Grand Montpellier ( Site 0508)
        • Contact:
          • Study Coordinator
          • Phone Number: +33467926155
    • Puy-de-Dome
      • Clermont-Ferrand, Puy-de-Dome, France, 63011
        • Recruiting
        • Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne-ONCOLOGY ( Site 0510)
        • Contact:
          • Study Coordinator
          • Phone Number: 33473278141
    • Seine-Maritime
      • Rouen, Seine-Maritime, France, 76038
        • Recruiting
        • Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen ( Site 0509)
        • Contact:
          • Study Coordinator
          • Phone Number: 33146252410
    • Val-de-Marne
      • Villejuif, Val-de-Marne, France, 94805
        • Recruiting
        • Institut Gustave Roussy ( Site 0505)
        • Contact:
          • Study Coordinator
          • Phone Number: +33142114637
  • Israel
      • Be'er Sheva, Israel, 8400000
        • Recruiting
        • Soroka Medical Center-Oncology ( Site 0604)
        • Contact:
          • Study Coordinator
          • Phone Number: 97286400189
      • Haifa, Israel, 3109601
        • Recruiting
        • Rambam Health Care Campus-Oncology Division ( Site 0602)
        • Contact:
          • Study Coordinator
          • Phone Number: +972502061161
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Medical Center. Ein Kerem ( Site 0601)
        • Contact:
          • Study Coordinator
          • Phone Number: +972508946244
      • Ramat Gan, Israel, 5265601
        • Completed
        • Chaim Sheba Medical Center ( Site 0600)
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • Severance Hospital Yonsei University Health System ( Site 1800)
        • Contact:
          • Study Coordinator
          • Phone Number: +8215991004
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center ( Site 1803)
        • Contact:
          • Study Coordinator
          • Phone Number: +82234106489
    • Kyonggi-do
      • Seongnam, Kyonggi-do, Korea, Republic of, 13620
        • Recruiting
        • Seoul National University Bundang Hospital ( Site 1801)
        • Contact:
          • Study Coordinator
          • Phone Number: +82317877084
      • Suwon, Kyonggi-do, Korea, Republic of, 16499
        • Completed
        • Ajou University Hospital ( Site 1802)
  • Norway
      • Oslo, Norway, 0310
        • Recruiting
        • Oslo universitetssykehus, Radiumhospitalet ( Site 1102)
        • Contact:
          • Study Coordinator
          • Phone Number: +4722934000
  • Portugal
      • Porto, Portugal, 4200-072
        • Recruiting
        • Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1400)
        • Contact:
          • Study Coordinator
          • Phone Number: +351225084000
    • Porto
      • Vila Nova de Gaia, Porto, Portugal, 4434-502
        • Recruiting
        • Centro Hospitalar Vila Nova de Gaia. Espinho EPE ( Site 1401)
        • Contact:
          • Study Coordinator
          • Phone Number: +351227865100
  • Romania
      • Bucuresti, Romania, 022548
        • Recruiting
        • S.C.Focus Lab Plus S.R.L ( Site 1703)
        • Contact:
          • Study Coordinator
          • Phone Number: +40721298677
    • Bucuresti
      • București, Bucuresti, Romania, 030171
        • Recruiting
        • Spitalul Clinic Colțea ( Site 1708)
        • Contact:
          • Study Coordinator
          • Phone Number: 40722559551
    • Cluj
      • Cluj Napoca, Cluj, Romania, 400015
        • Recruiting
        • Cardiomed SRL Cluj-Napoca ( Site 1701)
        • Contact:
          • Study Coordinator
          • Phone Number: +40721254415
      • Cluj Napoca, Cluj, Romania, 400015
        • Recruiting
        • Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1702)
        • Contact:
          • Study Coordinator
          • Phone Number: +4026459831
      • Floresti, Cluj, Romania, 407280
        • Recruiting
        • S.C. Radiotherapy Center Cluj S.R.L ( Site 1706)
        • Contact:
          • Study Coordinator
          • Phone Number: 40742206212
    • Dolj
      • Craiova, Dolj, Romania, 200542
        • Recruiting
        • S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1704)
        • Contact:
          • Study Coordinator
          • Phone Number: +40727774974
    • Timis
      • Timișoara, Timis, Romania, 300239
        • Recruiting
        • Cabinet Medical Oncomed ( Site 1707)
        • Contact:
          • Study Coordinator
          • Phone Number: +40745100495
  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d Hebron ( Site 0701)
        • Contact:
          • Study Coordinator
          • Phone Number: +34932746000
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Ramon y Cajal ( Site 0705)
        • Contact:
          • Study Coordinator
          • Phone Number: +34913368263
      • Malaga, Spain, 29010
        • Recruiting
        • Hospital Virgen de la Victoria ( Site 0702)
        • Contact:
          • Study Coordinator
          • Phone Number: +34952270497
    • Barcelona
      • Hospitalet de Llobregat, Barcelona, Spain, 08908
        • Recruiting
        • Instituto Catalan de Oncologia ICO - Hospital Duran i Reynals ( Site 0700)
        • Contact:
          • Study Coordinator
          • Phone Number: +34934014105
    • Cataluna
      • Barcelona, Cataluna, Spain, 08036
        • Recruiting
        • HOSPITAL CLÍNIC DE BARCELONA ( Site 0707)
        • Contact:
          • Study Coordinator
          • Phone Number: +34 93 227 54 02
    • Galicia
      • A Coruna, Galicia, Spain, 15009
        • Recruiting
        • Centro Oncologico de Galicia ( Site 0706)
        • Contact:
          • Study Coordinator
          • Phone Number: 981287499
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46014
        • Recruiting
        • Hospital General de Valencia ( Site 0703)
        • Contact:
          • Study Coordinator
          • Phone Number: +34963187527
  • Taiwan
      • Kaohsiung, Taiwan, 83301
        • Recruiting
        • Chang Gung Medical Foundation - Kaohsiung ( Site 1204)
        • Contact:
          • Study Coordinator
          • Phone Number: +88677317123
      • Taichung, Taiwan, 404332
        • Recruiting
        • China Medical University Hospital ( Site 1205)
        • Contact:
          • Study Coordinator
          • Phone Number: 8864220521215050
      • Taichung, Taiwan, 407
        • Recruiting
        • Taichung Veterans General Hospital ( Site 1206)
        • Contact:
          • Study Coordinator
          • Phone Number: 886-4-23592525
      • Tainan, Taiwan, 70403
        • Recruiting
        • National Cheng Kung University Hospital ( Site 1202)
        • Contact:
          • Study Coordinator
          • Phone Number: +8866235-3535
      • Taipei, Taiwan, 10048
        • Recruiting
        • National Taiwan University Hospital ( Site 1200)
        • Contact:
          • Study Coordinator
          • Phone Number: 886-2-23123456#67510
      • Taipei, Taiwan, 112
        • Recruiting
        • Taipei Veterans General Hospital ( Site 1201)
        • Contact:
          • Study Coordinator
          • Phone Number: 886-2-28267000 #7911
    • Taoyuan
      • Taoyuan County, Taoyuan, Taiwan, 333
        • Recruiting
        • Chang Gung Memorial Hospital - Linkou Branch ( Site 1203)
        • Contact:
          • Study Coordinator
          • Phone Number: +88633281200
  • United Kingdom
      • Manchester, United Kingdom, m20 4bx
        • Recruiting
        • The Christie NHS Foundation Trust ( Site 0907)
        • Contact:
          • Study Coordinator
          • Phone Number: +441614463317
    • Aberdeen City
      • Aberdeen, Aberdeen City, United Kingdom, AB25 2ZN
        • Recruiting
        • Aberdeen Royal Infirmary ( Site 0911)
        • Contact:
          • Study Coordinator
          • Phone Number: 01224 553876
    • East Riding Of Yorkshire
      • Cottingham, East Riding Of Yorkshire, United Kingdom, HU16 5JQ
        • Completed
        • Castle Hill Hospital ( Site 0910)
    • Glasgow City
      • Glasgow, Glasgow City, United Kingdom, G12 0YN
        • Recruiting
        • The Beatson West of Scotland Cancer Centre ( Site 0909)
        • Contact:
          • Study Coordinator
          • Phone Number: +441413017070
    • Great Britain
      • London, Great Britain, United Kingdom, SE1 9RT
        • Completed
        • Guy s and St Thomas Hospital NHS Foundation Trust ( Site 0903)
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • Recruiting
        • University Hospital Southampton NHS Foundation Trust ( Site 0905)
        • Contact:
          • Study Coordinator
          • Phone Number: 02380777222
    • London, City Of
      • London, London, City Of, United Kingdom, SW3 6JJ
        • Recruiting
        • Royal Marsden Hospital ( Site 0902)
        • Contact:
          • Study Coordinator
          • Phone Number: 00441227866393
      • London, London, City Of, United Kingdom, W6 8RF
        • Completed
        • Charing Cross Hospital ( Site 0908)
    • Somerset
      • Taunton, Somerset, United Kingdom, TA1 5DA
        • Recruiting
        • Musgrove Park Hospital ( Site 0904)
        • Contact:
          • Study Coordinator
          • Phone Number: 01823333444
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • Royal Marsden Hospital. ( Site 0901)
        • Contact:
          • Study Coordinator
          • Phone Number: 00441227866393
  • United States
    • California
      • Duarte, California, United States, 91010
        • Completed
        • City of Hope ( Site 1519)
      • Los Angeles, California, United States, 90095
        • Recruiting
        • UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568)
        • Contact:
          • Study Coordinator
          • Phone Number: 310-794-4955
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale-New Haven Hospital-Yale Cancer Center ( Site 1505)
        • Contact:
          • Study Coordinator
          • Phone Number: 203-737-7981
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Recruiting
        • Georgetown University Medical Center ( Site 1520)
        • Contact:
          • Study Coordinator
          • Phone Number: 202-444-2223
    • Florida
      • Gainesville, Florida, United States, 32608
        • Active, not recruiting
        • UF Health ( Site 1554)
      • Orange City, Florida, United States, 32763
        • Recruiting
        • Mid Florida Hematology and Oncology Center ( Site 1606)
        • Contact:
          • Study Coordinator
          • Phone Number: 386-774-1223
      • Weston, Florida, United States, 33331
        • Recruiting
        • Cleveland Clinic Florida ( Site 1596)
        • Contact:
          • Study Coordinator
          • Phone Number: 786-413-9673
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Completed
        • Georgia Cancer Center at Augusta University ( Site 1575)
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital-Research ( Site 1521)
        • Contact:
          • Study Coordinator
          • Phone Number: 770-812-1928
      • Savannah, Georgia, United States, 31404
        • Recruiting
        • Memorial Health University Medical Center ( Site 1626)
        • Contact:
          • Study Coordinator
          • Phone Number: 912-658-5756
    • Idaho
      • Post Falls, Idaho, United States, 83854
        • Recruiting
        • Beacon Cancer Care ( Site 1599)
        • Contact:
          • Study Coordinator
          • Phone Number: 208-755-2408
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • Rush University Medical Center ( Site 1560)
        • Contact:
          • Study Coordinator
          • Phone Number: 312-563-8756
      • Evanston, Illinois, United States, 60201
        • Recruiting
        • NorthShore University HealthSystem - Evanston Hospital ( Site 1614)
        • Contact:
          • Study Coordinator
          • Phone Number: 847-570-2515
    • Indiana
      • Muncie, Indiana, United States, 47303
        • Recruiting
        • IU Health Ball Memorial Hospital, Inc.-IU Health Ball Memorial Cancer Center ( Site 1612)
        • Contact:
          • Study Coordinator
          • Phone Number: 765-751-5850
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Completed
        • University of Iowa ( Site 1572)
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • University of Kansas Cancer Center ( Site 1538)
        • Contact:
          • Study Coordinator
          • Phone Number: 913-588-1227
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Recruiting
        • Norton Hospital-Norton Cancer Institute - Downtown ( Site 1601)
        • Contact:
          • Study Coordinator
          • Phone Number: 502-394-6350
      • Paducah, Kentucky, United States, 42003
        • Recruiting
        • Mercy Health-Paducah Medical Oncology and Hematology ( Site 1623)
        • Contact:
          • Study Coordinator
          • Phone Number: 248-632-0743
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Recruiting
        • Mary Bird Perkins Cancer Center Baton Rouge ( Site 1622)
        • Contact:
          • Study Coordinator
          • Phone Number: 225-215-1185
      • Baton Rouge, Louisiana, United States, 70808
        • Recruiting
        • Our Lady of the Lake RMC-Clinical Research ( Site 1624)
        • Contact:
          • Study Coordinator
          • Phone Number: 225-765-3344
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland Greenebaum Cancer Center ( Site 1522)
        • Contact:
          • Study Coordinator
          • Phone Number: 410-328-2703
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Recruiting
        • Boston Medical Center ( Site 1605)
        • Contact:
          • Study Coordinator
          • Phone Number: 617-638-8265
      • Worcester, Massachusetts, United States, 01655
        • Recruiting
        • University of Massachusetts Chan Medical School ( Site 1616)
        • Contact:
          • Study Coordinator
          • Phone Number: 508-856-3216
    • Michigan
      • Ann Arbor, Michigan, United States, 48105
        • Recruiting
        • VA Ann Arbor Healthcare System ( Site 1584)
        • Contact:
          • Study Coordinator
          • Phone Number: 734-769-7100
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Barbara Ann Karmanos Cancer Institute ( Site 1566)
        • Contact:
          • Study Coordinator
          • Phone Number: 313-576-8778
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • Henry Ford Health System ( Site 1544)
        • Contact:
          • Study Coordinator
          • Phone Number: 313-916-2600
    • Mississippi
      • Hattiesburg, Mississippi, United States, 39401
        • Completed
        • Hattiesburg Clinic ( Site 1515)
      • Jackson, Mississippi, United States, 39202
        • Recruiting
        • Jackson Oncology Associates, PLLC-Clinical Trials ( Site 1625)
        • Contact:
          • Study Coordinator
          • Phone Number: 601-355-2485
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Active, not recruiting
        • Washington University School of Medicine ( Site 1500)
    • Montana
      • Billings, Montana, United States, 59102
        • Recruiting
        • St. Vincent Frontier Cancer Center ( Site 1507)
        • Contact:
          • Study Coordinator
          • Phone Number: 406-238-6290
    • Nebraska
      • Omaha, Nebraska, United States, 68105
        • Completed
        • University Of Nebraska Medical Center ( Site 1570)
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • Oncology Hematology West P.C. dba Nebraska Cancer Specialists ( Site 1627)
        • Contact:
          • Study Coordinator
          • Phone Number: 402-354-8124
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • Completed
        • John Theurer Cancer Center at Hackensack University Medical Center ( Site 1555)
      • New Brunswick, New Jersey, United States, 08903
        • Completed
        • Rutgers Cancer Institute of New Jersey ( Site 1523)
    • New York
      • Mineola, New York, United States, 11501
        • Completed
        • Perlmutter Cancer Center at Winthrop Oncology Hematology Associates NYU Langone Health ( Site 1597)
      • New York, New York, United States, 10016
        • Completed
        • Laura and Isaac Perlmutter Cancer Center ( Site 1582)
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Completed
        • Levine Cancer Institute ( Site 1590)
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Institute ( Site 1541)
        • Contact:
          • Study Coordinator
          • Phone Number: 919-681-4768
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Recruiting
        • University of Cincinnati ( Site 1567)
        • Contact:
          • Study Coordinator
          • Phone Number: 513-584-7698
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic ( Site 1598)
        • Contact:
          • Study Coordinator
          • Phone Number: 866-223-8100
      • Cleveland, Ohio, United States, 44106
        • Completed
        • University Hospital Cleveland ( Site 1578)
      • Columbus, Ohio, United States, 43210
        • Completed
        • The James Cancer Hospital and Solove Research Institute at The Ohio State University Comprehensive C
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Completed
        • Oklahoma Cancer Specialists and Research Institute, LLC ( Site 1508)
    • Pennsylvania
      • Gettysburg, Pennsylvania, United States, 17325
        • Completed
        • Gettysburg Cancer Center ( Site 1594)
      • Hershey, Pennsylvania, United States, 17033
        • Completed
        • Penn State Hershey Medical Center ( Site 1561)
      • Philadelphia, Pennsylvania, United States, 19111
        • Recruiting
        • Fox Chase Cancer Center ( Site 1502)
        • Contact:
          • Study Coordinator
          • Phone Number: 215-214-1515
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Recruiting
        • Medical University of South Carolina ( Site 1579)
        • Contact:
          • Study Coordinator
          • Phone Number: 843-792-9321
      • Greenville, South Carolina, United States, 29607
        • Completed
        • St Francis Cancer Center-Research Office ( Site 1607)
    • Texas
      • Fort Worth, Texas, United States, 76104
        • Completed
        • The Center For Cancer And Blood Disorders ( Site 1569)
    • Utah
      • Salt Lake City, Utah, United States, 84106
        • Recruiting
        • Utah Cancer Specialists ( Site 1621)
        • Contact:
          • Study Coordinator
          • Phone Number: 801-462-1053
      • Salt Lake City, Utah, United States, 84112
        • Active, not recruiting
        • Huntsman Cancer Institute ( Site 1532)
    • Virginia
      • Fairfax, Virginia, United States, 22031-4867
        • Recruiting
        • Inova Schar Cancer Institute ( Site 1550)
        • Contact:
          • Study Coordinator
          • Phone Number: 571-472-0624
      • Fredericksburg, Virginia, United States, 22408
        • Recruiting
        • Hematology Oncology Associates of Fredericksburg ( Site 1537)
        • Contact:
          • Study Coordinator
          • Phone Number: 540-371-0079 X360
    • Washington
      • Tacoma, Washington, United States, 98405
        • Recruiting
        • MultiCare Health System-MultiCare Oncology - Puget Sound ( Site 1609)
        • Contact:
          • Study Coordinator
          • Phone Number: 253-403-0791
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin Clinical Cancer Center ( Site 1574)
        • Contact:
          • Study Coordinator
          • Phone Number: 414-805-4600

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pathologically confirmed recurrent (not amenable to curative treatment with local and/or systemic therapies) or metastatic (disseminated) HNSCC of the oral cavity, oropharynx, hypopharynx, and/or larynx that is considered incurable by local therapies
  • Disease progression at any time during or after treatment with a platinum-containing (e.g., carboplatin or cisplatin) regimen
  • Disease progression on or after treatment with an anti-PD-1/PD-L1 mAb (programmed cell death protein 1/programmed death-ligand 1 monoclonal antibody)
  • Pre-study imaging that demonstrates evidence of disease progression based on investigator review of at least 2 pre-study images per RECIST 1.1, following initiation of treatment with a PD-1/PD-L1 inhibitor
  • Measurable disease by CT or MRI based on Response Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as verified by blinded independent central review (BICR). Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions
  • ECOG performance status of 0 or 1 assessed within 7 days of the first dose of study intervention

  • Male participants are eligible to participate if they agree to the following during the intervention period and for at least 1 week after the last dose of lenvatinib, 3 months after the last dose of capecitabine and paclitaxel, and and 6 months after the last dose of docetaxel:

    • Refrain from donating sperm
    • Be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis) and agree to remain abstinent; or must agree to use contraception unless confirmed to be azoospermic
    • Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies

  • A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies:

    • Is not a woman of childbearing potential (WOCBP)
    • Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of <1% per year), with low user dependency or be abstinent from heterosexual intercourse as their preferred and usual lifestyle (abstinent on a long term and persistent basis), during the intervention period and for at least 120 days post pembrolizumab or 1 month post lenvatinib, whichever occurs last (Arms 1 and 3), or during the intervention period and for at least 6 months after the last dose of capecitabine, docetaxel, paclitaxel; and 2 months after the last dose of cetuximab (Arm 2)
    • Female participants who randomize to Arm 2 must also agree not to donate or freeze/store eggs during the intervention period and for at least 6 months after the last dose of capecitabine, docetaxel, paclitaxel; and 2 months after the last dose of cetuximab
  • Adequately controlled blood pressure (BP) with or without antihypertensive medications
  • Participants who are hepatitis B surface antigen (HBsAg) positive are eligible if they have received hepatitis B virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load prior to randomization
  • Participants with history of hepatitis C virus (HCV) infection are eligible if HCV viral load is undetectable at screening
  • Adequate organ function

Exclusion Criteria:

  • Disease that is suitable for local therapy administered with curative intent
  • Life expectancy of less than 3 months and/or has rapidly progressing disease in the opinion of the treating investigator
  • History of (noninfectious) pneumonitis/interstitial lung disease that required steroids, or has current pneumonitis/interstitial lung disease
  • Active infection requiring systemic therapy
  • Diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to the first dose of study drug
  • Known active central nervous system (CNS) metastases and/or carcinomatous meningitis
  • Known additional malignancy that is progressing or has required active systemic treatment within the past 3 years, except basal cell carcinoma of the skin, squamous cell carcinoma of the skin, superficial bladder cancer, or carcinoma in situ that have undergone potentially curative therapy
  • Active autoimmune disease that has required systemic treatment in the past 2 years
  • Had an allogeneic tissue/solid organ transplant
  • Known history of human immunodeficiency virus (HIV) infection
  • History of any contraindication or has a severe hypersensitivity to any components of pembrolizumab, lenvatinib or SOC chemotherapy.
  • Pre-existing ≥Grade 3 gastrointestinal or non-gastrointestinal fistula
  • History of a gastrointestinal malabsorption or any other condition or procedure that may affect oral study drug absorption
  • Had major surgery within 3 weeks prior to first dose of study interventions
  • Clinically significant cardiovascular impairment within 12 months of the first dose of study drug
  • Active tuberculosis
  • Has difficulty swallowing capsules or ingesting a suspension orally, or by a feeding tube
  • Prior treatment with lenvatinib
  • Prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to Study Day 1 or has not recovered from adverse events (AEs) due to a previously administered agent. Participants with endocrine-related AEs Grade ≤2 requiring treatment or hormone replacement may be eligible
  • Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention. Note: Administration of killed vaccines is allowed
  • Previously treated with 4 or more systemic regimens given for recurrent/metastatic disease
  • Has received an investigational agent or has used an investigational device within 4 weeks prior to study intervention administration
  • Known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lenvatinib + Pembrolizumab
Participants will be treated with the combination of lenvatinib (once daily 20 mg oral dose) plus pembrolizumab (200 mg 30-minute intravenous (IV) infusion on Day 1 of each 21-day cycle for 35 cycles), until centrally verified disease progression, or until a protocol-specified discontinuation criterion is met. Participants may receive up to an additional 17 cycles of pembrolizumab as Second Course treatment, with or without lenvatinib.
Drug: Lenvatinib
20 mg once daily, taken as oral capsules
Other Names:
  • E7080
  • MK-7902
  • LENVIMA®
Biological: Pembrolizumab
200 mg 30-minute IV infusion on day 1 of each 21-day cycle
Other Names:
  • MK-3475
  • SCH 900475
  • KEYTRUDA®
Drug: Lenvatinib
24 mg once daily, taken as oral capsules
Other Names:
  • E7080
  • MK-7902
  • LENVIMA®
Active Comparator: SOC Chemotherapy
Participants will be treated with investigator's choice of standard of care (SOC) chemotherapy (docetaxel, paclitaxel, cetuximab, or capecitabine) until centrally verified disease progression, or until a protocol-specified discontinuation criterion is met.
Drug: Docetaxel
75 mg/m^2 administered as an IV infusion on day 1 of each 21-day cycle
Other Names:
  • TAXOTERE®
Drug: Capecitabine
1250 mg/m^2 twice daily on days 1-14 of each 21-day cycle, taken as oral tablets
Other Names:
  • Xeloda®
Drug: Paclitaxel
80 mg/m^2 administered as an IV infusion on days 1, 8, and 15 of each 21-day cycle
Other Names:
  • Taxol
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
Other Names:
  • ERBITUX®
Active Comparator: Lenvatinib Monotherapy
Participants will be treated with lenvatinib monotherapy (once daily 24 mg oral dose) until centrally verified disease progression, or until a protocol-specified discontinuation criterion is met.
Drug: Lenvatinib
20 mg once daily, taken as oral capsules
Other Names:
  • E7080
  • MK-7902
  • LENVIMA®
Drug: Lenvatinib
24 mg once daily, taken as oral capsules
Other Names:
  • E7080
  • MK-7902
  • LENVIMA®

