Clinical trial NCT04662710: Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (MK-7902-015/E7080-G000-321/LEAP-015)
Official title: Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Lenvatinib (E7080/MK-7902) Plus Pembrolizumab (MK-3475) Plus Chemotherapy Compared With Standard of Care Therapy as First-line Intervention in Participants With Advanced/Metastatic Gastroesophageal Adenocarcinoma (LEAP-015)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Advanced/Metastatic Gastroesophageal Adenocarcinoma
Keywords: Programmed Cell Death-1 (PD1, PD-1)
Programmed Death-Ligand 1 (PDL1, PD-L1)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Eisai Inc.
First posted: 2020-12-10
Enrollment: 895
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: The purpose of this study is to assess the efficacy and safety of lenvatinib (E7080/MK-7902) plus pembrolizumab (MK-3475) plus chemotherapy compared with chemotherapy alone in participants with advanced/metastatic gastroesophageal cancer.

The primary study hypotheses are that lenvatinib plus pembrolizumab plus chemotherapy is superior to chemotherapy alone for both overall survival (OS) and 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), in participants with programmed cell death-ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1 and in all participants.

Detailed description: There will be 2 parts to the study: a Safety Run-in (Part 1) and the Main Study (Part 2). In Part 1 (Safety Run-in), approximately 12 participants will be treated with lenvatinib in combination with pembrolizumab and chemotherapy with either capecitabine and oxaliplatin (CAPOX), or 5-fluorouracil (5-FU), Leucovorin, and oxaliplatin (mFOLFOX6). Participants will be closely followed for dose-limiting toxicities for 21 days after the first dose of study intervention.

In Part 2, up to 878 eligible participants (not including those participating in Part 1) will be randomly assigned in a 1:1 ratio to either lenvatinib plus pembrolizumab plus chemotherapy (CAPOX or mFOLFOX6) or Chemotherapy alone (CAPOX or mFOLFOX6).

Participants can receive up to 18 infusions (up to 2 years) of pembrolizumab in the first course. Participants may be eligible to receive a second course of pembrolizumab (approximately 1 year) at the investigator's discretion.

Eligibility criteria: Inclusion Criteria:

* Has histologically and/or cytologically confirmed diagnosis of previously untreated, locally advanced unresectable or metastatic gastroesophageal adenocarcinoma
* Is not expected to require tumor resection during the treatment course
* Has gastroesophageal adenocarcinoma that is not HER-2/neu positive
* Has measurable disease as defined by RECIST 1.1 by scan with IV contrast as determined by the local site investigator
* Male participants agree to refrain from donating sperm and agree to either remain abstinent from heterosexual intercourse as their preferred and usual lifestyle OR agree to use contraception, during the intervention period and for ≥7 days after last dose of lenvatinib or 90 days after last dose of chemotherapy-whichever comes last
* Female participants not pregnant or breastfeeding are eligible to participate if not a women of childbearing potential (WOCBP), or if a WOCBP they either use a contraceptive method that is highly effective OR remain abstinent from heterosexual intercourse as their preferred and usual lifestyle, and do not donate eggs (ova, oocytes) to others or freeze/store for their own use, and abstain from breastfeeding during the intervention period through 120 days after last dose of pembrolizumab, 30 days after last dose of lenvatinib, or 180 days after last dose of chemotherapy-whichever occurs last
* Has a performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Performance Scale within 3 days prior to the first dose of study treatment
* Has adequately controlled blood pressure with or without antihypertensive medications
* Has adequate organ function

Exclusion Criteria:

* Has had previous therapy for locally advanced unresectable or metastatic gastric/gastroesophageal junction (GEJ) esophageal adenocarcinoma
* Has had major surgery within 28 days prior to first dose of study interventions
* Has had radiotherapy within 14 days of randomization
* Has a known additional malignancy that is progressing or has required active treatment within the past 5 years
* Has known CNS metastases and/or carcinomatous meningitis
* Has severe hypersensitivity (≥Grade 3) to treatment with an monoclonal antibody (mAb) or known sensitivity or intolerance to any component of lenvatinib, pembrolizumab, study chemotherapy agents and/or to any excipients, murine proteins, or platinum containing products
* Has had an allogeneic tissue/solid organ transplant
* Has perforation risks or significant gastrointestinal (GI) bleeding
* Has GI obstruction, poor oral intake (CAPOX participants), or difficulty in taking oral medication (CAPOX participants)
* 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 coinhibitory T-cell receptor
* Has received prior therapy with anti- vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor or anti-VEGF mAb
* Has received a live or live-attenuated vaccine within 30 days before the first dose of study drug
* Has an active autoimmune disease that has required systemic treatment in past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs)
* Has radiographic evidence of encasement or invasion of a major blood vessel, or of intratumoral cavitation
* Has inadequate cardiac function
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has poorly controlled diarrhea
* Has accumulation of pleural, ascitic, or pericardial fluid requiring drainage or diuretic drugs within 2 weeks prior to enrollment.
* Has peripheral neuropathy ≥Grade 2
* Has a known history of human immunodeficiency virus (HIV) or HIV 1/2 antibodies
* Has a known history of hepatitis B (defined as HBsAg reactive) or known active hepatitis C virus (defined as HCV RNA \[qualitative\] is detected) infection
* Has weight loss of \>20% within the last 3 months

Primary outcomes:
measure: Part 1: Number of Participants with Dose Limiting Toxicities (DLTs)
timeFrame: Up to ~21 days
measure: Part 1: Number of Participants with Adverse Events (AEs)
timeFrame: Up to ~28 months
measure: Part 1: Number of Participants who Discontinued Study Treatment Due to an AE
timeFrame: Up to ~25 months
measure: Part 2: Overall Survival (OS) in Participants with Programmed Cell Death Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥1
timeFrame: Up to ~41 months
measure: Part 2: OS in All Participants
timeFrame: Up to ~41 months
measure: Part 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) in Participants with PD-L1 CPS ≥1
timeFrame: Up to ~31 months
measure: Part 2: PFS Per RECIST 1.1 as Assessed by BICR in All Participants
timeFrame: Up to ~31 months
Secondary outcomes:
measure: Part 2: Objective Response Rate (ORR) Per RECIST 1.1 as Assessed by BICR in Participants with PD-L1 CPS ≥1
timeFrame: Up to ~31 months
measure: Part 2: ORR Per RECIST 1.1 as Assessed by BICR in All Participants
timeFrame: Up to ~31 months
measure: Part 2: Duration of Response (DOR) Per RECIST 1.1 as Assessed by BICR in Participants with PD-L1 CPS ≥1
timeFrame: Up to ~31 months
measure: Part 2: DOR Per RECIST 1.1 as Assessed by BICR in All Participants
timeFrame: Up to ~31 months
measure: Part 2: Number of Participants with AEs
timeFrame: Up to ~28 months
measure: Part 2: Number of Participants who Discontinued Study Treatment Due to an AE
timeFrame: Up to ~25 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Santa Monica ( Site 0003)
state: California
city: Washington
country: United States
facility: Georgetown University Medical Center ( Site 0009)
state: District of Columbia
city: Louisville
country: United States
facility: James Graham Brown Cancer Center ( Site 0017)
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins University ( Site 0052)
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Center ( Site 0019)
state: Massachusetts
city: Worcester
country: United States
facility: UMASS Memorial Medical Center ( Site 0020)
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Health System ( Site 0023)
state: Michigan
city: Grand Rapids
country: United States
facility: Cancer and Hematology Centers of Western Michigan ( Site 0025)
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine ( Site 0027)
state: Missouri
city: New York
country: United States
facility: Mount Sinai Hospital ( Site 0051)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center ( Site 0032)
state: New York
city: Pittsburgh
country: United States
facility: AHN West Penn Hospital-AHN Esophageal and Lung Institute ( Site 0058)
state: Pennsylvania
city: Caba
country: Argentina
facility: IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0202)
state: Buenos Aires
city: Ciudad Autonoma de Buenos Aires
country: Argentina
facility: Instituto Medico Alexander Fleming ( Site 0208)
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Fundacion Favaloro ( Site 0201)
city: Buenos Aires
country: Argentina
facility: Hospital Aleman ( Site 0210)
city: Buenos Aires
country: Argentina
facility: Hospital Municipal de Gastroenterologia Dr. Bonorino Udaondo ( Site 0207)
city: Buenos Aires
country: Argentina
facility: CEMIC ( Site 0209)
city: Cordoba
country: Argentina
facility: Hospital Privado de Cordoba ( Site 0204)
city: Kingswood
country: Australia
facility: Nepean Hospital ( Site 2305)
state: New South Wales
city: Wollongong
country: Australia
facility: Wollongong Hospital ( Site 2307)
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women s Hospital ( Site 2304)
state: Queensland
city: Nedlands
country: Australia
facility: Hollywood Private Hospital-Medical Oncology ( Site 2308)
state: Western Australia
city: Yvoir
country: Belgium
facility: CHU UCL Namur Site de Godinne ( Site 1005)
state: Namur
city: Gent
country: Belgium
facility: UZ Gent ( Site 1002)
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Leuven ( Site 1004)
state: Vlaams-Brabant
city: Roeselare
country: Belgium
facility: AZ Delta ( Site 1006)
state: West-Vlaanderen
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre ( Site 0101)
state: Nova Scotia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences - Juravinski Site ( Site 0106)
state: Ontario
city: Sherbrooke
country: Canada
facility: CIUSSS de l Estrie - CHUS - Centre Hosp. Univ. Sherbrooke ( Site 0103)
state: Quebec
city: Temuco
country: Chile
facility: Centro Investigación del Cáncer James Lind ( Site 0414)
state: Araucania
city: La Serena
country: Chile
facility: IC La Serena Research ( Site 0410)
state: Coquimbo
city: Talca
country: Chile
facility: Clinica Universidad Catolica del Maule ( Site 0411)
state: Maule
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez FALP ( Site 0403)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Clínica San Carlos de Apoquindo Red Salud UC Christus ( Site 0407)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill ( Site 0404)
state: Region M. De Santiago
city: Hefei
country: China
facility: Anhui Provincial Hospital ( Site 2415)
state: Anhui
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Sciences ( Site 2403)
state: Beijing
city: Beijing
country: China
facility: Beijing Cancer Hospital ( Site 2453)
state: Beijing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital ( Site 2408)
state: Fujian
city: Fuzhou
country: China
facility: The 900th Hospital of the Joint Logistics Support Force of the Chinese People's Liberation Army ( Si
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University ( Site 2420)
state: Fujian
city: Xiamen
country: China
facility: The First Affiliated Hospital of Xiamen University ( Site 2446)
state: Fujian
city: Xiamen
country: China
facility: Zhongshan Hospital Affiliated to Xiamen University ( Site 2421)
state: Fujian
city: Lanzhou
country: China
facility: First Hospital of Lanzhou University ( Site 2417)
state: Gansu
city: Guangzhou
country: China
facility: Nanfang Hospital ( Site 2456)
state: Guangdong
city: Haikou
country: China
facility: The Affiliated Hospital Of Hainan Medical University-Cancer rehabilitation and palliative treatment
state: Hainan
city: Shijiazhuang
country: China
facility: Fourth Hospital Of Hebei Medical University ( Site 2441)
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital ( Site 2410)
state: Heilongjiang
city: Zhengzhou
country: China
facility: Henan Cancer Hospital ( Site 2443)
state: Henan
city: Wuhan
country: China
facility: Hubei Cancer Hospital ( Site 2429)
state: Hubei
city: Changsha
country: China
facility: Hunan Cancer Hospital ( Site 2440)
state: Hunan
city: Changzhou
country: China
facility: Changzhou Cancer Hospital-Department of Oncology ( Site 2458)
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital ( Site 2419)
state: Jiangsu
city: Nantong
country: China
facility: Nantong Tumor Hospital-Digestive Oncology ( Site 2464)
state: Jiangsu
city: Changchun
country: China
facility: Jilin Cancer Hospital ( Site 2438)
state: Jilin
city: XI An
country: China
facility: Tang Du Hospital ( Site 2432)
state: Shaanxi
city: Linyi
country: China
facility: LinYi Cancer Hospital-Gastrology department ( Site 2463)
state: Shandong
city: Shanghai
country: China
facility: Shanghai General Hospital ( Site 2424)
state: Shanghai
city: Shanghai
country: China
facility: Shanghai East Hospital ( Site 2455)
state: Shanghai
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital ( Site 2447)
state: Tianjin
city: Urumqi
country: China
facility: Cancer Hospital Affiliated to Xinjiang Medical University ( Site 2428)
state: Xinjiang
city: Hangzhou
country: China
facility: The First Affiliated Hospital of Zhejiang University ( Site 2414)
state: Zhejiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital ( Site 2412)
state: Zhejiang
city: Barranquilla
country: Colombia
facility: Clinica de la Costa S.A.S. ( Site 0502)
state: Atlantico
city: Valledupar
country: Colombia
facility: Sociedad de Oncología Y Hematología del Cesar S.A.S. ( Site 0508)
state: Cesar
city: Monteria
country: Colombia
facility: Oncomedica S.A. ( Site 0507)
state: Cordoba
city: Bogota
country: Colombia
facility: Clinica Colsanitas S.A. Sede Clinica Universitaria Colombia ( Site 0501)
state: Distrito Capital De Bogota
city: Pasto
country: Colombia
facility: Instituto Cancerologico de Narino Ltda ( Site 0504)
state: Narino
city: Pereira
country: Colombia
facility: Oncologos del Occidente S.A. ( Site 0525)
state: Risaralda
city: San José
country: Costa Rica
facility: CIMCA-Hemato-Oncology ( Site 0601)
state: San Jose
city: Santa Ana
country: Costa Rica
facility: Hospital Metropolitano - Sede Lindora-Metropolitano Research Institute Sede Lindora ( Site 0602)
state: San Jose
city: Caen
country: France
facility: Centre Francois Baclesse ( Site 1107)
state: Calvados
city: Dijon
country: France
facility: Centre Georges Francois Leclerc ( Site 1106)
state: Cote-d Or
city: Pessac
country: France
facility: CHU Bordeaux Haut-Leveque ( Site 1110)
state: Gironde
city: Epagny Metz-Tessy
country: France
facility: Centre Hospitalier Annecy Genevois ( Site 1117)
state: Haute-Savoie
city: Nantes
country: France
facility: CHU Hotel Dieu Nantes ( Site 1101)
state: Pays-de-la-Loire
city: Lyon
country: France
facility: Hôpital Edouard Herriot ( Site 1116)
state: Rhone-Alpes
city: Creteil
country: France
facility: Hopital Henri Mondor ( Site 1105)
state: Val-de-Marne
city: Avignon
country: France
facility: Institut du Cancer Avignon-Provence ( Site 1103)
state: Vaucluse
city: Paris
country: France
facility: Hopital Saint Louis ( Site 1100)
city: Paris
country: France
facility: CHU Hopital Saint Antoine ( Site 1102)
city: Muechen
country: Germany
facility: Klinikum Rechts der Isar der TU Muenchen ( Site 1200)
state: Bayern
city: Regensburg
country: Germany
facility: Universitaetsklinikum Regensburg ( Site 1203)
state: Bayern
city: Frankfurt am Main
country: Germany
facility: Krankenhaus Nordwest ( Site 1205)
state: Hessen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover ( Site 1210)
state: Niedersachsen
city: Leipzig
country: Germany
facility: Universitaetsklinikum Leipzig ( Site 1211)
state: Sachsen
city: Berlin
country: Germany
facility: Charite Berlin Campus Virchow-Klinikum ( Site 1202)
city: Hamburg
country: Germany
facility: Facharztzentrum Eppendorf ( Site 1201)
city: Guatemala
country: Guatemala
facility: Clinica Privada Dr Rixci Ramirez Fallas ( Site 0702)
city: Guatemala
country: Guatemala
facility: Oncologika S.A. ( Site 0704)
city: Guatemala
country: Guatemala
facility: Oncomedica ( Site 0701)
city: Guatemala
country: Guatemala
facility: Soluciones Gastrointestinales S.A. ( Site 0706)
city: Guatemala
country: Guatemala
facility: Sanatorio Nuestra Senora del Pilar ( Site 0705)
city: Guatemala
country: Guatemala
facility: Medi-K Cayala ( Site 0700)
city: Hong Kong
country: Hong Kong
facility: Prince of Wales Hospital ( Site 2503)
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital. ( Site 2502)
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital ( Site 2501)
city: Dublin
country: Ireland
facility: St James Hospital ( Site 1400)
state: Leinster
city: Dublin
country: Ireland
facility: Beaumont Hospital ( Site 1402)
city: Be'er Sheva
country: Israel
facility: Soroka Medical Center ( Site 1507)
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center ( Site 1503)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Oncology Division ( Site 1502)
city: Jerusalem
country: Israel
facility: Hadassah Ein Kerem Medical Center ( Site 1501)
city: Kfar-Saba
country: Israel
facility: Meir Medical Center ( Site 1504)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 1506)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 1500)
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per Studio e Cura Tumori IRST ( Site 1608)
state: Abruzzo
city: Udine
country: Italy
facility: Presidio Ospedaliero Universitario Santa Maria della Misericordia ( Site 1609)
state: Friuli-Venezia Giulia
city: Milan
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori-Struttura Complessa Oncologia Medica 1 ( Site 1610)
state: Lombardia
city: Rozzano
country: Italy
facility: Humanitas Research Hospital ( Site 1600)
state: Lombardia
city: Vicenza
country: Italy
facility: AULSS8 Berica-Ospedale S.Bortolo ( Site 1607)
state: Veneto
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Mater Domini-Translational Oncology Unit ( Site 1611)
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele di Milano ( Site 1603)
city: Napoli
country: Italy
facility: A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1604)
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 2603)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 2601)
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center ( Site 2610)
state: Ehime
city: Akashi
country: Japan
facility: Hyogo Cancer Center ( Site 2621)
state: Hyogo
city: Kobe
country: Japan
facility: Kobe City Medical Center General Hospital ( Site 2606)
state: Hyogo
city: Kasama
country: Japan
facility: Ibaraki Prefectural Central Hospital ( Site 2618)
state: Ibaraki
city: Kita-gun
country: Japan
facility: Kagawa University Hospital ( Site 2611)
state: Kagawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 2608)
state: Kanagawa
city: Hirakata
country: Japan
facility: Kansai Medical University Hospital ( Site 2622)
state: Osaka
city: Osakasayama
country: Japan
facility: Kindai University Hospital ( Site 2600)
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Saitama Cancer Center ( Site 2604)
state: Saitama
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center ( Site 2609)
city: Hiroshima
country: Japan
facility: Hiroshima City Hiroshima Citizens Hospital ( Site 2612)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 2607)
city: Tokyo
country: Japan
facility: National Cancer Center Hospital ( Site 2602)
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR ( Site 2605)
city: Anyang-si
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital ( Site 2806)
state: Kyonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital ( Site 2804)
state: Kyonggi-do
city: Songpagu
country: Korea, Republic of
facility: Asan Medical Center ( Site 2802)
state: Seoul
city: Daejeon
country: Korea, Republic of
facility: Konyang University ( Site 2807)
state: Taejon-Kwangyokshi
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital ( Site 2803)
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System ( Site 2800)
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital ( Site 2805)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 2801)
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital ( Site 2808)
city: Wroclaw
country: Poland
facility: Dolnoslaskie Centrum Onkologii. ( Site 1712)
state: Dolnoslaskie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 1704)
state: Mazowieckie
city: Przemysl
country: Poland
facility: Wojewodzki Szpital im. Sw. Ojca Pio w Przemyslu ( Site 1702)
state: Podkarpackie
city: Konin
country: Poland
facility: Przychodnia Lekarska KOMED ( Site 1701)
state: Wielkopolskie
city: Poznan
country: Poland
facility: Szpital Kliniczny im. Heliodora Swiecickiego Uniwers Medyczn ( Site 1703)
state: Wielkopolskie
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Oncological Dispensary ( Site 1816)
state: Chelyabinskaya Oblast
city: Moscow
country: Russian Federation
facility: National Medical and Surgical Center n.a.N.I.Pirogov ( Site 1805)
state: Moskva
city: Moscow
country: Russian Federation
facility: Blokhin National Medical Oncology ( Site 1800)
state: Moskva
city: Moscow
country: Russian Federation
facility: Central Clinical Hospital with Polyclinic ( Site 1801)
state: Moskva
city: Samara
country: Russian Federation
facility: Medical University REAVIZ ( Site 1814)
state: Samarskaya Oblast
city: Saint Petersburg
country: Russian Federation
facility: St Petersburg City Clinical Oncology Dispensary ( Site 1808)
state: Sankt-Peterburg
city: Saint-Petersburg
country: Russian Federation
facility: Leningrad Regional Oncology Center ( Site 1810)
state: Sankt-Peterburg
city: Saint-Petersburg
country: Russian Federation
facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1809)
state: Sankt-Peterburg
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1821)
state: Yaroslavskaya Oblast
city: Oviedo
country: Spain
facility: Hospital Universitario General de Asturias ( Site 1901)
state: Asturias
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla ( Site 1902)
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital General Universitari Vall d Hebron ( Site 1907)
city: Madrid
country: Spain
facility: Hospital General Gregorio Maranon de Madrid ( Site 1904)
city: Taichung
country: Taiwan
facility: China Medical University Hospital ( Site 2903)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 2904)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 2901)
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation. Linkou ( Site 2902)
city: Sakarya
country: Turkey
facility: Sakarya Universitesi Tip Fakultesi ( Site 2007)
state: Istanbul
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 2003)
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi ( Site 2004)
city: Edirne
country: Turkey
facility: Trakya Universitesi Tip Fakultesi ( Site 2000)
city: Erzurum
country: Turkey
facility: Ataturk Universitesi Tip Fakultesi Hastanesi ( Site 2005)
city: Istanbul
country: Turkey
facility: Istanbul Universitesi Cerrahpasa Tip Fakultesi ( Site 2002)
city: Izmir
country: Turkey
facility: Ege Universitesi Tip Fakultesi Hastanesi ( Site 2001)
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital ( Site 2200)
state: Cambridgeshire
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School ( Site 2207)
state: Dundee City
city: Glasgow
country: United Kingdom
facility: The Beatson West of Scotland Cancer Centre ( Site 2204)
state: Glasgow City
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust ( Site 2201)
state: London, City Of
city: London
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust ( Site 2202)
state: London, City Of
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Trust ( Site 2203)
state: Surrey
city: Coventry
country: United Kingdom
facility: University Hospital Coventry and Warwickshire NHS Trust ( Site 2205)
state: Warwickshire
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust ( Site 2209)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: