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)
NCT ID: NCT04199104
Last Updated: 2025-04-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
511 participants
INTERVENTIONAL
2020-02-05
2025-03-31
Brief Summary
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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).
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Pembrolizumab with Lenvatinib
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.
Lenvatinib
Lenvatinib, 20 mg (two 10-mg oral capsules) administered QD
Pembrolizumab
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W) by intravenous (IV) infusion for up to 35 3-week cycles
Pembrolizumab with Placebo
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).
Pembrolizumab
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W) by intravenous (IV) infusion for up to 35 3-week cycles
Placebo
Lenvatinib-matching placebo, oral capsules, administered once daily (QD)
Interventions
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Lenvatinib
Lenvatinib, 20 mg (two 10-mg oral capsules) administered QD
Pembrolizumab
Pembrolizumab (MK-3475), 200 mg, every 3 weeks (Q3W) by intravenous (IV) infusion for up to 35 3-week cycles
Placebo
Lenvatinib-matching placebo, oral capsules, administered once daily (QD)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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.
Exclusion Criteria
* 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.
* 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.
18 Years
ALL
No
Sponsors
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Eisai Inc.
INDUSTRY
Merck Sharp & Dohme LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Merck Sharp & Dohme LLC
Locations
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California Cancer Associates for Research & Excellence ( Site 0025)
Fresno, California, United States
California Cancer Associates for Research & Excellence ( Site 0059)
San Marcos, California, United States
University of Colorado Cancer Center ( Site 0023)
Aurora, Colorado, United States
University of Connecticut Health Center ( Site 0020)
Farmington, Connecticut, United States
Memorial Regional Hospital-Memorial Cancer Institute ( Site 0069)
Hollywood, Florida, United States
Georgia Cancer Center at Augusta University ( Site 0013)
Augusta, Georgia, United States
Northwest Georgia Oncology Centers PC ( Site 0028)
Marietta, Georgia, United States
University of Kansas Cancer Center ( Site 0033)
Westwood, Kansas, United States
University of Louisville, James Graham Brown Cancer Center ( Site 0045)
Louisville, Kentucky, United States
Dana Farber Cancer Institute ( Site 0019)
Boston, Massachusetts, United States
University of Michigan ( Site 0064)
Ann Arbor, Michigan, United States
Karmanos Cancer Institute ( Site 0054)
Detroit, Michigan, United States
Henry Ford Health System ( Site 0001)
Detroit, Michigan, United States
Washington University School of Medicine ( Site 0060)
St Louis, Missouri, United States
St. Vincent Frontier Cancer Center ( Site 0008)
Billings, Montana, United States
Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0053)
Omaha, Nebraska, United States
John Theurer Cancer Center at Hackensack University Medical Center ( Site 0002)
Hackensack, New Jersey, United States
Weill Cornell Medicine New York Presbyterian Hospital ( Site 0040)
New York, New York, United States
SUNY Upstate Medical University ( Site 0051)
Syracuse, New York, United States
University of North Carolina- Chapel Hill ( Site 0056)
Chapel Hill, North Carolina, United States
Duke Cancer Center ( Site 0044)
Durham, North Carolina, United States
Providence Portland Medical Center ( Site 0048)
Portland, Oregon, United States
Blue Ridge Cancer Care ( Site 0015)
Blacksburg, Virginia, United States
Inova Schar Cancer Institute ( Site 0009)
Fairfax, Virginia, United States
Cancer Care Northwest ( Site 0017)
Spokane Valley, Washington, United States
University of Wisconsin- Madison Carbone Cancer Center ( Site 0006)
Madison, Wisconsin, United States
Chris OBrien Lifehouse ( Site 1002)
Camperdown, New South Wales, Australia
St George Hospital ( Site 1001)
Kogarah, New South Wales, Australia
Royal Adelaide Hospital ( Site 1004)
Adelaide, South Australia, Australia
Oncocentro Ceara ( Site 0412)
Fortaleza, Ceará, Brazil
Fundacao Sao Francisco Xavier ( Site 0409)
Ipatinga, Minas Gerais, Brazil
ELO Pesquisa Clinica ( Site 0405)
Maringá, Paraná, Brazil
Hospital de Passo Fundo ( Site 0401)
Passo Fundo, Rio Grande do Sul, Brazil
Clinica LACKS ( Site 0402)
Pelotas, Rio Grande do Sul, Brazil
Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0414)
Porto Alegre, Rio Grande do Sul, Brazil
A.C. Camargo Cancer Center ( Site 0407)
São Paulo, , Brazil
Princess Margaret Cancer Centre ( Site 0200)
Toronto, Ontario, Canada
McGill University Health Centre ( Site 0206)
Montreal, Quebec, Canada
Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
Québec, Quebec, Canada
Beijing Cancer Hospital ( Site 3314)
Beining, Beijing Municipality, China
Peking Union Medical College Hospital ( Site 3304)
Bejiing, Beijing Municipality, China
Chongqing Cancer Hospital ( Site 3327)
Chongqing, Chongqing Municipality, China
Fujian Provincial Cancer Hospital ( Site 3326)
Fuzhou, Fujian, China
Guangxi Medical University Affiliated Tumor Hospital ( Site 3322)
Nanning, Guangxi, China
Guizhou Cancer Hospital ( Site 3330)
Guiyang, Guizhou, China
The Third Affiliated Hospital of Harbin Medical University ( Site 3302)
Harbin, Heilongjiang, China
Henan Cancer Hospital ( Site 3309)
Zhengzhou, Henan, China
Wuhan Union hospital Cancer Center ( Site 3307)
Wuhan, Hubei, China
Tongji Hospital Tongji Medical,Science & Technology ( Site 3316)
Wuhan, Hubei, China
Hunan Cancer Hospital ( Site 3311)
Changsha, Hunan, China
Xiangya Hospital of Central South University ( Site 3305)
Changsha, Hunan, China
Jiangxi Cancer Hospital ( Site 3313)
Nanchang, Jiangxi, China
Jilin Cancer Hospital ( Site 3310)
Changchun, Jilin, China
The First Affiliated Hospital of Xi an Jiaotong University ( Site 3328)
Xi'an, Shaanxi, China
Fudan University Shanghai Cancer Center ( Site 3324)
Shanghai, Shanghai Municipality, China
Shanghai East Hospital ( Site 3300)
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University ( Site 3308)
Chengdu, Sichuan, China
Tianjin Medical University Cancer Hospital ( Site 3312)
Tianjin, Tianjin Municipality, China
Zhejiang Cancer Hospital ( Site 3303)
Hangzhou, Zhejiang, China
Centre Leon Berard ( Site 1901)
Lyon, Auvergne, France
Hopital de la Timone ( Site 1903)
Marseille, Bouches-du-Rhone, France
Hopital Foch ( Site 1905)
Suresnes, Hauts-de-Seine, France
Centre Henri Becquerel ( Site 1904)
Rouen, Seine-Maritime, France
Gustave Roussy ( Site 1906)
Villejuif, Val-de-Marne, France
Universitaetsklinikum Tuebingen ( Site 2108)
Tübingen, Baden-Wurttemberg, Germany
Universitaetsklinikum Ulm ( Site 2102)
Ulm, Baden-Wurttemberg, Germany
Universitaetsklinikum Regensburg ( Site 2100)
Regensburg, Bavaria, Germany
Universitaetsklinikum Frankfurt ( Site 2107)
Frankfurt am Main, Hesse, Germany
KRH Klinikum Siloah ( Site 2103)
Hanover, Lower Saxony, Germany
Universitaetsklinikum Koeln ( Site 2111)
Cologne, North Rhine-Westphalia, Germany
Universitätsklinikum Leipzig-Department for ENT ( Site 2106)
Leipzig, Saxony, Germany
Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 2112)
Berlin, , Germany
Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce
Miskolc, Borsod-Abauj Zemplen county, Hungary
Szegedi Egyetem Szent-Gyorgyi Albert Klinikai Kozpont ( Site 2207)
Szeged, Csongrád megye, Hungary
Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 2200)
Szolnok, Jász-Nagykun-Szolnok, Hungary
Uzsoki Utcai Korhaz ( Site 2201)
Budapest, Vas County, Hungary
Orszagos Onkologiai Intezet ( Site 2202)
Budapest, , Hungary
Debreceni Egyetem Klinikai Kozpont ( Site 2206)
Debrecen, , Hungary
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 2402)
Brescia, , Italy
Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2400)
Milan, , Italy
IEO Istituto Europeo di Oncologia ( Site 2406)
Milan, , Italy
ASST Santi Paolo e Carlo - Presidio Ospedaliero San Paolo ( Site 2405)
Milan, , Italy
Istituto Oncologico Veneto ( Site 2404)
Padua, , Italy
ASL Liguria 2 - Ospedale San Paolo ( Site 2401)
Savona, , Italy
Aichi Cancer Center Hospital ( Site 1113)
Nagoya, Aichi-ken, Japan
Nagoya University Hospital ( Site 1106)
Nagoya, Aichi-ken, Japan
Chiba cancer center ( Site 1110)
Chiba, Chiba, Japan
National Cancer Center Hospital East ( Site 1100)
Kashiwa, Chiba, Japan
Hyogo Cancer Center ( Site 1112)
Akashi, Hyōgo, Japan
Kagawa University Hospital ( Site 1108)
Kita-gun, Kagawa-ken, Japan
Yokohama City University Hospital ( Site 1104)
Yokohama, Kanagawa, Japan
Kindai University Hospital ( Site 1107)
Sayama, Osaka, Japan
Shizuoka Cancer Center Hospital and Research Institute ( Site 1105)
Sunto-gun, Shizuoka, Japan
National Hospital Organization Kyushu Medical Center ( Site 1111)
Fukuoka, , Japan
Hiroshima University Hospital ( Site 1109)
Hiroshima, , Japan
National Cancer Center Hospital ( Site 1102)
Tokyo, , Japan
The Cancer Institute Hospital of JFCR ( Site 1103)
Tokyo, , Japan
Tokyo Medical and Dental University Hospital ( Site 1101)
Tokyo, , Japan
Cryptex Investigación Clínica S.A. de C.V. ( Site 0608)
Cuauhtémoc, Mexico City, Mexico City, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0602)
Monterrey, Nuevo León, Mexico
Christus Muguerza Clinica Vidriera ( Site 0607)
Monterrey, Nuevo León, Mexico
Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 0604)
Cancún, Quintana Roo, Mexico
Oaxaca Site Management Organization S.C. ( Site 0603)
Oaxaca City, , Mexico
Instituto Nacional de Enfermedades Neoplasicas ( Site 0701)
Lima, Muni Metro de Lima, Peru
Hospital Nacional Guillermo Almenara Irigoyen ( Site 0700)
Lima, , Peru
Hospital Nacional Edgardo Rebagliati Martins ( Site 0702)
Lima, , Peru
Hospital Nacional Arzobispo Loayza ( Site 0703)
Lima, , Peru
Hospital Nacional Cayetano Heredia ( Site 0704)
Lima, , Peru
Przychodnia Lekarska Komed ( Site 2500)
Konin, Greater Poland Voivodeship, Poland
Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 2509)
Poznan, Greater Poland Voivodeship, Poland
Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 2508)
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 2502)
Krakow, Lesser Poland Voivodeship, Poland
Dolnoslaskie Centrum Onkologii. ( Site 2507)
Wroclaw, Lower Silesian Voivodeship, Poland
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Glowy i Szyi ( Site
