Clinical trial NCT03765918: Study of Pembrolizumab Given Prior to Surgery and in Combination With Radiotherapy Given Post-surgery for Advanced Head and Neck Squamous Cell Carcinoma (MK-3475-689)
Official title: A Phase III, Randomized, Open-label Study to Evaluate Pembrolizumab as Neoadjuvant Therapy and in Combination With Standard of Care as Adjuvant Therapy for Stage III-IVA Resectable Locoregionally Advanced Head and Neck Squamous Cell Carcinoma (LA HNSCC)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Head and Neck Neoplasms
Keywords: Programmed Cell Death-1 (PD1, PD-1)
Programmed Cell Death 1 Ligand 1 (PDL1, PD-L1)
Programmed Cell Death 1 Ligand 2 (PDL2, PD-L2)
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2018-12-05
Enrollment: 714
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 randomized, active-controlled, open-label study of pembrolizumab (Pembro) given prior to surgery and pembrolizumab in combination with standard of care radiotherapy (with or without cisplatin), as post-surgical therapy in treatment naïve participants with newly diagnosed Stage III/IVA, resectable, locoregionally advanced, head and neck squamous cell carcinoma (LA-HNSCC). Efficacy outcomes will be stratified by programmed cell death ligand 1 (PD-L1) combined positive score (CPS) status. The primary hypothesis is that pembrolizumab given before surgery and after surgery in combination with radiotherapy (with or without cisplatin) improves event-free survival compared to radiotherapy (with or without cisplatin) given after surgery alone.


Eligibility criteria: Inclusion Criteria:

* Has histologically confirmed new diagnosis of resectable, non-metastatic, squamous cell carcinoma that is either: Stage III Human Papillomavirus (HPV) positive oropharyngeal primary that is tumor size (T) 4, lymph node involvement (N) 0-2, no distant metastases (M0); Stage III or IVA oropharyngeal HPV negative; or Stage III or IVA larynx/hypopharynx/oral cavity primaries.
* Is eligible for primary surgery based on investigator decision and per local practice
* Female and male participants of reproductive potential must agree to use adequate contraception throughout the study period and for up to 180 days after the last dose of study therapy.
* Male participants must refrain from donating sperm throughout the study period and for up to 180 days after the last dose of study therapy
* Female participant that is not pregnant or breastfeeding
* Has evaluable tumor burden (measurable and/or non-measurable tumor lesions) assessed by computed tomography (CT) scan or magnetic resonance imaging (MRI), based on RECIST version 1.1
* Has provided newly obtained core or excisional biopsy of a tumor lesion not previously irradiated
* Has results from testing of HPV status for oropharyngeal cancer defined as p16
* Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 performed within 10 days of randomization

Exclusion Criteria:

* Has Stage T4B and/or N3 LA HNSCC and/or distant metastases
* Has cancer outside of the oropharynx, larynx, and hypopharynx or oral cavity. such as nasopharyngeal, sinus, other para-nasal, or other unknown primary head and neck cancer (HNC)
* Female participant who has a positive urine pregnancy test within 72 hours prior to study start or within 24 hours prior to the start of radiotherapy with or without cisplatin.
* Has received prior therapy with an anti-programmed cell death receptor 1(PD-1), anti-programmed cell death receptor ligand 1(PD-L1), or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another co-inhibitory T-cell receptor
* Has received prior radiotherapy treatment or systemic anti-cancer therapy including investigational agents for the HNC under study prior to study start
* Has received a live vaccine within 30 days prior to randomization
* Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to randomization
* Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive therapy within 7 days prior to randomization
* Has a known additional malignancy that is progressing or has required active treatment within the past 3 years with the exception of basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or carcinoma in situ (e.g. in situ cervical cancer or breast carcinoma) that have undergone potentially curative therapy
* Has radiographically detectable (even if asymptomatic and/or previously treated) central nervous system metastases and/or carcinomatous meningitis
* Has Grade ≥2 audiometric hearing loss
* Has Grade ≥2 neuropathy
* Has Grade 3-4 bleeding due to the underlying malignancy
* Has received major surgery or has not recovered adequately from the toxicity and/or complications from the intervention prior to study start
* Has had previous allogeneic tissue/solid organ transplant
* Has severe hypersensitivity (≥Grade 3) to pembrolizumab and/or any of its excipients, radiotherapy, cisplatin or their analogs
* Has an active autoimmune disease that has required systemic treatment in past 2 years
* Has a history of (non-infectious) pneumonitis that required steroids or has current pneumonitis
* Has an active infection requiring systemic therapy
* Has a known history of human immunodeficiency virus (HIV) infection
* Has a known history of or is positive for Hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known active Hepatitis C (defined as Hepatitis C virus \[HCV\] ribonucleic acid is detected).
* Has a history or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the participant's participation for the full duration of the study, or is not in the best interest of the participant to participate, in the opinion of the investigator
* 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: Event-free Survival (EFS)
timeFrame: Up to ~80 months
Secondary outcomes:
measure: Major Pathological Response (mPR)
timeFrame: Up to ~64 months
measure: Overall Survival (OS)
timeFrame: Up to ~92 months
measure: Pathological Complete Response (pCR)
timeFrame: Up to ~64 months
measure: Change From Baseline in Global Health Status/Quality of Life Scale (GHS/QoL)
timeFrame: Prior to the first dose of study therapy (Baseline) and at the time of last follow-up (up to ~92 months)
measure: Change From Baseline in Global Health Status/Physical Functioning Scales
timeFrame: Prior to the first dose of study therapy (Baseline) and at the time of last follow-up (up to ~92 months)
measure: Change from Baseline in Swallowing, Speech, and Pain Symptoms
timeFrame: Prior to the first dose of study therapy (Baseline) and at the time of last follow-up (up to ~92 months)
measure: Percentage of Participants Experiencing An Adverse Event (AEs)
timeFrame: From time of first dose of study treatment until the end of follow-up (up to ~92 months)
measure: Percentage of Participants Discontinuing Study Drug Due to AEs
timeFrame: From time of first dose of study treatment until the end of treatment (up to 12 months)
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Moores Cancer Center ( Site 1885)
state: California
city: Los Angeles
country: United States
facility: University of Southern California Norris Comprehensive Cancer Center ( Site 1850)
state: California
city: Newport Beach
country: United States
facility: Hoag Memoriall Hospital Presbyterian ( Site 2056)
state: California
city: Sacramento
country: United States
facility: UC Davis Health System ( Site 1864)
state: California
city: Santa Rosa
country: United States
facility: St. Joseph Heritage Healthcare ( Site 1806)
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center ( Site 1838)
state: Colorado
city: Washington
country: United States
facility: MedStar Washington Hospital Center ( Site 2062)
state: District of Columbia
city: Washington
country: United States
facility: George Washington University Medical Faculty Associates ( Site 2035)
state: District of Columbia
city: Gainesville
country: United States
facility: University of Florida ( Site 1832)
state: Florida
city: Miami
country: United States
facility: University of Miami, Sylvester Comprehensive Cancer Center ( Site 2008)
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando-AdventHealth Medical Group Hematology & Oncology at Orlando ( Site 2054)
state: Florida
city: Orlando
country: United States
facility: Orlando Health Cancer Institute ( Site 2061)
state: Florida
city: Boise
country: United States
facility: Saint Alphonsus Regional Medical Center ( Site 2021)
state: Idaho
city: Post Falls
country: United States
facility: Beacon Cancer Care ( Site 2052)
state: Idaho
city: Chicago
country: United States
facility: Rush University Medical Center ( Site 1823)
state: Illinois
city: Evanston
country: United States
facility: NorthShore University HealthSystem ( Site 1812)
state: Illinois
city: Maywood
country: United States
facility: Loyola University Medical Center [Maywood, IL] ( Site 1817)
state: Illinois
city: Westwood
country: United States
facility: University of Kansas Cancer Center ( Site 2004)
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky Chandler Medical Center-Medical Oncology ( Site 2069)
state: Kentucky
city: New Orleans
country: United States
facility: Ochsner Cancer Institute ( Site 2045)
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland ( Site 2031)
state: Maryland
city: Boston
country: United States
facility: Dana Farber Cancer Center ( Site 1873)
state: Massachusetts
city: Worcester
country: United States
facility: University of Massachusetts Memorial Medical Center ( Site 1875)
state: Massachusetts
city: Detroit
country: United States
facility: Karmanos Cancer Institute ( Site 1870)
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System ( Site 1803)
state: Michigan
city: Edina
country: United States
facility: Southdale Cancer Care, University of Minnesota Medical Center- Edina ( Site 2016)
state: Minnesota
city: Columbia
country: United States
facility: University of Missouri Hospital-Otolaryngology - Head and Neck Surgery ( Site 2058)
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine ( Site 1800)
state: Missouri
city: Springfield
country: United States
facility: Mercy Clinic Cancer and Hematology - Chub O'Reilly Cancer Center ( Site 1897)
state: Missouri
city: Billings
country: United States
facility: St. Vincent Healthcare Frontier Cancer Center ( Site 1818)
state: Montana
city: Basking Ridge
country: United States
facility: Memorial Sloan Kettering Cancer Center Basking Ridge ( Site 2036)
state: New Jersey
city: Middletown
country: United States
facility: Memorial Sloan Kettering Cancer Center- Monmouth ( Site 2039)
state: New Jersey
city: Montvale
country: United States
facility: MSKCC-Bergen ( Site 2037)
state: New Jersey
city: New Brunswick
country: United States
facility: Rutgers Cancer Institute of New Jersey ( Site 2071)
state: New Jersey
city: Newark
country: United States
facility: Rutgers New Jersey Medical School-department of Hematology oncology ( Site 2053)
state: New Jersey
city: Albuquerque
country: United States
facility: The University of New Mexico Comprehensive Cancer Center ( Site 1882)
state: New Mexico
city: Bronx
country: United States
facility: Montefiore Einstein Center ( Site 2028)
state: New York
city: Buffalo
country: United States
facility: Erie County Medical Center ( Site 2047)
state: New York
city: Commack
country: United States
facility: Memorial Sloan-Kettering Cancer Center at Commack ( Site 2038)
