The Regional University Hospital of Málaga has been the Spanish centre that has contributed the most patients to an international phase 3 trial studying a messenger RNA vaccine against high-risk melanoma. The results reduce relapse and the occurrence of metastasis.
The Regional University Hospital of Málaga has become the centre in Spain with the highest participation in an international phase 3 clinical trial testing a personalised messenger RNA vaccine against high-risk melanoma. Of the 71 patients initially evaluated in the country, 24 correspond to this hospital, nearly 34% of the total.
Ultimately, 15 Málaga patients have been included in the study, which compares standard treatment with immunotherapy against a new strategy that adds to that same treatment a vaccine specifically designed for each person. The trial, promoted by pharmaceutical companies Moderna and MSD, has achieved its main objectives with statistically significant results in reducing the risk of relapse and distant metastasis.
The vaccine is manufactured individually for each patient from a sample of the tumour extracted during surgery. The cancerous tissue is compared with healthy tissue to identify up to 34 specific proteins or neoantigens, which are incorporated into the messenger RNA vaccine with the aim of activating a more targeted immune response. It is not a preventive vaccine, but a therapy for those who have already been operated on and are at high risk of the disease reappearing.
Oncologist Miguel Berciano, researcher at IBIMA BIONAND Platform and coordinator of the trial at the hospital, has highlighted that these results reinforce a promising line of research towards an increasingly personalised oncology. In his words:
“These results reinforce a very promising line of research and represent a significant step towards an increasingly personalised oncology, where we can use the tumour's own information to design specific therapeutic strategies for each patient.”
The development of the trial has required multidisciplinary coordination between the services of Medical Oncology, Dermatology, Pathology, and the surgical teams involved in obtaining the samples. This complexity explains why not all initially evaluated patients can receive the vaccine, as it is necessary to have an adequate tumour sample and successfully complete the phases of analysis and individualised production.
For patients in the province of Málaga, this trial represents early access to an innovative therapy that, if confirmed in future phases, could change the approach to high-risk melanoma. The hospital is already working on incorporating this strategy into routine clinical practice.


