Poly-ICLC (Hiltonol®) Vaccine In Malignant Pleural Mesothelioma

Status Recruiting

Clinical Trial Summary

This study will examine the safety and potential effectiveness of poly-ICLC directly injected into malignant pleural mesothelioma at the time of biopsy up to 21 days prior to the cancer being removed by the surgeon

Clinical Trial Description

- To evaluate the safety and toxicity of IT Poly-ICLC, Hiltonol® prior to surgical resection for patients with MPM. - To determine objective response rate by RECIST 1.1 using CT imaging. - To determine recurrence free survival of subjects treated with IT Poly-ICLC followed by surgical resection defined as the time of injection until the first date that recurrent disease is confirmed or date of documented death. - To evaluate IT Poly-ICLC induced immune changes in the tumor microenvironment by comparing pre-injection biopsy to surgically resected tissue for immune cell infiltration and T cell receptor (TCR) diversity. - To characterize additional immune parameters in IT Poly-ICLC injected tumors including in-depth phenotypic and functional characterization of immune infiltrating cells. - To evaluate IT Poly-ICLC induced serological changes and changes of circulating immune cells, including regulatory T cells and NK cells, by comparing pre-injection to post-surgical resection blood samples. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04525859
Study type	Interventional
Source	Oncovir, Inc.
Contact	Director, New York Mesothelioma Program
Phone	212-241-9502
Email	andrea.wolf@mountsinai.org
Status	Recruiting
Phase	Phase 1
Start date	August 19, 2020
Completion date	August 31, 2024

View Details

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