Clinical trial NCT05855200: Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
Official title: A Phase 3, Open-Label, Randomized Study of Perioperative Dostarlimab Monotherapy Versus Standard of Care in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Colonic Neoplasms
Neoplasms, Colon
Keywords: JEMPERLI
Dostarlimab
dostarlimab-gxly
TSR-042
GSK4057190A
FOLFOX
CAPEOX
Colon Cancer
Resectable colon cancer
dMMR/MSI
Perioperative
Neoadjuvant
Adjuvant
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2023-05-11
Enrollment: 711
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 primary purpose of this study is to evaluate the efficacy of perioperative dostarlimab compared with standard of care (SOC) in participants with untreated T4N0 or Stage III (resectable), defective mismatch repair/ microsatellite instability high (dMMR/MSI-H) colon cancer.


Eligibility criteria: Inclusion Criteria:

* Has untreated pathologically confirmed colon adenocarcinoma
* Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III
* Has radiologically evaluable disease
* Has a tumor demonstrating the presence of either dMMR status or MSI-H

Exclusion Criteria:

* Has distant metastatic disease.
* Has received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of colon cancer
* Has a tumor that, in the investigator's judgment is causing symptomatic bowel obstruction or otherwise requires urgent/emergent surgery
* Has undergone any major surgical procedure, open biopsy, or experienced significant traumatic injury within 28 days prior to randomization
* Has any history of interstitial lung disease or pneumonitis
* Has cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal/gastric varices, or persistent jaundice
* Has a history of allogenic stem cell transplantation or organ transplantation
* Is receiving any other anticancer or experimental therapy. No other experimental therapies (including but not limited to chemotherapy, radiation, hormonal treatment, antibody therapy, immunotherapy, gene therapy, vaccine therapy, or other experimental drugs) of any kind are permitted while the participant is receiving study intervention
* Is pregnant, breastfeeding, or expecting to conceive children within the projected duration of the study
* Has a history of severe allergic and/or anaphylactic reactions to chimeric, human or humanized antibodies, fusion proteins, or known allergies to dostarlimab, or its excipients, or any components of FOLFOX or CAPEOX

