A Personalized NeoAntigen Cancer Vaccine Combined With Anti-PD-1 in Melanoma
Status:
Recruiting
Trial end date:
2022-09-01
Target enrollment:
Participant gender:
Summary
This study assessed the safety and efficacy of individualized new antigen cancer vaccine
combined with Programmed Cell Death Protein 1（PD1） inhibitor Toripalimab in the treatment of
metastatic cutaneous melanoma. Melanoma is the most malignant skin neoplasm. Immunotherapy is
the main treatment at present. PD1 is an immunological checkpoint and the inhibitors can
reduce the immune escape of tumors, enhance T cell function and kill tumors. At present, PD1
antibody is the representative drug of immunotherapy, but the overall efficiency of its
single drug treatment of acral melanoma is still low, and the combined treatment can
significantly improve the efficiency. Melanoma has a high mutation load, which makes each
patient have mutations specific to individual patients and tumors (changes in genetic
material). These mutations lead to tumour cells producing proteins that are distinct from
those of the body's own cells. These proteins used in vaccines may cause a strong immune
response, which may help participants' bodies fight against any cancer cells that may lead to
future recurrence of melanoma. Inhibition of PD1 can enhance the activity of T cells and form
T cells with sustained killing activity. Tumor vaccines activate human Antigen Presenting
Cells (APC) by injecting tumor antigens and adjuvants, and then activate T cells by APC to
produce specific killing T cells. Therefore, the combination of "tumor vaccine + PD1
inhibitor" can produce effective specific killing and sustained activation of T cells, and
prevent the establishment of inhibitory tumor microenvironment by tumor cells. The study will
examine the safety and efficiency of the combined therapy at different time points and assess
whether there is an immune response in the patient's peripheral blood and tumor tissue.