Ongoing clinical trial: phase 3 study of perioperative dostarlimab in participants with untreated T4N0 or stage III dMMR/MSI-H resectable colon cancer (AZUR-2)

April 2024 

This study aims to evaluate the efficacy of dostarlimab treatment given before and after surgery (perioperative) compared to standard of care in participants with T4N0 or stage III mismatch repair deficient (dMMR) / microsatellite instability high (MSI-H) colon cancer with no prior therapy or surgery. Learn more about biomarkers here.  

Stage 1	Stage 2	Stage 3	Stage 4
T1 or T2	T3 or T4	Any T	Any T
N0	N0	N1 or N2	Any N
M0	M0	M0	M1

 

T1. The cancer has grown through the first few layers of the colon or rectum 

T2. The cancer has grown into the thick muscular layer of the colon or rectum 

T3. The cancer has grown through the entire colon or rectum wall 

T4. The cancer has grown through the entire colon or rectum wall and into nearby tissue or organs 

 

N0. There is no spread to lymph nodes 

N1. Cancer is found in 1-3 lymph nodes 

N2. Cancer is found in four or more lymph nodes 

 

M0. There is no spread of cancer to distant organ(s). 

M1. Cancer is found in distant organ(s). 

 

Dostarlimab is an immune checkpoint inhibitor (a type of immunotherapy) that is used to treat cancers including colorectal cancer. in a study of 14 patients with early-stage rectal cancer, treatment with dostarlimab prior to surgery led to a remarkable clinical complete response in 100% of the patients.  Evidence from tumours that express dMMR/MSI-H suggests that a perioperative approach with an immunotherapy agent such as dostarlimab may further improve survival outcomes1.  For more information about this clinical trial: https://clinicaltrials.gov/study/NCT05855200 

There are currently four different clinical trial sites in Canada for AZUR-2: