Clinical trial NCT03833167: Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)
Official title: A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate Pembrolizumab Versus Placebo as Adjuvant Therapy Following Surgery and Radiation in Participants With High-risk Locally Advanced Cutaneous Squamous Cell Carcinoma (LA cSCC) (KEYNOTE-630)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Carcinoma, Squamous Cell
Keywords: Programmed Cell Death-1 (PD-1)
Programmed Cell Death 1
PD1
Programmed Cell Death Ligand 1 (PD-L1)
Programmed Cell Death Ligand 2 (PD-L2)
PDL1
PDL2
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2019-02-06
Enrollment: 450
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, double-blind, study that compares pembrolizumab (MK-3475) with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have undergone surgery with curative intent in combination with radiotherapy. The primary hypothesis is that pembrolizumab is superior to placebo in increasing recurrence free survival (RFS).


Eligibility criteria: Inclusion Criteria:

Inclusion Criteria include, but are not limited to:

* Has histologically confirmed cutaneous squamous cell carcinoma (cSCC) as the primary site of malignancy (metastatic skin involvement from another type of primary cancer or from an unknown primary cancer is not permitted)
* Has histologically confirmed locally advanced cutaneous squamous cell carcinoma (LA cSCC) with ≥1 high-risk feature(s) as the primary site of malignancy
* Has undergone complete macroscopic resection of all known cSCC disease with or without microscopic positive margins. For those participants with residual microscopic positive margin involvement, confirmation that additional re-excision is not possible must be provided
* Has completed adjuvant radiotherapy (RT) for LA cSCC with last dose of RT ≥4 weeks and ≤16 weeks from randomization
* Has received an adequate post-op dose of RT (either hypofractionated or conventional)
* Is disease free as assessed by the investigator with complete radiographic staging assessment ≤28 days from randomization
* Is not pregnant or breastfeeding
* Is not a person of childbearing potential (POCBP)
* Has a negative pregnancy test ≤72 hours before the first dose of study intervention.
* Has provided an archival or newly-obtained tumor tissue sample adequate for Programmed Cell Death Ligand 1 (PD-L1) testing as determined by central laboratory testing
* Has a life expectancy of \>3 months
* Has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 ≤10 days prior to the first dose of study intervention.

Exclusion Criteria:

Exclusion criteria include, but are not limited to:

* Has macroscopic residual cSCC after surgery and/or recurrence with active cSCC disease before randomization
* Has any other histologic type of skin cancer other than invasive cSCC (eg, basal cell carcinoma) that has not been definitively treated with surgery or radiation; Bowen's disease; Merkel cell carcinoma; or melanoma
* Has received prior therapy with an anti-programmed cell death receptor 1(PD-1), anti-PD-L1, or anti-programmed cell death receptor ligand 2 (PD-L2) agent or with an agent directed to another costimulatory or coinhibitory T-cell receptor (eg, cytotoxic T-lymphocyte-associated protein 4 \[CTLA-4\], OX-40, CD137)
* Has received prior systemic anticancer therapy including investigational agents for cSCC ≤4 weeks prior to before start of study intervention.
* Has not recovered from all radiation-related toxicities and has not had radiation pneumonitis
* Has received a live vaccine ≤30 days prior to the first dose of study intervention
* Has received an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study treatment.
* Has known additional malignancy that is progressing or has required active treatment within the past 2 years. Note: Participants with basal cell carcinoma of the skin, squamous cell carcinoma of the skin or carcinoma in situ, excluding carcinoma in situ of the bladder, that have undergone potentially curative therapy are not excluded. Other exceptions may be considered with Sponsor consultation. Note: Participants with low risk early-stage prostate cancer defined as below are not excluded: Stage T1c or T2a with a Gleason score ≤6 and a prostate-specific antigen (≤10 ng/ml) either treated with definitive intent or untreated in active surveillance that has been stable for the past year prior to study allocation. Early stage asymptomatic CLL without prior treatment and without any of the risk features (unmutated IGHV, lymphocytes \>15,000μL, palpable lymph nodes) will be eligible for the study
* Has an active autoimmune disease that has required systemic treatment in past 2 years except replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid).
