Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
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
2 other identifiers
interventional
892
27 countries
236
Brief Summary
The primary purpose of this study is to evaluate the efficacy of perioperative dostarlimab compared with standard of care (SOC) in participants with untreated T4N0 or Stage III (resectable), defective mismatch repair/ microsatellite instability high (dMMR/MSI-H) colon cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2023
Longer than P75 for phase_3
236 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2023
CompletedFirst Posted
Study publicly available on registry
May 11, 2023
CompletedStudy Start
First participant enrolled
August 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 19, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 27, 2031
January 23, 2026
January 1, 2026
5.6 years
May 3, 2023
January 22, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR)
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 Outcomes (9)
Overall Survival (OS)
Up to approximately 5 years
Number of Participants with Pathological Response
Up to approximately 5 years
Event-free Survival (EFS) assessed by local assessment
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
Up to approximately 5 years
Number of Participants with AEs and SAEs by Severity
Up to approximately 5 years
- +4 more secondary outcomes
Study Arms (2)
Dostarlimab
EXPERIMENTALParticipants will receive Dostarlimab pre and post surgery
Standard of Care (SOC)
ACTIVE COMPARATORParticipants will receive SOC (FOLFOX/CAPEOX) or undergo expectant observation post surgery.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (266)
GSK Investigational Site
Tucson, Arizona, 85715, United States
GSK Investigational Site
Los Angeles, California, 90027, United States
GSK Investigational Site
New Haven, Connecticut, 06520, United States
GSK Investigational Site
Washington D.C., District of Columbia, 20010, United States
GSK Investigational Site
Deerfield Beach, Florida, 33064, United States
GSK Investigational Site
Fort Lauderdale, Florida, 33316, United States
GSK Investigational Site
Marietta, Georgia, 30060, United States
GSK Investigational Site
Chicago, Illinois, 60611, United States
GSK Investigational Site
Chicago, Illinois, 60612, United States
GSK Investigational Site
Chicago, Illinois, 60637, United States
GSK Investigational Site
Naperville, Illinois, 60126, United States
GSK Investigational Site
Naperville, Illinois, 60540, United States
GSK Investigational Site
Westwood, Kansas, 66205, United States
GSK Investigational Site
Lexington, Kentucky, 40503, United States
GSK Investigational Site
Louisville, Kentucky, 40206, United States
GSK Investigational Site
Baton Rouge, Louisiana, 70809, United States
GSK Investigational Site
Bethesda, Maryland, 20817, United States
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Ann Arbor, Michigan, 48109, United States
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Detroit, Michigan, 48202, United States
GSK Investigational Site
Minneapolis, Minnesota, 55455, United States
GSK Investigational Site
Joplin, Missouri, 64804, United States
GSK Investigational Site
St Louis, Missouri, 63128, United States
GSK Investigational Site
St Louis, Missouri, 63141, United States
GSK Investigational Site
Grand Island, Nebraska, 68803, United States
GSK Investigational Site
Omaha, Nebraska, 68130, United States
GSK Investigational Site
Omaha, Nebraska, 68198, United States
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Lebanon, New Hampshire, 03756, United States
GSK Investigational Site
New York, New York, 10028, United States
GSK Investigational Site
New York, New York, 10469, United States
GSK Investigational Site
New York, New York, 11042, United States
GSK Investigational Site
New York, New York, 11967, United States
GSK Investigational Site
The Bronx, New York, 10461, United States
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Durham, North Carolina, 27710, United States
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Akron, Ohio, 44304, United States
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Cincinnati, Ohio, 45220, United States
GSK Investigational Site
Cleveland, Ohio, 44111, United States
GSK Investigational Site
Cleveland, Ohio, 44142, United States
GSK Investigational Site
Cleveland, Ohio, 44196, United States
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Oklahoma City, Oklahoma, 73104, United States
GSK Investigational Site
Oklahoma City, Oklahoma, 73120, United States
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Pittsburgh, Pennsylvania, 15212, United States
