Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer (AZUR-2)

February 18, 2024 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

711

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1181ACH
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Dolores Gomez Bradley
        • Contact:
        • Contact:
      • Buenos Aires, Argentina, 1093
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guillermo Mendez
      • Cordoba, Argentina, 5000
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Stefano Kim
        • Contact:
        • Contact:
      • Santa Fe, Argentina, S3000FUJ
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Lucas Pratta
        • Contact:
        • Contact:
    • Buenos Aires
      • Capital Federal, Buenos Aires, Argentina, C1426ANZ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Federico Esteso
      • Ciudad de Buenos Aires, Buenos Aires, Argentina, C1431FWO
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Julieta Grasselli
      • Mar del Plata, Buenos Aires, Argentina, 7600
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marcos Ariel Flores
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2002
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Miriam Raimondo
  • Australia
      • Melbourne, Australia, VIC 3004
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Benjamin Markman
    • New South Wales
      • St Leonards, New South Wales, Australia, 2065
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Connie Diakos
        • Contact:
        • Contact:
      • Waratah, New South Wales, Australia, 2298
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andre Van Der Westhuizen
    • Queensland
      • Woolloongabba, Queensland, Australia, 4102
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kate Roberts
    • Victoria
      • Heidelberg, Victoria, Australia, 3084
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Niall Tebbutt
        • Contact:
        • Contact:
  • Belgium
      • Aalst, Belgium, 9300
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Koenraad A.M. (Koen) Hendrickx
      • Anderlecht, Belgium, 1070
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Francesco Sclafani
        • Contact:
        • Contact:
      • Bruxelles, Belgium, 1200
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Marc Van den Eynde
        • Contact:
        • Contact:
      • Edegem, Belgium, 2650
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hans Prenen
      • Gent, Belgium, 9000
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Karen Geboes
        • Contact:
        • Contact:
      • Leuven, Belgium, 3000
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sabine Tejpar
        • Contact:
        • Contact:
      • Liège, Belgium, 4000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joëlle Collignon
      • Roeselare, Belgium, 8800
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sofie De Meulder
  • Brazil
      • São Paulo, Brazil, 01509-010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rachel Riechelmann
      • São Paulo, Brazil, 04312903
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Ignez Braghiroli
    • Bahia
      • Salvador, Bahia, Brazil, 40414-120
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Livia Maria Andrade
    • Espírito Santo
      • Vitória, Espírito Santo, Brazil, 29043-260
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Glaucio Antonio Bertollo
    • Piauí
      • Teresina, Piauí, Brazil, 64049-200
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Claudio Henrique Lima Rocha
    • Rio Grande Do Norte
      • Natal, Rio Grande Do Norte, Brazil, 59075-740
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sulene Oliveira
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gabriel Prolla
    • Santa Catarina
      • Lages, Santa Catarina, Brazil, 88501-001
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maite de Liz Vassen Schurmann
    • São Paulo
      • Barretos, São Paulo, Brazil, 14784-400
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Arinilda Campos Bragagnoli
        • Contact:
        • Contact:
      • Sao Jose do Rio Preto, São Paulo, Brazil, 15090-000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kathia Cristina Abdalla
  • Canada
      • Halifax, Canada, B3H 1V7
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Katerina Neumann
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jennifer Spratlin
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Rebecca Auer
        • Contact:
        • Contact:
      • Toronto, Ontario, Canada, M5G 2M9
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eric Chen
    • Quebec
      • Montreal, Quebec, Canada, H4A 3J1
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jamil Asselah
  • Estonia
      • Tallinn, Estonia, 13419
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anneli Elme
      • Tallinn, Estonia, 11312
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vivian Esko
      • Tartu, Estonia, 50501
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andrus Magi
  • Finland
      • Helsinki, Finland, 00029
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Siru Makela
      • Tampere, Finland, 33520
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tapio Salminen
      • Turku, Finland, 20521
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eetu Heerva
  • France
      • Lyon, France, 69008
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pascal Artru
      • Marseille Cedex 5, France, 13385
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Laetitia Dahan
      • Nantes, France, 44093
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Yann Touchefeu
        • Contact:
        • Contact:
      • Nice Cedex 2, France, 06189