* Has a history of (noninfectious) pneumonitis/interstitial lung disease that required steroids or has current pneumonitis/interstitial lung disease
* Has an active infection requiring systemic therapy
* Has a known history of human immunodeficiency virus (HIV) infection
* Has a known history of hepatitis B (defined as hepatitis B surface antigen \[HBsAg\] reactive) or known active hepatitis C virus (HCV; defined as HCV 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 allogeneic tissue/solid organ transplant

Primary outcomes:
measure: Recurrence-Free Survival (RFS) as Assessed by the Investigator and Confirmed by Biopsy
timeFrame: Up to approximately 62 months
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 62 months
measure: Change From Baseline in the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Score
timeFrame: Baseline and up to approximately 60 months
measure: Change From Baseline in Physical Functioning Using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) Items 1-5 Score
timeFrame: Baseline and up to approximately 60 months
measure: Percentage of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to approximately 63 months
measure: Percentage of Participants Who Discontinue Study Treatment Due to an Adverse Event (AE)
timeFrame: Up to approximately 38 months
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama, Mitchell Cancer Institute ( Site 1562)
state: Alabama
city: Duarte
country: United States
facility: City of Hope Medical Center ( Site 1505)
state: California
city: La Jolla
country: United States
facility: UCSD Moores Cancer Center ( Site 1561)
state: California
city: Los Angeles
country: United States
facility: UCLA Hematology/Oncology - Westwood (Building 100) ( Site 1568)
state: California
city: Sacramento
country: United States
facility: University of California Davis Comprehensive Cancer Center ( Site 1560)
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center ( Site 1503)
state: California
city: Aurora
country: United States
facility: University of Colorado Cancer Center ( Site 1506)
state: Colorado
city: New Haven
country: United States
facility: Smilow Cancer Center at Yale-New Haven ( Site 1507)
state: Connecticut
city: Boca Raton
country: United States
facility: Boca Raton Regional Hospital ( Site 1551)
state: Florida
city: Gainesville
country: United States
facility: UF Health ( Site 1511)
state: Florida
city: Miami
country: United States
facility: University of Miami Hospital and Clinics, Sylvester Cancer Center ( Site 1544)
state: Florida
city: Atlanta
country: United States
facility: Winship Cancer Institute of Emory University ( Site 1512)
state: Georgia
city: Indianapolis
country: United States
facility: Indiana University Melvin and Bren Simon Cancer Center ( Site 1515)
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospital and Clinics ( Site 1514)
state: Iowa
city: Lexington
country: United States
facility: University of Kentucky School of Medicine & Hospitals ( Site 1542)
state: Kentucky
city: Boston
country: United States
facility: Massachusetts General Hospital ( Site 1518)
state: Massachusetts
city: Boston
country: United States
facility: Dana Farber Cancer Center ( Site 1519)
state: Massachusetts
city: Hackensack
country: United States
facility: John Theurer Cancer Center at Hackensack University Medical Center ( Site 1526)
state: New Jersey
city: Lake Success
country: United States
facility: Northwell Health/ RJ Zuckerberg Cancer Center-Medical Oncology ( Site 1565)
state: New York
city: New York
country: United States
facility: Icahn School of Medicine at Mount Sinai ( Site 1575)
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic ( Site 1541)
state: Ohio
city: Portland
country: United States
facility: Providence Portland Medical Center ( Site 1530)
state: Oregon
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center ( Site 1570)
state: Pennsylvania
city: Charleston
country: United States
facility: MUSC Hollings Cancer Center ( Site 1533)
state: South Carolina
city: Germantown
country: United States
facility: West Cancer Center - East Campus ( Site 1535)