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Sioux Falls, South Dakota, 57078, United States
GSK Investigational Site
Sioux Falls, South Dakota, 57105, United States
GSK Investigational Site
Sioux Falls, South Dakota, 57401, United States
GSK Investigational Site
Sioux Falls, South Dakota, 57501, United States
GSK Investigational Site
Dallas, Texas, 75235, United States
GSK Investigational Site
Dallas, Texas, 75390, United States
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Richmond, Virginia, 23229, United States
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Appleton, Wisconsin, 54911, United States
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Buenos Aires, 1093, Argentina
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Buenos Aires, C1180AAX, Argentina
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Buenos Aires, C1181ACH, Argentina
GSK Investigational Site
Capital Federal, C1426ANZ, Argentina
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Ciudad Autonoma de Buenos Aire, C1431FWO, Argentina
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Córdoba, 5000, Argentina
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Mar del Plata, 7600, Argentina
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Rosario, S2002, Argentina
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San Miguel de Tucumán, T4000IHE, Argentina
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Santa Fe, S3000FUJ, Argentina
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Newcastle, New South Wales, 2298, Australia
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St Leonards, New South Wales, 2065, Australia
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Woolangabba, Queensland, 4102, Australia
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Heidelberg, Victoria, 3084, Australia
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Melbourne, Victoria, 3004, Australia
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Aalst, 9300, Belgium
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Brussels, 1070, Belgium
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Brussels, 1200, Belgium
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Edegem, 2650, Belgium
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Ghent, 9000, Belgium
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Leuven, 3000, Belgium
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Liège, 4000, Belgium
GSK Investigational Site
Roeselare, 8800, Belgium
GSK Investigational Site
Barretos, 14784-400, Brazil
GSK Investigational Site
Belém, 66.073-005, Brazil
GSK Investigational Site
Campo Grande, 79002-061, Brazil
GSK Investigational Site
Lages, 88501-001, Brazil
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Natal, 59075-740, Brazil
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Porto Alegre, 90610-000, Brazil
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Salvador, 40414-120, Brazil
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São José do Rio Preto, 15090-000, Brazil
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São Paulo, 01509-010, Brazil
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São Paulo, 04312903, Brazil
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Teresina, 64049-200, Brazil
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Vitória, 29043-260, Brazil
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Edmonton, Alberta, T6G 1Z2, Canada
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Halifax, Nova Scotia, B3H 1V7, Canada
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Ottawa, Ontario, K1H 8L6, Canada
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Toronto, Ontario, M5G 2M9, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Beijing, 100036, China
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Beijing, 100083, China
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Beijing, 100730, China
GSK Investigational Site
Changchun, 130021, China
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Changsha, 410013, China
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Chengdu, 610041, China
GSK Investigational Site
Chongqing, 400042, China
GSK Investigational Site
Chongqing, 400042, China
GSK Investigational Site
Guangzhou, 510060, China
GSK Investigational Site
Guangzhou, 510655, China
GSK Investigational Site
Hangzhou, 310016, China
GSK Investigational Site
Hangzhou, 310022, China
GSK Investigational Site
Hangzhou, 311100, China
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Hangzhou, China
GSK Investigational Site
Harbin, 150000, China
GSK Investigational Site
Jinan, 250117, China
GSK Investigational Site
