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

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

Es posible que algunos contenidos no estén disponibles en español.

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

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
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

John
Strickler

Protocol Number

PRO00113870

NCT ID

NCT05855200

Phase

III

Enrollment Status

Open to Enrollment
ClinicalTrials.gov