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
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.
Arms & interventions
- BiologicalDostarlimab
Dostarlimab will be administered.
- DrugCAPEOX
CAPEOX will be administered.
- DrugFOLFOX
FOLFOX will be administered.
Outcome measures
Primary
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
Time frame: Up to approximately 5 years
Secondary
Overall Survival (OS)
Time frame: Up to approximately 5 years
Number of Participants with Pathological Response
Time frame: Up to approximately 5 years
Event-free Survival (EFS) assessed by local assessment
Time frame: 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
Number of Participants with AEs and SAEs by Severity
Time frame: 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)
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)
Serum Predose trough concentration (Ctrough) of Dostarlimab
Time frame: 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
Eligibility criteria
Study locations (49)
GSK Investigational Site
Tucson, Arizona, 85715
GSK Investigational Site
Los Angeles, California, 90027
GSK Investigational Site
New Haven, Connecticut, 06520
GSK Investigational Site
Washington D.C., District of Columbia, 20010
GSK Investigational Site
Deerfield Beach, Florida, 33064
GSK Investigational Site
Fort Lauderdale, Florida, 33316
GSK Investigational Site
Marietta, Georgia, 30060
GSK Investigational Site
Chicago, Illinois, 60611
GSK Investigational Site
Chicago, Illinois, 60612
GSK Investigational Site
Chicago, Illinois, 60637
GSK Investigational Site
Naperville, Illinois, 60126
GSK Investigational Site
Naperville, Illinois, 60540
GSK Investigational Site
Westwood, Kansas, 66205
GSK Investigational Site
Lexington, Kentucky, 40503
GSK Investigational Site
Louisville, Kentucky, 40206
GSK Investigational Site
Baton Rouge, Louisiana, 70809
GSK Investigational Site
Bethesda, Maryland, 20817
GSK Investigational Site
Ann Arbor, Michigan, 48109
GSK Investigational Site
Detroit, Michigan, 48202
GSK Investigational Site
Minneapolis, Minnesota, 55455
GSK Investigational Site
Joplin, Missouri, 64804
GSK Investigational Site
St Louis, Missouri, 63128
GSK Investigational Site
St Louis, Missouri, 63141
GSK Investigational Site
Grand Island, Nebraska, 68803
GSK Investigational Site
Omaha, Nebraska, 68130
GSK Investigational Site
Omaha, Nebraska, 68198
GSK Investigational Site
Lebanon, New Hampshire, 03756
GSK Investigational Site
New York, New York, 10028
GSK Investigational Site
New York, New York, 10469
GSK Investigational Site
New York, New York, 11042
GSK Investigational Site
New York, New York, 11967
GSK Investigational Site
The Bronx, New York, 10461
GSK Investigational Site
Durham, North Carolina, 27710
GSK Investigational Site
Akron, Ohio, 44304
GSK Investigational Site
Cincinnati, Ohio, 45220
GSK Investigational Site
Cleveland, Ohio, 44111
GSK Investigational Site
Cleveland, Ohio, 44142
GSK Investigational Site
Cleveland, Ohio, 44196
GSK Investigational Site
Oklahoma City, Oklahoma, 73104
GSK Investigational Site
Oklahoma City, Oklahoma, 73120
GSK Investigational Site
Pittsburgh, Pennsylvania, 15212
GSK Investigational Site
Sioux Falls, South Dakota, 57078
GSK Investigational Site
Sioux Falls, South Dakota, 57105
GSK Investigational Site
Sioux Falls, South Dakota, 57401
GSK Investigational Site
Sioux Falls, South Dakota, 57501
GSK Investigational Site
Dallas, Texas, 75235
GSK Investigational Site
Dallas, Texas, 75390
GSK Investigational Site
Richmond, Virginia, 23229
GSK Investigational Site
Appleton, Wisconsin, 54911
References
- 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.(PubMed)