In July 2023 Merck and Moderna announced the initiation of a Phase III clinical trial evaluating V940 (mRNA-4157), an investigational individualised neoantigen therapy (INT), in combination with KEYTRUDA in patients with resected high-risk melanoma. Recruitment for V940-001 has begun globally, with the first patients enrolling in Australia. The approach, which has already been awarded BTD and PRIME, demonstrated positive DMFS results last month.  


The trial is global, randomised, double-blind, placebo- and active-comparator-controlled. It is expected to enrol around 1,089 patients at over 165 sites in more than 25 countries. The primary endpoint is recurrence-free survival (RFS), and secondary endpoints include distant metastasis-free survival (DMFS), overall survival (OS), and safety.

V940 is a novel investigational mRNA-based individualised neoantigen therapy, comprising a single synthetic mRNA coding for up to 34 neoantigens that is designed and produced in response to the “unique mutational signature of the DNA sequence of the patient’s tumour”.  

An important step forward 

Dr Marjorie Green, SVP and Head of Late-Stage Oncology, Global Clinical Development, Merck Research Laboratories, described the initiation of the trial as an “important step forward” in efforts to “advance novel treatment options” for patients with high-risk Stage IIB-IV melanoma.  

“We look forward to continuing to collaborate with Moderna to evaluate this promising new approach with V940 (mRNA-4157), while also building on a standard of care laid by KEYTRUDA.” 

Dr Kyle Holen, Moderna’s SVP and Head of Development, Therapeutics and Oncology, agreed that this is an “exciting and important milestone” as the team investigates the potential of individualised neoantigen therapy for transforming the treatment of “the most serious form of skin cancer”.  

“We thank the patients, investigators, and clinical trial sites across the world for helping us advance our efforts in this area.” 

Here at the World Vaccine Congress, we are thrilled that both Dr Holen and Dr Green are joining us for a cancer keynote in Barcelona later this year. Will you join us to learn more during this session? Don’t forget to subscribe for more like this.