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ludovic Evesque
      • Paris, France, 75015
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Claire Gallois
      • Pessac cedex, France, 33604
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Denis Smith
        • Contact:
        • Contact:
      • Rennes Cedex, France, 35042
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Julien EDELINE
        • Contact:
        • Contact:
      • Rouen, France, 76000
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Frederic Di Fiore
        • Contact:
        • Contact:
      • Saint-Priest en Jarez, France, 42270
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jean-Marc Phelip
        • Contact:
        • Contact:
      • Suresnes, France, 92150
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Asmahane Benmaziane
      • Toulouse Cedex 9, France, 31059
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Rosine Guimbaud
        • Contact:
        • Contact:
      • Villejuif Cedex, France, 94805
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Michel Ducreux
        • Contact:
        • Contact:
  • Germany
      • Berlin, Germany, 13353
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dominik Modest
    • Baden-Wuerttemberg
      • Mannheim, Baden-Wuerttemberg, Germany, 68167
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ralf-Dieter Hofheinz
    • Bayern
      • Muenchen, Bayern, Germany, 81377
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Volker Heinemann
        • Contact:
        • Contact:
    • Hessen
      • Frankfurt, Hessen, Germany, 60488
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Thorsten Oliver Goetze
        • Contact:
        • Contact:
      • Marburg, Hessen, Germany, 35043
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jorge Riera-Knorrenschild
    • Nordrhein-Westfalen
      • Duesseldorf, Nordrhein-Westfalen, Germany, 40225
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christoph Roderburg
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ulrich Hacker
        • Contact:
        • Contact:
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06120
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joern Ruessel
    • Schleswig-Holstein
      • Luebeck, Schleswig-Holstein, Germany, 23562
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jens Kisro
        • Contact:
        • Contact:
  • Greece
      • Athens, Greece, 11528
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • FLORA ZAGOURI
      • Thessaloniki, Greece, 54639
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Grigorios Rallis
      • Thessaloniki, Greece, 570 10
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Antonios Augerinos
  • Hungary
      • Debrecen, Hungary, 4032
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Peter Arkosy
  • Italy
    • Campania
      • Napoli, Campania, Italy, 80131
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Teresa Troiani
    • Emilia Romagna
      • Reggio Emilia, Emilia Romagna, Italy, 40123
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Angela Damato
    • Lazio
      • Roma, Lazio, Italy, 00168
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lisa Salvatore
      • Roma, Lazio, Italy, 00152
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carlo Garufi
    • Liguria
      • Genova, Liguria, Italy, 16132
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alessandro Pastorino
    • Lombardia
      • Milano, Lombardia, Italy, 20162
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Salvatore Siena
      • Rozzano (MI), Lombardia, Italy, 20089
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Armando Santoro
        • Contact:
        • Contact:
    • Sardegna
      • Monserrato, Sardegna, Italy, 09042
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mario Scartozzi
    • Toscana
      • Pisa, Toscana, Italy, 56126
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Chiara Cremolini
        • Contact:
        • Contact:
    • Veneto
      • Padova, Veneto, Italy, 35128
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sara Lonardi
        • Contact:
        • Contact:
  • Japan
      • Aichi, Japan, 464-8681
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Toshiki Masuishi
      • Chiba, Japan, 277-8577
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Akihito Kawazoe
      • Fukuoka, Japan, 812-8582
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Eiji Oki
      • Hokkaido, Japan, 060-8648
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yoshito Komatsu
      • Hyogo, Japan, 650-0047
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hisateru Yasui
      • Ibaraki, Japan, 309-1793
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kenji Amagai
      • Kanagawa, Japan, 232-0024
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jun Watanabe
      • Kanagawa, Japan, 216-8511
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yu Sunakawa
      • Kyoto, Japan, 606-8507
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Junichi Matsubara
      • Okayama, Japan, 710-8602
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mitsuru Yokota
      • Osaka, Japan, 541-8567
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Toshihiro Kudo
      • Osaka, Japan, 565-0871
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Taroh Satoh
        • Contact:
        • Contact:
      • Osaka, Japan, 540-0006
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Takeshi Kato
      • Osaka, Japan, 558-8558
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yoshinori Kagawa
      • Shizuoka, Japan, 411-8777
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kentaro Yamazaki
      • Tokyo, Japan, 104-0045
