Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
- Conditions
- Neoplasms, ColonColonic Neoplasms
- Interventions
- Drug: CAPEOXBiological: DostarlimabDrug: FOLFOX
- Registration Number
- NCT05855200
- Lead Sponsor
- GlaxoSmithKline
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 711
- 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
- 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 randomization
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard of Care (SOC) CAPEOX Participants will receive SOC (FOLFOX/CAPEOX) or undergo expectant observation post surgery. Standard of Care (SOC) FOLFOX Participants will receive SOC (FOLFOX/CAPEOX) or undergo expectant observation post surgery. Dostarlimab Dostarlimab Participants will receive Dostarlimab pre and post surgery
- Primary Outcome Measures
Name Time Method Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR) 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
- Secondary Outcome Measures
Name Time Method Number of Participants with Pathological Response 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.
Number of Participants with Anti-Drug Antibodies against Dostarlimab Up to approximately 5 years Overall Survival (OS) Up to approximately 5 years OS is defined as time from randomization to death from any cause
Event-free Survival (EFS) assessed by local assessment 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
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 Serum Concentration of Dostarlimab 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) End of Infusion (EoI) of Cycle 1 to Cycle 10 (each cycle is of 21 days) Serum Predose trough concentration (Ctrough) of Dostarlimab Predose of Cycle 1 to Cycle 10 (each cycle is of 21 days)
Trial Locations
- Locations (1)
GSK Investigational Site
🇬🇧Sutton, United Kingdom