Primary outcomes:
measure: Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)
timeFrame: Up to approximately 5 years
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to approximately 5 years
measure: Number of Participants with Pathological Response
timeFrame: Up to approximately 5 years
measure: Event-free Survival (EFS) assessed by local assessment
timeFrame: Up to approximately 5 years
measure: Number of Participants with treatment emergent adverse events (AEs), serious adverse events (SAEs), Immune-mediated Adverse Event (imAEs), AEs leading to death and AEs leading to discontinuation of study treatment
timeFrame: Up to approximately 5 years
measure: Number of Participants with AEs and SAEs by Severity
timeFrame: Up to approximately 5 years
measure: Serum Concentration of Dostarlimab
timeFrame: Predose and End of Infusion (EoI) of Cycle 1 and EoI of Cycle 2 to Cycle 10 (each cycle is of 21 days)
measure: Serum Concentration of Dostarlimab at End of Infusion (C-EoI)
timeFrame: End of Infusion (EoI) of Cycle 1 to Cycle 10 (each cycle is of 21 days)
measure: Serum Predose trough concentration (Ctrough) of Dostarlimab
timeFrame: Predose of Cycle 1 to Cycle 10 (each cycle is of 21 days)
measure: Number of Participants with Anti-Drug Antibodies against Dostarlimab
timeFrame: Up to approximately 5 years
Other outcomes:
Locations:
city: Tucson
country: United States
facility: GSK Investigational Site
state: Arizona
city: Los Angeles
country: United States
facility: GSK Investigational Site
state: California
city: New Haven
country: United States
facility: GSK Investigational Site
state: Connecticut
city: Washington
country: United States
facility: GSK Investigational Site
state: District of Columbia
city: Deerfield Beach
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state: Florida
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facility: GSK Investigational Site
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state: Georgia
city: Chicago
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city: Naperville
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state: Illinois
city: Westwood
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state: Kentucky
city: Louisville
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city: Baton Rouge
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facility: GSK Investigational Site
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state: Michigan
city: Detroit
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city: Saint Louis
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facility: GSK Investigational Site
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city: Saint Louis
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facility: GSK Investigational Site
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city: Omaha
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city: Omaha
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city: Lebanon
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state: New Hampshire
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state: New York
city: New York
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state: New York
city: New York
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facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: New York
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facility: GSK Investigational Site
state: New York
city: New York
country: United States
facility: GSK Investigational Site
state: New York
city: Durham
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state: North Carolina
city: Greenville
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facility: GSK Investigational Site
state: North Carolina
city: Akron
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facility: GSK Investigational Site
state: Ohio
city: Cincinnati
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facility: GSK Investigational Site
state: Ohio
city: Cleveland
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facility: GSK Investigational Site
state: Ohio
city: Cleveland
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facility: GSK Investigational Site
state: Ohio
city: Cleveland
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facility: GSK Investigational Site
state: Ohio
city: Oklahoma City
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facility: GSK Investigational Site
state: Oklahoma
city: Oklahoma City
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facility: GSK Investigational Site
state: Oklahoma
city: Pittsburgh
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facility: GSK Investigational Site
state: Pennsylvania
city: Wynnewood
country: United States
facility: GSK Investigational Site
state: Pennsylvania
city: Sioux Falls
country: United States
facility: GSK Investigational Site
state: South Dakota
city: Sioux Falls
country: United States
facility: GSK Investigational Site
state: South Dakota
city: Sioux Falls
country: United States
facility: GSK Investigational Site
state: South Dakota
city: Sioux Falls
country: United States
facility: GSK Investigational Site
state: South Dakota
city: Nashville
country: United States
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state: Tennessee
city: Dallas
country: United States
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state: Texas
city: Dallas
country: United States
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state: Texas
city: Richmond
country: United States
facility: GSK Investigational Site
state: Virginia
city: Appleton
country: United States
facility: GSK Investigational Site
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Buenos Aires
country: Argentina
facility: GSK Investigational Site
city: Capital Federal
country: Argentina
facility: GSK Investigational Site
city: Ciudad Autonoma de Buenos Aire
country: Argentina
facility: GSK Investigational Site
city: Cordoba
country: Argentina
facility: GSK Investigational Site
city: Mar del Plata
country: Argentina
facility: GSK Investigational Site
city: Rosario
country: Argentina
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city: Santa Fe
country: Argentina
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city: Heidelberg
country: Australia
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city: Melbourne
country: Australia
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city: Newcastle
country: Australia
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city: St Leonards
country: Australia
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country: Australia
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city: Aalst
country: Belgium
facility: GSK Investigational Site
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Bruxelles
country: Belgium
facility: GSK Investigational Site
city: Edegem
country: Belgium
facility: GSK Investigational Site
city: Gent
country: Belgium
facility: GSK Investigational Site
city: Leuven
country: Belgium
facility: GSK Investigational Site
city: LiEge
country: Belgium
facility: GSK Investigational Site
city: Roeselare
country: Belgium
facility: GSK Investigational Site
city: Barretos
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facility: GSK Investigational Site
city: Lages
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facility: GSK Investigational Site
city: Natal
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facility: GSK Investigational Site
city: Porto Alegre
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facility: GSK Investigational Site
city: Salvador
country: Brazil
facility: GSK Investigational Site
city: Sao Jose do Rio Preto
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facility: GSK Investigational Site
city: Sao Paulo
country: Brazil
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city: Sao Paulo
country: Brazil
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city: VitOria
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city: Edmonton
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city: Montreal
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country: China
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city: Beijing
country: China
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country: China
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city: Changchun
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city: Changsha
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facility: GSK Investigational Site
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country: China
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city: Guangzhou
country: China
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city: Guangzhou
country: China
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city: Hangzhou
country: China
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city: Hangzhou
country: China
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city: Hangzhou
country: China
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city: Hangzhou
country: China
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city: Harbin
country: China
facility: GSK Investigational Site
city: Jinan
country: China
facility: GSK Investigational Site
city: Kunming
country: China
facility: GSK Investigational Site
city: Meizhou
country: China
facility: GSK Investigational Site