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Atsuo Takashima
  • Korea, Republic of
      • Daegu, Korea, Republic of, 41404
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jong Gwang Kim
        • Contact:
        • Contact:
      • Seoul, Korea, Republic of, 03722
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Seung Hoon Beom
        • Contact:
        • Contact:
      • Seoul, Korea, Republic of, 06591
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Myung-Ah Lee
      • Seoul, Korea, Republic of, 138-736
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sun Young Kim
      • Seoul, Korea, Republic of, 06351
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Young Suk Park
      • Sungnam, Korea, Republic of, 463712
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jaekyung Cheon
  • Mexico
      • Mexico, Mexico, 14000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fidel David Huitzil-Melendez
    • Baja California
      • Tijuana, Baja California, Mexico, 22010
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jorge Alberto Guadarrama-Orozco
        • Contact:
        • Contact:
    • Estado De México
      • Ciudad de México, Estado De México, Mexico, 03810
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ana Karen Valenzuela-Vidales
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juan-Carlos Vazquez-Limon
      • Guadalajara, Jalisco, Mexico, 44650
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gilberto Lopez-Rosas
    • Nuevo Leon
      • San Pedro Garza Garcia, Nuevo Leon, Mexico, 66220
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alan Burguete-Torres
    • Oaxaca
      • Oaxaca de Juarez, Oaxaca, Mexico, 68020
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francisco Javier Castro-Alonso
  • Netherlands
      • Breda, Netherlands, 4818 CK
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mirte M. Streppel
      • Maastricht, Netherlands, 6229 HX
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Liselot Valkenburg-van Iersel
      • Nijmegen, Netherlands, 6525 GA
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Elske Gootjes
      • Utrecht, Netherlands, 3584 CX
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jeanine M.L. Roodhart-Wolters
  • Norway
      • Bergen, Norway, 5021
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kristine Aasebø
      • Drammen, Norway, N-3004
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Odd Terje Brustugun
        • Contact:
        • Contact:
      • Lørenskog, Norway, 1478
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Asa Dahle-Smith
        • Contact:
        • Contact:
      • Oslo, Norway, 0407
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jorgen Smeby
      • Stavanger, Norway, 4011
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Herish Garresori
      • Tromsø, Norway, 9019
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Helge Stenvold
  • Panama
      • Panama, Panama
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yong Pain Loo Lau
  • Portugal
      • Almada, Portugal, 2805-267
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Helder Mansinho
      • Coimbra, Portugal, 3000-075
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anabela Barros
      • Lisboa, Portugal, 1649-035
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Luis Costa
  • Spain
      • Baracaldo/Vizcaya, Spain, 48903
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • María Almudena Callejo Goena
      • Barcelona, Spain, 08035
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Elena Élez Fernández
        • Contact:
        • Contact:
      • Barcelona, Spain, 08036
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joan Maurel Santasusana
      • Barcelona, Spain, 08026
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • David Paez Lopez-Bravo
      • Barcelona, Spain, 08908
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cristina Santos Vivas
      • Córdoba, Spain, 14004
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • María José Ortiz Morales
      • Elche, Spain, 03203
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Javier Gallego Plazas
        • Contact:
        • Contact:
      • Granada, Spain, 18014
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Encarna González Flores
      • Jaén, Spain, 23007
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Francisco José García Verdejo
        • Contact:
        • Contact:
      • Las Palmas De Gran Canaria, Spain, 35016
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Henry Hernández Mejía
      • Madrid, Spain, 28046
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nuria Rodriguez Salas
      • Madrid, Spain, 28034
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Reyes Ferreiro Monteagudo
      • Madrid, Spain, 28009
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pilar Garcia Alfonso
      • Madrid, Spain, 28050
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carmen Toledano Rojas
      • Madrid, Spain, 28006
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • María de Toro Carmena
      • Málaga, Spain, 29010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Esperanza Torres Sánchez
      • Pamplona, Spain, 31008
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ruth Vera Garcia
        • Contact:
        • Contact:
      • San Sebastian, Spain, 20080
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adelaida La Casta Muñoa
      • Santander, Spain, 39011
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carlos López López
      • Sevilla, Spain, 41013
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mª Luisa Limón Mirón
      • Valencia, Spain, 46010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Noelia Tarazona Llavero
