Neo-POLEM

Protocol Title

A phase II trial of neoadjuvant PD-1 vaccine IMU-201 (PD1-Vaxx) in operable MSI high colon cancer (CRC).

Purpose of the Study

Colorectal cancer (CRC) is the third most common cancer. The risk of recurrence within 2 years of surgery is up to 40% for stage III mismatch repair deficient (dMMR) tumours despite standard of care adjuvant chemotherapy. Loss of MMR function leads to increase in tumour mutational load and failure to repair mutations known as microsatellite instability (MSI).

Stage III colon cancer patients who have dMMR are known to respond to PDL-1/PD-1 inhibitors. The IMU-201 (PD1-Vaxx) vaccine induces the production of anti-PD-1 antibodies in patients. By using a vaccine such as IMU-201 (PD1-Vaxx), a polyclonal antibody response may be more effective or as effective, with improved safety over current monoclonal antibody therapy.

The purpose of the Neo-POLEM study is to determine if MSI high, early CRCs respond to or benefit from PD-1 vaccine IMU-201 (PD1-Vaxx). If this study shows a significant response in this group of patients, adding the PD-1 vaccine to adjuvant chemotherapy could become standard of care.

Contact Email

agitg@gicancer.org.au

DETAILED INFORMATION AVAILABLE

More detailed information to come.

Study Chairs

Professor Tim Price
Dr Tharani Krishnan

Funding

Imugene Limited