Colon Cancer
Conditions
Interventions
Biological: Dostarlimab
Dostarlimab will be administered.
Drug: CAPEOX
CAPEOX will be administered.
Drug: FOLFOX
FOLFOX will be administered.
Sponsors
Ishibashi Hideyasu
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Has untreated pathologically confirmed colon adenocarcinoma -Has resectable colon adenocarcinoma defined as clinically T4N0 or Stage III -Has radiologically evaluable disease -Has a tumor demonstrating the presence of either dMMR status or MSI-H
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR) | — |
Secondary
| Measure | Time frame |
|---|---|
| -Number of Participants with Pathological Response -Overall Survival (OS) -Event-free Survival (EFS) assessed by local assessment -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 -Number of Participants with AEs and SAEs by Severity. -Serum Concentration of Dostarlimab -Serum Concentration of Dostarlimab at End of Infusion (C-EoI) -Serum Predose trough concentration (Ctrough) of Dostarlimab -Number of Participants with Anti-Drug Antibodies against Dostarlimab | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, China, Estonia, Finland, France, Germany, Greece, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Norway, Panama, Portugal, Spain, Sweden, Taiwan, Turkey, United Kingdom, United States
Contacts
Public ContactHideyasu Ishibashi
GlaxoSmithKline K.K.
Outcome results
None listed