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Ingram Cancer Center ( Site 1543)
state: Tennessee
city: Houston
country: United States
facility: The University of Texas-MD Anderson Cancer Center ( Site 1536)
state: Texas
city: Salt Lake City
country: United States
facility: Huntsman Cancer Institute ( Site 1537)
state: Utah
city: Fairfax
country: United States
facility: Inova Schar Cancer Institute ( Site 1538)
state: Virginia
city: Morgantown
country: United States
facility: West Virginia University ( Site 1569)
state: West Virginia
city: Ciudad Autónoma de Buenos Aires
country: Argentina
facility: Centro de Investigaciones Metabólicas (CINME)-Oncology ( Site 0028)
state: Buenos Aires
city: Capital
country: Argentina
facility: Centro Medico Privado CEMAIC ( Site 0024)
state: Cordoba
city: Rosario
country: Argentina
facility: Fundacion Estudios Clinicos-Oncology ( Site 0026)
state: Santa Fe
city: Rosario
country: Argentina
facility: Centro Oncológico de Rosario ( Site 0003)
state: Santa Fe
city: Buenos Aires
country: Argentina
facility: Hospital Italiano- Sociedad Italiana de Beneficencia en Buenos Aires ( Site 0009)
city: Buenos Aires
country: Argentina
facility: CEMIC ( Site 0012)
city: Caba
country: Argentina
facility: Fundacion CIDEA ( Site 0001)
city: La Rioja
country: Argentina
facility: Centro Oncologico Riojano Integral ( Site 0002)
city: Santiago del Estero
country: Argentina
facility: Centro Oncologico Norte ( Site 0023)
city: Camperdown
country: Australia
facility: Chris OBrien Lifehouse ( Site 0051)
state: New South Wales
city: Lismore
country: Australia
facility: Lismore Base Hospital ( Site 0050)
state: New South Wales
city: Orange
country: Australia
facility: Orange Health Services ( Site 0053)
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital ( Site 0052)
state: New South Wales
city: Southport
country: Australia
facility: Gold Coast University Hospital ( Site 0054)
state: Queensland
city: Sunshine Coast
country: Australia
facility: Sunshine Coast University Private Hospital-Coastal Cancer Care ( Site 0056)
state: Queensland
city: Melbourne
country: Australia
facility: Alfred Health ( Site 0055)
state: Victoria
city: Fortaleza
country: Brazil
facility: Oncocentro Ceara ( Site 0108)
state: Ceara
city: Curitiba
country: Brazil
facility: Hospital Erasto Gaertner ( Site 0101)
state: Parana
city: Bento Goncalves
country: Brazil
facility: Hospital Tacchini ( Site 0111)
state: Rio Grande Do Sul
city: Ijui
country: Brazil
facility: ONCOSITE - Centro de Pesquisa Clinica em Oncologia ( Site 0100)
state: Rio Grande Do Sul
city: Lajeado
country: Brazil
facility: Hospital Bruno Born ( Site 0107)
state: Rio Grande Do Sul
city: Passo Fundo
country: Brazil
facility: Hospital Sao Vicente de Paulo ( Site 0105)
state: Rio Grande Do Sul
city: Rio de Janeiro
country: Brazil
facility: Instituto Nacional de Câncer José Alencar Gomes da Silva - INCA-Pesquisa Clinica HC II ( Site 0103)
city: Sao Paulo
country: Brazil
facility: A. C. Camargo Cancer Center ( Site 0116)
city: Calgary
country: Canada
facility: Tom Baker Cancer Center ( Site 0161)
state: Alberta
city: Edmonton
country: Canada
facility: Cross Cancer Institute ( Site 0159)
state: Alberta
city: Hamilton
country: Canada
facility: Juravinski Cancer Center ( Site 0151)
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital Cancer Centre ( Site 0154)
state: Ontario
city: Montreal
country: Canada
facility: CIUSSS de l'Est-de-l'Île-de-Montréal ( Site 0163)
state: Quebec
city: Montréal
country: Canada
facility: McGill University Health Centre ( Site 0162)
state: Quebec
city: Temuco
country: Chile
facility: James Lind Centro de Investigación del Cáncer ( Site 1653)
state: Araucania
city: Santiago
country: Chile
facility: Enroll SpA ( Site 1654)
state: Region M. De Santiago
city: Santiago
country: Chile
facility: Bradfordhill ( Site 1651)
state: Region M. De Santiago
city: Antofagasta
country: Chile
facility: Bradford Hill Norte ( Site 1652)
city: Monteria
country: Colombia
facility: Oncomedica S.A. ( Site 0205)
state: Cordoba
city: Bogota
country: Colombia
facility: Sociedad de Cirugía de Bogotá - Hospital de San Jose ( Site 0201)
