NCT04525859

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Oncovir, Inc. · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Malignant Pleural Mesothelioma

Interventions

Type	Name	Description
BIOLOGICAL	Safety	See previous Safety group description
BIOLOGICAL	Expansion Cohort	See previous Expansion Cohort

Timeline

• Start date: 2020-08-19
• Primary completion: 2025-06-18
• Completion: 2025-06-18
• First posted: 2020-08-25
• Last updated: 2025-06-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study