      • Valencia, Spain, 46009
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marcos Melián Sosa
      • Zaragoza, Spain, 50009
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vicente Alonso Orduna
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Paula Jimenez Fonseca
        • Contact:
        • Contact:
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lourdes Gutiérrez Sanz
  • Sweden
      • Eskilstuna, Sweden, 63349
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Andreas Nearchou
      • Götebrog, Sweden, SE-413 45
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Leif Klint
      • Linköping, Sweden, SE-581 85
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Aristotelis Stefanis
      • Malmö, Sweden, 20502
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christina Siesing
      • Stockholm, Sweden, 11219
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Annika Svanström Röjvall
      • Stockholm, Sweden, 11883
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pehr Lind
      • Uppsala, Sweden, SE-751 85
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tanweera Khan
  • Taiwan
      • Kaohsiung, Taiwan, 833
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hong-Hwa Chen
      • Tainan, Taiwan, 704
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Yu-Min Yeh
        • Contact:
        • Contact:
      • Taipei, Taiwan, 100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kun-Huei Yeh
      • Taoyuan City, Taiwan, 333
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hung-Chih Hsu
  • Turkey
      • Ankara, Turkey, 06010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nuri Karadurmus
      • Ankara, Turkey, 06230
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Suayib Yalcin
      • Istanbul, Turkey, 34722
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mahmut Gumus
  • United Kingdom
      • Birmingham, United Kingdom, B9 5SS
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Shobhit Baijal
      • Cottingham, United Kingdom, HU16 5JQ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rajarshi Roy
      • Edinburgh, United Kingdom, EH4 2XU
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Faye Robertson
      • Leeds, United Kingdom, LS9 7TF
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jenny Seligmann
      • London, United Kingdom, NW3 2QG
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Robert Goldstein
      • London, United Kingdom, SW3 6JJ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Naureen Starling
      • Sutton, United Kingdom, SM2 5PT
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Naureen Starling
    • Essex
      • Chelmsford, Essex, United Kingdom, CM1 7ET
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rafiqul Islam
    • Gloucestershire
      • Cheltenham, Gloucestershire, United Kingdom, GL53 7AN
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Katie Wallace
    • Greater Manchester
      • Manchester, Greater Manchester, United Kingdom, M20 4BX
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Michael Braun
        • Contact:
        • Contact:
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85712
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Manuel R Modiano
        • Contact:
        • Contact:
    • California
      • Los Angeles, California, United States, 90027
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gary L Buchschacher Jr
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael Cecchini
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anteneh Tesfaye
    • Florida
      • Fort Lauderdale, Florida, United States, 33316
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alan Grosset
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Steven L McCune
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ardaman Shergill
      • Chicago, Illinois, United States, 60612
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Shikha Jain
        • Contact:
        • Contact:
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Al B Benson III
      • Elmhurst, Illinois, United States, 60126
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Andrew Wiele
        • Contact:
        • Contact:
      • Naperville, Illinois, United States, 60540
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Andrew Wiele
        • Contact:
        • Contact:
    • Kansas
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Benjamin Martin
    • Kentucky
      • Lexington, Kentucky, United States, 40503
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lee Hicks
      • Louisville, Kentucky, United States, 42061
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fred J Hendler
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Victor Lin
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Mark Goldstein
        • Contact:
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • John C Krauss
      • Detroit, Michigan, United States, 48202
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Maria Diab
        • Contact:
        • Contact:
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Emil Lou
        • Contact:
        • Contact:
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Laura Tenner
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Timothy Kevin Huyck
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gabriel Brooks
    • New York
      • Bronx, New York, United States, 10461
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Chaoyuan Kuang
        • Contact:
      • Bronx, New York, United States, 10469
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Richard Zuniga
        • Contact:
        • Contact:
      • New Hyde Park, New York, United States, 11042
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Richard Zuniga
        • Contact:
        • Contact:
      • New York, New York, United States, 10065
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Andrea Cercek
        • Contact:
      • New York, New York, United States, 10028
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Richard Zuniga
        • Contact:
        • Contact:
      • Shirley, New York, United States, 11967
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Richard Zuniga
        • Contact:
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • John H Strickler
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael D. Honaker
    • Ohio
      • Akron, Ohio, United States, 44304
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sameer Mahesh
      • Cincinnati, Ohio, United States, 45236
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • David J. Draper
      • Cleveland, Ohio, United States, 44196
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Smitha Krishnamurthi
        • Contact:
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sagila George
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Nathan Bahary
        • Contact:
        • Contact:
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Paul B Gilman
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ki Young Chung
        • Contact:
        • Contact:
    • South Dakota
      • Aberdeen, South Dakota, United States, 57401
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Heidi McKean
      • Pierre, South Dakota, United States, 57501
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Heidi McKean
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Heidi McKean
      • Yankton, South Dakota, United States, 57078
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Heidi McKean
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Principal Investigator:
          • Cathy Eng
        • Contact:
    • Texas
      • Dallas, Texas, United States, 75390-8565
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nilesh Verma
    • Virginia
      • Richmond, Virginia, United States, 23219
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Khalid Matin
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 enrollment
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dostarlimab
Participants will receive Dostarlimab pre and post surgery
Biological: Dostarlimab
Dostarlimab will be administered.
Active Comparator: Standard of Care (SOC)
Participants will receive SOC (FOLFOX/CAPEOX) or undergo expectant observation post surgery.
Drug: CAPEOX
CAPEOX will be administered.
Drug: FOLFOX
FOLFOX will be administered.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)
Time Frame: Up to approximately 5 years
EFS is defined as the time from randomization to either disease recurrence or death due to any cause or treatment related toxicity that results in the participant not being suitable for surgery
Up to approximately 5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Pathological Response
Time Frame: Up to approximately 5 years
Pathological response will be categorized as a complete pathologic response, major pathologic response, partial pathologic response, or negligible pathologic response.
Up to approximately 5 years
Overall Survival (OS)
Time Frame: Up to approximately 5 years
OS is defined as time from randomization to death from any cause
Up to approximately 5 years
Event-free Survival (EFS) assessed by local assessment
Time Frame: Up to approximately 5 years
EFS is defined as the time from randomization to either disease recurrence or death due to any cause or treatment related toxicity that results in the participant not being suitable for surgery
Up to approximately 5 years
Number of Participants with treatment emergent adverse events (AEs), serious adverse events (SAEs), Immune-related Adverse Event (irAEs), AEs leading to death and AEs leading to discontinuation of study treatment
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Number of Participants with AEs and SAEs by Severity
Time Frame: Up to approximately 5 years
Up to approximately 5 years
Serum Concentration of Dostarlimab
Time Frame: Predose and End of Infusion (EoI) of Cycle 1 and EoI of Cycle 2 to Cycle 10 (each cycle is of 21 days)
Predose and End of Infusion (EoI) of Cycle 1 and EoI of Cycle 2 to Cycle 10 (each cycle is of 21 days)
Serum Concentration of Dostarlimab at End of Infusion (C-EoI)
Time Frame: End of Infusion (EoI) of Cycle 1 to Cycle 10 (each cycle is of 21 days)
End of Infusion (EoI) of Cycle 1 to Cycle 10 (each cycle is of 21 days)
Serum Predose trough concentration (Ctrough) of Dostarlimab
Time Frame: Predose of Cycle 1 to Cycle 10 (each cycle is of 21 days)
Predose of Cycle 1 to Cycle 10 (each cycle is of 21 days)
Number of Participants with Anti-Drug Antibodies against Dostarlimab
Time Frame: Up to approximately 5 years
Up to approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Investigators

  • Study Director: GSK Clinical Trials, GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 2, 2023

Primary Completion (Estimated)

December 15, 2028

Study Completion (Estimated)

December 25, 2030

Study Registration Dates

First Submitted

May 3, 2023

First Submitted That Met QC Criteria

May 3, 2023

First Posted (Actual)

May 11, 2023

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 18, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 219606
  • 2023-503265-27-00 (Other Identifier: European Medicines Agency)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/

IPD Sharing Time Frame

Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.

IPD Sharing Access Criteria

Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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