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Colorectal CancerPhase 2Neo-POLEMNCT06692959

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

A Phase 2 study testing PD-1 vaccine IMU-201 (PD1-Vaxx) in people with Colorectal Cancer, run by University of Southampton at 2 sites in Australia.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Colorectal Cancer
What is being tested?
PD-1 vaccine IMU-201 (PD1-Vaxx)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
2 sitesAustralia
Study dates
16 Jun 2025to 11 Jun 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • Patients must be willing and able to comply with the schedule visits, treatment schedules, laboratory tests and other requirements of the study.
  • Target Population
  • Histologically confirmed adenocarcinoma cancer of the colon and high rectum.
  • ECOG Performance status 0 or 1
  • Measurable disease per RECIST 1.1 criteria
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  • 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...
  • In order in to be entered into the study, patients must be classified as MSI-High (confirmation of MMR deficiency or MSI-H).
  • Stage II (T3-T4 N0) III (any T, N1 or N2, M0) Colorectal cancer
  • Radiological evidence of operable CRC, determined by local MDT, usually CT scan.
  • Treatment naive patients (no prior anti CRC therapy).
  • Screening laboratory values must meet the following criteria
  • Neutrophils ≥ 1.5x 109/L
  • Platelets ≥ 100 x 109/L
  • Haemoglobin ≥ 9.0 g/dl
  • Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or calculated creatinine clearance 'CrCl' > 50 mL/min (using the Cockcroft Gault formula):
  • Female CrCl = (140 - age in years) x weight (kg) x 1.04 serum creatinine (µmol/l)
  • Male CrCl = (140 - age in years) x weight (kg) x 1.23 serum creatinine in µmol
  • Total bilirubin ≤ 1.5 x ULN; for patients with documented/suspected Gilbert's disease, bilirubin ≤3 x ULN
  • AST ≤1.5 x ULN
  • ALT ≤1.5 x ULN
  • Age and Reproductive Status
  • Age ≥ 18 years
  • Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of HCG) within 72 hours prior to the start of study drug.
  • Women must not be breastfeeding.
  • Women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception, as indicated in the informed consent form. Contraception must be used for the duration of treatment and for a period of 180 days after last dose of study drug.
  • Males who are sexually active with WOCBP must agree to follow instructions for method(s) of contraception, as indicated in the informed consent form for a period of 180 days. Men who are sexually active with WOCBP must continue contraception for 180 days after the last dose of investigational drug (combination or monotherapy). In addition, male patients must be willing to refrain from sperm donation during this time.
  • Azoospermic males are exempt from contraceptive requirements. WOCBP who are continuously not heterosexually active are also exempt from contraceptive requirements, and still must undergo pregnancy testing as described in this section.

Who cannot join

  • History of severe allergic reactions (i.e., Grade 4 allergy, anaphylactic reaction from which the patient did not recover within 6 hours of institution of supportive care) to any unknown allergens or any components of the PD-1 vaccine formulations.
  • Distant metastases or peritoneal nodules (M1)
  • Active or prior documented autoimmune disease (including inflammatory bowel disease, coeliac disease, and Wegener syndrome).
  • Any concurrent chemotherapy or biologic or hormonal therapy for CRC treatment. Concurrent use of hormones for non-cancer- related conditions (e.g. insulin for diabetes and hormone replacement therapy) is acceptable.
  • History of primary immunodeficiency, solid organ transplantation, or previous clinical diagnosis of tuberculosis.
  • If they are positive for hepatitis B virus surface antigen (HBVsAg) or hepatitis C virus ribonucleic acid (HCV antibody) indicating acute or chronic infection
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  • If they have known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS)
  • Receipt of live, attenuated vaccine within 28 days prior to the first dose of PD-1 vaccine PD1-Vaxx (patients, if enrolled, should not receive live vaccine during the study and 180 days after the last dose of Investigational Medicinal Product (IMP)).
  • Other invasive malignancy within two years except for non-invasive malignancies such as cervical carcinoma in situ, non-melanomatous carcinoma of the skin or ductal carcinoma in situ of the breast that has/have been surgically cured. Cancer patients with incidental histological findings of prostate cancer (tumour/node/metastasis stage of T1a or T1b or prostate-specific antigen ˂10) who have not received hormonal treatment may be included.
  • Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, uncontrolled hypertension, unstable angina pectoris, cardiac arrhythmia, active peptic ulcer disease or gastritis, or psychiatric illness/social situations that would limit compliance with study requirement or compromise the ability of the patient to give written informed consent.
  • Any condition that, in the opinion of the investigator or sponsor, would interfere with the evaluation of the investigational product or interpretation of patient safety or study results.
  • Patients with a condition requiring systemic treatment with either corticosteroids (>10 mg daily prednisolone equivalents) or other immunosuppressive medications within 14 days of study drug administration. Inhaled or topical steroids and adrenal replacement doses >10 mg daily prednisolone equivalents are permitted in the absence of active autoimmune disease.
  • Systemic antibiotic treatment within 7 days prior to the start of trial treatment.
  • Patients with a documented history of pneumonitis, regardless of the cause.

Trial locations and contacts

2 sites in 1 country.

Australia2 sites

  • The Queen Elizabeth Hospital

    Adelaide, South Australia

  • St John of God Subiaco Hospital

    Perth, Western Australia

Other trials in Australia

About this study

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.

Read the 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.

Being tested
PD-1 vaccine IMU-201 (PD1-Vaxx)
Keywords
PD-1 Vaccine, Operable Colorectal Cancer, Neo-adjuvant
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    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.

Study groups in NCT06692959
Study groupRoleWhat they receive
PD1-VaxxExperimentalAll 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.
Receives: Drug: PD-1 vaccine IMU-201 (PD1-Vaxx)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Major Pathological Response (MPR) rates after administering neoadjuvant PD-1 vaccine

    Proportion of participants with MPR (determined by ≤10% viable tumour cells after receiving PD1-Vaxx).

    Measured: At surgery

Secondary outcomes (8)

  1. Safety of PD-1 vaccine PD1-Vaxx in the neo-adjuvant setting

    Adverse events graded according to CTCAE v5

    Measured: From first vaccine dose until 100 days after the last study treatment

  2. Rate of complete response after receiving PD1-Vaxx

    Proportion of participants with complete response (no viable tumour cells after receiving PD1-Vaxx).

    Measured: At surgery

  3. Objective response rate

    Overall Response Rate (ORR) by RECIST 1.1

    Measured: 21 days after last vaccine

  4. Disease free survival

    Disease-free survival

    Measured: From surgery until completion of 2 year follow up

  5. Overall survival

    Overall survival

    Measured: From enrolment to completion of 2 years follow up

  6. Claviend-Dindo

    Clavien-Dindo grading

    Measured: 30 days post surgery

  7. Health-related quality of life

    EORTC QLQ-C30

    Measured: 21 days after last vaccine

  8. Health-related quality of life

    EQ-5D-5L

    Measured: 21 days after last vaccine

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Nov 2024
  2. Study start16 Jun 2025
  3. Primary completion11 Jun 2026
  4. Study completion11 Jun 2026

Why it stopped: funding withdrawal

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model 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.
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06692959
Sponsor's protocol ID
79361
Acronym
Neo-POLEM
Status last verified
Jun 2026
First submitted
7 Nov 2024
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing PD-1 vaccine IMU-201 (PD1-Vaxx) in people with Colorectal Cancer, run by University of Southampton at 2 sites in Australia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: funding withdrawal). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Major Pathological Response (MPR) rates after administering neoadjuvant PD-1 vaccine (time frame: At surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06692959.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.

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