Recently Developed mRNA Vaccine Offers Clinical Trial Option for Rare Cancer

Recently Developed mRNA Vaccine Offers Clinical Trial Option for Rare Cancer

June 30, 2025

Orlando Health Cancer Institute has enrolled the world’s first mucosal melanoma patient into a phase 1 expansion clinical trial studying the effect of a novel mRNA cancer vaccine. The rare disease is one of three cohorts being studied in the new trial utilizing mRNA vaccine technology in combination with existing immunotherapy.

Imran Siddiqui, MD
Yuanbin Chen, MD, PhD

The recently launched clinical trial is currently enrolling patients with cutaneous melanoma refractory to immunotherapy; mucosal melanoma; and metastatic non-small cell lung cancer as first-line treatment. Participants receive a total of nine doses of the mRNA vaccine by muscle injection once every 21 days in combination with immunotherapies such as pembrolizumab, nivolumab and ipilimumab.

“Mucosal melanoma is challenging to treat because it is harder to detect, and there is no early-screening method,” says Yuanbin Chen, MD, PhD, a board-certified medical oncologist with Orlando Health Cancer Institute, who specializes in thoracic cancers and melanoma. Dr. Chen also serves as director of the institute’s solid tumor early phase clinical trials program.

“Current targeted therapies effective for cutaneous melanomas are not proven effective for this rare melanoma subtype, hence the importance of finding an alternative therapy,”says Dr. Chen, who has led numerous international trials. His clinical research has been published in multiple medical journals, including the New England Journal of Medicine and The Lancet.

Mucosal melanoma accounts for less than 3% of all melanomas and arises in mucosal areas that contain melanocytes. Disease manifests most prevalently in the head and neck area, followed by the ano-rectal region, female genital tract, esophagus, gallbladder, bowel, intestine and urethra. Once diagnosed, the cancer is often advanced, metastatic or unresectable.

“With this protocol, we hope to provide the patient’s immune system with both a map of where the cancer cells are and a weapon to fight it,” says Dr. Chen. “ We are trying this therapeutic combination in different patient cohorts to determine efficacy. To date, patients have exhibited a good tolerability of treatment with no alarming safety issues.”

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