drugset / Trial / NCT06692959

A Phase II Trial of Neoadjuvant PD-1 Vaccine PD1-Vaxx in Operable MSI High Colorectal Cancer

NCT06692959 ↗

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2025-06-16
Primary completion
2026-06-11
Completion
2026-06-11

Outcome

Outcome not reported

Stopped (Business): “funding withdrawal”

Drugs

EvaluationDrugModalityDoseRoute
Subject PD1-Vaxx Vaccine — Intramuscular

Indications