OncoMatch/Clinical Trials/NCT05197322
NEOadjuvant PembRolizumab In Stratified Medicine - ColoRectal Cancer
Is NCT05197322 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Pembrolizumab for adenocarcinoma of the colon.
Treatment: Pembrolizumab — Colorectal cancer (CRC) is the 2nd to 3rd most common malignant disease in developed countries, with over 1 million new cases and 500,000 deaths worldwide each year. The primary treatment for early stage CRC is surgery to remove the tumour, which is possible in 80% of patients. Even after surgery up to half of patients will develop recurrence or spread of the disease (metastases) which is incurable. Survival after 5 years is approximately 14% for patients with metastatic disease. Clinical trials using immunotherapy drugs called 'immune checkpoint inhibitors' have shown excellent results in advanced colorectal cancer patients who have certain genetic characteristics called 'mismatch repair deficiency (MMR-d)' and 'high microsatellite instability (MSI-h)'. The benefits of immunotherapy as a treatment prior to surgery to remove the tumour (neoadjuvant treatment) has been observed in both melanoma and in glioblastoma with enhanced local and systemic anti-tumour responses. Pembrolizumab is an immunotherapy drug and works by helping the body's own immune system to fight the cancer cells. The NEOPRISM-CRC trial will investigate whether giving pembrolizumab before surgery is safe, whether it improves the chances of the tumour being removed completely and whether it delays or prevents the cancer from coming back. Pembrolizumab treatment lasts for a maximum of 9 weeks (maximum of 3 cycles of treatment, each cycle consisting of 3 weeks) and is given prior to surgery. Following surgery patients will be followed up for at least 3 years after their surgery and to a maximum of 5 years. Target recruitment is 78 patients and recruitment is expected to take place over a 42 month period. Blood, tissue, mouth swabs and stool samples will be collected from patients throughout the trial to better understand the biology of immunotherapy as a treatment for CRC prior to surgery.
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: MMR deficient by IHC
MMR-d by IHC
Required: MSI high by PCR or microsatellite testing
MSI-H by PCR (or microsatellite testing if routine practice)
Disease stage
Required: Stage RADIOLOGICAL NODE POSITIVE T1-4, NODE NEGATIVE HIGH RISK T3, NODE NEGATIVE T4
Radiological node positive T1-4 CRC or Node negative high risk T3 defined as EITHER ≥ 5mm of extramural depth of invasion OR unequivocal EMVI on imaging (regardless of depth) or Node negative T4 disease
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: anti-PD-1 therapy
Prior therapy with an anti-PD-1, anti-PD-L1 or anti-PD-L2 agent
Cannot have received: checkpoint inhibitor
agent directed to another stimulatory or co-inhibitory T-cell receptor (e.g. CTLA-4, OX-40, CD137)
Cannot have received: systemic anti-cancer therapy
Prior systemic anti-cancer therapy including investigational agents within 4 weeks prior to registration
Lab requirements
Blood counts
White Blood Cell >3.0 x 10^9/L; Absolute neutrophil count ≥1.5 x 10^9/L; Platelets ≥100 x 10^9/L; Haemoglobin ≥90 g/L
Kidney function
GFR >50 mL/min estimated using validated creatinine clearance calculation (e.g. Cockroft-Gault); if calculated CrCl < 50 mL/min, formal 24 hour urine collection or isotope clearance must demonstrate GFR ≥ 50 mL/min
Liver function
Total bilirubin < 1.5x ULN OR direct bilirubin ≤ULN for participants with total bilirubin >1.5 × ULN; AST and ALT ≤ 2.5 × ULN
Adequate bone marrow function: White Blood Cell >3.0 x 10^9/L; Absolute neutrophil count ≥1.5 x 10^9/L; Platelets ≥100 x 10^9/L. Haemoglobin ≥90 g/L. Adequate renal function: GFR >50 mL/min... Adequate liver function: Total bilirubin < 1.5x ULN OR direct bilirubin ≤ULN for participants with total bilirubin >1.5 × ULN; AST and ALT ≤ 2.5 × ULN
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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