Purpose of this Study
We are doing this study to see if the study drug, dostarlimab, can reduce the recurrence of cancer in people who have had their colon cancer surgically removed.
Who Can Participate?
Eligibility
Adults ages 18+ who:
- Are diagnosed with colon adenocarcinoma
- Have disease that is accessible and able to be removed by surgery
- Have a documented status of microsatellite instability high or mismatch repair deficient
What is Involved?
Description
If you choose to join this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:
- One group will get IV infusions of dostarlimab for 12 weeks, followed by surgery, then another 36 weeks of dostarlimab
- The other group will have surgery, followed by 12-24 weeks of chemotherapy or watchful waiting
Study Details
Full Title
[219606] 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
Principal Investigator
John
Strickler
Protocol Number
PRO00113870
NCT ID
NCT05855200
Phase
III
Enrollment Status
Open to Enrollment