NCT04072900

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Xiangya Hospital of Central South University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Melanoma (Skin)

Interventions

Type	Name	Description
DRUG	Peptide	4 x 3 mg all the peptides given on days 84，87，91，98，105，133，and 161
DRUG	Anti-PD-1	3mg/kg, ivgtt, Q2w
DRUG	rhGM-CSF	3μg/kg given on Days 81，82，83，95，96，97，102，103，104，130，131，132，158，159，and 160
DRUG	Imiquimod 5% Topical Cream	topical application on the injection site 6 hours before each NeoAntigen peptides injection

Timeline

• Start date: 2020-04-21
• Primary completion: 2021-09-01
• Completion: 2022-09-01
• First posted: 2019-08-28
• Last updated: 2020-04-28

Locations

1 site across 1 country: China