Kunming, 650106, China
GSK Investigational Site
Meizhou, 514700, China
GSK Investigational Site
Nanchang, 330006, China
GSK Investigational Site
Nanchang, 330029, China
GSK Investigational Site
Shanghai, 200032, China
GSK Investigational Site
Shanghai, 200032, China
GSK Investigational Site
Shenzhen, 518036, China
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Taiyuan, 030013, China
GSK Investigational Site
Tianjin, 300000, China
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Wuhan, 430030, China
GSK Investigational Site
Xiamen, 361004, China
GSK Investigational Site
Yangzhou, 225001, China
GSK Investigational Site
Zhengzhou, 450052, China
GSK Investigational Site
Hradec Králové, 500 05, Czechia
GSK Investigational Site
Nový Jičín, 741 01, Czechia
GSK Investigational Site
Prague, 150 06, Czechia
GSK Investigational Site
Tallinn, 11312, Estonia
GSK Investigational Site
Tallinn, 13419, Estonia
GSK Investigational Site
Tartu, 50501, Estonia
GSK Investigational Site
Helsinki, 00029, Finland
GSK Investigational Site
Tampere, 33520, Finland
GSK Investigational Site
Turku, 20521, Finland
GSK Investigational Site
Lyon, 69008, France
GSK Investigational Site
Marseille, 13385, France
GSK Investigational Site
Nantes, 44093, France
GSK Investigational Site
Paris, 75015, France
GSK Investigational Site
Pessac, 33604, France
GSK Investigational Site
Rennes, 35042, France
GSK Investigational Site
Rouen, 76000, France
GSK Investigational Site
Saint-Priest-en-Jarez, 42270, France
GSK Investigational Site
Suresnes, 92150, France
GSK Investigational Site
Toulouse, 31059, France
GSK Investigational Site
Villejuif, 94805, France
GSK Investigational Site
Berlin, 13353, Germany
GSK Investigational Site
Düsseldorf, 40225, Germany
GSK Investigational Site
Frankfurt, 60488, Germany
GSK Investigational Site
Halle, 06120, Germany
GSK Investigational Site
Lübeck, 23562, Germany
GSK Investigational Site
Mannheim, 68167, Germany
GSK Investigational Site
München, 81377, Germany
GSK Investigational Site
München, 81737, Germany
GSK Investigational Site
Athens, 11528, Greece
GSK Investigational Site
Thessaloniki, 54639, Greece
GSK Investigational Site
Thessaloniki, 570 10, Greece
GSK Investigational Site
Bengaluru, Karnataka, 560076, India
GSK Investigational Site
Ludhiana, Punjab, 141123, India
GSK Investigational Site
Belagavi, 590010, India
GSK Investigational Site
Hyderabad, 500034, India
GSK Investigational Site
Nashik, 422002, India
GSK Investigational Site
Pune, 411040, India
GSK Investigational Site
Cagliari, 09042, Italy
GSK Investigational Site
Genova, 16132, Italy
GSK Investigational Site
Milan, 20162, Italy
GSK Investigational Site
Naples, 80131, Italy
GSK Investigational Site
Padua, 35128, Italy
GSK Investigational Site
Pisa, 56126, Italy
GSK Investigational Site
Reggio Emilia, 40123, Italy
GSK Investigational Site
Roma, 00152, Italy
GSK Investigational Site
Roma, 00168, Italy
GSK Investigational Site
Rozzano MI, 20089, Italy
GSK Investigational Site
Aichi, 464-8681, Japan
GSK Investigational Site
Chiba, 277-8577, Japan
GSK Investigational Site
Fukuoka, 812-8582, Japan
GSK Investigational Site
Hokkaido, 060-8648, Japan
GSK Investigational Site
Hyōgo, 650-0047, Japan
GSK Investigational Site
Ibaraki, 309-1793, Japan
GSK Investigational Site
Kanagawa, 216-8511, Japan
GSK Investigational Site
Kanagawa, 232-0024, Japan
GSK Investigational Site
Kyoto, 606-8507, Japan
GSK Investigational Site
Okayama, 710-8602, Japan
GSK Investigational Site
Osaka, 540-0006, Japan
GSK Investigational Site
Osaka, 541-8567, Japan
GSK Investigational Site
Osaka, 558-8558, Japan
GSK Investigational Site
Osaka, 565-0871, Japan
GSK Investigational Site
Osaka, 573-1191, Japan
GSK Investigational Site
Shizuoka, 411-8777, Japan
GSK Investigational Site
Tokyo, 104-0045, Japan
GSK Investigational Site
Tokyo, 135-8550, Japan
GSK Investigational Site
DF, 14000, Mexico
GSK Investigational Site
Guadalajara, 44280, Mexico
GSK Investigational Site
Guadalajara, 44650, Mexico
GSK Investigational Site
Mexico City, 03100, Mexico
GSK Investigational Site
Oaxaca City, 68020, Mexico
GSK Investigational Site
San Pedro Garza García, 66220, Mexico
GSK Investigational Site
Tijuana, 22010, Mexico
GSK Investigational Site
Breda, 4818 CK, Netherlands
GSK Investigational Site
Maastricht, 6229 HX, Netherlands
GSK Investigational Site
Nijmegen, 6525 GA, Netherlands
GSK Investigational Site
Utrecht, 3584 CX, Netherlands
GSK Investigational Site
Bergen, 5021, Norway
GSK Investigational Site
Kristiansand, 4604, Norway
GSK Investigational Site
Lrenskog, 1474, Norway
GSK Investigational Site
Oslo, 0407, Norway
GSK Investigational Site
Stavanger, 4011, Norway
GSK Investigational Site
Tromsø, 9019, Norway
GSK Investigational Site
Punta Pacifica Panama City Panama, Panama
GSK Investigational Site
Bydgoszcz, 85-048, Poland
GSK Investigational Site
Warsaw, 02-034, Poland
GSK Investigational Site
Almada, 2805-267, Portugal
GSK Investigational Site
Coimbra, 3000-075, Portugal
GSK Investigational Site
Lisbon, 1649-035, Portugal
GSK Investigational Site
Daegu, 41404, South Korea
GSK Investigational Site
Gyeonggi-do, 463712, South Korea
GSK Investigational Site
Seoul, 06351, South Korea
GSK Investigational Site
Seoul, 06591, South Korea
GSK Investigational Site
Seoul, 138-736, South Korea
GSK Investigational Site
Badajoz, 06080, Spain
GSK Investigational Site
BaracaldoVizcaya, 48903, Spain
GSK Investigational Site
Barcelona, 08026, Spain
GSK Investigational Site
Barcelona, 08035, Spain
GSK Investigational Site
Barcelona, 08036, Spain
GSK Investigational Site
Córdoba, 14004, Spain
GSK Investigational Site
Donostia / San Sebastian, 20080, Spain
GSK Investigational Site
Elche Alicante, 03203, Spain
GSK Investigational Site
Granada, 18014, Spain
GSK Investigational Site
Jaén, 23007, Spain
GSK Investigational Site
L'Hospitalet de Llobrega, 08908, Spain
GSK Investigational Site
Las Palmas de Gran Canar, 35016, Spain
GSK Investigational Site
Madrid, 28006, Spain
GSK Investigational Site
Madrid, 28009, Spain
GSK Investigational Site
Madrid, 28034, Spain
GSK Investigational Site
Madrid, 28040, Spain
GSK Investigational Site
Madrid, 28040, Spain
GSK Investigational Site
Madrid, 28041, Spain
GSK Investigational Site
Madrid, 28046, Spain
GSK Investigational Site
Madrid, 28050, Spain
GSK Investigational Site
Madrid, 28222, Spain
GSK Investigational Site
Málaga, 29010, Spain
GSK Investigational Site
Oviedo, 33011, Spain
GSK Investigational Site
Pamplona, 31008, Spain
GSK Investigational Site
Santander, 39011, Spain
GSK Investigational Site
Seville, 41013, Spain
GSK Investigational Site
Valencia, 46009, Spain
GSK Investigational Site
Valencia, 46010, Spain
GSK Investigational Site
Valencia, 46014, Spain
GSK Investigational Site
Zaragoza, 50009, Spain
GSK Investigational Site
Eskilstuna, 63349, Sweden
GSK Investigational Site
Gothenburg, SE-413 45, Sweden
GSK Investigational Site
Linköping, SE-581 85, Sweden
GSK Investigational Site
Malmo, 20502, Sweden
GSK Investigational Site
Stockholm, 11219, Sweden
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Stockholm, 11883, Sweden
GSK Investigational Site
Uppsala, SE-751 85, Sweden
GSK Investigational Site
Kaohsiung City, 833, Taiwan
GSK Investigational Site
Tainan, 704, Taiwan
GSK Investigational Site
Taipei, 100, Taiwan
GSK Investigational Site
Taoyuan District, 333, Taiwan
GSK Investigational Site
Ankara, 06010, Turkey (Türkiye)
GSK Investigational Site
Ankara, 06230, Turkey (Türkiye)
GSK Investigational Site
Ankara, Turkey (Türkiye)
GSK Investigational Site
Istanbul, 34722, Turkey (Türkiye)
GSK Investigational Site
Birmingham, B9 5SS, United Kingdom
GSK Investigational Site
Chelmsford, CM1 7ET, United Kingdom
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Cheltenham, GL53 7AN, United Kingdom
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Edinburgh, EH4 2XU, United Kingdom
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Hull, HU16 5JQ, United Kingdom
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Leeds West Yorkshire, LS9 7TF, United Kingdom
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London, NW3 2QG, United Kingdom
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London, SW3 6JJ, United Kingdom
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Manchester, M20 4BX, United Kingdom
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Sutton, SM2 5PT, United Kingdom
Related Publications (1)
Starling N, Elez E, Strickler JH, Benson A, Oki E, Mendez G, Ferreiro R, Lau YL, Kawazoe A, Tian M, Campbell N, Cohen DN, Edwards K, Stjepanovic N, Seligmann JF. A Phase III study of perioperative dostarlimab in patients with dMMR/MSI-H resectable colon cancer: AZUR-2 study design. Future Oncol. 2026 Jan;22(2):137-145. doi: 10.1080/14796694.2025.2606910. Epub 2026 Jan 6.
PMID: 41492912DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Click here to enter text.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2023
First Posted
May 11, 2023
Study Start
August 1, 2023
Primary Completion (Estimated)
March 19, 2029
Study Completion (Estimated)
March 27, 2031
Last Updated
January 23, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- 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.
- 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.
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/