Clinical trial NCT04949256: Efficacy and Safety of Pembrolizumab (MK-3475) Plus Lenvatinib (E7080/MK-7902) Plus Chemotherapy in Participants With Metastatic Esophageal Carcinoma (MK-7902-014/E7080-G000-320/LEAP-014)
Official title: A Phase 3, Randomized Study to Evaluate the Efficacy and Safety of Pembrolizumab (MK-3475) + Lenvatinib (E7080/MK-7902) + Chemotherapy Compared With Standard of Care as First-line Intervention in Participants With Metastatic Esophageal Carcinoma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Metastatic Esophageal Squamous Cell Carcinoma
Keywords: programmed cell death 1 (PD-1, PD1)
programmed cell death ligand 1 (PD-L1, PDL1)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Eisai Inc.
First posted: 2021-07-02
Enrollment: 862
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 pembrolizumab plus lenvatinib plus chemotherapy compared with pembrolizumab plus chemotherapy as first-line intervention in participants with metastatic esophageal carcinoma.

The primary hypotheses are that pembrolizumab plus lenvatinib plus chemotherapy is superior to pembrolizumab plus chemotherapy with respect to overall survival (OS) per Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) by blinded independent central review (BICR).

Detailed description: There will be 2 parts to the study: the cisplatin and 5-fluorouracil (5-FU) (FP) and paclitaxel and cisplatin (TP) Safety Run-in (Part 1) and the Main Study (Part 2). In Part 1 (FP and TP Safety Run-in), participants will be treated with pembrolizumab plus lenvatinib plus FP or TP. Dose-limiting toxicities, safety, and tolerability will be assessed.

In Part 2 (Main Study), participants (not including those participating in Part 1) will be treated with pembrolizumab plus lenvatinib plus chemotherapy or pembrolizumab plus chemotherapy. Efficacy, safety, and tolerability will be assessed.

Eligibility criteria: Inclusion Criteria:

* Has a histologically or cytologically confirmed diagnosis of metastatic squamous cell carcinoma of the esophagus
* Male participants are abstinent from heterosexual intercourse or agree to use contraception during the intervention period and for at least 7 days after the last dose of lenvatinib or 90 days after the last dose of chemotherapy, whichever comes last; 7 days after lenvatinib is stopped, if the participant is on pembrolizumab only and is greater than 90 days post chemotherapy, no male contraception is needed
* Female participant is not pregnant or breastfeeding and is not a woman of childbearing potential (WOCBP) or is a WOCBP using a contraceptive method that is highly effective or is abstinent from heterosexual intercourse as their preferred and usual lifestyle during the intervention period and for at least 120 days after the last dose of pembrolizumab, 30 days after the last dose of lenvatinib, or 180 days after the last dose of chemotherapy, whichever occurs last, and agrees not to donate eggs during this period
* Has adequately controlled blood pressure (BP) with or without antihypertensive medications, defined as BP≤150/90 millimeters of mercury (mm Hg) with no change in antihypertensive medications within 1 week prior to randomization
* Has adequate organ function

Exclusion Criteria:

* Has had previous therapy for locally advanced unresectable or metastatic esophageal cancer
* Has locally advanced esophageal carcinoma
* Has metastatic adenocarcinoma of the esophagus
* Has direct invasion into adjacent organs such as the aorta or trachea
* Has radiographic evidence of encasement of a major blood vessel, or of intratumoral cavitation
* Has perforation risks or significant gastrointestinal (GI) bleeding
* Has had clinically significant hemoptysis within 3 weeks prior to the first dose of study drug or tumor bleeding within 2 weeks prior to the first dose of study intervention
* Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage or medical intervention
* Has GI obstruction, poor oral intake, difficulty in taking oral medication, or existing esophageal stent
* Has had major surgery, open biopsy, or significant traumatic injury within 3 weeks prior to first dose of study interventions
* Has received prior radiotherapy within 2 weeks of start of study intervention or have had a history of radiation pneumonitis
* Has received a live or live attenuated vaccine within 30 days prior to the first dose of study intervention; administration of killed vaccines is allowed
* Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any form of immunosuppressive therapy within 7 days prior to the first dose of study intervention, or has a history of organ transplant, including allogeneic stem cell transplant
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years
* 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 is not considered a form of systemic treatment and is allowed
* Has a history of non-infectious pneumonitis/interstitial lung disease that required steroids or current pneumonitis/interstitial lung disease
* Has poorly controlled diarrhea
* Has clinically significant cardiovascular disease within 12 months from first dose of study intervention
* Has peripheral neuropathy ≥Grade 2
* Has a known history of human immunodeficiency virus (HIV) infection
* Has a known history of Hepatitis B or know active Hepatitis C virus infection
* Has a weight loss of \>20% within the last 3 months

Primary outcomes:
measure: Part 1 (FP and TP Safety Run-in): Number of Participants With Dose Limiting Toxicities (DLTs)
timeFrame: Up to ~21 days
measure: Part 1 (FP and TP Safety Run-in): Number of Participants With Adverse Events (AEs)
timeFrame: Up to ~53 months
measure: Part 1 (FP and TP Safety Run-in): Number of Participants who Discontinued Study Treatment Due to an AE
timeFrame: Up to ~53 months
measure: Part 2 (Main Study): Overall Survival (OS) in all Participants
timeFrame: Up to ~48 months
Secondary outcomes:
measure: Part 2 (Main Study): 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 all Participants
timeFrame: Up to ~42 months
measure: Part 2 (Main Study): Objective Response Rate (ORR) per RECIST 1.1 as Assessed by BICR in all Participants
timeFrame: Up to ~42 months
measure: Part 2 (Main Study): Duration of Response (DOR) per RECIST 1.1 as Assessed by BICR in all Participants
timeFrame: Up to ~42 months
measure: Part 2 (Main Study): OS in Participants With Programmed Cell Death-Ligand 1 (PD-L1) Combined Positive Score (CPS) ≥10
timeFrame: Up to ~48 months
measure: Part 2 (Main Study): PFS per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10
timeFrame: Up to ~42 months
measure: Part 2 (Main Study): ORR per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10
timeFrame: Up to ~42 months
measure: Part 2 (Main Study): DOR per RECIST 1.1 as Assessed by BICR in Participants With PD-L1 CPS ≥10
timeFrame: Up to ~42 months
measure: Part 2 (Main Study): Number of Participants With AEs
timeFrame: Up to ~53 months
measure: Part 2 (Main Study): Number of Participants who Discontinued Study Treatment Due to an AE
timeFrame: Up to ~53 months
measure: Part 2 (Main Study): Change From Baseline in Health-related Quality of life (HRQoL) Score Using European Organization for the Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30)
timeFrame: Baseline and ~53 months
measure: Part 2 (Main Study): Change From Baseline in HRQoL Score Using EORTC Quality of Life Questionnaire-Oesophageal Module (QLQ-OES18)
timeFrame: Baseline and ~53 months
measure: Part 2 (Main Study): Time to Deterioration (TTD) in HRQoL Score Using EORTC QLQ-C30
timeFrame: Up to ~ 53 months
measure: Part 2 (Main Study): TTD in HRQoL Score Using EORTC QLQ-OES18
timeFrame: Up to ~ 53 months
Other outcomes:
Locations:
city: Duarte
country: United States
facility: City of Hope ( Site 0102)
state: California
city: Washington
country: United States
facility: MedStar Washington Hospital Center ( Site 0186)
state: District of Columbia
city: Louisville
country: United States
facility: James Graham Brown Cancer Center ( Site 0117)
state: Kentucky
city: Louisville
country: United States
facility: Norton Cancer Institute ( Site 0116)
state: Kentucky
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center ( Site 0152)
state: Maryland
city: Worcester
country: United States
facility: UMASS Memorial Medical Center ( Site 0120)
state: Massachusetts
city: Pennington
country: United States
facility: Capital Health Medical Center - Hopewell ( Site 0189)
state: New Jersey
city: East Syracuse
country: United States
facility: Hematology-Oncology Associates of CNY ( Site 0173)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center ( Site 0132)
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College ( Site 0133)
state: New York
city: Bethlehem
country: United States
facility: St. Luke's University Health Network ( Site 0185)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: AHN Allegheny General Hospital ( Site 0164)
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina-Hollings Cancer Center ( Site 0177)
state: South Carolina
city: Richmond
country: United States
facility: VCU Health Adult Outpatient Pavillion ( Site 0160)
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance ( Site 0145)
state: Washington
city: Berazategui
country: Argentina
facility: Centro de Oncologia e Investigacion Buenos Aires COIBA ( Site 0203)
state: Buenos Aires
city: Caba
country: Argentina
facility: IDIM Instituto de Diagnostico e Investigaciones Metabolicas ( Site 0202)
state: Buenos Aires
city: Mar del Plata.
country: Argentina
facility: Instituto de Investigaciones Clinicas Mar del Plata ( Site 0205)
state: Buenos Aires
city: Rosario
country: Argentina
facility: Fundacion Estudios Clinicos-Oncology ( Site 0215)
state: Santa Fe
city: Rosario
country: Argentina
facility: Sanatorio Parque ( Site 0206)
state: Santa Fe
city: Rosario
country: Argentina
facility: Hospital Provincial del Centenario ( Site 0217)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Fundacion Favaloro ( Site 0201)
city: Buenos Aires
country: Argentina
facility: Fundación Respirar ( Site 0216)
city: Cordoba
country: Argentina
facility: Hospital Italiano de Córdoba ( Site 0218)
city: La Rioja
country: Argentina
facility: Fundación CORI para la Investigación y Prevención del Cáncer ( Site 0221)
city: San Juan
country: Argentina
facility: Instituto San Marcos ( Site 0213)
city: Winnipeg
country: Canada
facility: CancerCare Manitoba ( Site 0001)
state: Manitoba
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0004)
state: Ontario
city: Levis
country: Canada
facility: Hotel-Dieu de Levis ( Site 0013)
state: Quebec
city: Temuco.
country: Chile
facility: Centro de Investigacion y desarrollo Oncologico SpA - CIDO SpA ( Site 0401)
state: Araucania
city: Temuco
country: Chile
facility: James Lind Centro de Investigacion del Cancer ( Site 0412)
state: Araucania
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez FALP ( Site 0403)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Oncovida ( Site 0413)
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: Bradford Hill Centro de Investigaciones Clinicas ( Site 0404)
state: Region M. De Santiago
city: Hefei
country: China
facility: Anhui Provincial Cancer Hospital ( Site 8058)
state: Anhui
city: Hefei
country: China
facility: The Second Affiliated Hospital of Anhui Medical University ( Site 8026)
state: Anhui
city: Beijing
country: China
facility: Beijing Cancer Hospital ( Site 8001)
state: Beijing
city: Fuzhou
country: China
facility: Fujian Provincial Cancer Hospital ( Site 8029)
state: Fujian
city: Xiamen City, Fujian Province
country: China
facility: The First Affiliated Hospital of Xiamen University ( Site 8003)
state: Fujian
city: Xiamen
country: China
facility: Zhongshan Hospital Affiliated to Xiamen University ( Site 8055)
state: Fujian
city: Guangzhou
country: China
facility: The First Affiliated Hospital.Sun Yat-sen University ( Site 8047)
state: Guangdong
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital ( Site 8031)
state: Guangdong
city: Changsha
country: China
facility: The Third Xiangya Hospital of Central South University ( Site 8046)
state: Hainan
city: Haikou
country: China
facility: The First Affiliated Hospital of Hainan Medical University ( Site 8042)
state: Hainan
city: Chengde
country: China
facility: Affiliated Hospital of Chengde Medical Univeristy ( Site 8053)
state: Hebei
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital ( Site 8009)
state: Heilongjiang
city: Anyang
country: China
facility: Anyang Cancer Hospital ( Site 8006)
state: Henan
city: Luoyang
country: China
facility: The First Affiliated Hospital of Henan University of Science &Technology-Tumor ( Site 8036)
state: Henan
city: Xinxiang
country: China
facility: The First Affiliated Hospital of Xinxiang Medical University ( Site 8018)
state: Henan
city: Wuhan
country: China
facility: Tongji Medical College Huazhong Uinversity Of Science and Technology ( Site 8025)
state: Hubei
city: Wuhan
country: China
facility: Hubei Cancer Hospital ( Site 8014)
state: Hubei
city: Wuxi
country: China
facility: Affiliated hospital of Jiangnan university ( Site 8049)
state: Jiangsu
city: Xuzhou
country: China
facility: The Affiliated Hospital of Xuzhou Medical University ( Site 8015)
state: Jiangsu
city: Changchun
country: China
facility: Jilin Cancer Hospital ( Site 8016)
state: Jilin
city: Jinan
country: China
facility: Jinan Central Hospital ( Site 8052)
state: Shandong
city: Jinan
country: China
facility: Shandong Cancer Hospital ( Site 8060)
state: Shandong
city: Jining
country: China
facility: Affiliated Hospital of Jining Medical University ( Site 8017)
state: Shandong
city: Linyi
country: China
facility: Linyi Cancer Hospital- Medical Oncology Department ( Site 8051)
state: Shandong
city: Taiyuan
country: China
facility: Shanxi Provincial Cancer Hospital ( Site 8019)
state: Shanxi
city: Chengdu
country: China
facility: West China Hospital of Sichuan University ( Site 8048)
state: Sichuan
city: Tianjin
country: China
facility: Tianjin Medical University Cancer Institute & Hospital ( Site 8035)
state: Tianjin
city: Urumqi
country: China
facility: The Affiliated Cancer Hospital of Xinjiang Medical University. ( Site 8041)
state: Xinjiang
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital ( Site 8021)
state: Zhejiang
city: San José
country: Costa Rica
facility: ICIMED-Oncology Research Unit ( Site 0903)
state: San Jose
city: San José
country: Costa Rica
facility: PROCLINICAL Pharma ( Site 0904)
state: San Jose
city: San Jose
country: Costa Rica
facility: CIMCA Centro de Investigacion y Manejo del Cancer ( Site 0902)
city: San Jose
country: Costa Rica
facility: Onco Tech S A ( Site 0901)
city: Copenhagen
country: Denmark
facility: Rigshospitalet ( Site 2102)
state: Hovedstaden
city: Odense
country: Denmark
facility: Odense University Hospital ( Site 2101)
state: Syddanmark
city: Vandoeuvre les Nancy
country: France
facility: Institut De Cancerologie De Lorraine ( Site 1010)
state: Ain
city: Strasbourg
country: France
facility: Institut de cancérologie Strasbourg Europe (ICANS) ( Site 1014)
state: Alsace
city: Caen
country: France
facility: Centre François Baclesse ( Site 1009)
state: Calvados
city: Dijon
country: France
facility: Centre Georges Francois Leclerc ( Site 1008)
state: Cote-d Or
city: Brest
country: France
facility: C.H. regional Unv. de Brest - Hopital La Cavale Blanche - Institut de Cancerologie et d Imagerie ( S
state: Finistere
city: Besançon
country: France
facility: CHU Besançon ( Site 1015)
state: Franche-Comte
city: Pessac
country: France
facility: CHU Bordeaux Haut-Leveque ( Site 1012)
state: Gironde
city: Montpellier
country: France
facility: Institut du Cancer de Montpellier ( Site 1002)
state: Herault
city: Tours
country: France
facility: CHRU de Tours - Hopital Bretonneau ( Site 1018)
state: Indre-et-Loire
city: Saint Herblain
country: France
facility: Institut De Cancerologie De L Ouest ( Site 1003)
state: Loire-Atlantique
city: Lille
country: France
facility: Hôpital Claude Huriez ( Site 1030)
state: Nord
city: Creteil
country: France
facility: Hopital Henri Mondor ( Site 1007)
state: Val-de-Marne
city: Paris
country: France
facility: Hopital Saint Louis ( Site 1029)
city: Guatemala
country: Guatemala
facility: Centro Regional de Sub Especialidades Medicas SA ( Site 0604)
state: Quetzaltenango
city: Guatemala
country: Guatemala
facility: MEDI-K ( Site 0601)
city: Guatemala
country: Guatemala
facility: Oncomedica ( Site 0602)
city: Guatemala
country: Guatemala
facility: Soluciones Gastrointestinales S.A. ( Site 0607)
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital ( Site 4001)
city: Kowloon
country: Hong Kong
facility: Queen Elizabeth Hospital. ( Site 4004)
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem AOK ( Site 1204)
state: Baranya
city: Gyor
country: Hungary
facility: Petz Aladar Egyetemi Oktato Korhaz ( Site 1210)
state: Gyor-Moson-Sopron
