NEOadjuvant PembRolizumab In Stratified Medicine - ColoRectal Cancer
Status:
Not yet recruiting
Trial end date:
2027-03-01
Target enrollment:
Participant gender:
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, and whether it improves the chances of the tumour being removed
completely, and whether this 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 32 patients and recruitment is expected to take place over a 24 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.
Phase:
Phase 2
Details
Lead Sponsor:
University College, London
Collaborators:
Foundation Medicine Merck Sharp & Dohme Corp. Sharp Clinical Services University College London (UCL) Cancer Institute University College London Hospitals University of Leeds