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)

NCT04199104 | Completed Phase 3 Results DMC FDA Drug

• 5 other identifiers: 7902-010MK-7902-010LEAP-102052402019-003717-34
• Study Type: interventional
• Target: 511
• Locations: 19 countries
• Sites: 152

Brief 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. 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).

Conditions

Head and Neck Squamous Cell Carcinoma

Keywords

head and neck squamous cell carcinoma; pembrolizumab; lenvatinib; PD-L1

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to ~ 37 months

• 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.

  Up to ~ 37 months

• Overall Survival (OS)

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

  Up to ~ 37 months

Secondary Outcomes (3)

• Duration of Response (DOR)

  Up to ~ 37 months

• Percentage of Participants Who Experienced an Adverse Event (AE)

  Up to ~ 61 months

• Percentage of Participants Who Discontinued Study Drug Due to an AE

  Up to ~ 46 months

Study Arms (2)

Pembrolizumab with Lenvatinib

EXPERIMENTAL

Participants 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.

Drug: Lenvatinib; Biological: Pembrolizumab

Pembrolizumab with Placebo

ACTIVE COMPARATOR

Participants 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).

Biological: Pembrolizumab; Drug: Placebo

Interventions

Lenvatinib DRUG

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

Also known as: E7080, MK-7902, LENVIMA®

Pembrolizumab with Lenvatinib

Pembrolizumab BIOLOGICAL

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

Also known as: MK-3475, Keytruda®

Pembrolizumab with Lenvatinib; Pembrolizumab with Placebo

Placebo DRUG

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

Pembrolizumab with Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Eisai Inc.: collaborator
• Merck Sharp & Dohme LLC: lead

Study Sites (152)

California Cancer Associates for Research & Excellence ( Site 0025)

Fresno, California, 93720, United States

Location

California Cancer Associates for Research & Excellence ( Site 0059)

San Marcos, California, 92069, United States

Location

University of Colorado Cancer Center ( Site 0023)

Aurora, Colorado, 80045, United States

Location

University of Connecticut Health Center ( Site 0020)

Farmington, Connecticut, 06030, United States

Location

Memorial Regional Hospital-Memorial Cancer Institute ( Site 0069)

Hollywood, Florida, 33021, United States

Location

Georgia Cancer Center at Augusta University ( Site 0013)

Augusta, Georgia, 30912, United States

Location

Northwest Georgia Oncology Centers PC ( Site 0028)

Marietta, Georgia, 30060, United States

Location

University of Kansas Cancer Center ( Site 0033)

Westwood, Kansas, 66205, United States

Location

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

Louisville, Kentucky, 40202, United States

Location

Dana Farber Cancer Institute ( Site 0019)

Boston, Massachusetts, 02215, United States

Location

University of Michigan ( Site 0064)

Ann Arbor, Michigan, 48109-5936, United States

Location

Karmanos Cancer Institute ( Site 0054)

Detroit, Michigan, 48201, United States

Location

Henry Ford Health System ( Site 0001)

Detroit, Michigan, 48202, United States

Location

Washington University School of Medicine ( Site 0060)

St Louis, Missouri, 63110, United States

Location

St. Vincent Frontier Cancer Center ( Site 0008)

Billings, Montana, 59102, United States

Location

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

Omaha, Nebraska, 68130, United States

Location

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

Hackensack, New Jersey, 07601, United States

Location

Weill Cornell Medicine New York Presbyterian Hospital ( Site 0040)

New York, New York, 10021, United States

Location

SUNY Upstate Medical University ( Site 0051)

Syracuse, New York, 13210, United States

Location

University of North Carolina- Chapel Hill ( Site 0056)

Chapel Hill, North Carolina, 27514, United States

Location

Duke Cancer Center ( Site 0044)

Durham, North Carolina, 27710, United States

Location

Providence Portland Medical Center ( Site 0048)

Portland, Oregon, 97213, United States

Location

Blue Ridge Cancer Care ( Site 0015)

Blacksburg, Virginia, 24060, United States

Location

Inova Schar Cancer Institute ( Site 0009)

Fairfax, Virginia, 22031, United States

Location

Cancer Care Northwest ( Site 0017)

Spokane Valley, Washington, 99216, United States

Location

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

Madison, Wisconsin, 53792, United States

Location

Chris OBrien Lifehouse ( Site 1002)

Camperdown, New South Wales, 2050, Australia

Location

St George Hospital ( Site 1001)

Kogarah, New South Wales, 2217, Australia

Location

Royal Adelaide Hospital ( Site 1004)

Adelaide, South Australia, 5000, Australia

Location

Oncocentro Ceara ( Site 0412)

Fortaleza, Ceará, 60135-237, Brazil

Location

Fundacao Sao Francisco Xavier ( Site 0409)

Ipatinga, Minas Gerais, 35162-189, Brazil

Location

ELO Pesquisa Clinica ( Site 0405)

Maringá, Paraná, 87015-200, Brazil

Location

Hospital de Passo Fundo ( Site 0401)

Passo Fundo, Rio Grande do Sul, 99010-260, Brazil

Location

Clinica LACKS ( Site 0402)

Pelotas, Rio Grande do Sul, 96020-080, Brazil

Location

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

Porto Alegre, Rio Grande do Sul, 91350-200, Brazil

Location

A.C. Camargo Cancer Center ( Site 0407)

São Paulo, 01509-900, Brazil

Location

Princess Margaret Cancer Centre ( Site 0200)

Toronto, Ontario, M5G 1Z5, Canada

Location

McGill University Health Centre ( Site 0206)

Montreal, Quebec, H4A 3J1, Canada

Location

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

Québec, Quebec, G1J 1Z4, Canada

Location

Beijing Cancer Hospital ( Site 3314)

Beining, Beijing Municipality, 100036, China

Location

Peking Union Medical College Hospital ( Site 3304)

Bejiing, Beijing Municipality, 100032, China

Location

Chongqing Cancer Hospital ( Site 3327)

Chongqing, Chongqing Municipality, 400030, China

Location

Fujian Provincial Cancer Hospital ( Site 3326)

Fuzhou, Fujian, 350014, China

Location

Guangxi Medical University Affiliated Tumor Hospital ( Site 3322)

Nanning, Guangxi, 530000, China

Location

Guizhou Cancer Hospital ( Site 3330)

Guiyang, Guizhou, 550003, China

Location

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

Harbin, Heilongjiang, 150081, China

Location

Henan Cancer Hospital ( Site 3309)

Zhengzhou, Henan, 450008, China

Location

Wuhan Union hospital Cancer Center ( Site 3307)

Wuhan, Hubei, 430000, China

Location

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

Wuhan, Hubei, 430030, China

Location

Hunan Cancer Hospital ( Site 3311)

Changsha, Hunan, 410000, China

Location

Xiangya Hospital of Central South University ( Site 3305)

Changsha, Hunan, 410008, China

Location

Jiangxi Cancer Hospital ( Site 3313)

Nanchang, Jiangxi, 330029, China

Location

Jilin Cancer Hospital ( Site 3310)

Changchun, Jilin, 130000, China

Location

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

Xi'an, Shaanxi, 710000, China

Location

Fudan University Shanghai Cancer Center ( Site 3324)

Shanghai, Shanghai Municipality, 200032, China

Location

Shanghai East Hospital ( Site 3300)

Shanghai, Shanghai Municipality, 200120, China

Location

West China Hospital of Sichuan University ( Site 3308)

Chengdu, Sichuan, 610047, China

Location

Tianjin Medical University Cancer Hospital ( Site 3312)

Tianjin, Tianjin Municipality, 300060, China

Location

Zhejiang Cancer Hospital ( Site 3303)

Hangzhou, Zhejiang, 310022, China

Location

Centre Leon Berard ( Site 1901)

Lyon, Auvergne, 69008, France

Location

Hopital de la Timone ( Site 1903)

Marseille, Bouches-du-Rhone, 13005, France

Location

Hopital Foch ( Site 1905)

Suresnes, Hauts-de-Seine, 92151, France

Location

Centre Henri Becquerel ( Site 1904)

Rouen, Seine-Maritime, 76038, France

Location

Gustave Roussy ( Site 1906)

Villejuif, Val-de-Marne, 94800, France

Location

Universitaetsklinikum Tuebingen ( Site 2108)

Tübingen, Baden-Wurttemberg, 72076, Germany

Location

Universitaetsklinikum Ulm ( Site 2102)

Ulm, Baden-Wurttemberg, 89075, Germany

Location

Universitaetsklinikum Regensburg ( Site 2100)

Regensburg, Bavaria, 93053, Germany

Location

Universitaetsklinikum Frankfurt ( Site 2107)

Frankfurt am Main, Hesse, 60590, Germany

Location

KRH Klinikum Siloah ( Site 2103)

Hanover, Lower Saxony, 30459, Germany

Location

Universitaetsklinikum Koeln ( Site 2111)

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Universitätsklinikum Leipzig-Department for ENT ( Site 2106)

Leipzig, Saxony, 04103, Germany

Location

Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 2112)

