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

January 22, 2026 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)

892

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
      • Buenos Aires, Argentina, C1180AAX
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Patricio Servienti
      • Capital Federal, Argentina, C1426ANZ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Federico Esteso
      • Ciudad Autonoma de Buenos Aire, Argentina, C1431FWO
        • Completed
        • GSK Investigational Site
      • Córdoba, Argentina, 5000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chong Hun Kim
      • Mar del Plata, Argentina, 7600
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Marcos Flores
      • Rosario, Argentina, S2002
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Miriam Raimondo
      • San Miguel de Tucumán, Argentina, T4000IHE
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ruben Segovia
      • Santa Fe, Argentina, S3000FUJ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cesar Blajman
  • Australia
    • New South Wales
      • Newcastle, New South Wales, Australia, 2298
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jordan Cohen
      • St Leonards, New South Wales, Australia, 2065
        • Withdrawn
        • GSK Investigational Site
    • Queensland
      • Woolangabba, 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:
      • Melbourne, Victoria, Australia, 3004
        • Withdrawn
        • GSK Investigational Site
  • Belgium
      • Aalst, Belgium, 9300
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Koenraad A.M. Hendrickx
      • Brussels, Belgium, 1200
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Marc Van den Eynde
        • Contact:
        • Contact:
      • Brussels, Belgium, 1070
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Francesco Sclafani
        • Contact:
        • Contact:
      • Edegem, Belgium, 2650
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hans Prenen
      • Ghent, 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:
          • Joelle Collignon
      • Roeselare, Belgium, 8800
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sofie De Meulder
  • Brazil
      • Barretos, Brazil, 14784-400
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Arinilda Bragagnoli
      • Belém, Brazil, 66.073-005
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bruno Fernandes
      • Campo Grande, Brazil, 79002-061
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cristina Sampaio
      • Lages, Brazil, 88501-001
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maite de Liz Vassen Schurmann
      • Natal, Brazil, 59075-740
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sulene Oliveira
      • Porto Alegre, Brazil, 90610-000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Caroline da Silva
      • Salvador, Brazil, 40414-120
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Livia Maria Andrade
      • São José do Rio Preto, Brazil, 15090-000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kathia Cristina Abdalla
      • São Paulo, Brazil, 01509-010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rodrigo Taboada
      • São Paulo, Brazil, 04312903
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Ignez Braghiroli
      • Teresina, Brazil, 64049-200
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Claudio Lima Rocha
      • Vitória, Brazil, 29043-260
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • GLAUCIO BERTOLLO
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 1Z2
        • Withdrawn
        • GSK Investigational Site
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Katerina Neumann
    • 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
  • China
      • Beijing, China, 100730
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Xicheng Wang
        • Contact:
        • Contact:
      • Beijing, China, 100083
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wei Fu
      • Beijing, China, 100036
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Lin Shen
        • Contact:
        • Contact:
      • Changchun, China, 130021
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Quan Wang
      • Changsha, China, 410013
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yingbin Hu
      • Chengdu, China, 610041
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Meng Qiu
        • Contact:
        • Contact:
      • Chongqing, China, 400042
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ziwei Wang
      • Guangzhou, China, 510060
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gong Chen
      • Guangzhou, China, 510655
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Yanhong Deng
        • Contact:
        • Contact:
      • Hangzhou, China, 310022
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yuping Zhu
      • Hangzhou, China, 310016
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhangfa Song
      • Hangzhou, China
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Kefeng Ding
      • Hangzhou, China, 311100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guosheng Wu
      • Harbin, China, 150000
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Yuxian Bai
        • Contact:
        • Contact:
      • Jinan, China, 250117
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • yanlai sun
      • Kunming, China, 650106
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jian Dong
      • Meizhou, China, 514700
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Xiwen Huang
        • Contact:
        • Contact:
      • Nanchang, China, 330006
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Taiyuan Li
      • Nanchang, China, 330029
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bo Yi
      • Shanghai, China, 200032
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jianmin Xu
        • Contact:
        • Contact:
      • Shenzhen, China, 518036
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guoqing Lv
      • Taiyuan, China, 030013
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wenhui Yang
      • Tianjin, China, 300000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Wang Huaqing
      • Wuhan, China, 430030
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Guihua Wang
      • Xiamen, China, 361004
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jun You
      • Yangzhou, China, 225001
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhu Wang
      • Zhengzhou, China, 450052
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Zhiyong Zhang
  • Czechia
      • Hradec Králové, Czechia, 500 05
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stanislav John
      • Nový Jičín, Czechia, 741 01
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vojtech Tlusty
      • Prague, Czechia, 150 06
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stanislav Batko
  • 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:
          • Elen Vettus
      • 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:
          • Pia Osterlund
      • 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, France, 13385
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Laétitia DAHAN
      • Nantes, France, 44093
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Yann Touchefeu
        • Contact:
        • Contact:
      • Paris, France, 75015
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Claire Gallois
      • Pessac, France, 33604
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Denis SMITH
        • Contact:
        • Contact:
      • Rennes, France, 35042
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Julien Edeline
        • Contact:
        • Contact:
      • Rouen, France, 76000
        • Completed
        • GSK Investigational Site
      • 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, France, 31059
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Rosine Guimbaud
        • Contact:
        • Contact:
      • Villejuif, 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
      • Düsseldorf, Germany, 40225
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christoph Roderburg
      • Frankfurt, Germany, 60488
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Thorsten Oliver Goetze
        • Contact:
        • Contact:
      • Halle, Germany, 06120
        • Withdrawn
        • GSK Investigational Site
      • Lübeck, Germany, 23562
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jens Kisro
        • Contact:
        • Contact:
      • Mannheim, Germany, 68167
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ralf-Dieter Hofheinz
      • München, Germany, 81377
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Volker Heinemann
        • Contact:
        • Contact:
      • München, Germany, 81737
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Stefan Boeck
  • Greece
      • Athens, Greece, 11528
        • Completed
        • GSK Investigational Site
      • Thessaloniki, Greece, 54639
        • Completed
        • GSK Investigational Site
      • Thessaloniki, Greece, 570 10
        • Completed
        • GSK Investigational Site
  • India
      • Belagavi, India, 590010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rohan Bhise
      • Hyderabad, India, 500034
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • MVT Krishna Mohan
      • Nashik, India, 422002
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mukesh Chaudhari
      • Pune, India, 411040
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Dr Minish Jain
    • Karnataka
      • Bengaluru, Karnataka, India, 560076
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Niti Raizada
    • Punjab
      • Ludhiana, Punjab, India, 141123
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Davinder Paul
  • Italy
      • Cagliari, Italy, 09042
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mario Scartozzi
      • Genova, Italy, 16132
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alessandro Pastorino
      • Milan, Italy, 20162
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Salvatore Siena
      • Napoli, Italy, 80131
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Teresa Troiani
      • Padua, Italy, 35128
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Sara Lonardi
        • Contact:
        • Contact:
      • Pisa, Italy, 56126
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Chiara Cremolini
        • Contact:
        • Contact:
      • Reggio Emilia, Italy, 40123
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francesco Iachetta
      • Roma, Italy, 00168
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lisa Salvatore
      • Roma, Italy, 00152
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carlo Garufi
      • Rozzano MI, Italy, 20089
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Armando Santoro
        • 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
      • Hyōgo, Japan, 650-0047
        • Withdrawn
        • GSK Investigational Site
      • 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:
          • Yusuke Suwa
      • 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
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mamoru Uemura
      • 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:
          • Taishi Hata
      • Osaka, Japan, 573-1191
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jun Watanabe
      • 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
      • Tokyo, Japan, 135-8550
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Takashi Akiyoshi
  • Mexico
      • DF, Mexico, 14000
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fidel David Huitzil-Melendez
      • Guadalajara, Mexico, 44280
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Juan Carlos Vazquez Limon
      • Guadalajara, Mexico, 44650
        • Completed
        • GSK Investigational Site
      • Mexico City, Mexico, 03100
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ana Karen Valenzuela-Vidales
      • Oaxaca City, Mexico, 68020
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Francisco Javier Castro-Alonso
      • San Pedro Garza García, Mexico, 66220
        • Completed
        • GSK Investigational Site
      • Tijuana, Mexico, 22010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jorge Guadarrama
  • 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:
          • Harm Westdorp
      • 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 Aaseboe
      • Kristiansand, Norway, 4604
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Linn Kruse
      • Lrenskog, Norway, 1474
        • 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
        • Withdrawn
        • GSK Investigational Site
  • Panama
      • Punta Pacifica Panama City Panama, Panama
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Yong Loo Lau
  • Poland
      • Bydgoszcz, Poland, 85-048
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Anna Krause
      • Warsaw, Poland, 02-034
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lucjan Wyrwicz
  • 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
      • Lisbon, Portugal, 1649-035
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Catarina Abreu
  • South Korea
      • Daegu, South Korea, 41404
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Jong Gwang Kim
        • Contact:
        • Contact:
      • Gyeonggi-do, South Korea, 463712
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Chan Kim
      • Seoul, South Korea, 06351
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Young Suk Park
      • Seoul, South Korea, 06591
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Myung Ah Lee
      • Seoul, South Korea, 138-736
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • SUNYOUNG KIM
  • Spain
      • Badajoz, Spain, 06080
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Fernanda Martinez Barragan
      • BaracaldoVizcaya, Spain, 48903
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Almudena Callejo Goena
      • Barcelona, Spain, 08035
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Elena Elez Fernandez
        • 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
      • Córdoba, Spain, 14004
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Jose Ortiz Morales
      • Donostia / San Sebastian, Spain, 20080
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Adelaida La Casta Muñoa
      • Elche Alicante, 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:
      • L'Hospitalet de Llobrega, Spain, 08908
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Cristina Santos Vivas
      • Las Palmas de Gran Canar, Spain, 35016
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Henry Hernandez Mejia
      • 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:
          • Íñigo Martínez Delfrade
      • Madrid, Spain, 28040
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Raquel Fuentes
      • Madrid, Spain, 28009
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pilar Garcia Alfonso
      • Madrid, Spain, 28041
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Maria Del Carmen Riesco Martinez
      • 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:
          • Maria De Toro Carmena
      • Madrid, Spain, 28222
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Lourdes Gutierrez Sanz
      • Málaga, Spain, 29010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Esperanza Torres Sánchez
      • Oviedo, Spain, 33011
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Paula Jimenez Fonseca
        • Contact:
        • Contact:
      • Pamplona, Spain, 31008
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Ruth Vera Garcìa
        • Contact:
        • Contact:
      • Santander, Spain, 39011
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Carlos Lopez Lopez
      • Seville, Spain, 41013
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ma Luisa Limon Miron
      • 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 Melian Sosa
      • Valencia, Spain, 46014
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • María José Safont Aguilera
        • Contact:
        • Contact:
      • Zaragoza, Spain, 50009
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Vicente Alonso Orduna
  • Sweden
      • Eskilstuna, Sweden, 63349
        • Withdrawn
        • GSK Investigational Site
      • Gothenburg, 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
      • Malmo, Sweden, 20502
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christina Siesing
      • Stockholm, Sweden, 11883
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pehr Lind
      • Stockholm, Sweden, 11219
        • Withdrawn
        • GSK Investigational Site
      • Uppsala, Sweden, SE-751 85
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Tanweera Khan
  • Taiwan
      • Kaohsiung City, 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 District, Taiwan, 333
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hung-Chih Hsu
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06010
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nuri Karadurmus
      • Ankara, Turkey (Türkiye), 06230
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Suayib Yalcin
      • Ankara, Turkey (Türkiye)
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mehmet Sendur
      • Istanbul, Turkey (Türkiye), 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
      • Chelmsford, United Kingdom, CM1 7ET
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rafiqul Islam
      • Cheltenham, United Kingdom, GL53 7AN
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Nick Reed
      • Edinburgh, United Kingdom, EH4 2XU
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Faye Robertson
      • Hull, United Kingdom, HU16 5JQ
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Rajarshi Roy
      • Leeds West Yorkshire, 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
      • Manchester, United Kingdom, M20 4BX
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Michael Braun
        • Contact:
        • Contact:
      • Sutton, United Kingdom, SM2 5PT
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Naureen Starling
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85715
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Manuel Modiano
    • California
      • Los Angeles, California, United States, 90027
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Gary Buchschacher Jr
    • Connecticut
      • New Haven, Connecticut, United States, 06520
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jeremy Kortmansky
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Withdrawn
        • GSK Investigational Site
    • Florida
      • Deerfield Beach, Florida, United States, 33064
        • Withdrawn
        • GSK Investigational Site
      • Fort Lauderdale, Florida, United States, 33316
        • Withdrawn
        • GSK Investigational Site
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Withdrawn
        • GSK Investigational Site
    • Illinois
      • 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 Benson Iii
      • Chicago, Illinois, United States, 60637
        • Withdrawn
        • GSK Investigational Site
      • Naperville, Illinois, United States, 60540
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Andrew Wiele
        • Contact:
        • Contact:
      • Naperville, Illinois, United States, 60126
        • 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
        • Withdrawn
        • GSK Investigational Site
      • Louisville, Kentucky, United States, 40206
        • Withdrawn
        • GSK Investigational Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Withdrawn
        • GSK Investigational Site
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Mark Goldstein
        • Contact:
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Withdrawn
        • GSK Investigational Site
      • 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
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ajay Prakash
    • Missouri
      • Joplin, Missouri, United States, 64804
        • Withdrawn
        • GSK Investigational Site
      • St Louis, Missouri, United States, 63128
        • Withdrawn
        • GSK Investigational Site
      • St Louis, Missouri, United States, 63141
        • Withdrawn
        • GSK Investigational Site
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Timothy Huyck
        • Contact:
        • Contact:
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Timothy Huyck
        • Contact:
        • Contact:
      • Omaha, Nebraska, United States, 68198
        • Withdrawn
        • GSK Investigational Site
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Withdrawn
        • GSK Investigational Site
    • New York
      • New York, New York, United States, 10028
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Richard Zuniga
        • Contact:
        • Contact:
      • New York, New York, United States, 10469
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Richard Zuniga
        • Contact:
        • Contact:
      • New York, New York, United States, 11042
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Richard Zuniga
        • Contact:
        • Contact:
      • New York, New York, United States, 11967
        • Recruiting
        • GSK Investigational Site
        • Principal Investigator:
          • Richard Zuniga
        • Contact:
        • Contact:
      • The Bronx, New York, United States, 10461
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Fernand Bteich
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • John Strickler
    • Ohio
      • Akron, Ohio, United States, 44304
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Sameer Mahesh
      • Cincinnati, Ohio, United States, 45220
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Benjamin Kuritzky
      • Cleveland, Ohio, United States, 44111
        • Withdrawn
        • GSK Investigational Site
      • Cleveland, Ohio, United States, 44142
        • Withdrawn
        • GSK Investigational Site
      • Cleveland, Ohio, United States, 44196
        • Withdrawn
        • GSK Investigational Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Withdrawn
        • GSK Investigational Site
      • Oklahoma City, Oklahoma, United States, 73120
        • Withdrawn
        • GSK Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Withdrawn
        • GSK Investigational Site
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Heidi McKean
      • Sioux Falls, South Dakota, United States, 57078
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Heidi McKean
      • Sioux Falls, South Dakota, United States, 57401
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Heidi McKean
      • Sioux Falls, South Dakota, United States, 57501
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Heidi McKean
    • Texas
      • Dallas, Texas, United States, 75235
        • Withdrawn
        • GSK Investigational Site
      • Dallas, Texas, United States, 75390
        • Completed
        • GSK Investigational Site
    • Virginia
      • Richmond, Virginia, United States, 23229
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Purvi Shah
    • Wisconsin
      • Appleton, Wisconsin, United States, 54911
        • Recruiting
        • GSK Investigational Site
        • Contact:
        • Contact:
        • Principal Investigator:
          • Joyce Philip

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 the current diagnosis of colon cancer
  • Has a tumor that, in the investigator's judgment is causing symptomatic bowel obstruction or otherwise requires urgent/emergent surgery at the time of screening. Participants with a history of colonic obstruction are eligible after obstruction is relieved by a diverting stoma (defunctioning ileostomy or colostomy). Patients with a history of colonic obstruction in the context of current colon cancer diagnosis and treated with colonic stents are not eligible.
  • 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 and/or history of radiation induced enteritis.
  • 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 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
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
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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 1, 2023

Primary Completion (Estimated)

March 19, 2029

Study Completion (Estimated)

March 27, 2031

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)

January 23, 2026

Last Update Submitted That Met QC Criteria

January 22, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 219606
  • 2023-503265-27-00 (Ctis: 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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