A Phase II Trial of Neoadjuvant PD-1 Vaccine PD1-Vaxx in Operable MSI High Colorectal Cancer
25 March 2026
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🅇 This trial is currently recruiting participants in the UK
Speak to your GP or specialist first. They can help you understand if you might be eligible and what taking part would involve.
🅇 This trial is currently recruiting volunteers
If you think you might be eligible, speak to your GP or specialist about this trial before applying.
Status
Recruiting
Phase
PHASE2
Participants
ALL
Age Range
18 Years+
About This Trial
The aim of Neo-POLEM is to determine the rate of Major Pathological Response (MPR) of <10% viable tumour cells after administering neoadjuvant PD-1 vaccine IMU-201 (PD1-Vaxx), as measured by percentage change pre- and post-treatment in operable MSI high CRC patients.
All patients will be administered three doses of the PD1-Vaxx prior to resection surgery and will be followed up for a minimum of 2 years.
Who Can Join?
Inclusion Criteria: 1. Patients must have signed and dated a written informed consent form. This must be performed before the performance of any protocol related procedures that are not part of the normal care. 2. Patients must be willing and able to comply with the schedule visits, treatment schedules, laboratory tests and other requirements of the study. Target Population 3. Histologically confirmed adenocarcinoma cancer of the colon and high rectum. 4. ECOG Performance status 0 or 1 5. Measurable disease per RECIST 1.1 criteria 6. Tumour tissue from a colonoscopy must be provided for biomarker analysis. Archival tumour tissue is mandatory for biomarker analysis. If no sample is available, patients will have the option to agree to acquisition of additional tumour tissue during the screening period for future biomarker analyses… 7. In order in to be entered into the study, patients must be classified as MSI-High (confirmation of MMR deficiency…
⚠ Always speak to your doctor before applying to any clinical trial.