Clinical trial NCT04199104: 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)
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).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Head and Neck Squamous Cell Carcinoma
Keywords: head and neck squamous cell carcinoma
pembrolizumab
lenvatinib
PD-L1
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Eisai Inc.
First posted: 2019-12-13
Enrollment: 511
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
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)
timeFrame: Up to ~ 37 months
measure: 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).
timeFrame: Up to ~ 37 months
measure: Overall Survival (OS)
timeFrame: Up to ~ 37 months
Secondary outcomes:
measure: Duration of Response (DOR)
timeFrame: Up to ~ 37 months
measure: Percentage of Participants Who Experienced an Adverse Event (AE)
timeFrame: Up to ~ 37 months
measure: Percentage of Participants Who Discontinued Study Drug Due to an AE
timeFrame: Up to ~ 34 months
Other outcomes:
Locations:
city: Fresno
country: United States
facility: California Cancer Associates for Research & Excellence ( Site 0025)
state: California
city: San Marcos
country: United States
facility: California Cancer Associates for Research & Excellence ( Site 0059)
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center ( Site 0023)
state: Colorado
city: Farmington
country: United States
facility: University of Connecticut Health Center ( Site 0020)
state: Connecticut
city: Hollywood
country: United States
facility: Memorial Regional Hospital-Memorial Cancer Institute ( Site 0069)
state: Florida
city: Augusta
country: United States
facility: Georgia Cancer Center at Augusta University ( Site 0013)
state: Georgia
city: Marietta
country: United States
facility: Northwest Georgia Oncology Centers PC ( Site 0028)
state: Georgia
city: Westwood
country: United States
facility: University of Kansas Cancer Center ( Site 0033)
state: Kansas
city: Louisville
country: United States
facility: University of Louisville, James Graham Brown Cancer Center ( Site 0045)
state: Kentucky
city: Boston
country: United States
facility: Dana Farber Cancer Institute ( Site 0019)
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan ( Site 0064)
state: Michigan
city: Detroit
country: United States
facility: Karmanos Cancer Institute ( Site 0054)
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System ( Site 0001)
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine ( Site 0060)
state: Missouri
city: Billings
country: United States
facility: St. Vincent Frontier Cancer Center ( Site 0008)
state: Montana
city: Omaha
country: United States
facility: Oncology Hematology West, PC dba Nebraska Cancer Specialists ( Site 0053)
state: Nebraska
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 0002)
state: New Jersey
city: New York
country: United States
facility: Weill Cornell Medicine New York Presbyterian Hospital ( Site 0040)
state: New York
city: Syracuse
country: United States
facility: SUNY Upstate Medical University ( Site 0051)
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina- Chapel Hill ( Site 0056)
state: North Carolina
city: Durham
country: United States
facility: Duke Cancer Center ( Site 0044)
state: North Carolina
city: Portland
country: United States
facility: Providence Portland Medical Center ( Site 0048)
state: Oregon
city: Blacksburg
country: United States
facility: Blue Ridge Cancer Care ( Site 0015)
state: Virginia
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute ( Site 0009)
state: Virginia
city: Spokane Valley
country: United States
facility: Cancer Care Northwest ( Site 0017)
state: Washington
city: Madison
country: United States
facility: University of Wisconsin- Madison Carbone Cancer Center ( Site 0006)
state: Wisconsin
city: Camperdown
country: Australia
facility: Chris OBrien Lifehouse ( Site 1002)
state: New South Wales
city: Kogarah
country: Australia
facility: St George Hospital ( Site 1001)
state: New South Wales
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital ( Site 1004)
state: South Australia
city: Fortaleza
country: Brazil
facility: Oncocentro Ceara ( Site 0412)
state: Ceara
city: Ipatinga
country: Brazil
facility: Fundacao Sao Francisco Xavier ( Site 0409)
state: Minas Gerais
city: Maringa
country: Brazil
facility: ELO Pesquisa Clinica ( Site 0405)
state: Parana
city: Passo Fundo
country: Brazil
facility: Hospital de Passo Fundo ( Site 0401)
state: Rio Grande Do Sul
city: Pelotas
country: Brazil
facility: Clinica LACKS ( Site 0402)
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceição-Centro Integrado de Pesquisa em Oncologia ( Site 0414)
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: A.C. Camargo Cancer Center ( Site 0407)
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0200)
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre ( Site 0206)
state: Quebec
city: Quebec City
country: Canada
facility: Centre intégré de cancérologie du CHU de Québec Université Laval, Hôpital de l'Enfant-Jésus ( Site 0
state: Quebec
city: Beining
country: China
facility: Beijing Cancer Hospital ( Site 3314)
state: Beijing
city: Bejiing
country: China
facility: Peking Union Medical College Hospital ( Site 3304)
state: Beijing
city: Chongqing
country: China
facility: Chongqing Cancer Hospital ( Site 3327)
state: Chongqing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital ( Site 3326)
state: Fujian
city: Nanning
country: China
facility: Guangxi Medical University Affiliated Tumor Hospital ( Site 3322)
state: Guangxi
city: Guiyang
country: China
facility: Guizhou Cancer Hospital ( Site 3330)
state: Guizhou
city: Harbin
country: China
facility: The Third Affiliated Hospital of Harbin Medical University ( Site 3302)
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital ( Site 3309)
state: Henan
city: Wuhan
country: China
facility: Wuhan Union hospital Cancer Center ( Site 3307)
state: Hubei
city: Wuhan
country: China
facility: Tongji Hospital Tongji Medical,Science & Technology ( Site 3316)
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 3311)
state: Hunan
city: Changsha
country: China
facility: Xiangya Hospital of Central South University ( Site 3305)
state: Hunan
city: Nanchang
country: China
facility: Jiangxi Cancer Hospital ( Site 3313)
state: Jiangxi
city: Changchun
country: China
facility: Jilin Cancer Hospital ( Site 3310)
state: Jilin
city: XI An
country: China
facility: The First Affiliated Hospital of Xi an Jiaotong University ( Site 3328)
state: Shaanxi
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center ( Site 3324)
state: Shanghai
city: Shanghai
country: China
facility: Shanghai East Hospital ( Site 3300)
state: Shanghai
city: Chengdu
country: China
facility: West China Hospital of Sichuan University ( Site 3308)
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Hospital ( Site 3312)
state: Tianjin
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital ( Site 3303)
state: Zhejiang
city: Lyon
country: France
facility: Centre Leon Berard ( Site 1901)
state: Auvergne
city: Marseille
country: France
facility: Hopital de la Timone ( Site 1903)
state: Bouches-du-Rhone
city: Suresnes
country: France
facility: Hopital Foch ( Site 1905)
state: Hauts-de-Seine
city: Rouen
country: France
facility: Centre Henri Becquerel ( Site 1904)
state: Seine-Maritime
city: Villejuif
country: France
facility: Gustave Roussy ( Site 1906)
state: Val-de-Marne
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen ( Site 2108)
state: Baden-Wurttemberg
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm ( Site 2102)
state: Baden-Wurttemberg
city: Regensburg
country: Germany
facility: Universitaetsklinikum Regensburg ( Site 2100)
state: Bayern
city: Frankfurt
country: Germany
facility: Universitaetsklinikum Frankfurt ( Site 2107)
state: Hessen
city: Hannover
country: Germany
facility: KRH Klinikum Siloah ( Site 2103)
state: Niedersachsen
city: Koeln
country: Germany
facility: Universitaetsklinikum Koeln ( Site 2111)
state: Nordrhein-Westfalen
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig-Department for ENT ( Site 2106)
state: Sachsen
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 2112)
city: Miskolc
country: Hungary
facility: Borsod-Abaúj-Zemplén Megyei Központi Kórház és Egyetemi Okta-Klinikai Onkológiai és Sugárterápiás Ce
state: Borsod-Abauj-Zemplen
city: Szeged
country: Hungary
facility: Szegedi Egyetem Szent-Gyorgyi Albert Klinikai Kozpont ( Site 2207)
state: Csongrad
city: Szolnok
country: Hungary
facility: Jasz Nagykun Szolnok Megyei Hetenyi Geza Korhaz Rendelointezet ( Site 2200)
state: Jasz-Nagykun-Szolnok
city: Budapest
country: Hungary
facility: Uzsoki Utcai Korhaz ( Site 2201)
state: Vas
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet ( Site 2202)
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont ( Site 2206)
city: Brescia
country: Italy
facility: Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia ( Site 2402)
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 2400)
city: Milano
country: Italy
facility: IEO Istituto Europeo di Oncologia ( Site 2406)
city: Milano
country: Italy
facility: ASST Santi Paolo e Carlo - Presidio Ospedaliero San Paolo ( Site 2405)
city: Padova
country: Italy
facility: Istituto Oncologico Veneto ( Site 2404)
city: Savona
country: Italy
facility: ASL Liguria 2 - Ospedale San Paolo ( Site 2401)
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 1113)
state: Aichi
city: Nagoya
country: Japan
facility: Nagoya University Hospital ( Site 1106)
state: Aichi
city: Chiba-shi
country: Japan
facility: Chiba cancer center ( Site 1110)
state: Chiba
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 1100)
state: Chiba
city: Akashi
country: Japan
facility: Hyogo Cancer Center ( Site 1112)
state: Hyogo
city: Kita-gun
country: Japan
facility: Kagawa University Hospital ( Site 1108)
state: Kagawa
city: Yokohama
country: Japan
facility: Yokohama City University Hospital ( Site 1104)
state: Kanagawa
city: Osakasayama
country: Japan
facility: Kindai University Hospital ( Site 1107)
state: Osaka
city: Sunto-gun
country: Japan
facility: Shizuoka Cancer Center Hospital and Research Institute ( Site 1105)
state: Shizuoka
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Medical Center ( Site 1111)
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital ( Site 1109)
city: Tokyo
country: Japan
facility: National Cancer Center Hospital ( Site 1102)
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR ( Site 1103)
city: Tokyo
country: Japan
facility: Tokyo Medical and Dental University Hospital ( Site 1101)
city: Hwasun-gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital ( Site 1202)
state: Jeonranamdo
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital ( Site 1205)
state: Kyonggi-do
city: Suwon-si
country: Korea, Republic of
facility: Ajou University Hospital ( Site 1200)
state: Kyonggi-do
city: Songpa-gu
country: Korea, Republic of
facility: Asan Medical Center ( Site 1201)
state: Seoul
city: Daegu
country: Korea, Republic of
facility: Keimyung University Dongsan Hospital ( Site 1203)
state: Taegu-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: The Catholic University of Korea Eunpyeong St Mary s Hospital ( Site 1204)
city: Cuauhtémoc, Mexico City
country: Mexico
facility: Cryptex Investigación Clínica S.A. de C.V. ( Site 0608)
state: Distrito Federal
city: Monterrey
country: Mexico
facility: Hospital Universitario "Dr. Jose Eleuterio Gonzalez" ( Site 0602)
state: Nuevo Leon
city: Monterrey
country: Mexico
facility: Christus Muguerza Clinica Vidriera ( Site 0607)
state: Nuevo Leon
city: Cancun
country: Mexico
facility: Centro de Investigacion y Avances Medicos Especializados -CIAME ( Site 0604)
state: Quintana Roo
city: Oaxaca
country: Mexico
facility: Oaxaca Site Management Organization S.C. ( Site 0603)
city: Lima
country: Peru
facility: Instituto Nacional de Enfermedades Neoplasicas ( Site 0701)