city: Nanchang
country: China
facility: GSK Investigational Site
city: Nanchang
country: China
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city: Shanghai
country: China
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city: Shanghai
country: China
facility: GSK Investigational Site
city: Shenyang
country: China
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city: Shenzhen
country: China
facility: GSK Investigational Site
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facility: GSK Investigational Site
city: Tianjin
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city: Wuhan
country: China
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city: Xiamen
country: China
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country: China
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city: Tallinn
country: Estonia
facility: GSK Investigational Site
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country: Estonia
facility: GSK Investigational Site
city: Tartu
country: Estonia
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city: Helsinki
country: Finland
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city: Tampere
country: Finland
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city: Turku
country: Finland
facility: GSK Investigational Site
city: Lyon
country: France
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city: Marseille Cedex 5
country: France
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city: Nantes cedex 1
country: France
facility: GSK Investigational Site
city: Paris
country: France
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city: Pessac cedex
country: France
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city: Rennes Cedex
country: France
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city: Rouen Cedex
country: France
facility: GSK Investigational Site
city: Saint-Priest en Jarez
country: France
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city: Suresnes
country: France
facility: GSK Investigational Site
city: Toulouse Cedex 9
country: France
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city: Villejuif Cedex
country: France
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city: Berlin
country: Germany
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city: Duesseldorf
country: Germany
facility: GSK Investigational Site
city: Frankfurt
country: Germany
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city: Halle
country: Germany
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city: Luebeck
country: Germany
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city: Mannheim
country: Germany
facility: GSK Investigational Site
city: MUnchen
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city: Munchen
country: Germany
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city: Athens
country: Greece
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city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Cagliari
country: Italy
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city: Genova
country: Italy
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city: Milano
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city: Napoli
country: Italy
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city: Padova
country: Italy
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city: Pisa
country: Italy
facility: GSK Investigational Site
city: Reggio Emilia
country: Italy
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city: Roma
country: Italy
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city: Roma
country: Italy
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city: Rozzano MI
country: Italy
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city: Aichi
country: Japan
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city: Chiba
country: Japan
facility: GSK Investigational Site
city: Fukuoka
country: Japan
facility: GSK Investigational Site
city: Hokkaido
country: Japan
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city: Hyogo
country: Japan
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city: Ibaraki
country: Japan
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city: Kanagawa
country: Japan
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city: Kanagawa
country: Japan
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city: Kyoto
country: Japan
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city: Okayama
country: Japan
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city: Osaka
country: Japan
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city: Osaka
country: Japan
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city: Osaka
country: Japan
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city: Osaka
country: Japan
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city: Shizuoka
country: Japan
facility: GSK Investigational Site
city: Tokyo
country: Japan
facility: GSK Investigational Site
city: Daegu
country: Korea, Republic of
facility: GSK Investigational Site
city: Gyeonggi-do
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: Seoul
country: Korea, Republic of
facility: GSK Investigational Site
city: DF
country: Mexico
facility: GSK Investigational Site
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
city: Guadalajara
country: Mexico
facility: GSK Investigational Site
city: Mexico City
country: Mexico
facility: GSK Investigational Site
city: Oaxaca
country: Mexico
facility: GSK Investigational Site
city: San Pedro Garza Garcia
country: Mexico
facility: GSK Investigational Site
city: Tijuana
country: Mexico
facility: GSK Investigational Site
city: Breda
country: Netherlands
facility: GSK Investigational Site
city: Maastricht
country: Netherlands
facility: GSK Investigational Site
city: Nijmegen
country: Netherlands
facility: GSK Investigational Site
city: Utrecht
country: Netherlands
facility: GSK Investigational Site
city: Bergen
country: Norway
facility: GSK Investigational Site
city: Drammen
country: Norway
facility: GSK Investigational Site
city: Kristiansand
country: Norway
facility: GSK Investigational Site
city: Lrenskog
country: Norway
facility: GSK Investigational Site
city: Oslo
country: Norway
facility: GSK Investigational Site
city: Stavanger
country: Norway
facility: GSK Investigational Site
city: Tromsoe
country: Norway
facility: GSK Investigational Site
city: Punta Pacifica Panama City Panama
country: Panama
facility: GSK Investigational Site
city: Almada
country: Portugal
facility: GSK Investigational Site
city: Coimbra
country: Portugal
facility: GSK Investigational Site
city: Lisboa
country: Portugal
facility: GSK Investigational Site
city: BaracaldoVizcaya
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: Barcelona
country: Spain
facility: GSK Investigational Site
city: COrdoba
country: Spain
facility: GSK Investigational Site
city: Elche Alicante
country: Spain
facility: GSK Investigational Site
city: Granada
country: Spain
facility: GSK Investigational Site
city: JaEn
country: Spain
facility: GSK Investigational Site
city: L'Hospitalet De Llobrega
country: Spain
facility: GSK Investigational Site
city: Las Palmas De Gran Canar
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: Madrid
country: Spain
facility: GSK Investigational Site
city: MAlaga
country: Spain
facility: GSK Investigational Site
city: Oviedo
country: Spain
facility: GSK Investigational Site
city: Pamplona
country: Spain
facility: GSK Investigational Site
city: San Sebastian
country: Spain
facility: GSK Investigational Site
city: Santander
country: Spain
facility: GSK Investigational Site
city: Sevilla
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Valencia
country: Spain
facility: GSK Investigational Site
city: Zaragoza
country: Spain
facility: GSK Investigational Site
city: Eskilstuna
country: Sweden
facility: GSK Investigational Site
city: Goteborg
country: Sweden
facility: GSK Investigational Site
city: Linkoping
country: Sweden
facility: GSK Investigational Site
city: Malmo
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Stockholm
country: Sweden
facility: GSK Investigational Site
city: Umea
country: Sweden
facility: GSK Investigational Site
city: Uppsala
country: Sweden
facility: GSK Investigational Site
city: Kaohsiung
country: Taiwan
facility: GSK Investigational Site
city: Tainan
country: Taiwan
facility: GSK Investigational Site
city: Taipei
country: Taiwan
facility: GSK Investigational Site
city: Taoyuan
country: Taiwan
facility: GSK Investigational Site
city: Ankara
country: Turkey
facility: GSK Investigational Site
city: Ankara
country: Turkey
facility: GSK Investigational Site
city: Istanbul
country: Turkey
facility: GSK Investigational Site
city: Birmingham
country: United Kingdom
facility: GSK Investigational Site
city: Chelmsford
country: United Kingdom
facility: GSK Investigational Site
city: Cheltenham
country: United Kingdom
facility: GSK Investigational Site
city: Edinburgh
country: United Kingdom
facility: GSK Investigational Site
city: Hull
country: United Kingdom
facility: GSK Investigational Site
city: Leeds West Yorkshire
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: London
country: United Kingdom
facility: GSK Investigational Site
city: Manchester
country: United Kingdom
facility: GSK Investigational Site
city: Sutton
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: