ClinicaliQ Trial Snapshot
- A Phase II Trial of Neoadjuvant PD-1 Vaccine PD1-Vaxx in Operable MSI High Colorectal Cancer — Recruiting • Phase II • Oncology • NCT06692959.
- The aim of Neo-POLEM is to determine the rate of Major Pathological Response (MPR) of.
- Sponsor: University of Southampton.
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- Quick orientation before opening the registry record.
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What This Trial Is Studying
The aim of Neo-POLEM is to determine the rate of Major Pathological Response (MPR) of
Eligibility Snapshot
- : 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 ≥…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.