state: Muni Metro De Lima
city: Lima
country: Peru
facility: Hospital Nacional Guillermo Almenara Irigoyen ( Site 0700)
city: Lima
country: Peru
facility: Hospital Nacional Edgardo Rebagliati Martins ( Site 0702)
city: Lima
country: Peru
facility: Hospital Nacional Arzobispo Loayza ( Site 0703)
city: Lima
country: Peru
facility: Hospital Nacional Cayetano Heredia ( Site 0704)
city: Wroclaw
country: Poland
facility: Dolnoslaskie Centrum Onkologii. ( Site 2507)
state: Dolnoslaskie
city: Bydgoszcz
country: Poland
facility: Centrum Onkologii im prof Franciszka Lukaszczyka ( Site 2508)
state: Kujawsko-pomorskie
city: Krakow
country: Poland
facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 2502)
state: Malopolskie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - P-Klinika Nowotworow Glowy i Szyi ( Site
state: Mazowieckie
city: Gdynia
country: Poland
facility: Szpital Morski im. PCK. Szpitale Pomorskie Sp. Z o.o ( Site 2504)
state: Pomorskie
city: Gliwice
country: Poland
facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 2506)
state: Slaskie
city: Konin
country: Poland
facility: Przychodnia Lekarska Komed ( Site 2500)
state: Wielkopolskie
city: Poznan
country: Poland
facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 2509)
state: Wielkopolskie
city: Barnaul
country: Russian Federation
facility: Altay Regional Oncology Dispensary ( Site 2611)
state: Altayskiy Kray
city: Moscow
country: Russian Federation
facility: FSCC FMBA of Russia ( Site 2603)
state: Moskva
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 2609)
state: Tatarstan, Respublika
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 2605)
state: Yaroslavskaya Oblast
city: Hospitalet de Llobregat
country: Spain
facility: Hospital Duran i Reynals ( Site 2701)
state: Barcelona
city: Barcelona
country: Spain
facility: H.U. Vall de Hebron ( Site 2700)
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre ( Site 2702)
city: Madrid
country: Spain
facility: Hospital Universitario La Paz ( Site 2706)
city: Sevilla
country: Spain
facility: Hospital de Valme ( Site 2705)
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa ( Site 2703)
city: Taiwan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 1603)
state: Tainan
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1604)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 1600)
city: Taipei
country: Taiwan
facility: MacKay Memorial Hospital ( Site 1602)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 1601)
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi ( Site 2805)
city: Ankara
country: Turkey
facility: Ankara Sehir Hastanesi ( Site 2802)
city: Edirne
country: Turkey
facility: Trakya Universitesi Tip Fakultesi ( Site 2801)
city: Istanbul
country: Turkey
facility: Medipol Universite Hastanesi ( Site 2800)
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 2804)
city: Izmir
country: Turkey
facility: Medical Park Izmir Hospital ( Site 2807)
city: Malatya
country: Turkey
facility: Inonu Universitesi Turgut Ozal Tip Merkezi ( Site 2803)
city: Aberdeen
country: United Kingdom
facility: Aberdeen Royal Infirmary ( Site 2905)
state: Aberdeen City
city: London
country: United Kingdom
facility: Guy's Hospital in London ( Site 2908)
state: London, City Of
city: London
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust ( Site 2910)
state: London, City Of
city: Northwood
country: United Kingdom
facility: Mount Vernon Cancer Centre ( Site 2902)
state: London, City Of
city: Sutton
country: United Kingdom
facility: Royal Marsden Hospital ( Site 2904)
state: London, City Of
city: Nottingham
country: United Kingdom
facility: Nottingham City Hospital ( Site 2907)
state: Nottinghamshire
city: Taunton
country: United Kingdom
facility: Taunton and Somerset Hospital ( Site 2900)
state: Somerset
city: Manchester
country: United Kingdom
facility: Christie NHS Foundation Trust ( Site 2903)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: 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.