An international trial of the world’s first personalised mRNA cancer immunotherapy for melanoma has begun at University College London Hospital (UCLH). The work is underpinned by support from NIHR infrastructure.
Immunotherapy is specifically tailored to the genetic signature of each patient’s tumour. The patient’s immune system recognises and attacks cancerous cells. The aim is to prevent the recurrence of cancer after removal of the tumour. The treatment is mRNA-based technology developed by Moderna and Merck Sharp and Dohme (MSD).
To personalise the treatment, a sample of the patient’s tumour is removed during surgery. Then DNA sequencing and artificial intelligence are used to custom-build a therapy that is specific to each tumour.
The Phase 2 study, published in The Lancet, found there was a 49% reduction in the risk of recurrence or death after three years compared with the standard treatment. The new, expanded Phase 3 trial has just been launched.
Dr Heather Shaw, Consultant Medical Oncologist and national coordinating investigator of the trial, said: “The idea behind this immunotherapy is that, by prompting the body to make these proteins, it can prepare the immune system to quickly identify and attack any cancer cells bearing them, with the aim of preventing recurrence of melanoma.”
The UK Vaccine Innovation Pathway (VIP) played a crucial role in advancing this complex and innovative clinical trial by providing the systems and processes to optimise set up and patient recruitment. The VIP, which is hosted by the NIHR on behalf of the four UK health departments, has been established to streamline and accelerate the delivery of vaccine studies.
The trial is taking place at UCLH, which receives NIHR support through its Biomedical Research Centre and its Clinical Research Facility. It is delivered with the support of the NIHR Clinical Research Network (CRN).
Professor Sarah Danson, NIHR CRN National Specialty Lead for Early Phase Cancer Research, said: "The UK Vaccine Innovation Pathway is recognised for its global leadership in accelerating clinical trials for personalised mRNA vaccines. This success reflects the efficiency and effectiveness of the UK's clinical trials system in delivering innovation for the benefit of cancer patients."
Patients who have had their high-risk melanomas (stage IIB to IV) cancer surgically removed are eligible. The researchers are evaluating a combination of mRNA-4157 (V940) and Keytruda (pembrolizumab), versus standard of care (pembrolizumab). The study is a randomised, double-blind, placebo- and active-comparator-controlled study.