state: Distrito Capital De Bogota
city: Bogota
country: Colombia
facility: Instituto Nacional de Cancerologia E.S.E ( Site 0204)
state: Distrito Capital De Bogota
city: Pereira
country: Colombia
facility: Oncologos del Occidente S.A. ( Site 0206)
state: Risaralda
city: Piedecuesta
country: Colombia
facility: Fundación Cardiovascular de Colombia ( Site 0207)
state: Santander
city: Cali
country: Colombia
facility: Fundación Valle del Lili ( Site 0202)
state: Valle Del Cauca
city: Nice
country: France
facility: Hopital ARCHET 2 ( Site 0356)
state: Alpes-Maritimes
city: Marseille
country: France
facility: Hopital Saint Joseph ( Site 0376)
state: Bouches-du-Rhone
city: Marseille
country: France
facility: Hopital La Timone ( Site 0353)
state: Bouches-du-Rhone
city: Caen
country: France
facility: Centre Hospitalier Universitaire de Caen Normandie-DERMATOLOGY ( Site 0365)
state: Calvados
city: Besancon
country: France
facility: CHU Besancon - Hopital Jean Minjoz ( Site 0359)
state: Doubs
city: Valence
country: France
facility: Centre Hospitalier de Valence ( Site 0377)
state: Drome
city: Nimes
country: France
facility: C.H.U. de Nimes. Hopital Caremeau ( Site 0368)
state: Gard
city: Bordeaux
country: France
facility: CHU de Bordeaux- Hopital Saint Andre ( Site 0370)
state: Gironde
city: Toulouse
country: France
facility: Institut Claudius Regaud IUCT Oncopole ( Site 0354)
state: Haute-Garonne
city: Pringy
country: France
facility: Centre Hospitalier Annecy Genevois ( Site 0361)
state: Haute-Savoie
city: Montpellier
country: France
facility: CHU Montpellier. ( Site 0367)
state: Herault
city: Lille
country: France
facility: CHRU de Lille - Hopital Claude Huriez ( Site 0355)
state: Nord
city: Clermont-Ferrand
country: France
facility: CHU Estaing ( Site 0360)
state: Puy-de-Dome
city: Pierre Benite
country: France
facility: CH Lyon Sud Hospices Civils de Lyon ( Site 0350)
state: Rhone
city: Bobigny
country: France
facility: Hopital Avicenne ( Site 0358)
state: Seine-Saint-Denis
city: Villejuif
country: France
facility: Institut Gustave Roussy ( Site 0352)
state: Val-de-Marne
city: Poitiers
country: France
facility: CHU Poitiers ( Site 0375)
state: Vienne
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen ( Site 0409)
state: Baden-Wurttemberg
city: Nürnberg
country: Germany
facility: Klinikum Nürnberg Nord ( Site 0415)
state: Bayern
city: Marburg
country: Germany
facility: Universitatsklinikum Giessen und Marburg GmbH ( Site 0413)
state: Hessen
city: Buxtehude
country: Germany
facility: Elbe Kliniken Stade-Buxtehude, Klinikum Buxtehude-Dermatologisches Zentrum ( Site 0411)
state: Niedersachsen
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover ( Site 0405)
state: Niedersachsen
city: Essen
country: Germany
facility: Universitaetsklinikum Essen ( Site 0403)
state: Nordrhein-Westfalen
city: Berlin
country: Germany
facility: Universitaetsklinikum Berlin - Charite - Campus Mitte ( Site 0400)
city: Hamburg
country: Germany
facility: Universitaetsklinikum Hamburg-Eppendorf ( Site 0414)
city: Athens
country: Greece
facility: Andreas Syggros Hospital ( Site 0450)
state: Achaia
city: Chaidari
country: Greece
facility: Attikon University General Hospital of Athens ( Site 0454)
state: Attiki
city: Neo Faliro
country: Greece
facility: Metropolitan Hospital ( Site 0453)
state: Attiki
city: Thessaloniki
country: Greece
facility: Papageorgiou General Hospital ( Site 0451)
city: Thessaloniki
country: Greece
facility: European Interbalkan Medical Center ( Site 0455)
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem AOK ( Site 0501)
state: Baranya
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem ( Site 0504)
state: Csongrad
city: Nyiregyhaza
country: Hungary
facility: Szabolcs Szatmar Bereg Megyei Korhazak es Egyetemi Oktatokorhaz ( Site 0500)
state: Szabolcs-Szatmar-Bereg
city: Debrecen
country: Hungary
facility: Debreceni Egyetem. ( Site 0506)
state: Vas
city: Budapest
country: Hungary
facility: Semmelweis Egyetem ( Site 0507)
city: Budapest
country: Hungary
facility: Szent Imre Egyetemi Oktatokorhaz ( Site 0502)
city: Dublin 8
country: Ireland
facility: St. James s Hospital ( Site 1601)