Berlin, 12203, Germany

Location

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

Miskolc, Borsod-Abauj Zemplen county, 3526, Hungary

Location

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

Szeged, Csongrád megye, 6720, Hungary

Location

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

Szolnok, Jász-Nagykun-Szolnok, 5004, Hungary

Location

Uzsoki Utcai Korhaz ( Site 2201)

Budapest, Vas County, 1145, Hungary

Location

Orszagos Onkologiai Intezet ( Site 2202)

Budapest, 1122, Hungary

Location

Debreceni Egyetem Klinikai Kozpont ( Site 2206)

Debrecen, 4032, Hungary

Location

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

Brescia, 25123, Italy

Location

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

Milan, 20133, Italy

Location

IEO Istituto Europeo di Oncologia ( Site 2406)

Milan, 20141, Italy

Location

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

Milan, 20142, Italy

Location

Istituto Oncologico Veneto ( Site 2404)

Padova, 35128, Italy

Location

ASL Liguria 2 - Ospedale San Paolo ( Site 2401)

Savona, 17100, Italy

Location

Aichi Cancer Center Hospital ( Site 1113)

Nagoya, Aichi-ken, 4648681, Japan

Location

Nagoya University Hospital ( Site 1106)

Nagoya, Aichi-ken, 466-8560, Japan

Location

Chiba cancer center ( Site 1110)

Chiba, Chiba, 260-8717, Japan

Location

National Cancer Center Hospital East ( Site 1100)

Kashiwa, Chiba, 2778577, Japan

Location

Hyogo Cancer Center ( Site 1112)

Akashi, Hyōgo, 673-8558, Japan

Location

Kagawa University Hospital ( Site 1108)

Kita-gun, Kagawa-ken, 761-0793, Japan

Location

Yokohama City University Hospital ( Site 1104)

Yokohama, Kanagawa, 2360064, Japan

Location

Kindai University Hospital ( Site 1107)

Sayama, Osaka, 5898511, Japan

Location

Shizuoka Cancer Center Hospital and Research Institute ( Site 1105)

Sunto-gun, Shizuoka, 411-8777, Japan

Location

National Hospital Organization Kyushu Medical Center ( Site 1111)

Fukuoka, 810-8563, Japan

Location

Hiroshima University Hospital ( Site 1109)

Hiroshima, 7348551, Japan

Location

National Cancer Center Hospital ( Site 1102)

Tokyo, 104-0045, Japan

Location

The Cancer Institute Hospital of JFCR ( Site 1103)

Tokyo, 135-8550, Japan

Location

Tokyo Medical and Dental University Hospital ( Site 1101)

Tokyo, Japan

Location

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

Cuauhtémoc, Mexico City, Mexico City, 06100, Mexico

Location

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

Monterrey, Nuevo León, 64460, Mexico

Location

Christus Muguerza Clinica Vidriera ( Site 0607)

Monterrey, Nuevo León, 64570, Mexico

Location

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

Cancún, Quintana Roo, 77500, Mexico

Location

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

Oaxaca City, 68000, Mexico

Location

Instituto Nacional de Enfermedades Neoplasicas ( Site 0701)

Lima, Muni Metro de Lima, Lima 34, Peru

Location

Hospital Nacional Guillermo Almenara Irigoyen ( Site 0700)

Lima, 15033, Peru

Location

Hospital Nacional Edgardo Rebagliati Martins ( Site 0702)

Lima, 15072, Peru

Location

Hospital Nacional Arzobispo Loayza ( Site 0703)

Lima, 15082, Peru

Location

Hospital Nacional Cayetano Heredia ( Site 0704)

Lima, 15102, Peru

Location

Przychodnia Lekarska Komed ( Site 2500)

Konin, Greater Poland Voivodeship, 62-500, Poland

Location

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

Poznan, Greater Poland Voivodeship, 60-780, Poland

Location

Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 2508)

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-796, Poland

Location

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

Krakow, Lesser Poland Voivodeship, 31-826, Poland

Location

Dolnoslaskie Centrum Onkologii. ( Site 2507)

Wroclaw, Lower Silesian Voivodeship, 53-413, Poland

Location

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

Warsaw, Masovian Voivodeship, 02-781, Poland

Location

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

Gdynia, Pomeranian Voivodeship, 81-519, Poland

Location

Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2506)

Gliwice, Silesian Voivodeship, 44-101, Poland

Location

Altay Regional Oncology Dispensary ( Site 2611)

Barnaul, Altayskiy Kray, 656045, Russia

Location

FSCC FMBA of Russia ( Site 2603)

Moscow, Moscow, 115682, Russia

Location

Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2609)