city: Szolnok
country: Hungary
facility: Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 1203)
state: Jasz-Nagykun-Szolnok
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet ( Site 1207)
city: Meldola
country: Italy
facility: Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori-Oncologia Medica ( Site 1313)
state: Emilia-Romagna
city: Udine
country: Italy
facility: A.O.U. Santa Maria della Misericordia di Udine ( Site 1302)
state: Friuli-Venezia Giulia
city: Rozzano
country: Italy
facility: Humanitas Research Hospital ( Site 1309)
state: Lombardia
city: Pisa
country: Italy
facility: Azienda Ospedaliera Universitaria Pisana ( Site 1312)
state: Toscana
city: Padova
country: Italy
facility: Istituto Oncologico Veneto IRCCS-Oncologia Medica 1 ( Site 1311)
state: Veneto
city: Catanzaro
country: Italy
facility: Azienda Ospedaliera Mater Domini-Translational Oncology Unit ( Site 1314)
city: Firenze
country: Italy
facility: Azienda Ospedaliero Universitaria Careggi ( Site 1301)
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele di Milano ( Site 1304)
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 1306)
city: Modena
country: Italy
facility: A.O. Universitaria di Modena ( Site 1307)
city: Napoli
country: Italy
facility: A.O.U. Universita degli Studi della Campania-Luigi Vanvitelli ( Site 1305)
city: Roma
country: Italy
facility: Universita Cattolica del Sacro Cuore - Policlinico Gemelli ( Site 1310)
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 9006)
state: Aichi
city: Chiba-shi
country: Japan
facility: Chiba Cancer Center ( Site 9023)
state: Chiba
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 9002)
state: Chiba
city: Matsuyama
country: Japan
facility: National Hospital Organization Shikoku Cancer Center ( Site 9019)
state: Ehime
city: Akashi
country: Japan
facility: Hyogo Cancer Center ( Site 9014)
state: Hyogo
city: Kasama
country: Japan
facility: Ibaraki Prefectural Central Hospital ( Site 9007)
state: Ibaraki
city: Kita-gun
country: Japan
facility: Kagawa University Hospital ( Site 9015)
state: Kagawa
city: Yokohama
country: Japan
facility: Kanagawa Cancer Center ( Site 9004)
state: Kanagawa
city: Sendai-shi
country: Japan
facility: Tohoku University Hospital ( Site 9013)
state: Miyagi
city: Niigata-shi
country: Japan
facility: Niigata Cancer Center Hospital ( Site 9022)
state: Niigata
city: Sayama
country: Japan
facility: Kindai University Hospital ( Site 9017)
state: Osaka
city: Suita
country: Japan
facility: Osaka University Hospital ( Site 9021)
state: Osaka
city: Takatsuki
country: Japan
facility: Osaka Medical and Pharmaceutical University Hospital ( Site 9008)
state: Osaka
city: Kitaadachi-gun
country: Japan
facility: Saitama Prefectural Cancer Center ( Site 9003)
state: Saitama
city: Nagaizumi
country: Japan
facility: Shizuoka Cancer Center ( Site 9016)
state: Shizuoka
city: Bunkyo ku
country: Japan
facility: Tokyo Metropolitan Komagome Hospital ( Site 9028)
state: Tokyo
city: Minato-ku
country: Japan
facility: Toranomon Hospital ( Site 9026)
state: Tokyo
city: Shinagawa
country: Japan
facility: Showa University Hospital ( Site 9025)
state: Tokyo
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center ( Site 9010)
city: Kyoto
country: Japan
facility: University Hospital,Kyoto Prefectural University of Medicine ( Site 9027)
city: Kyoto
country: Japan
facility: Kyoto University Hospital ( Site 9011)
city: Okayama
country: Japan
facility: Okayama University Hospital ( Site 9024)
city: Osaka
country: Japan
facility: Osaka International Cancer Institute ( Site 9009)
city: Osaka
country: Japan
facility: Osaka General Medical Center ( Site 9018)
city: Tokyo
country: Japan
