Ignite Creation Date:
2025-12-24 @ 2:56 PM
Ignite Modification Date:
2026-03-09 @ 4:22 PM
Study NCT ID:
NCT04525859
Status:
COMPLETED
Last Update Posted:
2025-06-24
First Post:
2020-08-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Poly-ICLC (Hiltonol®) Vaccine In Malignant Pleural Mesothelioma
Sponsor:
Oncovir, Inc.
Organization:
Study Overview
Official Title:
Direct Injection of Poly-ICLC (Hiltonol®) Vaccine In Malignant Pleural Mesothelioma
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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.
* 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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: