A phase II trial of neoadjuvant PD-1 vaccine (PD1-Vaxx) in operable MSI high colorectal cancer (CRC)
Early stage colon cancer that has spread to the local lymph nodes is best treated with surgery and chemotherapy, however, half of patients treated will have subsequent recurrence of their cancer. If this happens the cancer is often incurable.
About 1 in 7 colon cancer have ‘defective mismatch repair’ and recent small trials of immunotherapy drugs appear to work exceptionally well in this subtype of cancer. In Neo-POLEM we will use a vaccine approach that is hoped to have a durable effect. The vaccine, PD1-Vaxx, is designed to work by stimulating the immune system to attach the patient’s cancer and it’s predicted that this subtype of cancer may be particularly sensitive to this approach.
Neo-POLEM aims to recruit a maximum of 44 patients in total, 24 in the UK from 3 NHS sites and 20 in Australia. Participants in the study will receive 3 vaccinations, once every 2 weeks over a 6 week period. Following treatment patients will undergo standard care surgery and following this will be followed up for a maximum of two years.
Primary:
Secondary:
Tertiary:
Future exploratory endpoints will include translational work looking at immune related outcomes in MSI-High CRC pre- and post-anti PD-1 vaccine IMU-201 (PD1-Vaxx)
Open label, multi-centre phase II Bayesian optimal design
In set-up
Patients due to receive neoadjuvant treatment of operable MSI-H colon cancer (CRC)
Imugene
Senior Trial Manager
Kerry-Ann Longman
Email: [email protected]
Phone: 023 8120 5154
Email: [email protected]
Trial documents coming soon.