state: Dublin
city: Beer Sheva
country: Israel
facility: Soroka University Medical Center ( Site 0555)
city: Haifa
country: Israel
facility: Rambam Health Care Campus-Oncology Division ( Site 0552)
city: Jerusalem
country: Israel
facility: Haddassah Medical Organization - Ein Kerem ( Site 0553)
city: Kfar-Saba
country: Israel
facility: Meir Medical Center ( Site 0556)
city: Petah Tiqwa
country: Israel
facility: Rabin Medical Center ( Site 0550)
city: Ramat Gan
country: Israel
facility: Chaim Sheba Medical Center ( Site 0551)
city: Tel-Aviv
country: Israel
facility: Sourasky Medical Center ( Site 0554)
city: Bari
country: Italy
facility: Instituto Tumori Giovanni Paolo II ( Site 0604)
state: Puglia
city: Pisa
country: Italy
facility: Azienda Ospedaliero Universitaria Pisana ( Site 0603)
state: Toscana
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Nazionale dei Tumori di Milano ( Site 0600)
city: Milano
country: Italy
facility: Istituto Europeo di Oncologia ( Site 0602)
city: Napoli
country: Italy
facility: Istituto Nazionale Tumori IRCCS Fondazione Pascale ( Site 0601)
city: Tuxtla Gutierrez
country: Mexico
facility: San Lucas Cardiologica del Sureste S.A de C.V. ( Site 0722)
state: Chiapas
city: Torreon
country: Mexico
facility: Cimab SA de CV ( Site 0708)
state: Coahuila
city: Torreón
country: Mexico
facility: Centro de Investigación Clínica de Alta Especialidad ( Site 0715)
state: Coahuila
city: Guadalajara
country: Mexico
facility: Onco-Hematologia de Occidente ( Site 0716)
state: Jalisco
city: Guadalajara
country: Mexico
facility: Hospital de Especialidades Centro Medico de Occidente ( Site 0704)
state: Jalisco
city: Guadalajara
country: Mexico
facility: Consultorios de Medicina Especializada del Sector Privado ( Site 0701)
state: Jalisco
city: Merida
country: Mexico
facility: Centro de atencion e investigacion clinica en oncologia ( Site 0706)
state: Yucatan
city: Chihuahua
country: Mexico
facility: Centro Estatal de Cancerologia de Chihuahua ( Site 0703)
city: Veracruz
country: Mexico
facility: FAICIC Clinical Research ( Site 0700)
city: Auckland
country: New Zealand
facility: New Zealand Clinical Research (Auckland) ( Site 0800)
city: Bergen
country: Norway
facility: Haukeland sykehus ( Site 0851)
state: Hordaland
city: Trondheim
country: Norway
facility: St. Olavs Hospital HF ( Site 0852)
state: Sor-Trondelag
city: Oslo
country: Norway
facility: Oslo Universitetssykehus Radiumhospitalet ( Site 0850)
city: Krakow
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Oddzial w Krakowie ( Site 0959)
state: Malopolskie
city: Warszawa
country: Poland
facility: Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie ( Site 0951)
state: Mazowieckie
city: Gdańsk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne-Klinika Chirurgii Onkologicznej, Transplantacyjnej i Ogólnej ( Site
state: Pomorskie
city: Gliwice
country: Poland
facility: Narodowy Instytut Onkologii - Oddzial w Gliwicach ( Site 0958)
state: Slaskie
city: Faro
country: Portugal
facility: Hospital Particular do Algarve ( Site 1005)
city: Lisboa
country: Portugal
facility: Instituto Portugues de Oncologia de Lisboa ( Site 1003)
city: Lisboa
country: Portugal
facility: Hospital CUF - Tejo ( Site 1004)
city: Lisboa
country: Portugal
facility: CHLN Hospital Santa Maria ( Site 1001)
city: Porto
country: Portugal
facility: Inst. Portugues de Oncologia de Porto Francisco Gentil EPE ( Site 1000)
city: Oradea
country: Romania
facility: S C Pelican Impex SRL ( Site 1108)
state: Bihor
city: Bucharest
country: Romania
facility: Hifu Terramed Conformal SRL ( Site 1111)
state: Bucuresti
city: Cluj-Napoca
country: Romania
facility: Cardiomed SRL Cluj-Napoca ( Site 1104)
state: Cluj
city: Cluj-Napoca
country: Romania
facility: Institutul Oncologic Prof.Dr. Ion Chiricuta Cluj-Napoca ( Site 1113)
state: Cluj
city: Cluj-Napoca
country: Romania
facility: Spitalul Universitar CF Cluj-Napoca ( Site 1103)
state: Cluj
city: Craiova
country: Romania
facility: S.C. Centrul de Oncologie Sf. Nectarie SRL ( Site 1101)
state: Dolj
city: Timisoara
country: Romania
facility: S C Oncocenter Oncologie Medicala S R L ( Site 1106)
