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Trial begins for groundbreaking new personalised melanoma treatment

Published: 26 April 2024

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. 

Melanoma is the most serious form of skin cancer. In the UK there are 8,400 new cases every year. This makes it the fifth most common type of cancer.

How does the treatment work? 

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.”

Supported by the NIHR

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). 

Health and Social Care Secretary, Victoria Atkins, said: "The UK is once again at the forefront of innovation with today's potentially lifesaving melanoma treatment. Backed by government support through our strategic partnership with Moderna and the development of the Vaccines Innovation Pathway, we are helping to deliver these vital vaccines to save lives and support the NHS."

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." 

Dr Matt Hallsworth, NIHR Director of Strategic Partnerships, said: “We are delighted to be supporting this groundbreaking study through our NIHR research delivery infrastructure. NIHR's sustained investment in expertise and research capability has enabled the UK to be at the forefront of supporting these globally innovative trials.”

Who is eligible for the Phase 3 global clinical trial

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. Participants will know they have received the standard treatment but will not know if they have received the mRNA treatment. 

Can I join the study?

Yes. If you are interested in joining this study, please visit the Be Part of Research website and get in touch with the study team directly.  

Made possible by NIHR infrastructure

This research was possible thanks to people, infrastructure and facilities which benefit from underlying support from the NIHR.

The NIHR Biomedical Research Centre at UCLH and UCL has a dedicated cancer theme which includes focus on: translating the genetic understanding of cancer into better treatment; developing innovative cancer immunotherapies; revolutionising early diagnosis of cancer; and Integrating radiotherapy into precision oncology. NHS clinicians deliver first class clinical trials and run a large, dynamic early phase cancer trials programme facilitated by the NIHR Clinical Research Facility at UCLH and UCL.

With the support of the NIHR Clinical Research Network (CRN) the study was able to get up and running effectively through encouraging the selected sites to do as much set up activity as possible while awaiting regulatory approval. 

NIHR CRN helped increase accessibility of the trial by identifying sites in more geographically remote areas of England, including Norfolk and Norwich, as well as Bristol, allowing for people living in the southwest of England and East Anglia to more easily access the trial.

Find out more about the NIHR UCLH BRC Cancer theme.

Find out more about the NIHR Clinical Research Facility at UCLH.

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