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

Conditions

• Colonic Neoplasms
• Neoplasms, Colon

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Dostarlimab — BIOLOGICAL
  Dostarlimab will be administered.
• CAPEOX — DRUG
  CAPEOX will be administered.
• FOLFOX — DRUG
  FOLFOX will be administered.

Study Details

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.

Key Dates

Start date

Aug 1, 2023

Status verified

Jan 2026

Primary completion

Mar 19, 2029

Completion

Mar 27, 2031

Study Design

Enrollment

892 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Dostarlimab
  Participants will receive Dostarlimab pre and post surgery
• Active Comparator: Standard of Care (SOC)
  Participants will receive SOC (FOLFOX/CAPEOX) or undergo expectant observation post surgery.

Primary Outcome Measure

Event-free Survival (EFS) Assessed by Blinded Independent Central Review (BICR) [ Time Frame: Up to approximately 5 years ]

Central Contacts

• US GSK Clinical Trials Call Center
  877-379-3718
  [email protected]
• EU GSK Clinical Trials Call Center
  +44 (0) 20 89904466
  [email protected]

Locations (49)

Find similar trials in Tucson, AZ

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