Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Rare Diseases

Melanoma

Neoplasm Metastasis

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

All Drugs and Chemicals

Antineoplastic Agents

Anti-Infective Agents

Vaccines

Imiquimod

Immunomodulating Agents

Immunologic Factors

Adjuvants, Immunologic

Interferons

Personalized NeoAntigen Cancer Vaccine- Neo-Vac-Mn (peptides + rhGM-CSF+anti-PD1+Imiquimod 5% Topical Cream)

NeoAntigen peptides:4 x 2 mg the total peptides given on days 84，87，91，98，105，133，and 161

Anti-PD-1 Toripalimab: 3mg/kg, ivgtt, Q2w

rhGM-CSF: 3μg/kg given on Days 81，82，83，95，96，97，102，103，104，130，131，132，158，159，and 160

Imiquimod 5% Topical Cream:topical application on the injection site 6 hours before each NeoAntigen peptides injection

4 x 3 mg all the peptides given on days 84，87，91，98，105，133，and 161

Peptide

Anti-PD-1

3μg/kg given on Days 81，82，83，95，96，97，102，103，104，130，131，132，158，159，and 160

rhGM-CSF

topical application on the injection site 6 hours before each NeoAntigen peptides injection

Imiquimod 5% Topical Cream

Xiang Chen, Doctor's

Juan Su, Doctor's

Juan Su

Xiang Chen

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.

A Personalized NeoAntigen Cancer Vaccine Combined With Anti-PD-1 in Melanoma

A Phase I Study With a Personalized NeoAntigen Cancer Vaccine Combined With Anti-PD-1 in Metastatic Melanoma

Number of participants experiencing clinical and laboratory adverse events (AE)

Number of Patients with Complete Remission Rate（CRR）

Number of Patients with Progressive Disease（PD）

Number of Patients with Partial Response（PR）

the immune response of serum and tumor tissue

Xiangya Hospital of Central South University

Chen Xiang, Principal Investigator，Clinical Professor，Vice-President

Spots Global Cancer Trial Database for melanoma, metastasis