AzTrials
AzTrials

Head and Neck Squamous Cell CarcinomaPhase 3NCT04199104

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)

A Phase 3 study testing Lenvatinib and Pembrolizumab in people with Head and Neck Squamous Cell Carcinoma, run by Merck Sharp & Dohme LLC at 152 sites in 19 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Head and Neck Squamous Cell Carcinoma
What is being tested?
Lenvatinib and Pembrolizumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
511 participants
Where
152 sitesin 19 countries
Study dates
5 Feb 2020to 31 Mar 2025
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Has histologically confirmed diagnosis of R/M HNSCC that is considered incurable by local therapies.
  • Note: Participants with newly-diagnosed HNSCC must be M1/Stage IV.
  • Has a primary tumor location of oropharynx, oral cavity, hypopharynx, or larynx.
  • Note: Primary tumor site of nasopharynx (any histology) or unknown primary tumor (including p16+ unknown primary) are not eligible.
  • Contraceptive use by men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. If the contraception requirements in the local label for any of the study interventions is more stringent than the requirements above, the local label requirements are to be followed.
  • Male participants agree to use approved contraception during the treatment period for at least 7 days after the last dose of lenvatinib/placebo, or refrain from heterosexual intercourse during this period
Show all 12Show fewer
  • Female participants are not pregnant or breastfeeding, and are not a woman of childbearing potential (WOCBP), OR are a WOCBP that agrees to use contraception during the treatment period (or 14 days prior to the initiation of study treatment for oral contraception) and for at least 120 days post pembrolizumab, or 30 days post lenvatinib/placebo, whichever occurs last
  • Has measurable disease per RECIST 1.1 as assessed by BICR. Note: Lesions situated in a previously irradiated area are considered measurable if progression has been shown in such lesions.
  • Participants with oropharyngeal cancer must have results from testing of human papillomavirus HPV status.
  • Has an Eastern Cooperative Oncology Group (ECOG) performance score of 0 to 1.
  • Have adequately controlled blood pressure with or without antihypertensive medications.
  • Has adequate organ function.

Who cannot join

  • Has a history of any contraindication or has a severe hypersensitivity to any components of pembrolizumab (≥Grade 3) or lenvatinib.
  • Has pre-existing ≥Grade 3 gastrointestinal or non-gastrointestinal fistula.
  • Has a history of a gastrointestinal condition or procedure that, in the opinion of the investigator, may affect oral study drug absorption.
  • Has clinically significant cardiovascular impairment within 12 months of the first dose of study intervention, such as history of congestive heart failure greater than New York Heart Association (NYHA) Class II, unstable angina, myocardial infarction or cerebrovascular accident/transient ischemic attack (TIA)/stroke, cardiac revascularization, or cardiac arrhythmia associated with hemodynamic instability.
  • Has disease that is suitable for local therapy administered with curative intent.
  • Had PD within 6 months of completion of curatively intended systemic treatment for locoregionally advanced HNSCC.
Show all 27Show fewer
  • Has had major surgery within 3 weeks before to first dose of study interventions.
  • Has difficulty swallowing capsules or ingesting a suspension orally or by a feeding tube.
  • Has received prior therapy with lenvatinib or pembrolizumab.
  • Received last dose of systemic therapy for locoregionally advanced disease less than 6 months before signing consent.
  • Has received prior therapy with an anti-PD-1, anti-PD-L1, or anti PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137).
  • Has received prior systemic anticancer therapy including investigational agents within 4 weeks before randomization.
  • Has received prior radiotherapy within 2 weeks of start of study intervention.
  • Has received a live vaccine within 30 days before the first dose of study intervention. Administration of killed vaccines is allowed.
  • Received an investigational agent or has used an investigational device within 4 weeks prior to study intervention-administration.
  • Has a 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 the first dose of study intervention.
  • Has a known additional malignancy that is progressing or has required active treatment within the past 3 years.
  • Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g., breast carcinoma, cervical cancer in situ) that have undergone potentially curative therapy are not excluded.
  • Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis.
  • Has an active autoimmune disease that has required systemic treatment in past 2 years. Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid) is allowed.
  • Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
  • Has an active infection requiring systemic therapy. (e.g., tuberculosis, known viral or bacterial infections, etc.).
  • Has a known history of human immunodeficiency virus (HIV) infection.
  • Has a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV ribonucleic acid (RNA) [qualitative] is detected) infection.
  • Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study intervention.
  • Has had an allogenic tissue/solid organ transplant.
  • Has a known psychiatric or substance abuse disorder that would interfere with the participant's ability to cooperate with the requirements of the study.

