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Currently Recruiting
This trial is actively seeking participants in the UK. Discuss eligibility with your patient.
Status
Recruiting
Phase
PHASE2
NCT ID
NCT06692959
Trial Summary
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.
Sponsor: University of Southampton
Participants: ALL
Start: 2025-06-16
Completion: 2027-03-31
Min Age: 18 Years
Eligibility Criteria
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 or MSI-H). 8. Stage II (T3-T4 N0) III (any T, N1 or N2, M0) Colorectal cancer 9. Radiological evidence of operable CRC, determined by local MDT, usually CT scan. 10. Treatment naive patients (no prior anti CRC therapy). 11. Screening laboratory values must meet the following criteria 1. Neutrophils ≥…
Data from ClinicalTrials.gov. Always verify on the primary source before clinical use.