Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2025-12-26 @ 7:00 AM
Study NCT ID:
NCT06692959
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-05-02
First Post:
2024-11-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Trial of Neoadjuvant PD-1 Vaccine PD1-Vaxx in Operable MSI High Colorectal Cancer
Sponsor:
University of Southampton
Organization:
Study Overview
Official Title:
A Phase II Trial of Neoadjuvant PD-1 Vaccine PD1-Vaxx in Operable MSI High Colorectal Cancer
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Neo-POLEM
Brief 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.
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.
Detailed Description:
This is a phase II, Bayesian Optimal Design, single arm, one cohort, open label, multi-centre study of neoadjuvant PD-1 vaccine PD1-Vaxx and surgical resection in adult patients with operable MSI-high colorectal cancer. All patients will be administered PD1-Vaxx intramuscularly into the deltoid region of the upper arm on days 1,15 and 29. Patients will undergo resection surgery within 21 days, but up to 42 days of completing trial treatment. The resection sample will be examined locally for pathological response within 28 days of surgical resection. Patient will then remain in active follow up for up to 2 years. Once the last patient has completed their last visit a check will be made on all patients to confirm their recurrence and survival status.
The aim of the trial is to determine the major pathological response rates after administering neoadjuvant PD-1 vaccine PD1-Vaxx in operable MSI-high CRC patients.
The aim of the trial is to determine the major pathological response rates after administering neoadjuvant PD-1 vaccine PD1-Vaxx in operable MSI-high CRC patients.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: