Perioperative dostarlimab vs standard of care for resectable colon cancer (219606) (AZUR) - Clinical Trial

What is the 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.

What is the Condition Being Studied?

Colon Cancer

Who Can Participate in the Study?

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

For more information about who can join this study, contact the study team at 919-668-1861.

Age Group
Adults

What is Involved?

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

Throughout the course of the study, you will have regular visits to our clinic that involve blood draws and imaging tests (MRI and CT).

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
Medical Oncologist
Protocol Number
IRB: PRO00113870
NCT: NCT05855200
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment
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