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective Response Rate (ORR)
Time Frame: Up to approximately 4 years
ORR is defined as the percentage of participants who have a confirmed complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of the diameters of target lesions) until progressive disease (PD) or death due to any cause, whichever occurs first. Responses are according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR).
Up to approximately 4 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression-Free Survival (PFS)
Time Frame: Up to approximately 4 years
PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Responses are according to modified Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as assessed by blinded independent central review (BICR).
Up to approximately 4 years
Overall Survival (OS)
Time Frame: Up to approximately 4 years
OS is defined as the time from randomization to death due to any cause.
Up to approximately 4 years
Duration of Response (DOR)
Time Frame: Up to approximately 4 years
DOR is defined as the time from the first documented evidence of complete response (CR: disappearance of all target lesions) or partial response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum of the diameters of target lesions) until progressive disease (PD) or death due to any cause, whichever occurs first. Responses are according to modified RECIST 1.1 as assessed by BICR.
Up to approximately 4 years
Number of Participants Who Experienced One or More Adverse Events (AEs)
Time Frame: Up to approximately 4 years
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be presented.
Up to approximately 4 years
Number of Participants Who Discontinued Study Intervention Due to an Adverse Event (AE)
Time Frame: Up to approximately 4 years
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be presented.
Up to approximately 4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Eisai Inc.

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2020

Primary Completion (Estimated)

July 18, 2025

Study Completion (Estimated)

February 17, 2027

Study Registration Dates

First Submitted

June 9, 2020

First Submitted That Met QC Criteria

June 9, 2020

First Posted (Actual)

June 11, 2020

Study Record Updates

Last Update Posted (Estimated)

April 15, 2024

Last Update Submitted That Met QC Criteria

April 12, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7902-009
  • LEAP-009 (Other Identifier: Merck)
  • E7080-G000-228 (Other Identifier: Eisai)
  • MK-7902-009 (Other Identifier: Merck)
  • 2019-000569-19 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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