state: New York
city: Harrison
country: United States
facility: Memorial Sloan-Kettering Cancer Center at West Harrison ( Site 2041)
state: New York
city: Lake Success
country: United States
facility: Monter Cancer Center ( Site 2060)
state: New York
city: New York
country: United States
facility: Laura and Isaac Perlmutter Cancer Center at NYU Langone Health ( Site 2014)
state: New York
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center ( Site 1857)
state: New York
city: New York
country: United States
facility: Weill Cornell Medical College ( Site 2050)
state: New York
city: New York
country: United States
facility: Northwell Health Cancer Institute ( Site 2030)
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University ( Site 2063)
state: New York
city: Uniondale
country: United States
facility: Memorial Sloan Kettering Cancer Center - Nassau ( Site 2040)
state: New York
city: Charlotte
country: United States
facility: Levine Cancer Institute ( Site 2003)
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Compenhensive Cancer Center ( Site 2029)
state: North Carolina
city: Fargo
country: United States
facility: Sanford Health Roger Maris Cancer Center ( Site 2034)
state: North Dakota
city: Cleveland
country: United States
facility: University Hospitals ( Site 2032)
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University ( Site 2012)
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center ( Site 1843)
state: Oregon
city: Portland
country: United States
facility: Kaiser Permanente Center for Health Research-Kaiser Permanente Medical Center ( Site 2022)
state: Oregon
city: Portland
country: United States
facility: Oregon Health Science University ( Site 1871)
state: Oregon
city: Bethlehem
country: United States
facility: St. Luke's University Health Network ( Site 1801)
state: Pennsylvania
city: Philadelphia
country: United States
facility: Sidney Kimmel Cancer Center - Jefferson Health ( Site 2059)
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital ( Site 1833)
state: Pennsylvania
city: Sioux Falls
country: United States
facility: Sanford Cancer Center Oncology Clinic ( Site 1859)
state: South Dakota
city: Sioux Falls
country: United States
facility: Avera Cancer Institute- Research ( Site 2070)
state: South Dakota
city: Nashville
country: United States
facility: Henry Joyce Cancer Clinic ( Site 1827)
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center ( Site 1841)
state: Texas
city: San Antonio
country: United States
facility: USA Clinical Trials ( Site 2068)
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah, Huntsman Cancer Institute ( Site 1855)
state: Utah
city: Burlington
country: United States
facility: University of Vermont Medical Center ( Site 2009)
state: Vermont
city: Charlottesville
country: United States
facility: UVA Health System - Emily Couric Cancer Center ( Site 1826)
state: Virginia
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute ( Site 2026)
state: Virginia
city: Seattle
country: United States
facility: Seattle Cancer Care Alliance/Univ of Washington Medical Center ( Site 1865)
state: Washington
city: Pilar
country: Argentina
facility: Hospital Universitario Austral ( Site 0009)
state: Buenos Aires
city: Buenos Aires
country: Argentina
facility: Centro de Educación Médica e Investigaciones Clínicas (CEMIC)-Medical Oncology ( Site 0019)
state: Caba
city: Ciudad de Buenos Aires
country: Argentina
facility: Hospital Britanico de Buenos Aires ( Site 0012)
state: Caba
city: Rosario
country: Argentina
facility: Fundacion Estudios Clinicos-Oncology ( Site 0017)
state: Santa Fe
city: Rosario
country: Argentina
facility: Sanatorio Britanico ( Site 0013)
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto de Oncologia de Rosario ( Site 0002)
state: Santa Fe
city: Rosario
country: Argentina
facility: Hospital Provincial del Centenario ( Site 0008)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas ( Site 0016)
city: Buenos Aires
