OncoMatch/Clinical Trials/NCT06692959
A Phase II Trial of Neoadjuvant PD-1 Vaccine PD1-Vaxx in Operable MSI High Colorectal Cancer
Is NCT06692959 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies PD-1 vaccine IMU-201 (PD1-Vaxx) for colorectal cancer.
Treatment: PD-1 vaccine IMU-201 (PD1-Vaxx) — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Disease stage
Required: Stage II (T3-T4 N0), III (ANY T, N1 OR N2, M0)
Stage II (T3-T4 N0) III (any T, N1 or N2, M0) Colorectal cancer; Distant metastases or peritoneal nodules (M1) [excluded]
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
no prior anti CRC therapy
Cannot have received: biologic therapy
no prior anti CRC therapy
Cannot have received: hormonal therapy
no prior anti CRC therapy
Lab requirements
Blood counts
Neutrophils ≥ 1.5x 10^9/L; Platelets ≥ 100 x 10^9/L; Haemoglobin ≥ 9.0 g/dl
Kidney function
Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance > 50 mL/min (Cockcroft Gault formula)
Liver function
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
Screening laboratory values must meet the following criteria: Neutrophils ≥ 1.5x 10^9/L; Platelets ≥ 100 x 10^9/L; Haemoglobin ≥ 9.0 g/dl; Serum creatinine ≤ 1.5 x ULN or calculated creatinine clearance > 50 mL/min; 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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