The Regional Hospital and Ibima have included 15 patients in the phase 3 trial of the mRNA vaccine. Researchers urge caution until full results are known.
The announcement from Moderna and Merck about the positive results of their melanoma vaccine has generated excitement, but in Málaga, experts prefer to be cautious. The Regional University Hospital of Málaga and the Biomedical Research Institute of Málaga (Ibima Bionand Platform) have participated in this international phase 3 clinical trial, which has included 15 Málaga patients.
The vaccine, based on mRNA technology, is manufactured individually for each patient. To do this, a sample of the tumour is obtained through surgery, up to 34 specific proteins or neoantigens are identified, and these are incorporated into the vaccine to train the immune system. It is administered alongside immunotherapy, the standard treatment.
The aim of the trial is to determine whether adding this personalised vaccine to the standard treatment reduces the risk of relapse in high-risk melanoma patients who have already undergone surgery. The overall results have not yet been published, and Ibima researcher and trial coordinator at the Regional Hospital, Miguel Berciano, evaluates it "with enormous scientific caution".
"We are expectant because, as researchers, we do not yet have the raw data broken down, the analysis we can later do of the curves, nor the real magnitude of the overall survival benefit".
Berciano acknowledges that the trial's result opens "the door to hope in a very solid way", but insists that this is a preliminary analysis. In his opinion, this therapy could represent "a true paradigm shift" in melanoma treatment, moving from general therapies to precision medicine.
The real challenge, he warns, will be logistics: sequencing, custom manufacturing, costs, and funding. "We will have to see how long it takes for this innovation to reach patients, because, in the meantime, life goes on, patients continue, and diseases do not stop," he reflects.
Each year, around 600 melanomas are detected in the province of Málaga. At the Virgen de la Victoria University Clinical Hospital, 146 cases were recorded in 2023, 181 in 2024, and around 200 in 2025. Survival exceeds 90% when detected at early stages.
Researchers emphasize that the major challenge in high-risk stages remains preventing the disease from returning, as well as addressing resistance to immunotherapy and ensuring equity in access to innovation. The definitive results of the trial are expected to be published in a scientific journal and presented at a medical conference.
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