AZUR-4, a P2 study of dostarlimab + CAPEOX Vs CAPEOX w/ untreated colon cancer
Research type
Research Study
Full title
A Phase 2, open label, randomized study of neoadjuvant dostarlimab plus CAPEOX versus CAPEOX in participants with previously untreated T4N0 or Stage III MMRp/ MSS colon cancer
IRAS ID
1010414
Contact name
Derek Moriarty
Contact email
Sponsor organisation
GlaxoSmithKline Research & Development Limited
Clinicaltrials.gov Identifier
Research summary
This research study is focused on colon cancer that can be removed at an operation and has not spread to another part of the body.
The main goal of this study is to test a new treatment approach for colon cancer. Standard treatment is a combination of surgery and chemotherapy called capeox (short for“capecitabine + oxaliplatin”). This research will compare adding the study drug dostarlimab to capeox chemotherapy to test if this combination works better than using just capeox by itself. This treatment is given before surgery takes place; a method called “neoadjuvant therapy”.
The aim is to see if this new approach can show early signs of effectiveness in treating patients with a specific type of colon cancer known as mismatch repair proficient/microsatellite stable (MMRp/MSS), where the cells have normal repair systems and stable DNA sequences.
This study will also look at specific signs in the blood and tumour to see if they can help predict how well the treatment is working. This could help better understand how dostarlimab contributes to the response of the tumour to the treatment.
During this study participants will be split into 2 groups; 3 out of every 4 patients will be placed in the group receiving dosarlimab and capeox and 1 out of the 4 will be placed in the group just receiving capeox. Placement into a group will be at random, similar to drawing names from a hat, but all participants will know what treatment they are receiving. This study is open to adults aged 18 plus with MMRp/MSS colon cancer who meet certain further criteria.REC name
North East - Newcastle & North Tyneside 1 Research Ethics Committee
REC reference
24/NE/0163
Date of REC Opinion
14 Oct 2024
REC opinion
Further Information Favourable Opinion