Malignant melanoma have been reported to be characterized with high gp100 expression. Patients' autologous T cells will be isolated and transduced by GPA-TriMAR lentivirus to generate the GPA-TriMAR-T cells. When infused back to the patient, the GPA-TriMAR-T cells will recognize and kill target cells that express gp100(209-217) peptides in the form MHC-I complex, thus eliminating malignant melanoma from the body.
Consecutive patients treated with PD-1 therapy in Qingdao City were included in our study. The effecy and safety of the four PD-1 agents according to clinical outcomes in real world will be studied.
It is not known whether radiological assessments during follow up after surgery for high risk melanoma improve survival. Since radiological examinations are resource demanding, could inflict worry and cause irradiation exposure it is an important question to address. With the introduction of effective medical treatments for malignant melanoma patients, there is a tendency to introduce radiological assessments despite the lack of evidence.
This trial is a first-in-human drug combination with the first-in-class alkylating histone deacetylase inhibition (HDACi) fusion molecule Tinostamustine (EDO-S101) and the anti-PD-1 monoclonal antibody Nivolumab in patients with refractory, locally advanced or metastatic melanoma.