Safety of AV-MEL-1 With Anti-PD-1 Therapy in Metastatic Melanoma

Summary

Participation Requirements

Description

The sequence is as follows: Patients will provide consent for collection of blood and tumor, performance of leukapheresis, and intended plan to treat with a standard anti-PD-1 regimen, and to treat with their patient-specific AV-MEL-1 once it has been manufactured. Prior to starting anti-PD-1 therap...

The sequence is as follows: Patients will provide consent for collection of blood and tumor, performance of leukapheresis, and intended plan to treat with a standard anti-PD-1 regimen, and to treat with their patient-specific AV-MEL-1 once it has been manufactured. Prior to starting anti-PD-1 therapy, surgically resected tumor tissue will be sent to AIVITA Biomedical where it will be processed to establish a short-term cell line of autologous tumor cells. Approximately 1 cm3 of surgically excised tumor is preferred. Whenever possible the tissue should be obtained from a lesion no greater than 2 cm in longest diameter. Part of the sample should be assessed by pathologists to confirm melanoma and to test for PDL-1 expression. Prior to starting anti-PD-1 therapy, patients will undergo leukapheresis to obtain peripheral blood mononuclear cells that will be converted into dendritic cells (DC). Patients will initiate anti-PD-1 therapy monotherapy (e.g. pembrolizumab or nivolumab) using standard doses and schedules of administration. When the vaccine is ready, which will take approximately 8 weeks from the date of tumor resection, and the patient has had the opportunity to have received about two months of anti-PD-1 monotherapy, it is expected per standard of care that the patient will undergo radiographic assessment to classify disease status and response (if there was measurable disease at baseline) to the anti-PD-1 therapy. Starting week 10, AV-MEL-1 will be given concurrently with continuation of the anti-PD-1 therapy. AV-MEL-1 injections will be given weekly for 3 weeks, (weeks 10-12, then monthly at weeks 16, 20, 24, 28, and 32). Blood will be collected from patients prior to each injection for immune monitoring tests. If anti-PD-1 therapy is discontinued during vaccine treatment, the remaining vaccine doses may still be administered at the discretion of the patient's managing physician.

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