state: Timis
city: Timisoara
country: Romania
facility: Policlinica Oncomed SRL ( Site 1105)
state: Timis
city: Bucuresti
country: Romania
facility: S.C.Focus Lab Plus S.R.L ( Site 1107)
city: Bucuresti
country: Romania
facility: Spitalul de Psihiatrie Titan Dr. Constantin Gorgos ( Site 1112)
city: WBarnaularsaw
country: Russian Federation
facility: Altay Regional Oncology Dispensary ( Site 1168)
state: Altayskiy Kray
city: Ufa
country: Russian Federation
facility: GBUZ Republican Clinical Oncological Dispensary-Antitumor drug therapy department ( Site 1171)
state: Baskortostan, Respublika
city: Obninsk
country: Russian Federation
facility: A. Tsyb Medical Radiological Research Center - branch of the National Medical Research Radiological
state: Kaluzskaja Oblast
city: Sochi
country: Russian Federation
facility: Oncological Dispensary #2 of Ministry of Health of Krasnodar region ( Site 1159)
state: Krasnodarskiy Kray
city: Moscow
country: Russian Federation
facility: Hadassah Medical-Oncology department ( Site 1173)
state: Moskovskaya Oblast
city: Moscow
country: Russian Federation
facility: N.N. Blokhin NMRCO ( Site 1153)
state: Moskva
city: Moscow
country: Russian Federation
facility: FSCC FMBA of Russia ( Site 1163)
state: Moskva
city: Moscow
country: Russian Federation
facility: First Moscow State Medical University n.a. I.M.Sechenov ( Site 1164)
state: Moskva
city: Nizhny Novgorod
country: Russian Federation
facility: Nizhniy Novgorod regional clinical oncological dispensary ( Site 1169)
state: Nizhegorodskaya Oblast
city: Saint Petersburg
country: Russian Federation
facility: Railway Hospital of OJSC ( Site 1161)
state: Sankt-Peterburg
city: Izhevsk
country: Russian Federation
facility: Udmurtia Republic Regional Clinical Oncology Dispensary ( Site 1158)
state: Udmurtskaya Respublika
city: Yaroslavl
country: Russian Federation
facility: Yaroslavl Regional SBIH Clinical Oncology Hospital ( Site 1152)
state: Yaroslavskaya Oblast
city: Hospitalet del Llobregat
country: Spain
facility: Hospital Duran i Reynals ( Site 1254)
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marques de Valdecilla ( Site 1256)
state: Cantabria
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial Barcelona ( Site 1253)
state: Cataluna
city: Doniostia - San Sebastian
country: Spain
facility: Onkologikoa - Instituto Oncologico de San Sebastian ( Site 1258)
state: Gipuzkoa
city: Barcelona
country: Spain
facility: Hospital General Universitari Vall d Hebron ( Site 1252)
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal ( Site 1251)
city: Malaga
country: Spain
facility: Hospital Universitario Carlos Haya ( Site 1255)
city: Ivano-Frankivsk
country: Ukraine
facility: Communal Non-Commercial Enterprise "Prykarpatski Clinical On-Department for daily treated patient (
state: Ivano-Frankivska Oblast
city: Kharkiv
country: Ukraine
facility: Institute of General and Emergency Surgery named after V.T. Zaitsev NAMS of Ukraine ( Site 1450)
state: Kharkivska Oblast
city: Kropyvnytskyi
country: Ukraine
facility: Limited Liability Company Ukrainian Center of Tomotherapy-Department of Chemotherapy ( Site 1451)
state: Kirovohradska Oblast
city: Sumy
country: Ukraine
facility: Sumy regional clinical oncological dispensary-Oncothoracic department ( Site 1452)
state: Sumska Oblast
city: Kyiv
country: Ukraine
facility: Universal Clinic Oberig-Oncology Center ( Site 1461)
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospitals NHS Trust ( Site 1402)
state: Cornwall
city: London
country: United Kingdom
facility: University College Hospital London ( Site 1400)
state: London, City Of
city: London
country: United Kingdom
facility: Guy s & St Thomas NHS Foundation Trust ( Site 1407)
state: London, City Of
city: London
country: United Kingdom
facility: The Royal Marsden Hospital-Institute of Cancer Research ( Site 1406)
state: London, City Of
city: Sutton
country: United Kingdom
facility: Royal Marsden NHS Foundation Trust ( Site 1408)
state: London, City Of
city: Oxford
country: United Kingdom
facility: Churchill Hospital ( Site 1404)
state: Oxfordshire
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: