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

NCT06692959 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-03-23

No results posted yet for this study

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.

Conditions

Interventions

DRUG

PD-1 vaccine IMU-201 (PD1-Vaxx)

Investigational Medicinal Product (IMP) PD1-Vaxx is supplied as lyophilized drug substance APi2568, which is a B-cell epitope (amino acids 92-110 from PD-1) linked to a promiscuous T-cell epitope (amino acid residues 288-302 from measles virus fusion protein) via a 4-amino acid linker (G-P-S-L). IMU-201 is combined with water for Injection (WFI) and is emulsified with Montanide ISA 51 VG adjuvant to produce PD1-Vaxx.

Sponsors & Collaborators

  • Australasian Gastro-Intestinal Trials Group

    collaborator NETWORK

  • University of Southampton

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-16
Primary Completion
2027-03-31
Completion
2029-01-31

Countries

  • Australia
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06692959 on ClinicalTrials.gov