Phase 2 Trial of Poly-ICLC Vaccination for Solid Tumors

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Researchers are evaluating whether poly-ICLC vaccination is safe and efficacious for patients with melanoma, head and neck cancer, sarcoma, or a non-melanoma skin cancer.
Researchers are evaluating whether poly-ICLC vaccination is safe and efficacious for patients with melanoma, head and neck cancer, sarcoma, or a non-melanoma skin cancer.

Title: In Situ, Autologous Therapeutic Vaccination Against Solid Cancers With Intratumoral Hiltonol® (Poly-ICLC)1

Principal Investigators: Nina Bhardwaj, MD, PhD, Icahn School of Medicine at Mount Sinai; Erlich Rodrigro, MD, Bay Hematology Oncology; Dong M Shin, MD, FACP, Emory University School of Medicine, Winship Cancer Institute; Melissa Burgess, MD, University of Pittsburgh

Description: For this phase 2, single-group assignment study, researchers are evaluating whether polylysine and carboxymethylcellulose (poly-ICLC) vaccination is safe and efficacious for patients with melanoma, head and neck cancer, sarcoma, or a non-melanoma skin cancer.

All patients will have unresectable tumors previously treated with systemic therapy or radiation.

The primary study outcomes are safety and disease control rate. Secondary outcomes include overall survival and progression-free survival.

For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02423863.

Status: This study is open and recruiting patients as of June 16, 2017.

This study is sponsored by Oncovir, Inc, in collaboration with the National Institutes of Health (NIH), the Icahn School of Medicine at Mount Sinai, Bay Hematology Oncology, Emory University, University of Pittsburgh, National Cancer Institute (NCI), University of Missouri-Columbia, and the Medical University of South Carolina.

Title: In Situ, Autologous Therapeutic Vaccination Against Solid Cancers With Intratumoral Hiltonol® (Poly-ICLC)1

Principal Investigators: Nina Bhardwaj, MD, PhD, Icahn School of Medicine at Mount Sinai; Erlich Rodrigro, MD, Bay Hematology Oncology; Dong M Shin, MD, FACP, Emory University School of Medicine, Winship Cancer Institute; Melissa Burgess, MD, University of Pittsburgh

Description: For this phase 2, single-group assignment study, researchers are evaluating whether polylysine and carboxymethylcellulose (poly-ICLC) vaccination is safe and efficacious for patients with melanoma, head and neck cancer, sarcoma, or a non-melanoma skin cancer.

All patients will have unresectable tumors previously treated with systemic therapy or radiation.

The primary study outcomes are safety and disease control rate. Secondary outcomes include overall survival and progression-free survival.

For more study information, including inclusion and exclusion criteria, study locations, and contact information, visit https://clinicaltrials.gov/ct2/show/NCT02423863.

Status: This study is open and recruiting patients as of June 16, 2017.

This study is sponsored by Oncovir, Inc, in collaboration with the National Institutes of Health (NIH), the Icahn School of Medicine at Mount Sinai, Bay Hematology Oncology, Emory University, University of Pittsburgh, National Cancer Institute (NCI), University of Missouri-Columbia, and the Medical University of South Carolina.

Reference

  1. Clinicaltrials.gov. In situ, autologous therapeutic vaccination against solid cancers with intratumoral Hiltonol® (Poly-ICLC). NCT02423863. https://clinicaltrials.gov/ct2/show/NCT02423863. Accessed June 16, 2017.

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