facility: National Cancer Center Hospital ( Site 9001)
city: Tokyo
country: Japan
facility: The Cancer Institute Hospital of JFCR ( Site 9005)
city: Tokyo
country: Japan
facility: Keio University Hospital ( Site 9020)
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital ( Site 5006)
state: Kyonggi-do
city: Songpagu
country: Korea, Republic of
facility: Asan Medical Center ( Site 5002)
state: Seoul
city: Seoul
country: Korea, Republic of
facility: Severance Hospital ( Site 5003)
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center ( Site 5005)
city: Seoul
country: Korea, Republic of
facility: Korea University Guro Hospital ( Site 5001)
city: Lembah Pantai
country: Malaysia
facility: University Malaya Medical Centre ( Site 9101)
state: Kuala Lumpur
city: Kuching
country: Malaysia
facility: Sarawak General Hospital-Radiotherapy Unit ( Site 9100)
state: Sarawak
city: Kuala Lumpur
country: Malaysia
facility: Hospital Kuala Lumpur ( Site 9104)
city: Bucharest
country: Romania
facility: MEMORIAL HEALTHCARE INTERNATIONAL S.R.L. ( Site 2201)
state: Bucuresti
city: Cluj-Napoca
country: Romania
facility: Cardiomed SRL Cluj-Napoca-Medical Oncology ( Site 2207)
state: Cluj
city: Comuna Floresti
country: Romania
facility: SC Radiotherapy Center Cluj SRL ( Site 2202)
state: Cluj
city: Ovidiu
country: Romania
facility: Ovidius Clinical Hospital OCH-Oncology and Hematology ( Site 2203)
state: Constanta
city: Craiova
country: Romania
facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 2204)
state: Dolj
city: Timisoara
country: Romania
facility: Policlinica Oncomed SRL ( Site 2206)
state: Timis
city: Ufa
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Republic of Bashkortostan ( Site 1507)
state: Baskortostan, Respublika
city: Saint-Petersburg
country: Russian Federation
facility: GBUZ LOKB ( Site 1502)
state: Leningradskaya Oblast
city: Moscow
country: Russian Federation
facility: FSBI National Medical Oncology Research Center n.a. N.N. Blokhina ( Site 1510)
state: Moskva
city: Saint Petersburg
country: Russian Federation
facility: Scientific Research Oncology Institute n.a. N.N.Petrov ( Site 1503)
state: Sankt-Peterburg
city: Saint-Petersburg
country: Russian Federation
facility: Academician I.P. Pavlov First St. Petersburg State Medical University ( Site 1519)
state: Sankt-Peterburg
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Tatarstan MoH named after professor M.Z. Sigal ( Site 150
state: Tatarstan, Respublika
city: Tyumen
country: Russian Federation
facility: SAIH of Tyumen reg "Multifield clinical medical center "Medical city" ( Site 1520)
state: Tyumenskaya Oblast
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore ( Site 9201)
state: Central Singapore
city: Johannesburg
country: South Africa
facility: Wits Clinical Research ( Site 9502)
state: Gauteng
city: Durban
country: South Africa
facility: The Oncology Centre ( Site 9505)
state: Kwazulu-Natal
city: Oviedo
country: Spain
facility: Hospital Universitario General de Asturias ( Site 1601)
state: Asturias
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla ( Site 1602)
state: Cantabria
city: Ourense
country: Spain
facility: Complexo Hospitalario Universitario de Ourense-MEDICAL ONCOLOGY ( Site 1609)
state: Orense
city: Barcelona
country: Spain
facility: Hospital General Universitari Vall d Hebron ( Site 1607)
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon ( Site 1604)
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocio ( Site 1606)
city: Tainan City
country: Taiwan
facility: Chi Mei Hospital - Liouying Branch-Clinical Trial Center ( Site 6007)
state: Tainan
city: Kaohsiung
country: Taiwan
facility: Chang Gung Med Foundation. Kaohsiung Branch ( Site 6005)
city: Taichung