Kazan', Tatarstan, Respublika, 420029, Russia

Location

Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 2605)

Yaroslavl, Yaroslavl Oblast, 150054, Russia

Location

Chonnam National University Hwasun Hospital ( Site 1202)

Hwasun-gun, Jeonranamdo, 58128, South Korea

Location

Seoul National University Bundang Hospital ( Site 1205)

Seongnam-si, Kyonggi-do, 13620, South Korea

Location

Ajou University Hospital ( Site 1200)

Suwon, Kyonggi-do, 16499, South Korea

Location

Asan Medical Center ( Site 1201)

Songpa-gu, Seoul, 05505, South Korea

Location

Keimyung University Dongsan Hospital ( Site 1203)

Daegu, Taegu-Kwangyokshi, 42601, South Korea

Location

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

Seoul, 03312, South Korea

Location

Hospital Duran i Reynals ( Site 2701)

L'Hospitalet de Llobregat, Barcelona, 08908, Spain

Location

H.U. Vall de Hebron ( Site 2700)

Barcelona, 08035, Spain

Location

Hospital Universitario 12 de Octubre ( Site 2702)

Madrid, 28041, Spain

Location

Hospital Universitario La Paz ( Site 2706)

Madrid, 28046, Spain

Location

Hospital de Valme ( Site 2705)

Seville, 41014, Spain

Location

Hospital Clinico Universitario Lozano Blesa ( Site 2703)

Zaragoza, 50009, Spain

Location

National Cheng Kung University Hospital ( Site 1603)

Dawan, Tainan, 704, Taiwan

Location

Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1604)

Kaohsiung City, 833, Taiwan

Location

National Taiwan University Hospital ( Site 1600)

Taipei, 10048, Taiwan

Location

MacKay Memorial Hospital ( Site 1602)

Taipei, 10449, Taiwan

Location

Taipei Veterans General Hospital ( Site 1601)

Taipei, 11217, Taiwan

Location

Hacettepe Universitesi Tip Fakultesi ( Site 2805)

Ankara, 06230, Turkey (Türkiye)

Location

Ankara Sehir Hastanesi ( Site 2802)

Ankara, 06800, Turkey (Türkiye)

Location

Trakya Universitesi Tip Fakultesi ( Site 2801)

Edirne, 22030, Turkey (Türkiye)

Location

Medipol Universite Hastanesi ( Site 2800)

Istanbul, 34214, Turkey (Türkiye)

Location

Ege Universitesi Tip Fakultesi Hastanesi ( Site 2804)

Izmir, 35040, Turkey (Türkiye)

Location

Medical Park Izmir Hospital ( Site 2807)

Izmir, 35575, Turkey (Türkiye)

Location

Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 2803)

Malatya, 44280, Turkey (Türkiye)

Location

Aberdeen Royal Infirmary ( Site 2905)

Aberdeen, Aberdeen City, AB25 2ZN, United Kingdom

Location

Guy's Hospital in London ( Site 2908)

London, London, City of, SE1 9RT, United Kingdom

Location

Royal Marsden NHS Foundation Trust ( Site 2910)

London, London, City of, SW3 6JJ, United Kingdom

Location

Mount Vernon Cancer Centre ( Site 2902)

Northwood, London, City of, HA6 2RN, United Kingdom

Location

Royal Marsden Hospital ( Site 2904)

Sutton, London, City of, SM2 5PT, United Kingdom

Location

Nottingham City Hospital ( Site 2907)

Nottingham, Nottinghamshire, NG5 1PB, United Kingdom

Location

Taunton and Somerset Hospital ( Site 2900)

Taunton, Somerset, TA1 5DA, United Kingdom

Location

Christie NHS Foundation Trust ( Site 2903)

Manchester, M20 4BX, United Kingdom

Location

Related Publications (2)

• 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 Mar 12:JCO2500570. doi: 10.1200/JCO-25-00570. Online ahead of print.

  PMID: 41818638 DERIVED

• 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.

  PMID: 33300372 DERIVED

Related Links

• Merck Clinical Trials Information

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

lenvatinib; pembrolizumab

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme LLC

ClinicalTrialsDisclosure@msd.com

1-800-672-6372

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2019
• First Posted: December 13, 2019
• Study Start: February 5, 2020
• Primary Completion: May 30, 2023
• Study Completion: March 31, 2025
• Last Updated: May 5, 2026
• Results First Posted: July 16, 2024

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

JP (14); GB (8); ES (6); PE (5); PL (8); TU (7); IT (6); HU (6); US (26); FR (5); BR (7); TW (5); DE (8); CN (20); AU (3); CA (3); KR (6); RU (4); ME (5)