Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer
Categories (click each to see list of all clinical trials associated with that category): GI (ONC)
Current Status: Not open
Phase: III (Cancer Control)
Principal Investigator: Tenner, Laura
Contact Information:
Kacie Flaherty
kacie.flaherty@unmc.edu
Eligibility: https://clinicaltrials.gov/study/NCT05855200?term=NCT05855200&rank=1#participation-criteria
Summary
Primary Objective:
-To evaluate the efficacy of perioperative dostarlimab compared with SOC in participants with untreated T4N0 or Stage III (resectable), dMMR/MSI-H colon cancer
Secondary Objectives:
-To evaluate the efficacy of neo-adjuvant dostarlimab in participants with untreated T4N0 or Stage III (resectable), dMMR/MSI-H colon cancer. -To estimate the difference in OS for participants treated with perioperative dostarlimab compared with SOC in participants with untreated T4N0 or Stage III (resectable), dMMR/MSI-H colon cancer. -To evaluate the efficacy of peri-operative dostarlimab compared with SOC in participants with untreated T4N0 or Stage III (resectable), dMMR/MSI-H colon cancer. -To assess the safety and tolerability of dostarlimab compared with SOC in participants with untreated T4N0 or Stage III (resectable), dMMR/MSI-H colon cancer. -To describe the PK of dostarlimab in participants with untreated T4N0 or Stage III (resectable), dMMR/MSI-H colon cancer. -To determine the immunogenicity of dostarlimab in participants with untreated T4N0 or Stage III (resectable), dMMR/MSI-H colon cancer