country: Argentina
facility: Hospital Aleman Buenos Aires Argentina ( Site 0004)
city: Buenos Aires
country: Argentina
facility: Instituto de Oncología Angel Roffo ( Site 0003)
city: San Juan
country: Argentina
facility: CER San Juan Centro Polivalente de Asistencia e Investigacion Clinica ( Site 0010)
city: Westmead
country: Australia
facility: The Crown Princess Mary Cancer Centre - Westmead Hospital ( Site 0051)
state: New South Wales
city: Herston
country: Australia
facility: Royal Brisbane and Women s Hospital ( Site 0050)
state: Queensland
city: Linz
country: Austria
facility: Ordensklinikum Linz Gmbh - Barmherzige Schwestern ( Site 1901)
state: Oberosterreich
city: Graz
country: Austria
facility: Landeskrankenhaus - Universitatsklinikum Graz ( Site 1902)
state: Steiermark
city: Salzburg
country: Austria
facility: Landeskrankenhaus Salzburg - Universitatklinikum der PMU ( Site 1900)
city: Wien
country: Austria
facility: Medizinische Universität Wien ( Site 1903)
city: Haine Saint Paul
country: Belgium
facility: Hopital de Jolimont ( Site 0103)
state: Hainaut
city: Gent
country: Belgium
facility: UZ Gent ( Site 0101)
state: Oost-Vlaanderen
city: Sint-Niklaas
country: Belgium
facility: AZ Nikolaas ( Site 0104)
state: Oost-Vlaanderen
city: Salvador
country: Brazil
facility: Hospital Santa Izabel - Santa Casa de Misericordia da Bahia ( Site 0155)
state: Bahia
city: Fortaleza
country: Brazil
facility: Centro Regional Integrado de Oncologia ( Site 0160)
state: Ceara
city: Ipatinga
country: Brazil
facility: Hospital Marcio Cunha-Unidade de Pesquisa Clínica ( Site 0177)
state: Minas Gerais
city: Natal
country: Brazil
facility: Liga Norte Riograndense Contra o Cancer ( Site 0171)
state: Rio Grande Do Norte
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceicao ( Site 0165)
state: Rio Grande Do Sul
city: Sao Jose do Rio Preto
country: Brazil
facility: Hospital de Base de Sao Jose de Rio Preto ( Site 0153)
state: Sao Paulo
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional do Cancer Jose Alencar Gomes da Silva INCA ( Site 0169)
city: Sao Paulo
country: Brazil
facility: Instituto do Cancer do Estado de Sao Paulo - ICESP ( Site 0167)
city: Sao Paulo
country: Brazil
facility: BP - A Beneficencia Portuguesa de São Paulo-Medical Oncology ( Site 0175)
city: Edmonton
country: Canada
facility: Cross Cancer Institute ( Site 0201)
state: Alberta
city: Toronto
country: Canada
facility: Sunnybrook Research Institute ( Site 0211)
state: Ontario
city: Toronto
country: Canada
facility: Princess Margaret Cancer Centre ( Site 0202)
state: Ontario
city: Montreal
country: Canada
facility: McGill University Health Centre ( Site 0210)
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l'Estrie-CHUS ( Site 0209)
state: Quebec
city: Santiago
country: Chile
facility: Fundacion Arturo Lopez Perez FALP ( Site 0251)
state: Region M. De Santiago
city: Barranquilla
country: Colombia
facility: Clinica de la Costa S.A.S. ( Site 0307)
state: Atlantico
city: Bogota
country: Colombia
facility: Centro de Investigacion Clinica del Country ( Site 0304)
state: Distrito Capital De Bogota
city: Pereira
country: Colombia
facility: Oncologos del Occidente S.A. ( Site 0310)
state: Risaralda
city: Cali
country: Colombia
facility: Centro Medico Imbanaco de Cali S.A ( Site 0300)
state: Valle Del Cauca
city: Nice
country: France
facility: Centre Antoine Lacassagne ( Site 0351)
state: Alpes-Maritimes
city: Marseille
country: France
facility: Hopital de la Timone ( Site 0356)
state: Bouches-du-Rhone
city: Toulouse
country: France
facility: Institut Claudius Regaud IUCT Oncopole ( Site 0355)
state: Haute-Garonne
city: Villejuif
country: France
facility: Institut Gustave Roussy ( Site 0353)
state: Val-de-Marne
city: Avignon
country: France
facility: Institut Sainte Catherine ( Site 0352)
state: Vaucluse
city: Paris
country: France
facility: Hopital Europeen Georges Pompidou ( Site 0358)
city: Paris
country: France
facility: Institut Curie ( Site 0350)
