Study of Perioperative Dostarlimab in Participants With Untreated T4N0 or Stage III dMMR/MSI-H Resectable Colon Cancer (AZUR-2)

Edward Cancer Center - Naperville
Edward Cancer Center - Plainfield
Nancy Knowles Cancer Center - Elmhurst

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.

Sponsor: GlaxoSmithKline

https://clinicaltrials.gov/ct2/show/NCT05855200

• Must have untreated pathologically confirmed colon adenocarcinoma.
• Has a tumor demonstrating the presence of either:
  - dMMR status determined or
  - MSI-H phenotype.
• Must be willing to use adequate contraception.
• Must not have distant metastatic disease.
• Must not have received prior medical therapy (chemotherapy, immunotherapy, biologic, or targeted therapy), radiation therapy or surgery for management of colon cancer.
• Must have a tumor that is amenable to surgery.
• Must not have a known additional malignancy that progressed or required active treatment within the past 2 years. 
• Must not have any history of interstitial lung disease or pneumonitis or have a history of or evidence of cardiac abnormalities.