Trial locations and contacts

152 sites in 19 countries.

152 sites in 19 countries

United States26 sites

  • University of Michigan ( Site 0064)

    Ann Arbor, Michigan, 48109-5936

  • Georgia Cancer Center at Augusta University ( Site 0013)

    Augusta, Georgia, 30912

  • University of Colorado Cancer Center ( Site 0023)

    Aurora, Colorado, 80045

  • St. Vincent Frontier Cancer Center ( Site 0008)

    Billings, Montana, 59102

  • Blue Ridge Cancer Care ( Site 0015)

    Blacksburg, Virginia, 24060

  • Dana Farber Cancer Institute ( Site 0019)

    Boston, Massachusetts, 02215

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

    Chapel Hill, North Carolina, 27514

  • Karmanos Cancer Institute ( Site 0054)

    Detroit, Michigan, 48201

  • Henry Ford Health System ( Site 0001)

    Detroit, Michigan, 48202

  • Duke Cancer Center ( Site 0044)

    Durham, North Carolina, 27710

  • Inova Schar Cancer Institute ( Site 0009)

    Fairfax, Virginia, 22031

  • University of Connecticut Health Center ( Site 0020)

    Farmington, Connecticut, 06030

  • California Cancer Associates for Research & Excellence ( Site 0025)

    Fresno, California, 93720

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

    Hackensack, New Jersey, 07601

  • Memorial Regional Hospital-Memorial Cancer Institute ( Site 0069)

    Hollywood, Florida, 33021

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

    Louisville, Kentucky, 40202

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

    Madison, Wisconsin, 53792

  • Northwest Georgia Oncology Centers PC ( Site 0028)

    Marietta, Georgia, 30060

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

    New York, New York, 10021

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

    Omaha, Nebraska, 68130

  • Providence Portland Medical Center ( Site 0048)

    Portland, Oregon, 97213

  • California Cancer Associates for Research & Excellence ( Site 0059)

    San Marcos, California, 92069

  • Cancer Care Northwest ( Site 0017)

    Spokane Valley, Washington, 99216

  • Washington University School of Medicine ( Site 0060)

    St Louis, Missouri, 63110

  • SUNY Upstate Medical University ( Site 0051)

    Syracuse, New York, 13210

  • University of Kansas Cancer Center ( Site 0033)

    Westwood, Kansas, 66205

Other trials in United States

China20 sites

  • Beijing Cancer Hospital ( Site 3314)

    Beining, Beijing Municipality, 100036

  • Peking Union Medical College Hospital ( Site 3304)

    Bejiing, Beijing Municipality, 100032

  • Jilin Cancer Hospital ( Site 3310)

    Changchun, Jilin, 130000

  • Hunan Cancer Hospital ( Site 3311)

    Changsha, Hunan, 410000

  • Xiangya Hospital of Central South University ( Site 3305)

    Changsha, Hunan, 410008

  • West China Hospital of Sichuan University ( Site 3308)

    Chengdu, Sichuan, 610047

  • Chongqing Cancer Hospital ( Site 3327)

    Chongqing, Chongqing Municipality, 400030

  • Fujian Provincial Cancer Hospital ( Site 3326)

    Fuzhou, Fujian, 350014

  • Guizhou Cancer Hospital ( Site 3330)

    Guiyang, Guizhou, 550003

  • Zhejiang Cancer Hospital ( Site 3303)

    Hangzhou, Zhejiang, 310022

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

    Harbin, Heilongjiang, 150081

  • Jiangxi Cancer Hospital ( Site 3313)

    Nanchang, Jiangxi, 330029

  • Guangxi Medical University Affiliated Tumor Hospital ( Site 3322)

    Nanning, Guangxi, 530000

  • Fudan University Shanghai Cancer Center ( Site 3324)