Warsaw, Masovian Voivodeship, Poland
Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 2504)
Gdynia, Pomeranian Voivodeship, Poland
Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2506)
Gliwice, Silesian Voivodeship, Poland
Altay Regional Oncology Dispensary ( Site 2611)
Barnaul, Altayskiy Kray, Russia
FSCC FMBA of Russia ( Site 2603)
Moscow, Moscow, Russia
Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2609)
Kazan', Tatarstan, Respublika, Russia
Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 2605)
Yaroslavl, Yaroslavl Oblast, Russia
Chonnam National University Hwasun Hospital ( Site 1202)
Hwasun-gun, Jeonranamdo, South Korea
Seoul National University Bundang Hospital ( Site 1205)
Seongnam-si, Kyonggi-do, South Korea
Ajou University Hospital ( Site 1200)
Suwon, Kyonggi-do, South Korea
Asan Medical Center ( Site 1201)
Songpa-gu, Seoul, South Korea
Keimyung University Dongsan Hospital ( Site 1203)
Daegu, Taegu-Kwangyokshi, South Korea
The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 1204)
Seoul, , South Korea
Hospital Duran i Reynals ( Site 2701)
L'Hospitalet de Llobregat, Barcelona, Spain
H.U. Vall de Hebron ( Site 2700)
Barcelona, , Spain
Hospital Universitario 12 de Octubre ( Site 2702)
Madrid, , Spain
Hospital Universitario La Paz ( Site 2706)
Madrid, , Spain
Hospital de Valme ( Site 2705)
Seville, , Spain
Hospital Clinico Universitario Lozano Blesa ( Site 2703)
Zaragoza, , Spain
National Cheng Kung University Hospital ( Site 1603)
Dawan, Tainan, Taiwan
Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1604)
Kaohsiung City, , Taiwan
National Taiwan University Hospital ( Site 1600)
Taipei, , Taiwan
MacKay Memorial Hospital ( Site 1602)
Taipei, , Taiwan
Taipei Veterans General Hospital ( Site 1601)
Taipei, , Taiwan
Hacettepe Universitesi Tip Fakultesi ( Site 2805)
Ankara, , Turkey (Türkiye)
Ankara Sehir Hastanesi ( Site 2802)
Ankara, , Turkey (Türkiye)
Trakya Universitesi Tip Fakultesi ( Site 2801)
Edirne, , Turkey (Türkiye)
Medipol Universite Hastanesi ( Site 2800)
Istanbul, , Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi ( Site 2804)
Izmir, , Turkey (Türkiye)
Medical Park Izmir Hospital ( Site 2807)
Izmir, , Turkey (Türkiye)
Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 2803)
Malatya, , Turkey (Türkiye)
Aberdeen Royal Infirmary ( Site 2905)
Aberdeen, Aberdeen City, United Kingdom
Guy's Hospital in London ( Site 2908)
London, London, City of, United Kingdom
Royal Marsden NHS Foundation Trust ( Site 2910)
London, London, City of, United Kingdom
Mount Vernon Cancer Centre ( Site 2902)
Northwood, London, City of, United Kingdom
Royal Marsden Hospital ( Site 2904)
Sutton, London, City of, United Kingdom
Nottingham City Hospital ( Site 2907)
Nottingham, Nottinghamshire, United Kingdom
Taunton and Somerset Hospital ( Site 2900)
Taunton, Somerset, United Kingdom
Christie NHS Foundation Trust ( Site 2903)
Manchester, , United Kingdom
Countries
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Related Links
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Merck Clinical Trials Information
Other Identifiers
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MK-7902-010
Identifier Type: OTHER
Identifier Source: secondary_id
LEAP-10
Identifier Type: OTHER
Identifier Source: secondary_id
205240
Identifier Type: REGISTRY
Identifier Source: secondary_id
2019-003717-34
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
7902-010
Identifier Type: -
Identifier Source: org_study_id
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