Perioperative Dostarlimab in Untreated T4N0/Stage 3 dMMR/MSI-H Locally Advanced Colon Cancer (AZUR2)
Research type
Research Study
Full title
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
IRAS ID
1006247
Contact name
Sean O’Donnell
Contact email
sean.x.o'donnell@gsk.com
Sponsor organisation
Glaxosmithkline Research & Development Limited
Clinicaltrials.gov Identifier
Research summary
This research study is being done to learn more about an investigational treatment, Dostarlimab, in its treatment of patients with early-stage colon cancer. Dostarlimab belongs to a class of drugs called PD-1 inhibitors that uses the immune system to treat cancer (immunotherapy). Dostarlimab is designed to stop cancer from growing by helping the immune system recognise and fight the cancer.
This study’s aim is to learn more about colon cancer and the interaction between cancer and Dostarlimab compared with the Standard Of Care treatment/SOC (surgery plus chemotherapy or surgery without chemotherapy) with the goal to potentially spare patients from the side effect of chemotherapy and reduce the risk of cancer returning after surgery.
Participants will undergo screening to assess their eligibility, involving review of safety blood tests, a stool sample, vital signs, ECG, full physical exam, disease assessment scans (such as CT-scan) and completion of health assessment questionnaires. All eligible participants will receive surgery and treatment; a computer will randomly decide the treatment, either Dostarlimab or SOC. Neither the participants nor the study doctor can choose the treatment but they will be able to see which treatment the participant is on.
Common assessments during the treatment period include vital signs, further safety blood samples, health questionnaires, and a brief physical exam. Participants will be treated until Dostarlimab or SOC therapy is completed then closely monitored for safety (up to 90 days after the last dose of Dostarlimab or chemotherapy or surgery).
Thereafter, participants will enter a long-term follow up period until the study ends (when the last study participant completes 5 years of follow-up). Collection of some additional blood samples, disease scans and review of the colon using a scope, a very fine camera, (colonoscopy) will also be performed to further help understand the effects of Dostarlimab.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
23/NW/0184
Date of REC Opinion
31 Aug 2023
REC opinion
Further Information Favourable Opinion