Actively Recruiting
A Phase II Trial of Neoadjuvant PD-1 Vaccine PD1-Vaxx in Operable MSI High Colorectal Cancer
Led by University of Southampton · Updated on 2026-03-23
44
Participants Needed
4
Research Sites
189 weeks
Total Duration
On this page
Sponsors
U
University of Southampton
Lead Sponsor
A
Australasian Gastro-Intestinal Trials Group
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
A Phase II Trial of Neoadjuvant PD-1 Vaccine PD1-Vaxx in Operable MSI High Colorectal Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed and dated informed consent before any study procedures
- Willing and able to follow study visits, treatment schedules, and tests
- Histologically confirmed adenocarcinoma of colon or high rectum
- ECOG performance status of 0 or 1
- Measurable disease according to RECIST 1.1 criteria
- Tumor tissue available for biomarker analysis from colonoscopy or archival sample
- Classified as MSI-High (MMR deficiency or MSI-H confirmed)
- Stage II (T3-T4 N0) or Stage III (any T, N1 or N2, M0) colorectal cancer
- Radiological evidence of operable colorectal cancer
- No prior anti-colorectal cancer therapy
- Laboratory values within specified limits for neutrophils, platelets, hemoglobin, creatinine, bilirubin, AST, and ALT
- Age 18 years or older
- Women of childbearing potential must have a negative pregnancy test before treatment
- Women must not be breastfeeding
- Women of childbearing potential must agree to contraception during treatment and for 180 days after last dose
- Sexually active men with women of childbearing potential must agree to contraception during treatment and for 180 days after last dose
- Azoospermic men and women not heterosexually active are exempt from contraception but must follow pregnancy testing requirements
You will not qualify if you...
- History of severe allergic reactions to any PD-1 vaccine component
- Presence of distant metastases or peritoneal nodules (M1)
- Active or prior autoimmune diseases, including inflammatory bowel disease, coeliac disease, Wegener syndrome
- Concurrent chemotherapy, biologic, or hormonal therapy for colorectal cancer
- History of primary immunodeficiency, organ transplantation, or tuberculosis
- Positive for hepatitis B surface antigen or hepatitis C antibody indicating infection
- Known HIV infection or AIDS
- Receipt of live attenuated vaccine within 28 days before first PD1-Vaxx dose or planned live vaccine during study and 180 days after last dose
- Other invasive malignancies within two years except certain non-invasive cancers
- Uncontrolled illnesses such as active infection, heart failure, hypertension, unstable angina, arrhythmia, peptic ulcer disease, gastritis, psychiatric illness, or social situations limiting compliance
- Any condition interfering with investigational product evaluation or patient safety
- Use of systemic corticosteroids (>10 mg prednisolone equivalent) or immunosuppressive medications within 14 days before treatment
- Systemic antibiotic treatment within 7 days before treatment
- History of pneumonitis of any cause
AI-Screening
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Trial Site Locations
Total: 4 locations
1
The Queen Elizabeth Hospital
Adelaide, South Australia, Australia
Actively Recruiting
2
St John of God Subiaco Hospital
Perth, Western Australia, Australia
Actively Recruiting
3
Royal Surrey County Hospital NHS Foundation Trust
Guildford, Surrey, United Kingdom, GU2 7XX
Not Yet Recruiting
4
The Christie NHS Foundation Trust
Manchester, United Kingdom, M20 4BX
Not Yet Recruiting
Research Team
T
Tony Dhillon
CONTACT
T
Tracey Mason
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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