    Shanghai, Shanghai Municipality, 200032

  • Shanghai East Hospital ( Site 3300)

    Shanghai, Shanghai Municipality, 200120

  • Tianjin Medical University Cancer Hospital ( Site 3312)

    Tianjin, Tianjin Municipality, 300060

  • Wuhan Union hospital Cancer Center ( Site 3307)

    Wuhan, Hubei, 430000

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

    Wuhan, Hubei, 430030

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

    Xi'an, Shaanxi, 710000

  • Henan Cancer Hospital ( Site 3309)

    Zhengzhou, Henan, 450008

Other trials in China

Japan14 sites

  • Hyogo Cancer Center ( Site 1112)

    Akashi, Hyōgo, 673-8558

  • Chiba cancer center ( Site 1110)

    Chiba, Chiba, 260-8717

  • National Hospital Organization Kyushu Medical Center ( Site 1111)

    Fukuoka, 810-8563

  • Hiroshima University Hospital ( Site 1109)

    Hiroshima, 7348551

  • National Cancer Center Hospital East ( Site 1100)

    Kashiwa, Chiba, 2778577

  • Kagawa University Hospital ( Site 1108)

    Kita-gun, Kagawa-ken, 761-0793

  • Aichi Cancer Center Hospital ( Site 1113)

    Nagoya, Aichi-ken, 4648681

  • Nagoya University Hospital ( Site 1106)

    Nagoya, Aichi-ken, 466-8560

  • Kindai University Hospital ( Site 1107)

    Sayama, Osaka, 5898511

  • Shizuoka Cancer Center Hospital and Research Institute ( Site 1105)

    Sunto-gun, Shizuoka, 411-8777

  • National Cancer Center Hospital ( Site 1102)

    Tokyo, 104-0045

  • The Cancer Institute Hospital of JFCR ( Site 1103)

    Tokyo, 135-8550

  • Tokyo Medical and Dental University Hospital ( Site 1101)

    Tokyo

  • Yokohama City University Hospital ( Site 1104)

    Yokohama, Kanagawa, 2360064

Other trials in Japan

Germany8 sites

  • Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 2112)

    Berlin, 12203

  • Universitaetsklinikum Koeln ( Site 2111)

    Cologne, North Rhine-Westphalia, 50937

  • Universitaetsklinikum Frankfurt ( Site 2107)

    Frankfurt am Main, Hesse, 60590

  • KRH Klinikum Siloah ( Site 2103)

    Hanover, Lower Saxony, 30459

  • Universitätsklinikum Leipzig-Department for ENT ( Site 2106)

    Leipzig, Saxony, 04103

  • Universitaetsklinikum Regensburg ( Site 2100)

    Regensburg, Bavaria, 93053

  • Universitaetsklinikum Tuebingen ( Site 2108)

    Tübingen, Baden-Wurttemberg, 72076

  • Universitaetsklinikum Ulm ( Site 2102)

    Ulm, Baden-Wurttemberg, 89075

Other trials in Germany

Poland8 sites

  • Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 2508)

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796

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

    Gdynia, Pomeranian Voivodeship, 81-519

  • Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2506)

    Gliwice, Silesian Voivodeship, 44-101

  • Przychodnia Lekarska Komed ( Site 2500)

    Konin, Greater Poland Voivodeship, 62-500

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

    Krakow, Lesser Poland Voivodeship, 31-826

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

    Poznan, Greater Poland Voivodeship, 60-780

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

    Warsaw, Masovian Voivodeship, 02-781

  • Dolnoslaskie Centrum Onkologii. ( Site 2507)

    Wroclaw, Lower Silesian Voivodeship, 53-413

Other trials in Poland

United Kingdom8 sites

  • Aberdeen Royal Infirmary ( Site 2905)

    Aberdeen, Aberdeen City, AB25 2ZN

  • Guy's Hospital in London ( Site 2908)

    London, London, City of, SE1 9RT

  • Royal Marsden NHS Foundation Trust ( Site 2910)

    London, London, City of, SW3 6JJ

  • Christie NHS Foundation Trust ( Site 2903)

    Manchester, M20 4BX

  • Mount Vernon Cancer Centre ( Site 2902)

    Northwood, London, City of, HA6 2RN

  • Nottingham City Hospital ( Site 2907)

    Nottingham, Nottinghamshire, NG5 1PB

  • Royal Marsden Hospital ( Site 2904)

    Sutton, London, City of, SM2 5PT

  • Taunton and Somerset Hospital ( Site 2900)

    Taunton, Somerset, TA1 5DA

Other trials in United Kingdom

Brazil7 sites

  • Oncocentro Ceara ( Site 0412)

    Fortaleza, Ceará, 60135-237

  • Fundacao Sao Francisco Xavier ( Site 0409)

    Ipatinga, Minas Gerais, 35162-189

  • ELO Pesquisa Clinica ( Site 0405)

    Maringá, Paraná, 87015-200

  • Hospital de Passo Fundo ( Site 0401)

    Passo Fundo, Rio Grande do Sul, 99010-260

  • Clinica LACKS ( Site 0402)

    Pelotas, Rio Grande do Sul, 96020-080

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

    Porto Alegre, Rio Grande do Sul, 91350-200

  • A.C. Camargo Cancer Center ( Site 0407)

    São Paulo, 01509-900

Other trials in Brazil

Turkey (Türkiye)7 sites

  • Hacettepe Universitesi Tip Fakultesi ( Site 2805)

    Ankara, 06230

  • Ankara Sehir Hastanesi ( Site 2802)

    Ankara, 06800

  • Trakya Universitesi Tip Fakultesi ( Site 2801)

    Edirne, 22030

  • Medipol Universite Hastanesi ( Site 2800)

    Istanbul, 34214

  • Ege Universitesi Tip Fakultesi Hastanesi ( Site 2804)

    Izmir, 35040

  • Medical Park Izmir Hospital ( Site 2807)

    Izmir, 35575

  • Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 2803)

    Malatya, 44280

Other trials in Turkey (Türkiye)

Hungary6 sites

  • Uzsoki Utcai Korhaz ( Site 2201)

    Budapest, Vas County, 1145

  • Orszagos Onkologiai Intezet ( Site 2202)

    Budapest, 1122

  • Debreceni Egyetem Klinikai Kozpont ( Site 2206)

    Debrecen, 4032

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

    Miskolc, Borsod-Abauj Zemplen county, 3526

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

    Szeged, Csongrád megye, 6720

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

    Szolnok, Jász-Nagykun-Szolnok, 5004

Other trials in Hungary

Italy6 sites

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

    Brescia, 25123

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

    Milan, 20133

  • IEO Istituto Europeo di Oncologia ( Site 2406)

    Milan, 20141

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

    Milan, 20142

  • Istituto Oncologico Veneto ( Site 2404)

    Padova, 35128

  • ASL Liguria 2 - Ospedale San Paolo ( Site 2401)

    Savona, 17100

Other trials in Italy

South Korea6 sites

  • Keimyung University Dongsan Hospital ( Site 1203)

    Daegu, Taegu-Kwangyokshi, 42601

  • Chonnam National University Hwasun Hospital ( Site 1202)

    Hwasun-gun, Jeonranamdo, 58128

  • Seoul National University Bundang Hospital ( Site 1205)

    Seongnam-si, Kyonggi-do, 13620

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

    Seoul, 03312

  • Asan Medical Center ( Site 1201)

    Songpa-gu, Seoul, 05505

  • Ajou University Hospital ( Site 1200)

    Suwon, Kyonggi-do, 16499

Other trials in South Korea

Spain6 sites

  • H.U. Vall de Hebron ( Site 2700)

    Barcelona, 08035

  • Hospital Duran i Reynals ( Site 2701)

    L'Hospitalet de Llobregat, Barcelona, 08908

  • Hospital Universitario 12 de Octubre ( Site 2702)

    Madrid, 28041

  • Hospital Universitario La Paz ( Site 2706)

    Madrid, 28046

  • Hospital de Valme ( Site 2705)

    Seville, 41014

  • Hospital Clinico Universitario Lozano Blesa ( Site 2703)

    Zaragoza, 50009

Other trials in Spain

France5 sites

  • Centre Leon Berard ( Site 1901)

    Lyon, Auvergne, 69008

  • Hopital de la Timone ( Site 1903)

    Marseille, Bouches-du-Rhone, 13005

  • Centre Henri Becquerel ( Site 1904)

    Rouen, Seine-Maritime, 76038

  • Hopital Foch ( Site 1905)

    Suresnes, Hauts-de-Seine, 92151

  • Gustave Roussy ( Site 1906)

    Villejuif, Val-de-Marne, 94800

Other trials in France

Mexico5 sites

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

    Cancún, Quintana Roo, 77500

  • Cryptex Investigación Clínica S.A. de C.V. ( Site 0608)

    Cuauhtémoc, Mexico City, Mexico City, 06100

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

    Monterrey, Nuevo León, 64460

  • Christus Muguerza Clinica Vidriera ( Site 0607)

    Monterrey, Nuevo León, 64570

  • Oaxaca Site Management Organization S.C. ( Site 0603)

    Oaxaca City, 68000

Other trials in Mexico

Peru5 sites

  • Instituto Nacional de Enfermedades Neoplasicas ( Site 0701)

    Lima, Muni Metro de Lima, Lima 34

  • Hospital Nacional Guillermo Almenara Irigoyen ( Site 0700)

    Lima, 15033

  • Hospital Nacional Edgardo Rebagliati Martins ( Site 0702)

    Lima, 15072

  • Hospital Nacional Arzobispo Loayza ( Site 0703)

    Lima, 15082

  • Hospital Nacional Cayetano Heredia ( Site 0704)

    Lima, 15102

Other trials in Peru

Taiwan5 sites

  • National Cheng Kung University Hospital ( Site 1603)

    Dawan, Tainan, 704

  • Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1604)

    Kaohsiung City, 833

  • National Taiwan University Hospital ( Site 1600)

    Taipei, 10048

  • MacKay Memorial Hospital ( Site 1602)

    Taipei, 10449

  • Taipei Veterans General Hospital ( Site 1601)

    Taipei, 11217

Other trials in Taiwan

Russia4 sites

  • Altay Regional Oncology Dispensary ( Site 2611)

    Barnaul, Altayskiy Kray, 656045

  • Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2609)

    Kazan', Tatarstan, Respublika, 420029

  • FSCC FMBA of Russia ( Site 2603)

    Moscow, Moscow, 115682

  • Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 2605)

    Yaroslavl, Yaroslavl Oblast, 150054

Other trials in Russia

Australia3 sites

  • Royal Adelaide Hospital ( Site 1004)

    Adelaide, South Australia, 5000

  • Chris OBrien Lifehouse ( Site 1002)

    Camperdown, New South Wales, 2050

  • St George Hospital ( Site 1001)

    Kogarah, New South Wales, 2217

Other trials in Australia

Canada3 sites

  • McGill University Health Centre ( Site 0206)

    Montreal, Quebec, H4A 3J1

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

    Québec, Quebec, G1J 1Z4

  • Princess Margaret Cancer Centre ( Site 0200)

    Toronto, Ontario, M5G 1Z5

Other trials in Canada

About this study

Official title: A Phase 3, Randomized, Placebo-controlled, Double-blind Clinical Study of Pembrolizumab (MK-3475) With or Without Lenvatinib (E7080/MK-7902) to Evaluate the Safety and Efficacy of Pembrolizumab and Lenvatinib as 1L Intervention in a PD-L1 Selected Population of Participants With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC) (LEAP-010).

This is a study of pembrolizumab (MK-3475) with or without lenvatinib (E7080/MK-7902) as a first line intervention in a PD-L1 selected population with participants with recurrent or metastatic head and neck squamous cell carcinoma.

Hypotheses include:

  • Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Objective Response Rate (ORR) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).
  • Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to Progression Free Survival (PFS) per RECIST 1.1 as assessed by BICR.
  • Pembrolizumab + lenvatinib is superior to pembrolizumab + placebo with respect to overall survival (OS).
Being tested
Lenvatinib, Pembrolizumab, Placebo
Keywords
head and neck squamous cell carcinoma, pembrolizumab, lenvatinib, PD-L1
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • LenvatinibDrug

    Also called E7080, MK-7902, LENVIMA®

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

  • PembrolizumabBiological

    Also called MK-3475, Keytruda®

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

  • PlaceboDrug

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

Study groups in NCT04199104
Study groupRoleWhat they receive
Pembrolizumab with LenvatinibExperimentalParticipants receive lenvatinib 20 mg orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months). Lenvatinib will be administered until progressive disease or unacceptable toxicity.
Receives: Drug: Lenvatinib; Biological: Pembrolizumab
Pembrolizumab with PlaceboActive comparatorParticipants receive lenvatinib-matching placebo orally once a day (QD) plus pembrolizumab 200 mg by intravenous (IV) infusion on Day 1 of each 21-day cycle (Q3W). Pembrolizumab will be administered for up to 35 cycles (approximately 24 months).
Receives: Biological: Pembrolizumab; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR)

    ORR is defined as the percentage of participants who had a Complete Response (CR: Disappearance of all target lesions) or a Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters) per RECIST 1.1 modified to follow a maximum of 10 target lesions and a maximum of 5 target lesions per organ. The percentage of participants who experienced a CR or PR based on modified RECIST 1.1 is presented.

    Measured: Up to ~ 37 months

  2. Progression Free Survival (PFS) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR).

    PFS is defined as the time from randomization to the first documented progressive disease (PD) or death due to any cause, whichever occurs first. Per RECIST 1.1, PD was defined as ≥20% increase in the sum of diameters of target lesions. In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of ≥5 mm. Note: The appearance of one or more new lesions is also considered PD.

    Measured: Up to ~ 37 months

  3. Overall Survival (OS)

    OS is the time from randomization to death due to any cause.

    Measured: Up to ~ 37 months

Secondary outcomes (3)

  1. Duration of Response (DOR)

    For participants who demonstrate a confirmed complete response (CR: Disappearance of all target lesions) or confirmed Partial Response (PR: At least a 30% decrease in the sum of diameters of target lesions) per RECIST 1.1, DOR is defined as the time from first documented evidence of CR or PR until disease progression or death.

    Measured: Up to ~ 37 months

  2. Percentage of Participants Who Experienced an Adverse Event (AE)

    An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

    Measured: Up to ~ 61 months

  3. Percentage of Participants Who Discontinued Study Drug Due to an AE

    An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study.

    Measured: Up to ~ 46 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2019
  2. Study start5 Feb 2020
  3. Primary completion30 May 2023
  4. Study completion31 Mar 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
511 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04199104
Sponsor's protocol ID
7902-010
Other IDs
MK-7902-010, LEAP-10, 205240, 2019-003717-34, 2019
Status last verified
Apr 2026
First submitted
12 Dec 2019
Last updated
5 May 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Publications

  • Licitra L, Tahara M, Harrington K, Olivera Hurtado de Mendoza M, Guo Y, Aksoy S, Fang M, Csoszi T, Klochikhin M, Bueno de Oliveira T, Takahashi S, Yang MH, Swiecicki PL, Even C, Fayette J, Dutcus C, Okpara CE, Shen J, Benjamin K, Gumuscu B, Haddad RI; LEAP-010 investigators. Pembrolizumab With or Without Lenvatinib as First-Line Therapy for Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma: Phase III LEAP-010 Study. J Clin Oncol. 2026 Apr 20;44(12):1098-1107. doi: 10.1200/JCO-25-00570. Epub 2026 Mar 12.

    PubMed 41818638

  • Taylor MH, Schmidt EV, Dutcus C, Pinheiro EM, Funahashi Y, Lubiniecki G, Rasco D. The LEAP program: lenvatinib plus pembrolizumab for the treatment of advanced solid tumors. Future Oncol. 2021 Feb;17(6):637-648. doi: 10.2217/fon-2020-0937. Epub 2020 Dec 10.

    PubMed 33300372

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Lenvatinib and Pembrolizumab in people with Head and Neck Squamous Cell Carcinoma, run by Merck Sharp & Dohme LLC at 152 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 152 sites in United States, China, Japan, Germany, Poland and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) Per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Blinded Independent Central Review (BICR) (time frame: Up to ~ 37 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04199104, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in