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen - Medizinische Klinik ( Site 0401)
state: Baden-Wurttemberg
city: Ulm
country: Germany
facility: Universitaetsklinikum Ulm ( Site 0402)
state: Baden-Wurttemberg
city: Erlangen
country: Germany
facility: Universitaetsklinikum Erlangen-Strahlenklinik ( Site 0412)
state: Bayern
city: Muenchen
country: Germany
facility: Klinikum rechts der Isar der Technischen Universitaet ( Site 0409)
state: Bayern
city: München
country: Germany
facility: Klinikum rechts der Isar der Technischen Universität München-HNO Klinik ( Site 0405)
state: Bayern
city: Frankfurt
country: Germany
facility: Universitaetsklinikum Frankfurt ( Site 0403)
state: Hessen
city: Kassel
country: Germany
facility: Klinikum Kassel GmbH ( Site 0404)
state: Hessen
city: Köln
country: Germany
facility: Universitaetsklinikum Koeln ( Site 0413)
state: Nordrhein-Westfalen
city: Luebeck
country: Germany
facility: Universitätsklinikum Schleswig-Holstein ( Site 0411)
state: Schleswig-Holstein
city: Gera
country: Germany
facility: SRH Wald-Klinikum Gera GmbH ( Site 0406)
state: Thuringen
city: Berlin
country: Germany
facility: Charite Universitätsmedizin Berlin Campus Benjamin Franklin ( Site 0414)
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg Eppendorf ( Site 0407)
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Onkoterapias Intezet ( Site 0452)
state: Baranya
city: Szolnok
country: Hungary
facility: Jász-Nagykun-Szolnok Vármegyei Hetényi Géza Kórház ( Site 0450)
state: Jasz-Nagykun-Szolnok
city: Budapest
country: Hungary
facility: Eszak-Pesti Centrumkorhaz-Honvedkorhaz ( Site 0453)
city: Budapest
country: Hungary
facility: Orszagos Onkologiai Intezet ( Site 0454)
city: Dublin
country: Ireland
facility: St. James s Hospital ( Site 0500)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Oncology Division ( Site 0550)
city: Jerusalem
country: Israel
facility: Hadassah Medical Center. Ein Kerem ( Site 0554)
city: Petah Tikva
country: Israel
facility: Rabin Medical Center ( Site 0552)
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center. ( Site 0553)
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center ( Site 0551)
city: Nagoya
country: Japan
facility: Aichi Cancer Center Hospital ( Site 0658)
state: Aichi
city: Kashiwa
country: Japan
facility: National Cancer Center Hospital East ( Site 0661)
state: Chiba
city: Akashi
country: Japan
facility: Hyogo Cancer Center ( Site 0656)
state: Hyogo
city: Kita-gun
country: Japan
facility: Kagawa University Hospital ( Site 0651)
state: Kagawa
city: Yokohama
country: Japan
facility: Yokohama City University Hospital ( Site 0657)
state: Kanagawa
city: Chiba
country: Japan
facility: Chiba Cancer Center ( Site 0652)
city: Fukuoka
country: Japan
facility: National Hospital Organization Kyushu Cancer Center ( Site 0660)
city: Hiroshima
country: Japan
facility: Hiroshima University Hospital ( Site 0655)
city: Tokyo
country: Japan
facility: National Cancer Center Hospital ( Site 0650)
city: Tokyo
country: Japan
facility: Tokyo Medical and Dental University Hospital ( Site 0654)
city: Tokyo
country: Japan
facility: Tokyo Medical University Hospital ( Site 0659)
city: Hwasun Gun
country: Korea, Republic of
facility: Chonnam National University Hwasun Hospital ( Site 0705)
state: Jeonranamdo
city: Goyang-si
country: Korea, Republic of
facility: National Cancer Center ( Site 0702)
state: Kyonggi-do
city: Gyeonggi-do
country: Korea, Republic of
facility: The Catholic University of Korea St. Vincent s Hospital ( Site 0704)
state: Kyonggi-do
city: Seongnam-si
country: Korea, Republic of
facility: Seoul National University Bundang Hospital ( Site 0703)
state: Kyonggi-do
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System ( Site 0701)
city: Lodz
country: Poland
facility: Wojewodzki Szpital Specjalistyczny im. M. Kopernika w Lodzi ( Site 0920)
state: Lodzkie
city: Krakow
country: Poland
facility: Szpital Specjalistyczny im. Ludwika Rydygiera w Krakowie ( Site 0905)