country: Taiwan
facility: China Medical University Hospital ( Site 6003)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 6004)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 6001)
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital ( Site 6006)
city: Bangkok
country: Thailand
facility: Faculty of Medicine Siriraj Hospital ( Site 7002)
state: Krung Thep Maha Nakhon
city: HatYai
country: Thailand
facility: Songklanagarind hospital ( Site 7001)
state: Songkhla
city: Adana
country: Turkey
facility: Adana Medical Park Seyhan Hastanesi-Medikal Onkoloji ( Site 1714)
city: Ankara
country: Turkey
facility: Hacettepe Universitesi Tip Fakultesi Hastanesi ( Site 1701)
city: Ankara
country: Turkey
facility: Memorial Ankara Hastanesi ( Site 1702)
city: Ankara
country: Turkey
facility: Ankara Bilkent Şehir Hastanesi-Medical Oncology ( Site 1715)
city: Erzurum
country: Turkey
facility: Atatürk Üniversitesi-onkoloji ( Site 1712)
city: Istanbul
country: Turkey
facility: Acibadem Universitesi Atakent Hastanesi-Medical Oncology ( Site 1716)
city: Istanbul
country: Turkey
facility: Istanbul Okmeydanı Egitim ve Arastirma Hastanesi ( Site 1711)
city: İstanbul
country: Turkey
facility: Medeniyet Universitesi Tip Fakultesi ( Site 1703)
city: Chernihiv
country: Ukraine
facility: Chernihiv Medical Center of Modern Oncology ( Site 1811)
state: Chernihivska Oblast
city: Chernivtsi
country: Ukraine
facility: Regional Municipal Non-profit Enterprise "Bukovinian Clinical Oncology Center" ( Site 1819)
state: Chernivetska Oblast
city: Kryviy Rih
country: Ukraine
facility: MI Kryvyi Rih Oncology Dispensary of Dnipropetrovsk Regional Council ( Site 1804)
state: Dnipropetrovska Oblast
city: Kharkiv
country: Ukraine
facility: Kharkiv Regional Clinical Oncology Center ( Site 1812)
state: Kharkivska Oblast
city: Kharkiv
country: Ukraine
facility: Institute of General and Emergency Surgery n.a Zaitsev NAMS of Ukraine ( Site 1813)
state: Kharkivska Oblast
city: Antonivka Village
country: Ukraine
facility: Communal nonprofit enterprise "Kherson Regional Oncology Dispensary" of Kherson Regional Council (
state: Khersonska Oblast
city: Kyiv
country: Ukraine
facility: SNPE National Cancer Institute ( Site 1806)
state: Kyivska Oblast
city: Rivne
country: Ukraine
facility: Rivne Regional Clinical Hospital ( Site 1817)
state: Rivnenska Oblast
city: Vinnytsia
country: Ukraine
facility: Podillya Regional Center of Oncology ( Site 1809)
state: Vinnytska Oblast
city: Lutsk
country: Ukraine
facility: Volyn Regional Oncological Dispensary ( Site 1816)
state: Volynska Oblast
city: Kyiv
country: Ukraine
facility: Shalimov Institute of Surgery and Transplantation ( Site 1818)
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHSFT ( Site 1908)
state: Cambridgeshire
city: Dundee
country: United Kingdom
facility: Ninewells Hospital and Medical School ( Site 1907)
state: Dundee City
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospital NHS Trust ( Site 1910)
state: England
city: London
country: United Kingdom
facility: St Bartholomew's Hospital-Centre for Experimental Cancer Medicine ( Site 1915)
state: London, City Of
city: London
country: United Kingdom
facility: University College London Hospitals NHS Foundation Trust ( Site 1901)
state: London, City Of
city: London
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust ( Site 1905)
state: London, City Of
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Trust. ( Site 1906)
state: London, City Of
city: Edinburgh
country: United Kingdom
facility: Western General Hospital ( Site 1912)
state: Midlothian
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust ( Site 1909)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: