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NEOadjuvant PembRolizumab In Stratified Medicine - ColoRectal Cancer

NCT05197322 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 88

Last updated 2026-04-17

No results posted yet for this study

Summary

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 88 patients and recruitment is expected to take place over a 48 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.

Conditions

  • Adenocarcinoma of the Colon

Interventions

DRUG

Pembrolizumab

Dose: 200mg by IV infusion on Day 1 of each treatment cycle

DRUG

Pembrolizumab

Dose: 200mg by IV infusion on Day 1 of Cycle 1 only

Sponsors & Collaborators

  • Merck Sharp & Dohme LLC

    collaborator INDUSTRY

  • Sharp

    collaborator INDUSTRY

  • Foundation Medicine

    collaborator INDUSTRY

  • University College London (UCL) Cancer Institute

    collaborator OTHER

  • University of Leeds

    collaborator OTHER

  • University College London Hospitals

    collaborator OTHER

  • Personalis Inc.

    collaborator INDUSTRY

  • University College, London

    lead OTHER

Principal Investigators

  • Kai-Keen Shiu · University College London Hospitals

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-07-20
Primary Completion
2026-07-31
Completion
2029-07-31

Countries

  • United Kingdom

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05197322 on ClinicalTrials.gov