state: Malopolskie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie (
state: Mazowieckie
city: Gdynia
country: Poland
facility: Szpitale Pomorskie Sp. z o.o. ( Site 0935)
state: Pomorskie
city: Gliwice
country: Poland
facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0901)
state: Slaskie
city: Braga
country: Portugal
facility: Hospital de Braga ( Site 0951)
city: Lisboa
country: Portugal
facility: CHLN Hospital Santa Maria ( Site 0952)
city: Lisboa
country: Portugal
facility: Hospital CUF Descobertas ( Site 0953)
city: Porto
country: Portugal
facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 0950)
city: Moscow
country: Russian Federation
facility: N.N. Blokhin NMRCO ( Site 1005)
state: Moskva
city: Kazan
country: Russian Federation
facility: Republican Clinical Oncology Dispensary of Tatarstan MoH ( Site 1000)
state: Tatarstan, Respublika
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1001)
state: Yaroslavskaya Oblast
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol. ICO de Badalona ( Site 1204)
state: Barcelona
city: Hospitalet de Llobregat
country: Spain
facility: ICO L Hospitalet ( Site 1208)
state: Barcelona
city: Santiago de Compostela
country: Spain
facility: Hospital Clinico Universitario de Santiago ( Site 1207)
state: La Coruna
city: Barcelona
country: Spain
facility: Hospital Vall D Hebron ( Site 1200)
city: Madrid
country: Spain
facility: Hospital Universitario La Paz ( Site 1201)
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio ( Site 1206)
city: Zuerich
country: Switzerland
facility: Universitaetsspital Zurich ( Site 1923)
state: Aargau
city: Bellinzona
country: Switzerland
facility: Istituto Oncologica della Svizzera Italiana (IOSI) ( Site 1921)
state: Ticino
city: Geneve
country: Switzerland
facility: Hopitaux Universitaires de Geneve HUG ( Site 1920)
city: Kaohsiung
country: Taiwan
facility: Chang Gung Medical Foundation. Kaohsiung Branch ( Site 1303)
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital ( Site 1301)
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital ( Site 1302)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital ( Site 1300)
city: Dnipropetrovsk
country: Ukraine
facility: Dnipropetrovsk Regional Hospital n.a. I.I. Mechnikov ( Site 1709)
state: Dnipropetrovska Oblast
city: Dnipro
country: Ukraine
facility: Clinical oncology dispensary of Dnipro ( Site 1706)
state: Dnipropetrovska Oblast
city: Dnipro
country: Ukraine
facility: Municipal Non-Profit Enterprise City Clinical Hospital 4 of Dnipro City Council ( Site 1705)
state: Dnipropetrovska Oblast
city: Kropyvnitskiy
country: Ukraine
facility: Ukrainian Center of Tomotherapy ( Site 1708)
state: Kirovohradska Oblast
city: Kropyvnytskyi
country: Ukraine
facility: PP PPC Acinus Medical and Diagnostic Centre ( Site 1704)
state: Kirovohradska Oblast
city: Kapitanivka Village
country: Ukraine
facility: Medical Center of Yuriy Spizhenko LLC.-Clinical Trial ( Site 1703)
state: Kyivska Oblast
city: Kyiv
country: Ukraine
facility: National Cancer Institute of the MoH of Ukraine ( Site 1702)
state: Kyivska Oblast
city: Pliuty
country: Ukraine
facility: LISOD. Hospital ( Site 1707)
state: Kyiv
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Oncology Centre ( Site 1701)
city: Cambridge
country: United Kingdom
facility: Addenbrooke's Hospital ( Site 1610)
state: Cambridgeshire
city: Cottingham-Hull
country: United Kingdom
facility: Castle Hill Hospital ( Site 1601)
state: Kingston Upon Hull
city: London
country: United Kingdom
facility: Guy s & St Thomas NHS Foundation Trust ( Site 1604)
state: London, City Of
city: London
country: United Kingdom
facility: Royal Marsden Hospital - Fulham Road London ( Site 1609)
state: London, City Of
city: London
country: United Kingdom
facility: Imperial Healthcare NHS Trust Charing Cross Hospital ( Site 1603)
state: London, City Of
city: Sheffield
country: United Kingdom
facility: Weston Park Hospital ( Site 1607)
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: